DOC20220330133829ROSIA TD2 Challenge Brief

Grant Agreement 101017606 ROSIA
TD2 - CHALLENGE BRIEF
This project has received funding from the European Union’s Horizon 2020 research and innovation
programme under Grant Agreement No 101017606
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TD2 – ROSIA Challenge Brief
ABBREVIATIONS AND ACRONYMS
ABI Acquired Brain Injury
ACHI Australian Classification of Health Interventions
API Application Programming Interface
APS Authenticated Persistent Session
ARM Application reference model (ARM)
ATNA Audit Trail and Node Authentication
BAA Business Associate Agreement
BP Blood pressure
BRM Business reference model (BRM)
BSP Basic Security Profile
BYOD Bring Your Own (medical) Device
BYOD Bring Your Own Device
CAPAs Corrective and preventive actions
CDA Clinical Document Architecture
CDG Continua Design Guidelines
CDVC Care Delivery Value Chain
CHO Community Health Organisation
CHUC Centro Hospitalar e Universitário de Coimbra
CM Change Management
COPD Chronic Obstructive Pulmonary Disease
CRPD Convention on the Rights of Persons with Disabilities
CSP Cloud Service Provider
CVDs Cardiovascular Diseases
DEC Device Enterprise Communication
DEN Document Encryption
DMP Data Management Policy
DPIA Data Protection Impact Assessment
EHR Electronic Healthcare Record
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EMR Electronic Medical Record
ePREM Patient Reported Experience Measures
ePROM Patient Reported Outcome Measures
EU European Union
FHIR Fast Healthcare Interoperability Resources
FIDO Fast Identity online
GBDS Global Burden of Disease Study
GDPR General Data Protection Regulation
HCP Health Care Professional
HEP Home Exercise Programme
HIMSS Healthcare Information Management Systems Society
HIS Healthcare Information System
HL7 Health Level 7 International
HR Heart rate
HTTP Hypertext Transfer Protocol
IACS Instituto Aragonés de Ciencias de la Salud
ICD International Classification of Disease
ICT Information and Communication Technology
ICU Intensive Care Unit
IDT Interdisciplinary Team
IoMT Internet of Medical Things
IP Internet Protocol
IPUs Integrated Practice Units
IRM Information reference model (IRM)
ISO International Standards Organisation
ISO/IEEE 11073 ISO/IEEE 11073 Personal Health Data (PHD) Standards
IT Information Technologies
IT Information Technology
ITU International Telecommunications Union
JSON JavaScript Object Notation
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MDR Medical device regulatory
MDS Minimum Data Set
MSF Most Significant Changes Questionnaire
NFC Near-Field Communications
NRH National Rehabilitation University Hospital
OMOP Observational Medical Outcomes Partnership
PCD Personal Connected Device
PCHA Personal Connected Health Alliance
PHI Personal Health Information
PHMR Personal Health Monitoring Report
PIX Patient Identifier Cross-Reference
PREM Patient Reported Experience Measure
PROM Patient Reported Outcome Measure
RBAC Role Based Access Control
RCA Root Cause Analysis
REST Representational State Transfer
RLUS Retrieval, Location and Update Service
S/MIME Secure/Multipurpose Internet Mail Extensions
SALUD Servicio Aragonés de Salud
SAML Security Assertion Markup Language
SCI Spinal Cord Injury
SDK's Software Development Kits
SMS Short Message Service
SNOMED Clinical Terms

SNOMED CT
Systematised Nomenclature of Medicine
SOAP Simple Object Access Protocol
Spo2 Peripheral Oxygen Saturation
TDABC Time-Driven-Activity-Based Costing
TLS Transport Layer Security
TRM Infrastructure (Technical) reference model (TRM)
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UN United Nations
USA United States of America
VBHC Value-Based Healthcare
VLD El Sitio de Valdelatarra S.L.
W3C Mobile Web Best Practices
WCAG Web Content Accessibility Guidelines (WCAG) 2.0
WHO World Health Organisation
WS-I Web Services – Interoperability
XDM Cross-Enterprise Document Media Interchange
XDR Cross-Enterprise Document Reliable Interchange
XDS Cross-Enterprise Document Sharing
XML Extensible Markup Language
YLDs Years Lived with Disability
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GLOSSARY
Adherence refers to the degree to which a patient follows medical

advice, especially drug compliance, but it can be applied to medical
Adherence to device use, self-directed exercises, or therapy sessions.
treatment in Rehabilitation treatments are long, tedious, sometimes painful and
telerehabilitation patients with severe life changing conditions, may experience
depression and loss of self-esteem. Motivation and behavioural
change are vital components of any rehabilitation program.
Activities of Daily Living (ADL). These are standard physical activities

required of a person to function in the world. They include:
Get into/out of bed or chair
Toilet hygiene
Bathing or Showering
ADL
Getting Dressed
Personal hygiene
Eating
Walking / Climbing Stairs
Safety /emergency responses
Administrator shall refer to the super user who will be responsible

Administrator
for the enterprise master data setup
An application programming interface (API) is a connection

between computers or between computer programs. It is a type of
software interface, offering a service to other pieces of software. A
document or standard that describes how to build or use such a
API
connection or interface is called an API specification. A computer
system that meets this standard is said to implement or expose an
API. The term API may refer either to the specification or to the
implementation.
Abbreviation for application: a computer program that is designed

App
for a particular purpose
Application shall refer to the client application (mobile) that is used

Application
by the end user
Clinical Data Acquisition Standards Harmonisation. The intent of

CDASH is to develop content standards for the basic set of global
CDASH
CRF fields. These are global CRF standards that apply for all
therapeutic areas (TA) across phases
The Clinical Data Interchange Standards Consortium (CDISC) is a

standards developing organisation (SDO) dealing with medical
CDISC research data linked with healthcare, to "enable information system
interoperability to improve medical research and related areas of
healthcare". CDISC standards are harmonised through a model that
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is also a HL7 standard and is in the process of becoming an ISO/CEN

standard.
An infectious disease caused by a coronavirus (= a type of virus),

that usually causes fever, tiredness, a cough, and changes to the
COVID-19
senses of smell and taste, and can lead to breathing problem and
severe illness in some people
Current Procedural Terminology Version 4 by the American Medical

CPT4/HCPCS
Association (AMA)
Conditional Random Fields, are a class of statistical modelling

methods often applied in pattern recognition and machine learning
CRF
and used for structured prediction that can take context into
account to label an entity.
Digital Imaging and Communications in Medicine (DICOM) is a

standard for storing and transmitting medical images enabling the
DICOM integration of medical imaging devices such as scanners, servers,
workstations, printers, network hardware, and picture archiving
and communication systems (PACS) from multiple manufacturers
Disruptive technology is an innovation that significantly alters the

Disruptive way that consumers, industries, or businesses operate. A disruptive
technologies technology sweeps away the systems or habits it replaces because
it has attributes that are recognizably superior.
Ethical issues in our context are a situation where a moral conflict

arises and must be addressed. In other words, it is an occasion
Ethical issues
where a moral standard is questioned, such as equity, privacy, or
right to choose, for instance.
European The European interoperability framework is a commonly agreed

interoperability approach to the delivery of European public services in an
framework interoperable manner. It defines basic interoperability guidelines.
A European public service comprises any sector service exposed to

European public a cross-border dimension and that is supplied by public
service administrations, either to one another or to businesses and citizens
in the union.
Healthcare Common Procedure Coding System (HCPCS) is a coding

standard designed to provide a standardized coding system in order
HCPCS
to describe specific items and services that are provided when
health care is delivered
(Health Insurance Portability and Accountability Act of 1996) is

HIPAA United States legislation that provides data privacy and security
provisions for safeguarding medical information
The commitment to reliable health and medical information on the

HONCode
internet
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The version of the HTML Standard which is a markup language used

HTML5
for structuring and presenting content on the World Wide Web.
International Statistical Classification of Diseases and Related

Health Problems (ICD), a medical classification list by the World
ICD10 AM Health Organization (WHO). It contains codes for diseases, signs and
symptoms, abnormal findings, complaints, social circumstances,
and external causes of injury or diseases
ICD10 CM International Classification of Diseases - Australian Modified Version
Integrating the Healthcare Enterprise (IHE) is a non-profit

organization based in the US state of Illinois - an initiative by the
IHE
healthcare industry to improve the way computer systems share
information
For the purpose of the EIF, interoperability is the ability of

organisations to interact towards mutually beneficial goals,
Interoperability involving the sharing of information and knowledge between
organisations, through the business processes they support, by
means of the exchange of data between their ICT systems.
Information Technology Infrastructure Library (Version 3) is a set of

detailed practices for IT service management (ITSM) that focuses on
ITIL V3 aligning IT services with the needs of business thru' a framework for
service strategy, design, transition, operation and continual service
improvement.
A process area containing the goals that must be reached in order

KPA
to improve a process.
Key Performance Indicator is a measurable value that demonstrates

how effectively a company is achieving key business objectives.
Organizations use KPIs at multiple levels to evaluate their success at
KPI
reaching targets. High-level KPIs may focus on the overall
performance of the enterprise, while low-level KPIs may focus on
processes in departments such as sales, marketing or a call center.
A key result area (KRA) is a strategic factor either internal to the

organization or external, where strong positive results must be
KRA realized for the organization to achieve its strategic goal(s), and
therefore, move toward realizing the organization's longer term
vision of success.
Logical Observation Identifiers Names and Codes - a database and

LOINC
universal standard for identifying medical laboratory observations
Medical Devices Includes non-invasive devices, invasive devices which are not
Class 1 (low risk) surgical device
Medical Devices Includes certain types of surgically invasive device for short-term
Class 2a (medium use, implants in teeth and active devices intended to supply or
risk) exchange energy or for use in diagnosis.
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For example, surgically invasive devices for surgery or other active

Medical Devices devices which are used short-term to supply ionizing radiation, have
Class 2b (medium a biological effect, or are intended to administer medicines. In
risk) addition, certain types of implants and surgically invasive devices
for long-term use.
Includes surgically invasive devices and implants used in the heart

Medical Devices
or central nervous system as well as devices which cause a chemical
Class 3 (high risk)
change in the body.
Refers to a list of to public and private entities and care providers

including but not limited to hospitals, physicians, laboratories,
Network Provider pharmacies, and other health services providers that provide
medical care to its members. These providers are called “network
providers”, “in-network providers”, or “providers”
Observational Medical Outcomes Partnership. The OMOP Common

Data Model allows for the systematic analysis of disparate
observational databases. The concept behind this approach is to
transform data contained within those databases into a common
OMOP
format (data model) as well as a common representation
(terminologies, vocabularies, coding schemes), and then perform
systematic analyses using a library of standard analytic routines that
have been written based on the common format.
PCHAlliance Continua 2017 Design Guidelines for an end-to-end

PCHAlliance interoperability, safe, secure, and reliable exchange of data to and
from personal health devices
A mix of clinical, environmental, and other remote sensing devices,

that monitors the patient's vital signs, activities and physical
parameters to give a comprehensive model of their clinical
Remote Patient
condition and activities of daily living (ADL) capabilities. These
Monitoring
clinical IoMT devices are connected to the platform providing
device health metrics along with utilisation information to facilitate
fleet management.
ROSIA Catalogue
Apps and devices in the ROSIA catalogue
Services
WHO defines self-care as “the ability of individuals, families and

communities to promote health, prevent disease, maintain health,
Self-Care
and to cope with illness and disability with or without the support of
a healthcare provider”.
Implies the provision of meaningful empowerment, improved

health and digital literacy, digital communities, and support for
Self-Management carers. The use of new technological solutions for active therapy
intervention and maintenance is the key element to reshape
services in order to meet patients’ current and future needs,
providing the basis for an integrated, accessible and modern service
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of rehabilitation that the public systems could afford within the

budget limits.
Systematized NOmenclature of MEDicine – Clinical Terms is the

most comprehensive and precise clinical health terminology
SNOMED CT
product in the world, owned and distributed around the world by
the SNOMED International
System shall refer to the centrally hosted application server backed

System
by a suitable database
Synchronous or asynchronous consultation using information and

communication technology to omit geographical and functional
Teleconsultation distance. This can be between two health providers, between a
health provider and a patient, or between two health providers and
a patient.
The virtual delivery of rehabilitation services into the patient's

home, facilitated by devices and applications which allow
Telerehabilitation
healthcare providers to monitor, educate, treat, and support
patients in their own environment.
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TABLE OF CONTENTS
1. Introduction...................................................................................................................... 11
1.1. Rationale, the local and global needs. ................................................................................. 11
1.2. The ROSIA buyers group ...................................................................................................... 16
1.3. Targeted pathologies and their current clinical pathways .................................................. 20
2. The ROSIA challenge description ..................................................................................... 23
2.1. Unmet needs – the innovation GAP .................................................................................... 23
2.2. The ROSIA model ................................................................................................................. 31
2.3. The common challenge ........................................................................................................ 47
2.4. Requirements....................................................................................................................... 55
2.5. A use case to illustrate the ROSIA model implementation. ................................................. 86
3. Final remarks .................................................................................................................... 92
3.1. Expected results per phase .................................................................................................. 92
3.2. Expected outputs ................................................................................................................. 93
List of images ............................................................................................................................ 96
List of tables ............................................................................................................................. 97
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1. Introduction
1.1. Rationale, the local and global needs.
What is the problem?
Rehabilitation is a complex and vital process as part of the continuum of care for those
seeking to regain or maintain their quality of life and improve function following significant
injury or illness. Rehabilitation can reduce disability, improve function and quality of life, and
provide cost-effective benefits in the short and long term. However, rehabilitation needs
professional long-term follow-up 1, and often daily intervention. This is usually done at
specialised/central/referral hospitals, which are often far from the patients’ rural or isolated
homes. Failing to provide some form of rehabilitative service will increase morbidity and
mortality; in areas where rehabilitative services are not available there is a bigger and
increasing demand of acute care and long-term care services. Demand for rehabilitation
services is growing and it is expected to continue to be in high demand due to the ageing
population, improvements in healthcare (survival rates from catastrophic injuries is higher
than ever), and new technologies and treatments.
Health systems in Europe are facing the combined challenge of the increasing demand with
limited resources to tackle it. This situation creates a pressing need for a fundamental
rethinking of how health services and systems are organised.
Reorganising rehabilitation services has been identified as an urgent need, due to the
significant implications it has on patients’ lives, the long and costly processes it incurs for the
health care system, the long and difficult journeys for the patient, shifting costs for the public
health and care systems towards transportation rather than towards improved care. Even
worse, these difficulties could act as a barrier against those patients receiving adequate and
timely rehabilitation treatment, negatively affecting outcomes as a consequence of patients’
location.
The current COVID-19 crisis has made traditional rehabilitation more difficult or even
impossible for those not living near a hospital. It has also added the need to treat sequelae
from the disease, particularly in patients who required ICU admission (i.e., patients who
required ventilation and/or experienced severe pneumonia) such as lung fibrosis and
pulmonary hypertension, among other sequelae.
ROSIA procurers need:
• Facilitating the rehabilitation of patients for whom travelling is a burden by using

telerehabilitation services under the clinicians’ supervision.
• Extending the rehabilitation period for those patients who could benefit from it by
developing self-management and self-care supported by technologies and services.
1
Specialist neuro-rehabilitation services: providing for patients with complex rehabilitation needs. London:
British Society of Rehabilitation Medicine. 2010.]
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Supported self-care and self-management for patients and their informal caregivers is a key
component of rehabilitation. It enables people to be as independent as possible, building on
their assets and capabilities. The public health and care system should aim for patient-centred
services to effectively support these features. Redesigning rehabilitation services to better
align with patients’ needs and expectations, regardless of where they live, is the most efficient
way to deliver these services, while maintaining and improving not only health outcomes, but
also patients’ experience of the care system.
Supported self-management in rehabilitation requires providing the patient with tools and
contextual personalised guidance to help them manage their health condition following
formal rehabilitation and transition to long-term health maintenance goals.
Why it is important?
The UN Convention on the Rights of Persons with Disabilities (CRPD) recognises access to
rehabilitation as a human right 2. Rehabilitation is an essential component of universal health
coverage along with promotion, prevention, treatment, and palliation.
There is an increasing need for rehabilitation worldwide, associated with increasing

prevalence of non-communicable diseases and population ageing. One in three people
worldwide could benefit from rehabilitation at least once in the course of their illness or injury,
as a first global study estimates3. The proportion of individuals aged over 60 is expected to
double by 2050 and there has been an 18% increase in the prevalence of non-communicable
diseases in the last 10 years.
In 2017 WHO launched the Rehabilitation 2030 initiative 4, which calls for concerted and
coordinated global action by all stakeholders to scale up rehabilitation. Action 5 calls on
countries to build comprehensive rehabilitation service delivery models to progressively
achieve equitable access to quality services, including assistive products, for all the population,
including those in rural and remote areas 5.
2
Article 26 – (Habitation and rehabilitation) [General Assembly, U.G. and Session, S.F., 2006. The Convention on
the rights of persons with disabilities and its optional protocol]
3
https://www.healthdata.org/news-release/lancet-one-three-people-worldwide-could-benefit-rehabilitation-
least-once-course-their
4
initiatives/rehabilitation-2030
5
Gimigliano, F. and Negrini, S., 2017. The World Health Organization “rehabilitation 2030–a call for action”. Eur
J Phys Rehabil Med, 53(2), pp.155-168.
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Recently published data on the Global Burden of Disease Study (GBDS) shows that 74% of the
total number of years lived with disability (YLDs) in the world is due to health conditions which
can benefit from rehabilitation. Additionally, 15% of the total number of YLDs is caused by
health conditions associated with severe levels of disability, such as cancer and stroke. The
prevalence of these diseases has increased by almost 23% 6.
The Global Telerehabilitation Market Size is projected to reach USD 9.13 billion by 2027,
exhibiting a CAGR of 13.4% during the forecast period from 2020-2027 7. Data from the QYR
Pharma & Healthcare Research Center confirms the growth trend of the telerehabilitation
market in the United States 8.
Why is this still a problem?
Broad deployment of telerehabilitation services can address this situation successfully. This is
because the tools are already available: devices and Apps based on state-of-the-art
technologies such as virtual reality, augmented reality, gamification, depth cameras, sensors,
AI, which have been clinically proven effective in supporting telerehabilitation.
However, despite the evidence of the added value from its adoption, there is a gap between
research and the integration of digital solutions into the care pathway.
Many factors9 contribute to this phenomenon, with cost, efficiency/workflow issues, lack of
technology support/ technology gap and privacy/security concerns cited in the literature. A
holistic approach has been suggested to successfully implement digital solutions, including
technology, organisation structures, management, economic feasibility, societal impacts,
perceptions, user-friendliness, evaluation and evidence, legislation, policy and governance.
Digital Health Europe released a report 10 Supporting demand and supply for scaling up digital
health and care solutions. The report presents an overview of the barriers and enablers to the
implementation at scale of digital person-centred health and care solutions and the need to
mobilise investments by focusing on both the demand side (policymakers, healthcare
providers, patients/citizens, insurers, etc.) and the supply side (large companies, start-ups and
SMEs, researchers, etc.). In summary, there is an agreement between the demand and supply
stakeholders on the most important barriers11 to be considered:
6
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the
Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1545–602
7
https://www.fortunebusinessinsights.com/telerehabilitation-market-103112
8
QYR Pharma & Healthcare Research Center. Global and United States telerehabilitation systems market size,
status and forecast 2022. 2017
9
Maruthappu, Mahiben & Hasan, Ali & Zeltner, Thomas. (2015). Enablers and Barriers in Implementing
Integrated Care. Health Systems & Reform. 1. 00-00. 10.1080/23288604.2015.1077301
10
https://digitalhealtheurope.eu/wp-content/uploads/2021/04/Support-of-digital-health-and-care-solutions-
Rev4.pdf
11
https://academic.oup.com/ehjdh/article/2/1/62/6128570
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Integration of health & social care and patient engagement. The low health and social care
integration levels are still a big challenge from a societal perspective. The participation and
empowerment of citizens need to be improved to foster system transformation.
Technical considerations. Procurers stated that lack of technical expertise and understanding
about the tools, standards, and regulations required to facilitate interoperability, inequalities
in health and digital literacy and citizens and low digital access are barriers to a more extensive
implementation of digital solutions. Transparency regarding the utilisation of data collected
by ICT is also a barrier.
Regulatory framework. While several countries (such as Ireland, Portugal, and Spain) have
made progress with the digital transformation of health systems, most regional, national, and
European funding schemes do not support prescriptions for the installation of digital solutions
at home; and IPR, ethics, and regulatory procedures are often burdening, confusing, long, and
bureaucratic, impeding agile processes.
Cost and access. According to Digital Health Europe report, electronic health records, health
facility improvements, and hospital-community integration procedures are the most critical
expenditures in many EU countries. However, investments that target prevention, diagnosis,
and treatment using digital health solutions remain limited. In addition, there are obstacles to
integrating new ICT solutions into clinical practice, such as a lack of infrastructure, challenges
with intellectual property rights (IPR), regulatory harmonisation, and low levels of private
sector investment (also in consideration of an unpredictable and slow return on the
investments). This situation is further worsened by inadequate or fragmented legal
frameworks, including the lack of reimbursement schemes for digital health services.
Image 1 Enablers, challenges, and core factors for integrated care adoption
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Consequently, telerehabilitation is complex to implement:
• For the healthcare system:

o it implies an internal transformation process towards specifically tailored
integrated-care models with new roles, tools and responsibilities, and
increased health and digital literacy for patients.
o In addition, it implies handling the transference of sensitive data and
integrating a large and diverse set of digital services into their ICT systems.
• For the developer, fragmented care models, lack of prescription procedures, and the
diversity of ICT health systems to integrate, mean the costs of development are
prohibitive.
The telerehabilitation market is currently locked, as there is no comprehensive solution for

the easy integration of the diverse tools available. What is required is a solution that opens
a path towards the speedy development of new answers and solutions, while facilitating the
integration of these tools in the daily clinical practice of healthcare providers, simultaneously
supporting the implementation of tailored clinical pathways.
How can this problem be solved?
The cost- effectiveness of using telerehabilitation services has been shown in the application
of tele-stroke 12, cardiac rehabilitation 13 14, traumatic brain injury 15 and hip replacement
rehabilitation 16. Although coverage for telerehabilitation services varies across countries, the
cost of technology is decreasing, making telerehabilitation modalities more affordable and a
viable alternative 17.
In this stand-off, a PCP process, where public procurers work in direct collaboration with the
market’s research capacity, is in a unique position to unlock the situation.
ROSIA PCP is willing to unlock the telerehabilitation market by purchasing the development
of a technological innovation ecosystem, enabling service providers to provide
telerehabilitation, and self-management & self-care of rehabilitation at home, at scale.
12
Sarfo FS, Ulasavets U, Opare-Sem OK, et al. Tele-rehabilitation after stroke: an updated systematic review of
the literature. J Stroke Cerebrovasc Dis 2018; 27(9):2306–18.
13
Frederix I, Solmi F, Piepoli MF, et al. Cardiac telerehabilitation: a novel cost efficient care delivery strategy that
can induce long-term health benefits. Eur J Prev Cardiol 2017;24(16):1708–17.
14
Frederix I, Vandijck D, Hens N, et al. Economic and social impact of increased cardiac rehabilitation uptake and
cardiac telerehabilitation in Belgium—a cost–benefit analysis. Acta Cardiolo 2017;73(3):222–9.
15
Ownsworth T, Arnautovska U, Beadle E, et al. Efficacy of telerehabilitation for adults with traumatic brain
injury: a systematic review. J Head Trauma Rehabilitation 2017;33(4):E33–46.
16
Nelson M, Bourke M, Crossley K, et al. Telerehabilitation versus traditional care following total hip
replacement: a randomized controlled trial protocol. JMIR Res Protoc 2017;6(3):e34.
17
Marzano G, Ochoa-Siguencia L, Pellegrino A. Towards a new wave of telerehabilitation applications. The Open
Public Health Journal 2017;1(1):1–9.
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The ecosystem’s design should enable the flexible implementation of a value-based and
integrated-care model, enable data-driven intervention and the seamless integration of
third-party solutions.
Further interventions will be needed, at political level, to include procedures for prescribing
ROSIA digital services into the clinical practice, in the participant regions, for scaling-up. To do
so, the generation of evidence in the field will prove that the ROSIA Model really works and will
encourage other regions to integrate into their Healthcare services the ROSIA Innovation Ecosystem.
This will activate a domino effect in the industry generating critical mass around the ROSIA Innovation
Ecosystem.
1.2. The ROSIA buyers group
The lead procurer in ROSIA is IACS, and it is appointed to coordinate and lead the joint PCP,
and to sign and award the framework agreement and the specific contracts for all phases of
the PCP on behalf of the Buyers Group, which is composed by: Aragón Healthcare Service
(Spain), National Rehabilitation University Hospital (Ireland), and University Hospital Coimbra
(Portugal).
ROSIA consortium is also coordinated by IACS, and there are other eight entities with
complementary profiles supporting the buyers group by: VALDE INNOVA (Spain), Instituto
Pedro Nunes (Portugal), The International Foundation for Integrated Care (The Netherlands),
The Decision Group (The Netherlands), Instituto para la Experiencia del Paciente (Spain),
PPCN.xyz Aps (Denmark) and the Municipalities of Penela and Soure (Portugal).
Instituto Aragonés de Ciencias de la Salud (IACS)
IACS is an independent public entity under the umbrella of the Regional Health Department.
IACS’ mission is to promote research, innovation and knowledge brokering in biomedicine and
health sciences for the Aragon Health System. Regarding R&D responsibilities, IACS supports
stable research and innovation groups in clinical and translational medical research,
biomedicine, public health, health systems and policy research. Organisational change and
innovation (living labs, ideas exchange platform, public procurement of innovation, patent
office) are coordinated from the Innovation Unit. As part of its support to biomedical research,
IACS provides support for all grant application processes through the Project Office and
specialised scientific services through its 10 Research Core Facilities. Moreover, IACS is the
regional authority for the authorization and monitoring (private and public) of randomised
control clinical trials as well as post authorization observational studies for drugs and devices.
Servicio Aragonés de Salud (SALUD)
Servicio Aragonés de Salud (SALUD) provides primary, secondary, mental-health, and geriatric
care, including the management of homecare in the Spanish autonomous community of
Aragón, an interior region located in the northeast of Spain, divided into three provinces
(Huesca, Zaragoza and Teruel) and populated by 1.32M inhabitants. Its capital, Zaragoza, is
the most densely populated city of the region with nearly 50% of the population living in the
city. However, current demographic distribution within the territory is uneven, showing that
66 municipalities are home to 73.33% of the Aragonese population in contrast to another 872
municipalities in vastly depopulated areas covering 72.77% of the territory that are home to
only 2.06% of the inhabitants of Aragon.
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Aragon is one of the most aged regions in Spain with more than 21% of the population over
65. Average age in Aragon is 44.6 compared to 43 in Spain. The ageing index is 147,76 % higher
than the Spanish average and 129.1% in 2021, regarding people under 19, with an old-age
dependency rate of 55.1%. The index of over-aging (% of population of persons with 84 years
and more over the population of 65 years and more) is 19.1% compared to 16% of Spain. In
sum, this is a very large region of almost 47.720 Km2 that counts with an increasingly ageing
population at potential risk of social isolation and inequalities in access to care because of
these demographic trends.
SALUD is committed to promoting and protecting individual and public health in this region.
Its mission is to provide integral and universally accessible healthcare services, promote
healthy lifestyles, contribute to the prevention of diseases and to the protection of the
population, and help maintain patients’ autonomy and their social inclusion.
SALUD has a network of 12 general hospitals, 110 primary care health centres and five geriatric
hospitals. In addition, it has introduced innovation in the regular practice of healthcare
through the integration of telemedicine solutions thanks to collaborating in several strategic
projects.
The public authorities in Aragón are very much concerned with the ageing of the population
and are developing several initiatives to deal with its consequences. SALUD has just been
awarded as a four-stars reference site from the EIP on AHA, recognizing its commitment to
investing in innovation for active and healthy ageing, and supporting the transfer and scaling
up of this innovation across the region.
National Rehabilitation University Hospital (NRH)
The National Rehabilitation University Hospital (NRH) is the only hospital in Ireland providing
comprehensive, specialist neuro‐rehabilitation programmes to adult and paediatric patients
following acquired brain injury (ABI), stroke, spinal cord injury (SCI), and amputation or
congenital limb absence.
Delivering and developing specialist rehabilitation services since 1961, the NRH has sought to
continuously evolve to best meet the needs of patients and become a centre for the education
of healthcare professionals. It has become the primary site and teaching hospital for the
education and training of undergraduate and graduate students of medicine, nursing, and
health and social care professions in the principles and practises of interdisciplinary
rehabilitation.
As the national provider of rehabilitation in Ireland, NRH is committed to research and has
recently established an Academic Department to further enhance participation in a wide
range of national and international research studies. Research activity at NRH has resulted in
numerous articles in peer reviewed journals, conference presentations and awards. The NRH
has 485 staff (FTE) with an annual turnover of circa €41 million and is accredited by the
Commission on Accreditation of Rehabilitation Facilities (CARF). In 2020, NRH discharged 426
patients from its inpatient programmes, including 115 people with spinal cord injuries, 114
people with acquired brain injuries, and 73 stroke survivors. NRH provided a total of 11,817
outpatient appointments in 2020, including consultant-led clinics and therapy-led clinics.
Outpatients following SCI, ABI or stroke attended a combined total of 8,703 appointments in
NRH.
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In implementing the pilot testing for ROSIA, the NRH will work with two Community Health
Organisations under the Health Service Executive; CHO 6 & 7, responsible for providing
community-based health and social care services to its communities. These organisations are
perfectly positioned to deliver the ROSIA model in combination with the specialist
rehabilitation centre, NRH, to those living with disabilities in their local communities, and to
the ageing populations in CHOs 6 & 7. Community healthcare delivers primary care services,
social inclusion services, older persons’ and palliative care services, disability services and
mental health services to adults as close as possible to their homes. These services are
provided by general practitioners, public health nurses and Health and Social Care
Professionals (HSCPs) through primary care teams and community health networks.
CHO 6, Community Healthcare East covers the areas of Dublin South East, Dun Laoghaire,
Wicklow. This area has a population of approximately 398,000 and continues to grow; it is
expected to increase by 6.6% by 2021 (Planning for Health Trends and Priorities to Inform
Health Service Planning, HSE 2016).
CHO 7 provides services to Dublin South, Kildare, and West Wicklow. This area has a
population of approximately 697,644. In CHO 7 over 10% of the population is over the age of
65, which leads to a growing demand for services, including but not limited to, home support
from the community and acute hospital settings. Approximately 13.28% of the population of
CHO 7 have stated they have a disability. (Census 2016). Disability services continue to face
financial challenges relating to continued high levels of demand for service enhancements as
a result of changing needs.
In recent years in response to the COVID-19 pandemic, there has been significant growth in
the use of virtual platforms across many areas of CHO activity, with the highest usage levels
observed in Psychology, Speech & Language Therapy, Mental Health Community Teams and
Occupational Therapy. The ROSIA solution will further facilitate the use of telehealth solutions
and enhance the delivery of rehabilitation services remotely to patients living in these
communities.
Centro Hospitalar e Universitário de Coimbra (CHUC)
Centro Hospitalar e Universitário de Coimbra (CHUC) delivers high‐quality clinical care in a

context of pre and postgraduate training with a strong focus on research, scientific knowledge,
and innovation. The hospital offers comprehensive care across all leading medical and surgical
specialties.
CHUC´s excellence centres (where, since 1991, more than 1,100 liver transplants have been
carried out) ensure high standard healthcare services. It is the medical institution in Portugal
with more accredited reference centres, belonging to 10 European Reference Networks. As
an associate partner of InnoSTARS - EIT Health KIC, CHUC is developing partnerships with
several biotech and IT companies, implementing the concept of an innovative pioneering
hospital. CHUC also belongs to the collaborative network M8 Alliance of Academic Health
Centres, Universities and National Academies, known for their educational and research
excellence.
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In CHUC, 70% of medical hospitalisations and 73% of inpatient days belong to patients over
65 years of age. However, data on the hospitalisation of these individuals have shown negative
health outcomes, namely functional and cognitive decline and high risk of adverse events.
Sousa‐Pinto et al. (2013) show that 5.3% of patients over 65 are readmitted to hospital in less
than 30 days, showing that the discontinuity of care between the hospital and home has a
more pronounced effect on the elderly population.
This reflects the societal pressure related with fast ageing of resident populations experienced
in Coimbra, in the Centro Region of Portugal. In 2018 a total of 24% of 435.482 people were
older than 65 years. People living in the Centro Region of Portugal face important challenges
concerning quality of life in advanced age related to social diversity in rural versus urban areas.
The Centro Region is therefore a large living laboratory where many of the future challenges
related with population ageing can be piloted in real-life scenarios. Accordingly, ageing and
ageing-related health and innovative social good practices are important drivers of products
and services that bring quality of life and economic value, and are supported by a vivid
ecosystem of knowledge and entrepreneurship. The Centro Region of Portugal is now
recognized as one of the 74 European reference sites for active and healthy ageing.
As procurers for ROSIA, these institutions are responsible for preparing the PCP, participating
in the evaluation of the proposals, and managing the monitoring and evaluation of the field
tests.
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1.3. Targeted pathologies and their current clinical pathways
ROSIA will validate the implementation of the ROSIA Ecosystem addressing seven pathologies,
four of which are mandatory and three convenient. The pathologies selected are those in the
following table. The selection of the pathologies to be validated per procurer site is described
in TD1.
Condition Current care pathway User experience
The current pathway implies

four main stages: admission,
rehabilitation in hospital,
Cardiovascular conditions have a
follow up and rehabilitation in
physical and an emotional impact.
hospital, and rehabilitation at
Mental health is an important factor
home. Since cardiovascular
for rehabilitation that must be
condition often starts with an
considered in rehabilitation. The
CVD acute event and lifestyle
user experience in cardiovascular
changes are essential,
(Cardiovascular rehabilitation implies deep changes
psychological, and psychiatric
disease) in long established habits such as
support is necessary and often
Desirable smoking, nutrition, and exercise.
provided by the healthcare
These changes often produce
organisation. User associations
anxiety and stress, which together
are an important factor in
with post-traumatic stress and
users adhering to lifestyle
depression make psychological
changes and physical exercise
support advisable.
regimes, although they work
better in cities and towns than
in remote areas.
ABI is characterised by the

The rehabilitation process variability of the secondary
theoretically takes place in conditions or symptoms.
hospital and after discharge at Respiratory, memory and affective
home, often for the rest of and emotional problems are some
users’ lives, depending on the of the consequences. Public spaces
severity of the damage. But and transport are not adapted for
users have a long way to go this type of disability, and it impacts
ABI (Acquired before they are admitted to their social life and interactions. The
Brain Injury) central hospitals (national or loss of social interaction and value
regional), ABI users face can lead to mental health problems,
Mandatory waiting times of 6 to 8 weeks including identity crisis. Family
in normal times and up to members play an essential
three months during the supporting role through the
pandemic. This is a critical recovery and rehabilitation process.
time: users are left on their ABI impacts not only in people with
own because local hospitals do lived experience but also in their
not have the resources, not family, who can also present with
even for partial rehabilitation. mental health issues and adaptive
problems.
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SCI changes the life of the people

with lived experience and those
close to them completely. After the
initial trauma frequent and regular
The Spinal Cord Injury (SCI) rehabilitation is necessary and the
process has many similarities whole daily plans revolve around
to the ABI process. It usually them. Therefore, the anxiety that it
SCI takes place in central hospitals can cause especially in the first
but waiting lists until months of rehabilitation can be
(Spinal Cord
admission and lack of local decisive in the face of possible
Injury)
healthcare and community problems of monitoring and
Mandatory services mean that many constancy of the process. On the
people cannot be attended other hand, the issue of dependency
while waiting for their care creates a feeling of guilt since they
plan and after discharge. feel useless and a burden. It is
important to understand that these
factors can lead to psychological,
emotional, and mental health
issues.
Rehabilitation for pulmonary

obstructive condition is a
process with 7 steps under 4 People with moderate or severe
main stages: hospital, COPD have significant limitations to
COPD intermediate care, primary perform their day-to-day activities.
(Chronic care, and home. After an Users require constant adaptation
Obtrusive intense rehabilitation in to their condition and everyday
Pulmonary hospital the process continues, challenges. Self-management is
Disease) in short intervals, towards essential for people living with
Mandatory intermediate care and finally COPD. Pulmonary rehabilitation
towards follow up and includes lifestyle changes such as
monitoring in primary care, smoking cessation.
until the user can continue
unassisted at home.
The current post COVID-19 People needing rehabilitation post

condition rehabilitation COVID-19 have far less information
pathway takes place in the than those with other conditions,
hospital, in primary care and at simply because COVID-19 is a new
home. In hospital, users condition, and the knowledge is
recover their physical limited. The physical experience is
Post COVID-19 condition and undergo marked by exhaustion, and from the
condition respiratory physiotherapy. psychological point of view, lack of
Later, the patients are memory, within a framework of
Desirable
assessed as a basis for a anxiety and sometimes depression.
comprehensive rehabilitation The care experience is marked by
program that is designed in the lack of information, the lack of
primary care. Before this stage coordination and the lack of
a psychological evaluation may resources, together with the feeling
take place. In general, the and gratitude for the humanity of
follow up takes place in healthcare professionals. The key
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primary care, and in its last aspect in this picture is

stage rehabilitation takes place disorientation: because of lack of
at home. information, because of lack of
clarity within the healthcare system
and because of the common
symptoms including fatigue,
shortness of breath, cognitive
dysfunction among others.
The current arthroplasty

rehabilitation pathway starts
immediately after surgery and
demands of home exercises,
Individuals who need arthroplasty
which start very soon with the
deal with pain in the affected area,
home care plan defined right
Knee and mobility limitation. Mobility
after hospital rehabilitation.
arthroplasty. limitation poses difficulties to
Follow up should be carried
complete everyday tasks and
Desirable out by both the traumatologist
chores. People have a risk of
and /or orthopaedic surgeon
isolation and mental health issues
as well as physical
such as depression.
rehabilitation. In fact, lack of
resources prevents proper
follow up and monitoring of
users’ progress.
Some users could suffer from

dementia, and this means an
added difficulty in Hip fracture surgery is closely
rehabilitation with heavy related to mobility restrictions, pain,
involvement of families and and dependence. As in chronic
caregivers. There is an conditions that affect mobility and
ambulatory follow-up after produce dependence, the condition
Hip fracture. discharge. An evaluation has a great psychological impact in
Mandatory establishes the kind of the form of depression and other
rehabilitation required: at mental health disorders. Besides
home, in the health centre or that, in many cases -due to the age
in the hospital. When there is of users- individuals with a hip
no dementia nor fracture could be living with
comorbidities, there is a fast- dementia.
track, post-surgery pathway in
medium-sized hospitals.
Table 1 Summary of the current care process pathway and user experience by condition
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2. The ROSIA challenge description

2.1. Unmet needs – the innovation GAP
ROSIA addresses the needs of several users:
• Patients and their family and/or caregivers.

• Health care professionals.
• Health care Systems.
• Developers of telerehabilitation solutions.
These needs have been identified through workshops and questionnaires, analysis of the state
of the art, and Open Market Consultation. Procurers have prioritised and discussed such
needs.
To overcome the identified needs ROSIA proposed to address the Common Challenges are
described in the next chapter.
Relates to
COMMON
COMMON NEEDS CHALLENGES
(Chapter 2.2)
PATIENTS AND CAREGIVERS
Increase or enable the rehabilitation period. Because currently it

has been identified that:
• There is a short rehabilitation period during the acute
hospital stay and there are often difficulties in continuity
and transitions to community-based rehabilitation.
• Often there are not enough resources to complete
established rehabilitation pathways in ABI, SCI, Post-Acute CH1, CH2,
COVID Syndrome (PACS) and arthroplasty. CH3, CH4,
N1
• There is a risk of lack of resources and/or insufficient CH5, CH6,
awareness of the benefits of rehabilitation for some CH7
pathologies, such as COPD or CVD. Very often these
pathologies completely lack rehabilitation services in the
rural setting.
• Patients require a personalised, flexible solution that can be
easily and frequently accessed at any time in order to
achieve their identified rehabilitation goals
Improve adherence in remote rehabilitation and long-term self-

management by fostering motivation.
• Rehabilitation processes are optimised when motivational,
N2 emotional, and mental health elements are addressed, by CH3, CH6
improving levels of engagement and adherence which are
often overlooked.
• Adherence is commonly poor with self-management.
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• Motivation for behavioural change: There is insufficient

support for adoption of healthy lifestyles and positive
lifestyle changes.
• Mental health support: Psychological support may assist
patients in overcoming barriers to adherence in addition to
providing resources to support the patients’ mental health.
• Peer support: user associations and peers play a very
important role in supporting people with the condition and
their family and care partners. Enabling patients to remain
at home for their rehabilitation care allows them to receive
support from friends and community networks. Conversely,
the lack of regular attendance to a specialist centre reduces
the face to face access to peer support, and there may be
fewer community resources for specific conditions in the
rural settings. Some associations are present in rural and
isolated areas, although many users have difficulties in
getting this kind of support. Accessing peer support
remotely would bridge this gap.
Provide education and training to improve delivery of effective,

person-centred remote rehabilitation, and promote long-term
self-management.
Patients and families or the caring environment need education,
information, training, and support.
• Specific training for families: rehabilitation users in all
conditions covered by ROSIA rely heavily on families and
care providers. Families face significant challenges when
they must take care of a relative in need of this, and benefit
from support and rehabilitation specific training.
• Patients and/or family need digital and health education,
including digital education when any technology is to be
used for their rehabilitation care.
• Knowledge repositories: repositories are needed for various
N3 stakeholder groups, such as patients, healthcare CH3, CH6
professionals, families, and formal and informal care
providers. The expected characteristics are:
o Each group profile should be personalised in design,
content, and form. They are needed to provide
training, share information, improve health and
digital literacy level, reduce misunderstandings, and
allow for ease of recall of information when stored in
the repository.
o Materials should be regularly reviewed and updated,
in addition to being both digitally accessible and easy
to access.
o Education and training can be very effective when
elements are available for patients to access on
demand, i.e., asynchronous training.
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Improve effectiveness in remote rehabilitation (including self-

management) by close monitoring and follow-up.
There is a lack of regular and frequent communication with the care
team. Close follow-up and monitoring are not always possible due
to insufficient resources, even though they are essential for success.
• Additional methods for remote monitoring of
rehabilitation are becoming more readily available:
teleconsultation, augmented reality, use of sensors, CH1, CH2,
N4
wearable technology, and the analysis of data obtained via CH6
these methods.
• Real-time follow up is valuable to both patients and service
providers: To determine when to progress or regress the
rehabilitation programme, to enable live interactions with
patients, to provide context to the therapist to see the
patient’s home environment, and to improve motivation
and adherence to therapy.
Reduce travelling long distances for rehabilitation appointments.

Reducing unnecessary travel would positively impact users' out-of-
pocket expenses, time, effort, and wellbeing.
• Geographical dispersion and lack of local services create a
significant travel burden for users. Sometimes it makes
rehabilitation unachievable. CH1, CH2,
N5 CH3, CH4,
• Rural and remote areas cannot offer specialist care, CH5, CH6
requiring patients to travel to the specialist centres for vital
rehabilitation services.
• For people of working age, travelling to rehabilitation
appointments can be unrealistic due to clashes with work
schedules.
Enable home rehabilitation: Effective rehabilitation for people in

remote areas implies moving their care from hospital to home
and/or community facilities.
• The services needed are wide in scope and can include
evaluation, assessment, monitoring, prevention,
intervention, supervision, education, consultation, and
coaching.
• If training and exercises are perceived merely as stored
N6 material, understanding and adherence will be low. This CH1, CH6
must remain a dynamic process, tailored to the patient and
their needs.
• Advanced technological rehabilitation could improve
engagement through gamification and appealing interfaces.
• Home rehabilitation would be further enhanced by the
delivery of real-time virtual follow-up appointments.
• The rehabilitation plan should be delivered as close as
possible to the patient.
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The telerehabilitation plan should be co-designed with all the

patient’ care team.
Creation of one care pathway involving all key players will result in:
• Coordination of care
N7 • Shared resources and knowledge CH2, CH4
• Clear knowledge of each other’s roles and responsibilities
• Support for local resources from specialist centres
• Better quality of care and follow up for patients living in
isolated areas
Promote partnership with patients in designing their

rehabilitation plan: patients and caregivers should be involved in
shared decision making and goal setting. Potential advantages are:
• Realistic goal setting
• Better compliance and adherence as a result of patients
N8 CH2, CH4
feeling more ownership over their goals and rehabilitation
programme
• Provision of person-centred rehabilitation care
• Patient empowerment, increased self-efficacy in the
management of their condition
HEALTHCARE PROFESSIONALS
Lack of resources in rehabilitation:

Inpatient rehabilitation services are in high demand, with pressure
to expedite discharge to allow for more rapid turnover.
Consequently, patients may be discharged with ongoing
rehabilitation needs despite varying follow-up options available for
patients, particularly older people and those living in rural settings.
There is difficulty accessing community resources and insufficient CH1, CH2,
N9 numbers of community health providers skilled in delivering CH4, CH6
rehabilitation for the ROSIA listed pathologies. The low
implementation rate of telerehabilitation resources prior to the
COVID-19 pandemic and once again upon easing of restrictions, has
negatively impacted communication between patients, specialist
healthcare professionals and local service providers. This can result
in poorly coordinated follow up and organisation of services and
resources for patients with ongoing complex rehabilitation needs.
Training and knowledge repositories: repositories are needed for

different stakeholder groups, such as practitioners, community
CH2, CH4,
N10 health care, social workers. They should have a personalised design,
CH6
in content and form, for each group profile. Materials should be
regularly updated.
Training and support for local and community practitioners: in CH2, CH4,
N11 many cases remote rehabilitation requires support for local CH6
practitioners that may not have experience with specific
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rehabilitation conditions. Support, case management and training in

rehabilitation are essential for referrals coming from specialist
rehabilitation centres.
HEALTHCARE SYSTEM
Difficulties in guaranteeing equity and effectiveness in the service

provision:
Regional hospitals do not have specialists for all pathologies;
therefore, services are concentrated in central hospitals. CH1, CH2,
The delays incurred whilst awaiting specialist inpatient CH3, CH4,
N12
rehabilitation contributes to poorer rehabilitation outcomes. CH5, CH6,
CH7
Lack of resources in and out of the hospital to provide optimised
care. Under-resourced primary and community care services also
contribute to the poorly coordinated care, particularly in rural
settings.
Lack of coordination between all involved teams leads to

underutilisation of services and resources due to inadequate
organisation and coordination.
• Lack of coordination between health care providers,
N13 CH2, CH4
hospitals, primary care, and NGOs/third party providers.
• Lack of coordination between health and social care services
which can contribute to unnecessary institutionalisation of
older people.
Lack of integrated care approach with a comprehensive

assessment and care plan for each person.
• Lack of shared decision making and shared care plan
between patient and multiple providers
N14 • There is often duplication of assessment by various service CH2, CH4
providers at the various transitions of care throughout the
rehabilitation pathway. Without a shared care plan, the care
received may be poorly coordinated, resulting in poorer
outcomes.
Difficulties in making use of current technology for remote

rehabilitation:
• Commercially available devices and apps may not have been
evaluated for targeted conditions or not have been proven
clinical data quality. CH1, CH4,
N15 • No validated solutions for all the listed ROSIA pathologies. CH5, CH6,
• Challenges with minimally invasive methods to measure CH7
users’ activity levels in their home environment, even
though it has potential advantages over traditional self-
reported and clinic-based measures.
• Lack of evidence in relation to cost-condition ratio.
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• Poor reporting of clinical implementation parameters

related to frequency, intensity, duration, and number of
sessions of remotely supervised interventions. Without this
specific information, clinical replication of the intervention
can be difficult.
• Barriers in the adoption of technology and remote virtual
care by the care team due to challenges from the
organisational perspective, and lack of competencies and
skills with using new technologies.
• Need for more IT staff to install the technology at users’
houses.
Make home / community facilities as point of care: this is referred

to as one of the most important needs. It not only refers to
ensuring access to rehabilitation but also to allow continuation of
rehabilitation beyond formal clinical settings where possible.
• Lack of capacity and competency in the community and local
hospitals to care for people with some complex pathologies. CH1, CH2,
N16
• Lack of capacity and competencies at the community level CH4, CH6
to support people in rehabilitation, especially in remote
areas.
• Insufficient use of community resources (facilities,
technology, people) such as gym, swimming pool, wi-fi, and
support staff, for local rehabilitation.
Telerehabilitation services are perceived as difficult to implement

due to:
• The low health literacy and understanding about their care
needs and self-management process by the patient, and
their family or care partner
• Technological and digital literacy, and cultural barriers.
• Training family and care partners is difficult, especially CH3, CH4,
N17
remotely for complex pathologies, such as SCI. CH6, CH7
• Lack of adaptation to technological solutions to the profile
and skills of each individual.
• Insufficient or weak of evidence for physical health
outcomes with home rehabilitation with the current
implementation and support approach.
• Lack of reimbursement model for technologies.
Build evidence of effectiveness. Clinical and economical evidence

of the advantages of telerehabilitation need to be built:
• Outcome based monitoring (clinical data PROM and PREM
N18 among others). Use of questionnaires (e.g., Quality of Life CH4, CH7
measures), medical tests, nutrition data, etc. in order to
track, assess and analyse clinical progress over the course of
the rehabilitation programme.
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• Data capture and data analysis as well as clinical data, data

from devices and sensors.
• Data capture comes from clinical data and data from devices
and sensors. It allows a broad data analysis: data
correlation, studies and trials, epidemiology, population
patterns, benchmark, quality control, etc.
• Generate evidence of the value (to patients, providers, and
procurers) and cost-effectiveness of the intervention.
DEVELOPERS
Remove barriers in the market development: existing innovative-

disruptive high-tech solutions for telerehabilitation at home can’t
easily be integrated in the common general practice of public health
care providers. These kinds of technologies are usually developed
as standalone, isolated and disease specific products and services,
coming with their own dashboards and backends. These CH4, CH5,
N19
characteristics make them difficult to integrate into the HCP care CH6
workflow for a given health condition and into a health system’s
infrastructure. This constitutes a barrier to market deployment of
telerehabilitation solutions that could otherwise be adopted as
standard practice and reimbursed by national health systems and
insurance companies.
Reduce overhead and complexity on the collection and

compliance with integration requirements: Currently, different
healthcare systems have their own integration requirements. It
N20 results in a great overhead for the collection of these requirements, CH4
and in the production of highly complex solutions that need to
ensure case-by-case compliance with a given health system
infrastructure.
Public Administrations generally lack a procedure for prescribing

safe Apps or devices. The certification process to apply to
telerehabilitation solutions should be conformant with e.g., the
Medical Device Directive and commonly used data interoperability
N21 CH6
standards. The lack of standard guidelines and streamlined tools for
preparing and conducting the certification of solutions adds to the
overhead development of compliant solutions and complexity of
the required documentation.
Public administrations apply diverse requirements for certifying fit

N22 for purpose Apps/devices, or may lack any certification CH6
requirements.
Usually, the full scope of developing and implementing

telerehabilitation solutions, can become a complex process that
yields solutions that try to deliver too many functionalities at once
N23 CH5
(e.g.: physical training, gamification, motivation, education, etc.).
These complex implementations may be difficult to be developed
by a single company.
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Solutions need to comply with flexible, easy, and standardised data

exchange formats from any certified health device/application.
N24 Such is the case, to ensure interoperability between different CH4
applications and devices and improve remote rehabilitation services
being provided.
Facilitate the utilisation of certain applications and devices for

different uses than their initial purposes by integration of SDKs
N25 CH5
suppliers into a dynamic integrated telerehabilitation care model
for supported self-management
Table 2 Common needs related to common challenges
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2.2. The ROSIA model

2.2.1. Introduction
In the past decade, the use of technology for remote assessment and intervention in
rehabilitation has grown exponentially, paving the way for the development of
telerehabilitation.
The services provided under this term are wide in scope and can include evaluation,
assessment, monitoring, prevention, intervention, supervision, education, consultation, and
coaching.
There is no formal structure for telehealth delivery, and so far, the exchange of data may occur
in numerous forms. Some examples are telephone, messaging and e-mail, or multimodal
systems, such as video conferencing, virtual therapists, and interactive Web-based platforms.
In the field of rehabilitation, the patient-centred team approach has guided the identification
of ad hoc solutions to overcome geographic, temporal, social, and financial barriers.
Telerehabilitation has been shown to strengthen the patient-provider connection by (1)

enhancing the knowledge of the patients and their contextual factors, (2) providing
information exchange and facilitating education, and (3) establishing shared goal setting and
action planning.
ROSIA model aims to enable the deployment at scale of the paradigm shift to move from
hospital-based rehabilitation to:
• Telerehabilitation under follow-up of clinicians.

• Self-management of rehabilitation at home.
The bases of the ROSIA model to enable this paradigm shift are a combination of technology,
integrated care models for telerehabilitation, and a value-based model.
2.2.2. The ROSIA model components and the Building Blocks.
Removing barriers in market development: there are often barriers for services to incorporate
devices and apps which are generally standalone, isolated, disease specific and not integrated
into the care workflow or health and care system infrastructure
The ROSIA Innovation Ecosystem (partitioned here in three building blocks to simplify
description) can help overcome this barrier by using:
• The ROSIA Open Platform, for managing data and communications, and running
shared services & solutions.
• The ROSIA Developer Layer, to facilitate the collaboration between service providers
to either develop test and/or deploy services for remote telerehabilitation.
• The ROSIA Catalogue, that provides a ROSIA compliant certified list of safe
telerehabilitation digital therapeutics apps and smart devices to be “prescribed” for
the patient for self-care and self-monitoring.
• A proactive and dynamic integrated telerehabilitation care model for supported
self-management and community resources engagement.
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It has been divided into three building blocks:
• Telerehabilitation: Implementation of procedures, supported by technology, to

facilitate the remote rehabilitation and self-management of rehabilitation.
• Integrated care: Development of new shared tools & services to facilitate the
implementation of new care pathways to support the new model of rehabilitation.
• Motivation and empowerment of patients and carers: development of innovative
approaches to tools & services to support patients and carers to self-manage.
A value-based model for business modelling and long-term sustainability, based on the
paradigm of improving value for all stakeholders by measuring patient outcomes and costs.
Image 2 ROSIA model building blocks
This Building Blocks schema is used to define the Common Challenges in ROSIA.
The core of ROSIA development is the ROSIA Ecosystem (ROSIA Catalogue, ROSIA Developers
Layer, and ROSIA Open Platform); the rest of the Building Blocks are needed to implement
ROSIA's telerehabilitation care model and will make use of the resources available in the ROSIA
Ecosystem in view of validating it.
2.2.3. ROSIA Ecosystem
2.2.3.1. Introduction to ICT enabled services for rehabilitation
As seen in our analysis of the market, differences between national and regional health and
care systems, and changes in new requirements in the legal frameworks, imply an endless
need to redesign, adapt or change the products and services to be able to expand to new
markets, which implies the need to know the different systems and regulations; constant
reinvestments in development; and difficulties in implementing cross-border initiatives.
Siloed and unstructured repositories of data, that do not allow for solutions to be
implemented in different EU countries (without being tailored or specifically adapted to each
national/regional context), are also referred to, in many of the analysis, as huge obstacles for
scaling research and new insights based on access to ethical and anonymous data-sharing
using the many new 3rd party data intermediaries.
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To solve this situation ROSIA’s solutions should include: the development of a modern state-
of-the-art Open Platform; the creation of a Catalogue of services and apps that integrate
seamlessly into health care and formal and informal care; and the set-up of a network of
developers, in the ROSIA Developers Layer, to continuously improve and multiply the number
of services in the catalogue.
The ROSIA Catalogue should work in two ways: make available high-tech innovations with
positive clinical evidence and impact for both clinicians and patients; and open opportunities
for the European industry to better scale their products into the primary public sector buyer
group.
2.2.3.2. The ROSIA ecosystem components
The ROSIA Innovation Ecosystem shall include three core elements that the 3 buyers can share
across regions:
ROSIA Open Catalogue: a menu of evidence-based safe certified ICT solutions and services
that could be prescribed by the care team. All these services will allow the seamless sharing
of clinical data with the patient’s consent.
ROSIA Developer Layer: the development of architecture and layer for developers with open
API’s & governance tools to facilitate apps and services that uniformly can plug into the diverse
backends of the buyer’s regional infrastructures. We expect this to be defined as interoperable
APIs, which will allow building up solutions based on existing modules and will aid existing
research projects in becoming market solutions.
ROSIA Open Platform: an agile open cloud-native platform to host shared services,
communication, and manage e.g., Integrated Clinical Care Pathway builders, ePROM/ePROM
protocol editor, data sharing, consent, login, business logic and other core shared services.
2.2.3.3. The ROSIA Key principles for building the ROSIA Open Platform
The ROSIA Open platform should be built on the following key principles:
• With a high degree of flexibility.

• To share data across sectors and facilitate the involvement of patients.
• To ensure a high degree of automation.
• To facilitate light user interfaces relying on a “heavy” infrastructure.
• To support BYOD (Bring Your Own (medical) Device) where feasible.
• To have existing EU, national and/or regional infrastructure components and
frameworks as the first choice 18.
• To be based on industry standards.
• Not to accept proprietary solutions.
• To be developed using proven cloud-native platform-tools.
• To let the citizens be able to share their data for research securely and without being
able to be identified.
18 European Commission, Directorate-General for Informatics,New European interoperability framework:

promoting seamless services and data flows for European public administrations, Publications Office,
2017, https://data.europa.eu/doi/10.2799/360327
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• Consent management to give the citizens full control of their data and how they wish
to share it.
2.2.3.4. Governance framework
In order to build this ROSIA Open Platform infrastructure, the materialisation of its ROSIA
Developer Layer and ROSIA Catalogue all comes down to how the development is handled
through these 4 thematic approaches to deliver the ROSIA Open Platform:
• Best Practises and Standards.

• Openness.
• Handover & Education for each region.
• Maintenance and updating.
Governance
This is key and should be built to fit each regional buyer organisation. Having a micro-services-
based platform on which many smaller systems are running, opens for a finer granulated
governance model.
Not every component will then have to go through the usual, ITIL and QA processes. It is
possible to look at each individual component/system and define the risk level and then have
less complicated governance models for the less risky components.
This is relevant because identifying the less risky components and having lightweight
processes for these components will allow shortening time‐to‐market for these components,
lower administrative costs, etc. But this depends on the region’s policies, risk assessment and
the region’s IT organisation and the vendor(s) delivering the actual components.
Best practises and standards
Key to success is how the bidders are determining the requirements for components running
on the ROSIA Open Platform. The motivation for this is to potentially remove unreasonable
requirements for 3rd parties and foster only feasible changes.
Openness
Openness on all levels is key to the ROSIA Open platform. We propose it to be truly open in
terms of creating a multivendor environment since every component and service should lend
itself to be replaced and delivered by e.g., several companies, and that the open API’s are
based on open international standards and in terms of ownership, since most of the software
stack should be open source and the rest can be made available for the ROSIA buyers’ own
usage, support, and maintenance. Thus, the aim is to create a multi‐vendor platform without
hard constraints and vendor lock‐in. It should be possible for several regions to be served by
the same self-care remote patient monitoring service or telerehabilitation service.
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Handover and education
The ROSIA platform should be built with the possibility for the handover of the supplier in
mind from the beginning. As a part of the services around the installation and operation of
the ROSIA platform, technical education should be offered. Typically, the education should
start at the lowest levels, with hosting, network and then move to the private cloud, security
and later to the actual services and then the source code. But it can of course be structured
differently if relevant.
2.2.3.5. ROSIA and standards: Achieving organisational interoperability
In the ROSIA Model, it is seen that one of the gaps in the current state of the art is the enabling
ROSIA Open Platform where innovators can plug in their services, and care staff can easily
access and use the services safely the same easy and accepted way a doctor can prescribe
medicine.
With the emerging field of digital health Apps and digital therapeutics, an increasing number
of health systems prescribing apps as an intervention is to be expected. It has not taken off on
a broader scale yet, but this could change with a clearer regulatory framework, in both the EU
& the US, around certifying digital interventions via apps (ISO 13485 & Medical Device
Regulation (EU MDR)).
ROSIA solutions should focus on bridging the gap of achieving organisational interoperability,
in this sense the list of technological principles of the ROSIA open platform has been inspired
by best practices.
Image 3 Healthcare interoperability standards
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The diagram is a good representation of how standards layer on top of one another. The ROSIA
Open Platform should follow this interoperability layer cake:
• The platform must be very prescriptive in the Technical and Syntactic levels as these
standards are the most mature and most adopted by healthcare delivery and other
industries.
• The Semantic layer can be more flexible and language sets, clinical domain speciality
modelling, and vocabulary can be used. But the focus has to be on being able to map
data to other code sets for expanded use: a physician may prescribe and describe a
patient condition in SNOMED CT, but the platform will report the statistics to the local
health authority and insurance payer in ICD10 CM.
• This mapping and translation capability has to be available on the platform.
• For research, all the activities documented and reported in the integrated care plan
could be reformatted and transmitted as an OMOP record for clinical research.
• The upper layer, the Organisational layer, is where the service provider has autonomy.
This layer has to allow providers to develop new methods of care delivery, by using the
platform: they will know their services, will be able to capture information and
outcomes in a consistent manner that will be able to be securely, efficiently and,
effectively obtain, format, and communicate.
To summarise, the concept of ROSIA Open Platform is foresight as a modern cloud-native

architecture, using a modern micro-service-based dynamic cloud infrastructure, that is geared
towards supporting regional or even a nationwide construction of a highly modern and
scalable IT platform that can encompass all regional or government level services, and provide
a standardised environment for Apps and services in the healthcare sector. The goal is to
provide consistency in data gathering, information communication, and knowledge transfer.
Only an endeavour in that direction can support a continued expanding array of services and
solutions ‐ providing all necessary services to allow 3rd party developers to develop innovative
Apps and services that can be deployed and maintained in concert with the underlying
services.
2.2.3.6. The ROSIA ecosystem functional architecture
General view
The following description provides an overview of how the various layers of the solutions for
the ROSIA ecosystem are expected to interact with each other and the purpose of their
existence. The following image is intended to support the vision of the ROSIA ecosystem and
should be considered as an example for how the ROSIA ecosystem could look like: it is by no
means a finished model, but a guideline, and could (and should) lend itself to be adapted to
new ideas for other micro services currently not available. The process by which services and
devices are brought on to the platform will be evaluated by all layers through the governance
model to ensure quality and interoperability, thus making it a flexible and adaptive concept to
solve the ROSIA Challenges.
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Image 4 ROSIA model 2.0: Conceptual architecture for a novel selfcare telerehabilitation microservice cloud native platform
TD2 – Challenge Brief [Final] 37 Public

People/Actors
Image 5 ROSIA Model v2.0 Identified Personas
The ROSIA model is a comprehensive model keeping all personas and actors in mind for the
related use cases that will want to use the platform. Through standard processes for access,
documentation, communication, and delivery of care. The platform will serve the needs of all
users. As services are tailored for different groups and pathologies the platform will learn and
adapt to the most effective ways of supporting people needing and providing care.
Service Delivery Channel
Image 6 ROSIA Model v2.0 Service delivery channel
The Service Delivery Channel is the layer of the model which is designed to communicate with
the actors. It can be a robust and detailed channel providing large amounts of data and
analytics such as an integrated care plan for a stroke patient or simple as an SMS message
sending a reminder for a scheduled virtual rehabilitation session. The platform can adjust the
volume and detail of information as needed or mandated.
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TD2 – Challenge Brief [Final]
ROSIA Service Catalogue Io(M)T & apps
Image 7 ROSIA Model v2.0 Service Catalogue
This is the dynamic layer of the model. In this layer, service providers and provider
organisations add various devices and services to create unique programs for patients and
their carers. The Catalogue will be able deploy a wealth of services and features as needed to
address the desired pathology. This catalogue will be quick to implement and scalable to meet
expanding demands. To create this trusted and interoperable catalogue, the services and
devices offered in the catalogue must engage and align with the Regulatory Compliance &
Certifications, ROSIA development governance, and natively use the Healthcare
interoperability fabric
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Regulatory Compliance & Certifications
Image 8 ROSIA Model v2.0 Regulatory Compliance & Certifications
Certifications and use of standards must be mandatory for service providers, application
developers, and device manufacturers of the ROSIA Open Platform to be allowed to use the
platform when it eventually goes operational.
The regulatory requirements need to be divided into 2 categories, as we both deal with a
ROSIA Open Platform provider and service providers:
Required Regulations ROSIA Open Platform Service providers in ROSIA

and certifications provider Catalogue
Service providers should ensure

ISO 13485 - Quality that all devices and automated
Platform suppliers will
Management System processes comply with ISO
document its compliance
13485 when going to the
with support services for the
market commercially. Service
Company/Consortium Service provider’s devices
providers should document or
Focused and/or automated processes.
obtain from device suppliers all
certification documents
Cyber security should be

Cyber security should be
assessed on all four areas of
assessed on all four areas of the
the regulations the above
regulations the above and
IEC 62443 - and below standards should
below standards should
Cybersecurity incorporate the needed
incorporate the needed
documentation for the
documentation for the various
various security components,
Company/Consortium security components, the
the bidders should need to
Focused bidders should need to ensure
ensure that all components
that all components are
are identified and
identified and documented to
documented to the
the appropriate level
appropriate level
If applicable, Service providers

should follow the process with
ISO 14155:2020 - If applicable, the platform an acute understanding of the
Clinical Evaluation provider should supply need for effective root cause
Process supporting documentation to analysis (RCA) and corrective
demonstrate expected and preventive actions (CAPAs)
Company/Consortium software development for significant non-compliance
Focused practises as well as for device
deficiencies throughout the
conduct of clinical trials.
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The platform provider should

ISO 14971 - Risk supply all applicable Service providers should ensure
Management supporting documentation all appropriate documentation
such as audits and error logs for tracking risk of devices and
Product & Services as needed for service services in accordance with ISO
Focused providers to maintain regulations
effective risk documentation
Platform providers should

IEC 62304 - Software The service provider should
supply supporting
life cycle supply supporting
documentation to
documentation to demonstrate
demonstrate expected
expected software
Software Focused software development
development practises
practises
IEC 82304 - Software The platform provider should

The service provider should
life cycle supply supporting
supply supporting
documentation to
Software focused in an expected software
software development
open environment development practises
practises
The platform provider should

The service provider should
IEC 62366 - Usability supply supporting
supply supporting
documentation to
Software Focused expected software
software development
development practises
practises
Table 3 Required regulations and certifications
ROSIA Developer & Governance
Image 9 ROSIA Model v2.0 Developer & Governance
The ROSIA platform will have a testing and documentation process that will allow all
interested parties to create and be confident that they are providing a quality service, meeting
the needs of all actors. Like the Apple store, this will create consumer confidence that this is
a quality service being delivered at the right level of service.
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Healthcare Interoperability Fabric
Image 10 ROSIA MODEL V2.0 Healthcare Interoperability Fabric
The healthcare domain has set standards to help facilitate clear understanding of what care is
being provided, how it was provided, and its effectiveness. Classification, communication, and
documentation are paramount in a distributed care environment. The ROSIA platform will
maintain champion clinical standards of care.
ROSIA Open Platform
Image 11 ROSIA Model 2.0 ROSIA Open platform
The open platform layer is a trusted layer where services can share data, and then analytics
and targeted interventions can be developed. All the while communicating to engaged parties’
performance, trends and next steps.
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ROSIA Cloud Platform
Image 12 ROSIA Model 2.0 ROSIA Cloud platform
This cloud platform is an agnostic layer where general cloud services are provided. These are
the generic services of information management, infrastructure management, and security
management. The cloud platform can be provided privately or publicly as long as it complies
with the defined governance model set out in the ROSIA governance.
ROSIA healthcare interoperability layer (In sandbox mode)
Image 13 ROSIA healthcare interoperability layer (In sandbox mode)
This layer aims to have the interface between the user services and the healthcare staff
wherever feasible. We don’t anticipate that actual integration will take place during the ROSIA
PCP Challenge, so we propose a sandbox environment during the competition phase, that use
light interfaces (web based) simulating e.g., an EMR or other system, showing dashboards if
applicable, that can be used for simulating each individual use case that is evaluated and
tested by the buyer regions.
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2.2.4. Integrated telerehabilitation care model
2.2.4.1. Integrated Care
Integrated care is a promising concept for the solution to the lack of access to rehabilitation
care in remote areas requiring close collaboration, networking and alignment of several health
or social service providers, patients, and other stakeholders. Information and communication
technologies are seen as one possible way to enable integrated care across the entire care
continuum. In this regard, the use of information and communication technology might
improve the way in which care is delivered in rural areas thanks to technological
improvements and cost reduction of telemedicine solutions combined with both the high-
speed internet and mass spread of smartphones.
The ROSIA Telerehabilitation Care Model aims at (1) improving health outputs of the persons
in need of rehabilitation care; (2) increasing adherence to rehabilitation treatment; (3)
improving care experience for all; and (4) optimising the use of health services and local
community resources.
The guiding principles for the design of the digitally enabled delivery of integrated
telerehabilitation care are:
• Person Centeredness and Holistic Care.

• Promoting accessibility and equity of rehabilitation services in remote areas.
• Coordinated care and continuous care.
• Adaptability to local health and care systems and the needs and preferences of the
individuals.
• Sustainability of ROSIA telerehabilitation care model.
Answering to these principles, ROSIA Care Model for Telerehabilitation meets three different
aspects of rehabilitation care:
• Moment in the continuum of care (prevention & preconditioning, early rehabilitation,

chronic rehabilitation and/or life-long rehabilitation and self-management support)
• Rehabilitation objective (pre-rehabilitation, recovery, and maintenance)
• Expected output of the rehabilitation care (exit/discharge or self-management and
lifelong).
The centre of the ROSIA Telerehabilitation Care Model is the individual and their care teams
(including family and informal caregivers), as well as the continuous feedback loop between
all of them, supported by information and communication technology. Moreover, the care
model considers five elements to guarantee the optimum provision of telerehabilitation care:
digital education as a facilitator for optimum telerehabilitation care, self-management
support, the re-design of rehabilitation delivery system adopting digital solutions, shared-
clinical decision support, and the development of technological ecosystems.
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2.2.4.2. Telerehabilitation
Rehabilitation is a complex and vital process as part of the continuum of care for those seeking
to regain or maintain their quality of life and improve function following significant injury or
illness.
Rehabilitation in response to any of the listed ROSIA pathologies must be comprehensive,

patient-centred, completed by a broad range of healthcare professionals (i.e., an
interdisciplinary team) to improve physical function and community participation. Currently,
rehabilitation commences in the acute hospital, and is transferred to either the regional
community setting which is under resourced to deliver the required frequency and expertise,
or is completed in the specialist centre where the patient is required to travel long distances
to appointments.
The rehabilitation provided to these patients is complex and includes a range of interventions
to address the physical, cognitive and psychosocial needs of the patient.
2.2.4.3. Education, motivation, empowerment of patients and carers.
Because the psychological status of the patient could be severely damaged after suffering an
episode that requires rehabilitation, motivation is delicate yet key to obtaining positive results
from telerehabilitation. Goal-oriented rehabilitation processes have the advantage of
introducing patients into positive cycles where motivation is reinforced as the rehabilitation
process is followed and its goals are met.
Treatments where multiple medications are involved and where new habits need to be
created are complex to manage. This, coupled with the fact that patients and their carers must
become familiar with the new devices, apps and assistive technologies, make education and
training key factors in successful telerehabilitation processes. If patients are given the tools
and information to understand their condition, they will be increasingly motivated to modify
their behaviour and take control of the rehabilitation processes, in a positive feedback loop
where education, empowerment and motivation feed each other.
2.2.5. Value based model
The purpose of the ROSIA Value-Based (RVB) Model is to facilitate the creation and build-up
of tele-rehabilitation practises dedicated to patients' value creation with high impact on
integrated care solutions, community intervention, personalised services and patient
empowerment.
Patients value is the key lens of the RVB Telerehabilitation Model. In this respect, the RVB
Telerehabilitation Model has been built upon the Value-Based Health Care literature and
frameworks, and matched with the EURIPHI Patient-centred assessment framework. Finally,
the Decision Group Value-Based Healthcare (VBHC) tested implementation tools and
frameworks, the strategic approach typical of the sustainable and value-based business
canvas, and The Decision Institute Value-Based Health Care (VBHC) e-health best practices,
applications, case studies, and educational materials have been used. The VBHC application
tools certified by the Value Health Care Green Belt Track exam (CRKBO Registered Educational
program) have been customized to the e-health and telerehabilitation ecosystems, and the
seven ROSIA medical conditions.
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The solutions formulated according to the RVB Telerehabilitation Model will result in a
sustainable model thanks to three components: their capacity to generate and create value
according to the above definition, their organizational strengths and capabilities, their
financial plan and their potential to scale up.
That’s why the RVB Model is built on four main pillars:
• Patient Value Creation

• Organisational sustainability
• Financial sustainability
• Scalability
The RVB Model is built on four main pillars (Image 14) that enable to judge and score the
tenders solutions by evaluating their:
• Core value proposition.

• The relevant medical outcomes the solution influences.
• The relevant process KPIs the solutions are improving.
• The way the tele-rehab and e-health solution creates value across the care pathway
process.
• The way the solution is changing and addressing the specific care delivery pathway.
• The way the solution contains or lowers the costs per patient, payers, and providers.
• The impact the solution has on other relevant stakeholders and the society.
• The way the solution is organisational and financially sustainable.
• The way the solution has the potential to scale up.
Image 14 The RVB Model
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2.3. The common challenge
The procurers derive the common challenges to be met from an analysis of identified common
needs. The expected features to address these common challenges will be further refined into
requirements (section 2.4), making them more specific and providing details, such as whether
they are mandatory or just convenient, or whether they are illustrative or specific.
Complementary and/or alternative features will be welcomed in solutions, just as long as the
results they provide are equivalent and that they meet all mandatory requirements.
Compliance with expected features will be assessed by the assessment of the related
requirements, described in chapter 2.4.
COMMON CHALLENGE
CH1. Provision of a telerehabilitation service to facilitate remote rehabilitation across the

continuum of care, from clinician-led therapy to self-managed rehabilitation in the long-
term.
Rationale:
The interventions provided to patients in need of rehabilitation may include:
• Physical rehabilitation, exercise therapy supported by healthcare professionals
and/or caregivers to address physical impairments or restrictions in specific
activities (e.g. gait and balance retraining, task-specific training and muscle
strengthening, community mobility such as walking outdoors).
• Cognitive and/or communication rehabilitation (e.g., sequencing and planning of
activities such as meal preparation or personal care tasks, speech, and language
therapy to address impairments of communication).
• Nutrition and swallowing rehabilitation - to address impairments of swallowing as
a result of the patient’s medical condition, in addition to receiving nutritional
education and support in both the short- and long- term following the acute
episode.
• Activity promotion as part of long-term health promotion and self-management
strategies.
• Remote monitoring via use of wearable technology, sensors, analysis of data
submitted (pushed) by devices and apps used as part of the patient’s rehabilitation
programme.
Health systems need:
• Tools to facilitate rehabilitation for patients living in remote areas.
• To make more efficient use of the available resources in the health-care system,
including increased collaboration with local providers to increase competencies
and knowledge for rehabilitation service provision.
• To extend the rehabilitation process by facilitating self-management.
Current shortcomings:
There are some solutions for some pathologies for self-management, there are also tools
for teleconsultation for remote rehabilitation, but all these are disconnected, each of
them is conceived to be used alone and therefore the individual elements do not meet
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the broader needs for telerehabilitation of a regional health system. The current potential
of technologies (AI, virtual reality, augmented reality, sensors, deep cameras, etc.) applied
to tele-rehabilitation is underused despite the pressing needs for such solutions.
Expected features:
• Physical and cognitive Tele-Rehabilitation with clinicians’ intervention: Availability
of easy to use tools for clinicians and patients, facilitating the rehabilitation
process in remote areas, from the patient’s home, with the active intervention of
the rehabilitation team.
• Self-management of physical and cognitive rehabilitation: Availability of tools for
patients to continue their rehabilitation by self-management.
• Provide training and education for tele-rehabilitation. For all the involved
stakeholders.
• Remote monitoring of the patient's health status.
CH2 Facilitate implementation of integrated care pathways optimised for remote

rehabilitation and telerehabilitation.
Rationale:
The vision of integrated care is to provide people, families, and communities with person-
centred multidisciplinary care to maximise their health, wellbeing, and independence.
The core values supporting this vision are:
• Holistic: A people-centred approach that addresses physical, socio-economic,
mental, and emotional wellness
• Co-produced: Through proactive multi-sectoral partnerships with people and
communities at an individual, organisational and policy-level
• Continuous: Continuity of care that is provided across the life-course
• Coordinated: Care that is integrated around people’s needs and expectations,
effectively coordinated across multiple providers and settings
• Equitable: Care that is accessible and available to all
• Sustainable: Care that is efficient, effective and of high value such that it
contributes to sustainable development of care systems over time
Current shortcomings:
• The lack of communication and coordination between care providers, settings,
levels, and teams is a significant care delivery shortcoming.
• The lack of resources to deliver the desired duration and frequency of
rehabilitation care is a common shortcoming for all ROSIA listed conditions, with a
direct impact on health outcomes and user experience. Remote resources to
facilitate a new pathway would enable community rehabilitation with lower
healthcare pressure and cost.
• Limited follow-up and therefore lack of adaptation of the therapy during the
rehabilitation process has a direct impact on outcomes. A co-designed care
pathway can improve follow-up and monitoring that is essential for therapy
adherence and goal attainment.
Expected features:
• Personalised digital rehabilitation pathway and shared care planning.
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• Shared data across professionals and sectors (Integration of existing IT systems)

• Improved communication among health and care professionals and with patients
and carers.
CH3 Facilitate patient empowerment, education, and motivation to facilitate adherence

to rehabilitation at home and self-management
Rationale:
• Rehabilitation in the home, both supported by remote clinicians and independent
self-managed rehabilitation will be more successful if the individual understands
their condition and is motivated to modify their behaviours.
• To participate in telerehabilitation, patients and their carers/social supports must
become familiar with new devices, apps and assistive technologies.
• Treatments including medication management, behaviour change, and training
could be complex to manage.
• Rehabilitation follows a process, including defining goals and following them.
• Human resources from the public services to support and guide patients during
this process are scarce.
Current shortcoming:
Recovery and rehabilitation processes have an important motivational, emotional, and
psychological component to optimise engagement and adherence that are not often
considered.
Demand is increasing while resources remain scarce.
There are technologies at different maturity levels which have proven to be effective for
the purposes described above. Behavioural change and psychological support are
research areas which offer promising perspectives based on AI and insight data.
However,
• No virtual coaching is currently specialised in supporting telerehabilitation
program.
• All the previously described functionalities are not integrated offering to the
patient a coherent and user friendly experience.
Expected features:
• Education and support for patients and caregivers.
• Promote permanent lifestyle change, and motivational support.
CH4 Deployment of an open platform to host solutions and services that responds to
the needs of the patients, healthcare professionals and health care systems
Rationale:
In order to implement CH1, CH2 and CH3, patients, health care professionals and
healthcare providers need an open platform that hosts home and telerehabilitation care
solutions and services that allows the prescription of particular component targets that
are integrated into delivery of the care pathway for a given medical condition.
• From the patient perspective, the platform needs to:
o Ensure solutions and services are available in continuous, error robust way.
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o Ensure the protection of the medical data collected through connected

devices and protection of their privacy, during data transfer and usage,
within the platform.
o Ensure that the solution and service interfaces are lightweight and comply
with accessibility requirements.
• From the healthcare professional perspective, the platform needs to:
o Offer an extended collection of rehabilitation solutions and services that
provide interchangeable options for the delivery of the care pathway for a
given condition.
o Support the participation of healthcare professionals in the definition of
new services, solutions and integrated care pathways.
• From the healthcare providers’ perspective, the platform needs to:
o Integrate services and solutions in the context of current health care
infrastructure, without extensive costs for deployment.
o Not implicate health care institutions to handle licensing costs of external
proprietary solutions or integrated services.
Current Shortcomings:
• The current digital Healthcare landscape across the EU is fragmented, still using a
huge amount of manual and paper-based workflows, and asynchronous
communication.
• The ability to virtualise the treatment and services is still relying on a physical
meeting and little use of e.g., digital apps and services from 3rd party, except from
some video consultations services, and to some extent but limited use of Remote
Patient Monitoring and devices that sees an increasing complexity of both training,
logistics and communication. The situation for Telerehabilitation is even more
scattered.
• The current integration platform is mainly focused on combining the many
different Health IT legacy systems, with e.g., intra-regional, national services or
reporting, communication etc.
• ICT services for operating healthcare is in many cases built on platforms that are
not agile and modern in both its architecture and data interoperability capabilities.
• Innovators have difficulties entering the health care back, making it complicated
for these innovators to scale their solutions to reach a broader customer base.
Expected Features:
ROSIA’s open platform should be implemented in light of the following principles:
• Availability: The implemented platform should be available to its users (patients
and healthcare professionals) at any time, and in any channel of their choosing
(desktop, mobile, etc...).
• Flexibility: support for hosting any number of heterogeneous solutions and
services.
• Scalability: Autonomous response to workload changes at any given time.
• Resilience: High tolerance to service failure events, being able to autonomously
recover service instances.
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• Faster development and automatic deployment: Ensure high coverage for

multiple health conditions, definition of a clear methodology for fast development
of new solutions and services, supporting automatic deployment and fast bug
fixing and patching.
• Integration capability: Fast integration between multiple services and solutions
from different architectural layers, to provide interchangeable options.
• Data Interoperability: A well-defined, standard based, data interoperability
strategy to ensure data handling and transparency between the devices and
services associated with its architectural layers for integration capability with
current health system infrastructures.
• Data Protection, sharing Privacy and ethics: Data protection and privacy protocols
in minimum compliance with the GDPR.
• Governance & Handover: Define a clear governance model to facilitate
cooperation with all stakeholders, that describes procedures for education,
maintenance and handover to buyers.
• Interfaces: Deploy light user interfaces that conform to standard accessibility
requirements, relying on a “heavy” infrastructure.
• Openness: Exclusion proprietary solutions.
• Devices: Support for BYOD (Bring Your Own (medical) Device) wherever feasible.
The ROSIA Open platform should be cloud-native and as stateless as possible this will
allow the platform to take advantage of the cloud's inherent strength of being resource
dynamic in its ability to add more processing and data resources as demanded and to
leverage other nodes as needed. State actors limiting cloud services or imposing national
fences around the cloud will limit the flexibility of the platform. To adopt such a platform,
it will follow a minimal data storage approach and leading encryption approaches. These
two efforts are best achieved in a cloud-native environment. examples of these
approaches can be found here: https://www.cncf.io/
An agile open cloud-native platform to host shared services, communication, and manage
e.g., Integrated Clinical Care Pathway builders, ePROM/ePROM protocol editor, data
sharing, consent, login, business logic and other core shared services.
CH5 Deployment of a development environment that supports ROSIA developers
Rationale:
• In order to implement an evolving and ever improving platform for services and
apps for home and tele-rehabilitation, the involvement of third-party developers is
key. ROSIA’s Developers will be the driver for the development of new services
and integration of services with diverse third-party technological solutions
(devices) for home and tele-rehabilitation.
• To do so third-party ROSIA developers must have access to a comprehensive set of
tools, guidelines, methodologies, and procedures, that will allow fast
development, integration and deployment within the ROSIA Open Platform.
• This development environment (ROSIA’s Developer Layer) will have to ensure that
the development process meets quality standards for deployment and must
ensure that final solutions are within the scope of the current directives for
Medical Devices, while easing and guiding developers through the inevitable
validation certification process. This is a necessary step since it conditions the
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deployment of services and solutions in health care systems and its integration
into the care pathway for a given medical condition as a standard of care.
Shortcomings:
• Scaling-up faces siloed and unstructured repositories of data that do not allow for
solutions to be implemented in different EU countries (without being tailored or
specifically adapted to each national/regional context)
• The deployment of apps and services inside health care systems requires them to
comply with established directives that regulate the development, production of
documentation, analysis, validation, and certification processes. It is still a very
difficult regulatory environment for many companies to navigate, let alone the
third-party developers themselves.
• Companies developing services for telerehabilitation are in an endless need of
redesign due to:
o National and/or regional healthcare systems have different requirements.
o Legal framework is continuously evolving
Expected features:
The development of architecture and layer for developers with open API’s & governance
tools to facilitate apps and services that uniformly can plug into the diverse backends of
the buyer’s regional infrastructures. We expect this to be defined as interoperable APIs,
which will allow building up solutions based on existing modules and will aid existing
research projects in becoming market solutions.
• Developer Tools: ROSIA’s Developer’s Layer should provide solution developers
with the SDK's and API's necessary to create, integrate and deploy new services to
the catalogue. To ease and accelerate the development process, this layer should
also offer tutorials, example code and standard code snippets.
• Developer Support: ROSIA’s Developer’s Layer should provide solution developers
with the documentation for the SDK's and API's necessary for development.
Developer support should also include the creation of a forum, for community
support, and a dedicated helpdesk, for more specific technical support.
• Development Process: ROSIA’s Developer’s Layer should provide solution
developers with the necessary integration, development, and quality assessment
workflows.
• Regulatory Compliance: ROSIA’s Developer’s Layer should implement the
development processes considering the current standards and regulations for the
deployment of e.g., medical devices and other relevant requirements such as the
GDPR.
CH6 Creation of a certified solutions and services catalogue for home and
telerehabilitation (ROSIA Catalogue)
Rationale:
The ROSIA Catalogue will offer to the care teams the possibility to prescribe, from within a
menu of evidence-based, safe and certified ICT solutions and services for home and tele-
rehabilitation for a given medical condition. These prescribed services and solutions
should address and be integrated into the multiple stages of the care pathway for a
specific medical condition.
Shortcomings:
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• The system for prescribing drugs is following a very organised flow and organised
in drug registries, providing regulatory and patient safety evidence, and with aid
appliances there is similar catalogues and data based on safe equipment and
devices.
• Digital therapeutics apps and smart devices are not yet enjoying the same
visibility, as the emergence of this field still is quite new and only recently is seeing
more regulatory scrutiny.
• Each service provider making new innovative devices and services, is not easily
tapping into the healthcare “marketplace” for e.g., reimbursed interventions.
• The health care providers can’t access a pool of tools to prescribe self-care and
remote rehabilitation.
• The service providers often use proprietary or own backends not integrated to the
healthcare ICT backends for the care provider.
Expected features:
• Openness: ROSIA’s Catalogue should support only services and devices built with
open access software and hardware.
• Accessibility: ROSIA’s Catalogue should ensure the accessibility of the services and
devices provided.
• Integrated Care Pathway: ROSIA’s Catalogue should integrate the relevant
solutions available for a given condition into each given step of the care pathway.
CH7 VALUE BASED CARE
Rationale
The vision of value-based healthcare is to provide patients with better medical outcomes
and the healthcare providers with lower costs per patient or patient stratification.
Shortcomings
Lack of evidence on the value generated by reducing the healthcare costs or costs per
patient and relevant medical outcomes generated by the proposed initiatives. Lack of
patient involvement in the definition of care pathways.
Expected features:
• Evidence on the relevant patient outcomes measurements (Porter's Tiers)
• Evidence on the CDVC analysis - Care Delivery Value Chain
• Evidence on the cost effect per patient (or patient population)
• Evidence on savings realised for providers
• Evidence on the TDABC analysis - Time-Driven-Activity-Based Costing
• Evidence on PROMS and PREMS Collection
The core value supporting this vision are:
• Value creation: Value creation is a function that depends on outcomes and costs.
The value is improved when costs are decreasing, or relevant medical outcomes
are improving. Scaling up in Value-Based healthcare includes the capability of the
solution to increase value for users and all the other relevant stakeholders.
• Organisational Capabilities: To assess the “organisational capabilities” pillar,
tenders are asked to provide information on the user involvement and the social
and/or family engagement set-ups, the key partners involved, and the internal
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knowledge and competencies related to Value-Based Health Care concepts and

implementation tools.
• Financial Sustainability: To assess the financial sustainability of the tender
solution, the core elements for a sustainable business model plan have been
selected. The tenders are asked to provide proof and/or information about experts
in financial planning/sustainability in their team, the solution costs structure plan,
the revenue structure plan, the internal audit sheet, the break-even point analysis
and their financial strategic goals and objectives plan.
• Scalability: To assess the scalability requirements, tenders can provide information
on volume, payment structure, value creation, data/platform integration and
teams and IPUs. The scalability requirement can be used in the business case if
tenders have already a plan to scale-up. On the contrary, the requirements can be
used to track the solution across the years. Hence, the requirements allow the
buyers to monitor the increasing independence and growth of the solution.
Table 4 Common challenges
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2.4. Requirements
Each of the features included in the challenge brief has been translated into concrete requirements. To avoid constraining innovation, requirements have
been defined as openly as possible.
Each of the requirements is classified as:
• Functional/Non-functional: Functional requirements explain how the system must work, while non-functional requirements explain how the system
should perform.
• Mandatory/Essential/Desirable: If a mandatory requirement is not met, the bid will be disqualified. Essential requirements have a high priority and
they should be addressed and contain specific details of how the requirement is met. Meeting requirements qualified as “Essential” and “Desirable” will
contribute to a higher score in the fields of Excellence, Impact, and Implementation, depending on the added value they provide. The
accomplishment of desirable requirements will add more points in evaluation, once mandatory and essential requirements have been met
• Specific/Illustrative: Requirements qualified as "Specific" must be precisely met, while those qualified as “Illustrative” allow room for interpretation
and seek outcomes rather than the precise implementation of the given definition.
Tenderers must include in their proposal a description of how and when (in which phase) they plan to comply with each requirement.

CHARACTERISTICS
Non-functional /
Functional
COMMON CHALLENGE ID Requirement
Mandatory/ Essential/
Desirable
Illustrative/ Specific
CH1. Enable remote rehabilitation supported by clinicians’ intervention and telerehabilitation based on self-management
Facilitating tools for remote patient management by healthcare

professionals: the bidders selected ROSIA Catalogue Services
(Apps/Devices) should be able to facilitate the remote assessment of
the patient status by clinicians through connecting to the ROSIA Open Functional
R1.1 Platform in Phase 3. Essential
This should also allow for assessing and training activities relevant for Illustrative
the rehabilitation of the targeted pathologies, that would otherwise
Physical Tele-Rehabilitation with clinicians require a face-to-face appointment (e.g., activities of Daily Living (ADL)
intervention using some of the services in the ROSIA Open Platform.
Facilitating tools for treatment & prescription by healthcare

professionals: ROSIA Open Platform should be able to facilitate the
definition and prescription of standard programmes of exercises and Functional
R1.2 activities, to be undertaken or supported by Apps and devices in the Essential
ROSIA Catalogue Illustrative
The ROSIA Services may make recommendations of tasks to be
prescribed (according to regulatory approved AI models, patients’

profile, assessment, location, resources available, etc..), in addition to

the healthcare professionals’ recommendations and guidance. The
service(s) may incorporate existing databases and resources from
those currently used by procuring sites.
Potential solutions to address this requirement should be provided,
documenting examples and references.
Provide tools for health professionals to follow-up, train, guidance, and

provide feedback on the rehabilitation program completed by
patients: Health professionals need tools, services and/or dashboards Functional
R1.3 to: e.g. facilitate follow-up on progress, perform remote training Essential
guidance, and provide feedback on the rehabilitation program Illustrative
completed by patients using the shared service components in the
ROSIA Open Platform (e.g. video and communication management)
Shared Care Plan shall allow for viewing data: The ROSIA Open
platform should have a functionality to have a Shared Care Plan that
shall allow for viewing data (e.g. measured parameters) by the patient
Self-management of physical rehabilitation
and the professionals. Patients shall be able to enter only specifically
Services included in the ROSIA Catalogue requested data (e.g., physical activity, nutrition). Some data entries Functional
should facilitate the telerehabilitation at R1.4 (e.g., measurements from devices) may be automatic. The data is Essential
home or in community facilities without or linked to the existing system infrastructures of the procuring sites.
minimum intervention of the rehabilitation Illustrative
The ROSIA solution may allow for collection and manual input of
team
specific outcome measures, and to track these over time. Potential
solutions to address this requirement should be provided,
documenting examples and references.

Availability of solutions for assessment of patient status/progress:

ROSIA Open Platform should include tools for the HCP to be able to do
different types of assessments/various methods of assessment of
patient status/progress design and make structured self-assessment,
vital signs measurement, tests, demonstrate achievement/ progress
towards goals., e.g. via a HCP controlled ePROM and ePREM
assessment generator. An assessment could be e.g. ICF, Barthel, SF-36, Functional
R1.5 Timed up and go test (TUG), vital signs questionnaires for automatic or Essential
manual input, or exercise follow-up goals that can be specified at Illustrative
specific time and intervals. The self-assessment protocols should be
available for the service providers in the catalogue via the developer
API. The HCP has to be able to access the data at any given time to be
used for follow-up, coordination or communication. Potential solutions
to address this requirement should be provided, documenting
examples and references.
Personalisation parameters: ROSIA Catalogue Services that is on- Functional

R1.6 boarded to the catalogue shall aim to be adaptive and personalise the Desirable
experience of the user Illustrative
Availability of services to define the exercise & monitoring programs:

The ROSIA catalogue services selected for self-management should be
able to modify (i.e., progress or regress) elements of the rehabilitation
programme according to the progress, based on previous Functional
R1.7 recommendations and guidance by healthcare professionals and shall Essential
be able to capture data and feedback from Patient users on Illustrative
unsuccessfulness (e.g., not met goals) and adapt to more realistic
targets set out where possible (e.g. diet, physical activity) using e.g.
advanced threshold alerting systems in the assigned protocols

The ROSIA Catalogue should include services for the proposed

pathologies providing:
1- Guidance for the patient in the proper execution of the exercises.
2- Gamification features and/or any other motivation strategies to Functional
R1.8 encourage a correct follow-up of the exercise programs (optional, but Essential
inclusion is encouraged).
Illustrative
3- Recording features for therapy sessions , with users' explicit
consent, at patient and healthcare professional discretion, to enhance
the effectiveness of rehabilitation sessions, is optional, but inclusion is
encouraged.
ROSIA Catalogue services shall provide guidance and

recommendations to the patient and/or healthcare professionals Functional
R1.9 regarding the patient’s status. Positively formulated feedback should Essential
be used, e.g., when certain goals are reached, or when not, Illustrative
encouraging the efforts made trying to achieve the goal.
Training patients, carers, and local practitioners in using the

apps/devices in the ROSIA catalogue: Suppliers should provide training
Functional
Provide training and education for tele- on the adequate use of the telerehabilitation devices.
R1.10 Essential
rehabilitation It would be convenient if existing material (booklets, videos) from
participating health care services could be incorporated. Illustrative
The services shall build a training program based on the user’s profile.

Facilitate training and support for local and community practitioners in Functional
rehabilitation in the use of the ROSIA Catalogue: Suppliers should
R1.11 Desirable
provide training on the adequate use of the ROSIA telerehabilitation
devices, and the proper follow-up of the telerehabilitation program. Illustrative

CHARACTERISTICS
Non-functional
/Functional
COMMON CHALLENGE ID Requirements
DesirableConvenient
CH2 Facilitate implementation of integrated care pathways optimised for remote rehabilitation and telerehabilitation
Shared Care Plan description: The ROSIA platform should include tools
facilitating the description of the shared care plan and for the
implementation of the clinical pathways: ROSIA platform should
facilitate the creation of a Shared Care Plan, that is a user-centred
health record designed to facilitate communication among members
of the care team, including the patients and informal carers. The
Shared Care Plan represents a structured common guidance by which Functional
Personalised digital rehabilitation pathway the care professionals and ROSIA patients can negotiate their co-
R2.1 Essential
and share care planning designed telerehabilitation plan. The Shared Care Plan should consider
the definition of case manager and care coordinator roles. The Shared Illustrative
Care Plan shall allow for any new information and be made ready for
the Healthcare interoperability layer (9) in the reference architecture.
(In sandbox mode). Unless any ready deployable API to the existing
buyer regions can be made or exist, please explain/describe how the
HCP can populate data in the Shared Care plan with EMR/EHR data
through e.g. a light web-based interface. (Note: there is no expectation

to have any live integrations to EMR/EHR's etc. in the competition

phase 1-3)
Setting and tracking of targets and goals: The Shared Care Plan shall
facilitate the setting and tracking of goals and targets. These are set
together by the care professional and the patient. The goals shall be Functional
adjustable and able to be prioritised, by the professionals and the
R2.2 patient and comparable against results. Essential
It should include areas relevant to the patient status (exercises, Illustrative

activity, nutrition, etc.), and these may be linked to some Services from
the ROSIA Catalogue
Summary Care Records: The ROSIA platform shall allow for sharing Functional
data from the Shared Care Plan and posting it to discuss goals, results,
R2.3 Essential
and progress. This will be an opt-in/opt-out service for patients, and
compliant with GDPR. Specific
Reminders for timely task execution: The ROSIA Open platform

services should wherever feasible be able to do alerting & reminders Functional
for timely task execution for both HCP's and Patients, preferably using
R2.4 best of breed nudging and intelligent alerting, reverse reminders etc. Essential
The nature and frequency of reminders should be programmable, e.g., Illustrative

for designing protocols, having time & date windows etc.
Managing care transition: The ROSIA Open platform should be able to

support relevant communication & information to handle transition
from one phase of care to another – from acute hospital to community Functional
R2.5 setting, and lifelong self-management. On occasion, it may include Essential
hospital readmission, care transitions, and demonstrate e.g., a Illustrative
discharge plan via the sandbox mode light interface through manual
input or upload, and be able to display via the Shared Care Plan service

Access to all patient information in the ROSIA Open Platform services Functional
R2.6 should be able to be granted via role based access to patients Essential
information using identity access management with real time logging Illustrative
Shared data across professionals and
sectors (Integration of existing IT systems) Functional
The ROSIA Open platform services shall allow healthcare professionals
R2.7 Desirable
to schedule and update events (i.e., appointments, training sessions)
Illustrative
Facilitate tools for improved communication among health and care

professionals and with patients and carers: The ROSIA Open Platform
shall be able to handle direct and indirect communication to and from
the patients in different ways using different channels either via the
social media channel management or the chat & messaging services.
All direct clinical information sent to enrolled patient's needs to
Improved communication among health comply with patient safety and privacy laws. The messaging service Functional
and care professionals and with patients R2.8 should be built as one interface for the HCP's and be able to be Essential
and carers integrated to each of the patients’ prescribed apps in the ROSIA Illustrative
Catalogue services
The ROSIA solution communication services should not be designed as
a 24/7/365. In case of out of office hours and/or the communication
should allow for custom messages e.g to indicate what to do in an
emergency situation, and that patient is advised to contact 112, their
GP, or await response to non-urgent queries within business hours.
Reporting: The ROSIA Open Platform services shall allow for generating Functional
reports using standard BI tools with visuals for different aspects, e.g.,
Dashboards, Notification and reporting R2.9 Desirable
goals, alerts, medication, queries. Reports shall be available in
different formats via (minimum: PDF, HTML) and print friendly. Illustrative

The ROSIA solution shall provide analysis and summaries of the care
provided and its outcomes per patient. The analysis can be viewed by
the healthcare professional on request (pull). The analysis shall include
medical (e.g., blood pressure values) and organisational (e.g., waiting
times to appointment, reaction to messages sent) quality parameters.
The healthcare professional shall be able to perform different data
extractions and data sorting for analysis purposes.
The Data report and insight shall aim to highlight patterns, e.g. by
using proven/regulatory AI analytics/ML from data parameters history
to support better decision making of health and care professionals.
The ROSIA solution shall aim to provide clear, user-friendly
visualisation of key data. The visualisation shall allow for selecting
various levels of detail (e.g., displaying blood pressure measurements
for the last month, three months, half year, one year) and shall use
suitable visualisation techniques (e.g., charts, tables).
Notifications: ROSIA Open Platform should allow defining of thresholds

related to a list of vital signs deviation, abnormal activity, poor
adherence, or drop out of the rehabilitation program, e.g., by using the
protocol editor services combined with a thresholding engine.
Frequency of notifications should be programmable and the ROSIA Functional
Catalogue Service providers should be able to access and programme
R2.10 this via the ePROM API's in the Developer layer. Essential
The notifications can be via a dashboard for all patients in different Illustrative
patient groups with e.g. different alerting levels (Red, yellow, Green),
non-compliance etc. The HCP's should be able to process the results of
the different ePROMS, e.g. via clinical notes and process and send
automatic receipts to patient that their data have been reviewed.

CHARACTERISTICS
Non-functional
/Functional
DesirableConvenient
CH3 Facilitate patient empowerment, education, and motivation to foster adherence to rehabilitation at home and self-management
Facilitate digital literacy for patients: The ROSIA Open Platform should
be able to facilitate and support digital literacy for patients, by
providing training, mentoring and support for patients and their
caregivers in the use of the digital tools necessary to make use of Functional
R3.1 ROSIA, including troubleshooting management. Essential
It could include interactive educational materials, manuals, videos, Illustrative
Education and support for patients and demonstrations, games, personal support, etc. that should be made
caregivers available in the health content management services and delivered
using the different Service delivery channels
Facilitate therapeutic education: The ROSIA solution shall support

education of its patients to promote long-term management of the Functional
R3.2 relevant condition and the rehabilitation process including education Essential
on managing co-morbidities, maintaining a healthy lifestyle, training Illustrative
on the use of assistive devices, etc.

The information shall be provided in a variety of formats - paper-

based, electronic documents, video and audio and be available via the
health content management service
Technical assistance to patients and family: ROSIA suppliers should

provide technical support to end users in all the processes related with Functional
Services in the ROSIA Catalogue: installation, maintenance, on-
R3.3 line/phone support and training. Essential
ROSIA suppliers should facilitate a communication line for patients in Illustrative

the languages of the procurers’ countries.
Provide Psychological and Emotional Support for patients and family:

In order to provide personalised tailored services, the ROSIA Catalogue
services shall take into account the following personalisation data
regarding a better provision of e.g. training to patients: age, sex,
literacy level, emotional state, numbers (individual and group Functional
sessions), diagnosis, etc. Service providers included in the ROSIA
R3.4 Catalogue shall aim to also provide psychological and emotional Desirable
support for patients and family using e.g. access to video-conferencing, Illustrative
Promote permanent lifestyle change, and offer peer-to-support etc.
motivational support Psychological and emotional support shall aim to be based on real time
insights and be personalised to the individual and context, e.g., using a
virtual coach or similar.
Peer support for patients and family: Include digital tools and
resources to engage patients with existing networks of peers. Functional
R3.5 The ROSIA platform shall enable HCP's to the identification of training Essential
partners (patients’ users) with similar training levels and training Illustrative
interests using the data reporting services.

The ROSIA solution shall provide channels for its patients to

communicate about their disease, and professionals to be able to
exchange ideas with colleagues and provide advice to patients if they
wish to do so, using e.g. the social media channel management or via
ROSIA Catalogue service providers’ offerings.
The ROSIA Open Platform shall allow the sharing and comparison of
patients’ data with consent to e.g. gamification purpose in e.g. group
training or peer-to-peer groups.
Functional
Nutritional support: Provide guidance and advice to patients and
R3.6 Desirable
carers following new nutritional recommendations.
Illustrative
Engage with community intervention: The municipalities and/or care

providers may promote activities to foster engagement of citizens with
healthy habits, such as soft sports or nutritional workshops. ROSIA
should provide tools to promote the engagement of the patients with Functional
R3.7 those activities, with guidance from their care team. Desirable
The ROSIA Catalogue should include Services to enable the collection Illustrative
and storage of various community supports and resources for patients,
including volunteer resources, community self-help groups or support
groups, or trusted resources (images, text, links to websites, etc.).

CHARACTERISTICS
Non-functional
/Functional
Desirable
CH4: OPEN PLATFORM
ROSIA Open Platform services should be available to its users at any

time, and in any channel of their choosing of the most used operating
system distributions (specify: Window / MacOS/ Linux OS's); Services Non-functional
R4.1 and Apps running on the browser should be compatible with of the Essential
most used browsers (specify: Chrome, Firefox, Opera); Services and Illustrative
Availability Apps running on mobile OS's should be compatible with of the most
used mobile OS's (Android, iOS, Huawei );
ROSIA Open Platform will be expected to be available in some capacity Non-functional

99.9 % of the time. Down-time should be expected and planned. The
R4.2 Essential
solution will employ industry best practice standards to ensure high
availability. Specific
Non-functional
ROSIA’s Open Platform should be designed with a high degree of
Flexibility R4.3 Essential
flexibility.
Specific

ROSIA Open Platform should be multi-organization and multi-tenant Non-functional

capable. i.e. Multiple organisation teams should be able to operate on
R4.4 Essential
a single instance of ROSIA Open Platform, and isolated from each other
utilising industry standard tenant structure. Specific
Non-functional
ROSIA’s Open Platform should be able to accommodate the integration
R4.5 Essential
of a heterogeneous variety of technological frameworks.
Specific
Non-functional
ROSIA’s Open Platform should be able to respond to the workload at
R4.6 Essential
any given time, automatically.
Specific
Non-functional
ROSIA Open Platform should be able to spin-up additional service
R4.7 Essential
instances during periods of high usage using e.g., load balancers.
Specific
Non-functional
ROSIA Open Platform should be able to terminate excess service
Scalability R4.8 Essential
instances during periods of low usage.
Specific
Non-functional
ROSIA Open Platform should be able to measure the usage of each
R4.9 Essential
service and its associated instances at any given time.
Specific
ROSIA Open Platform's web portal should be designed for use by Non-functional
R4.10 healthcare professionals and patients respectively, and modelled for Essential
scalability and resilience. Specific

Non-functional
ROSIA’s Open Platform should exhibit high tolerance to service failure
R4.11 Essential
events.
Specific
Non-functional
ROSIA Open Platform should be able to detect failure events on any
R.412 Essential
given service instance.
Specific
Resilience
Non-functional
ROSIA’ Open Platform should be able dispose of failing service
R4.13 Essential
instances automatically.
Specific
Non-functional
ROSIA Open Platform should be able to automatically build and spin-
R4.14 Essential
up replacement service instances.
Specific
The ROSIA Open Platform should be built as cloud native using proven Non-functional
and open source components as much as possible. The cloud is
R4.15 Essential
expected to be commercially available and approved by the sponsor
country or region for healthcare use. Specific
Non-functional
Architecture & Security The ROSIA Open Platform should be based on multi-tier architecture
R4.16 Essential
(at least 3-tiers)
Specific
Non-functional
ROSIA’s Open Platform should enable fast integration of multiple
R4.17 Essential
systems from its different architectural layers.
Specific

Bidders must ensure that documented processes and technical Non-functional

mechanisms exist for logging and continuous monitoring of secure
R4.18 Essential
access attempts, command execution to any/all information assets,
and Core Solution/App changes. Specific
Bidders must enable operational, security and administrative logs on

servers and applications. A log monitoring and correlation tool should Non-functional
be allowed to collect logs from servers. Logs should be retained at
R4.19 Essential
least for 180 days and follow applicable law. Vendor must restrict
access to security logs to authorised individuals, and protect security Specific
logs from unauthorised modification
Solution must use Certificate Pinning or HTTP Public Key Pinning

(HPKP) to prevent man-in-the-middle attacks and two-way
authentication to gain non-repudiation and authentication capability Non-Functional
of both the server and client. Make sure that all connections to your
R4.20 Essential
servers are encrypted (if applicable) using best practice configurations
(i.e. currently TLS 1.2 or TLS 1.3), do not accept user-accepted Specific
certificates as authorities, and make sure certificates are up-to-date
and signed by a trusted CA.
Functional
Operational feature to allow tracking of various steps being carried out
R4.21 Essential
as part of The ROSIA Open Platform’s processes.
Specific
Non-Functional
Solution should invalidate/verify a user’s session upon logout – on
R4.22 Essential
both the client and server side
Specific

ROSIA’s Open Platform should follow a methodology that enables fast

deployment of services and fast bug fixing and patching, which Non-Functional
Fast agile development and automatic
R4.23 includes the creation of a pre-deployment environment where testing Essential
deployment
(for performance) and benchmarking (of security) of apps and services Specific
could be carried out.
3.7.1 ROSIA’s Open Platform should ensure semantic interoperability Non-Functional

between services through compliance with the global Healthcare
R4.24 Essential
standards where applicable with: IEEE 11073 Personal Health Device,
Continua, HL-7/CDA, FHIR, ICD, LOINC, DICOM, IHE Specific
ROSIA’s Open Platform should implement an interoperability strategy Non-Functional

encompassing technical, software and semantic interoperability to
R4.25 Essential
Interoperability ensure data handling and transparency between the devices and
services associated with its architectural layers. Specific
Non-Functional
ROSIA Open Platform should be capable of integrating with SMART on
R4.26 Essential
FHIR compliant Solutions
Specific
Non-Functional
ROSIA’s Open Platform should implement data protection and privacy
R4.27 Mandatory
protocols in compliance, at minimum, with GDPR.
Specific
Data Protection, sharing Privacy and ethics
ROSIA Open Platform should be designed to share data directly with all Non-Functional
R4.28 stakeholders involved in the integrated care pathway across sectors, Mandatory
and to facilitate involvement of users. Specific

ROSIA’s Open Platform should be designed with privacy and data

ethics in mind, so that the user can exercise individual data control, Non-Functional
R4.29 and decide with whom they share their data and be able to see who Mandatory
has access to it. The platform should use technologies and services Specific
that create and communicate trust to users.
ROSIA Open Platform should have the capability to implement the Non-Functional
feature where the Data subject has the Right to data portability:
R4.30 Essential
personal data given in a structured, commonly used and machine-
readable format Specific
Non-Functional
Data Retention: Vendors should provide data retention periods that
R4.31 Essential
align with international best practises and law of the land.
Specific
ROSIA’s Open Platform should facilitate methods to allow e.g., Non-Functional

R4.32 anonymous data donation for secondary uses like research, using the Essential
best of breed of 0-proof knowledge technologies Specific
ROSIA Open Platform should have the capability to implement the Non-Functional
R4.33 feature where the Data subject has the Right to rectification of Mandatory
inaccurate personal data Specific
ROSIA’s Open Platform should implement a governance model that Non-Functional

Governance R4.34 facilitates cooperation with all stakeholders and that describes Essential
procedures for education, maintenance, and handover to buyers. Specific

The ROSIA Open Platform should have a provision for validation of Non-Functional
R4.35 business rules that can be changed easily by the user without program Essential
changes. Specific
Non-Functional
Documentation describing detailed business logic that's applied in the
R4.36 Essential
application must be provided.
Specific
Vendors must provide a detailed features list and functional Non-Functional

R4.37 specification design documents for the ROSIA Open platform Essential
Catalogue and Developer Layer Specific
Non-Functional
Detailed documentation of the various integrations across various
R4.38 Essential
solutions must be provided
Specific
Non-Functional
ROSIA’s Open Platform should facilitate light user interfaces relying on
R4.39 Essential
a “heavy” infrastructure.
Specific
Non-Functional
The application should be multi-language capable with support for
Interfaces R4.40 Mandatory
Portuguese, Spanish & English and other regional languages
Specific
Non-Functional
Corporate branded multilingual app or portal - The application should
R4.41 Mandatory
be customizable to each buyer regions branding and theme
Specific

Relevant ROSIA services in the open platform have to be accessible Non-Functional

R4.42 through a mobile responsive web interface, that can be branded to Essential
each buyer region Specific
Non-Functional
The solution shall conform to the UAAG 2.0. and WCAG 2.0 at a
R4.43 Essential
minimum level 2 (AA).
Specific
Non-Functional
R4.44 ROSIA’s Open Platform should not accept proprietary solutions. Essential
Specific
Openness
Non-Functional
ROSIA’s Open Platform should have proven existing EU, national
R4.45 Essential
and/or regional infrastructure components as first choice.
Specific
Non-functional
ROSIA’s Open Platform should support BYOD (Bring Your Own
R4.46 Desirable
(medical) Device) wherever feasible.
Specific
If feasible, ROSIA Open Platform should integrate with a suitable Non-functional

mobile device management middleware to remotely manage
Devices R4.47 enterprise apps installed on user's BYOD devices. Desirable
Specific
Functional
R4.48 Identified HCP user groups should be able to add/ update device Desirable
details, link the prescribed device to the Patient’s profile and EMR/HIS,
Specific

and check for connectivity with the applications on the ROSIA

Catalogue.
Compute resources provide processing capabilities for client service

requests. Compute servers can be physical (on-premise), virtualized Non-functional
R4.49 (virtualization software on existing server) or cloud based. This also Essential
includes a server side operating system such as Windows Server Specific
Infrastructure (licence-based) or Linux (open-source).
Storage servers allow for storing, accessing, securing and managing Non-functional
R4.50 data (documents, audio files, video files, operational data etc.). Data Essential
can be stored on-premise, or on cloud with a cloud service provider. Specific
Non-functional
All regulations described on table 3,“Required regulation &
Regulatory Compliance & Certifications R4.51 Essential
Certification”, in section 2.2.6.6 should be accomplished .
Specific

CHARACTERISTICS
Non-functional
/Functional
Desirable
CH5: ROSIA DEVELOPERS
ROSIA’s Developer’s Layer should provide solution developers with the Non-functional
R5.1 SDK's and API's necessary to create, integrate and deploy new services Essential
to the catalogue. Specific
Developer Tools ROSIAS's Developer's layer should provide resources to fast track the
first stages of development (E.g.: Tutorials for setting up services in the Non-functional
R5.2 ROSIA platform, reusable, and customizable code snippets for key Essential
standard functionalities, providing a base service code sample example Specific
functioning as a "Hello World" on the ROSIA Platform).
Non-functional
ROSIA’s Developer’s Layer should provide solution developers with the
Developer Support R5.3 Essential
documentation for the SDK's and API's necessary for development.
Specific

Non-functional
ROSIAS's Developer's layer should provide a Developer Community
R5.4 Desirable
Support Channel (E.g.: Developer Forum).
Specific
ROSIA’s Developer’s Layer should provide solution developers with the Non-functional
R5.5 necessary integration, development, and quality assessment Essential
workflows. Specific
ROSIA’s Developer Layer should implement an automated Continuous Non-functional

R5.6 Integration / Continuous Deployment (CI/CD) pipeline for the inclusion Essential
of new services and solutions into the platform. Specific
Development Process
Non-functional
ROSIA Developer’s Layer should provide solution developers with a
R5.7 Essential
best practises document for integration and deployment.
Specific
Non-functional
ROSIA’s Developer’s Layer should implement a Quality Assessment
R5.8 Essential
pipeline.
Specific
ROSIA’s Developer’s Layer should implement the development Non-functional

processes in light of the current standards and regulations for the
Regulatory Compliance R5.9 Essential
deployment of e.g., medical devices and other relevant requirements
such as the GDPR. Specific

CHARACTERISTICS
Non-functional
/Functional
DesirableConvenient
CH6: ROSIA Catalogue
Non-functional
ROSIA’s Catalogue should support only services and devices built with
Openness R6.1 Essential
open access software and hardware.
Specific
Non-functional
ROSIA’s Catalogue should ensure the accessibility of the services and
Accessibility R6.2 Essential
devices provided.
Specific
Non-functional
ROSIA’s Catalogue should integrate the relevant solutions available for
Integrated Care Pathway R6.3 Essential
a given condition into each given step of the care pathway.
Specific

Vendors should provide details of all the third-party libraries that are
being used in ROSIA Open Platform, especially (but not limited to) Functional
those APIs and libraries utilised for data access and security
R6.4 Essential
mechanisms (e.g., encryption). Vendors should provide clear
documentation related to what mechanisms have been followed to Specific
test and harden such code before using it in ROSIA Open Platform.
Vendors should provide details of all the third-party libraries that are
being used in ROSIA Open Platform, especially (but not limited to) Functional
those APIs and libraries utilised for data access and security
R6.5 Essential
mechanisms (e.g., encryption). Vendors should provide clear
documentation related to what mechanisms have been followed to Specific
test and harden such code before using it in ROSIA Open Platform.
Apps and Services brought into the ROSIA Catalogue should be

provided with documentation describing the handling of its Functional
R6.6 certification and testing procedures, including if feasible, a list of Essential
measures to ensure the creation of trust in the validation and test Specific
procedures.
The ROSIA catalogue should provide a quality management and Functional

certification strategy which may also allow for certifying the solution as
R6.7 Essential
medical devices, if necessary. Standards such as ISO 9000, ISO 13485
may apply. Specific

CHARACTERISTICS
Non-functional /
Functional
DesirableConvenient
CH7 Value Based Care Model
All Relevant data from ROP, e.g. intervention Types, outcomes etc. Functional
Provision of data for ABC analysis - Activity-
R7.1 should be available for analytics to facilitate the Activity Based Costing Essential
Based Costing
(ABC) models. Illustrative
Functional
Be able to capture all relevant information, including data from the
Data analytics capabilities R7.2 Essential
dynamic PREMs and PROMs questionnaire engine.
Illustrative
Functional
Be able to provide example template dashboards for presenting the
Value based healthcare visualisation R7.3 Essential
value based health care approach for analytics and reporting
Illustrative
Table 5 ROSIA requirements

Legal and Regulatory requirements
CHARACTERISTICS
Desirable
Essential
Include an adequate description of the nature of the provision of the
LR1 Illustrative
services where they involve the processing of personal data.
Adherence of a processor to an approved code of conduct as

referred to in Article 40 GDPR or an approved certification
Data processor reliability 19 mechanism as referred to in Article 42 GDPR or:
▪ Favourable compliance audit report issued by a trusted third party. Mandatory
LR2
▪ Favourable security audit report issued by a trusted third party. Illustrative
▪ Certification or accreditation of the training of its personnel in
personal data protection, confidentiality and security.
▪ Have a data protection officer or legal support in this area.
▪ Have a security officer or technical support in this area.
19 Providing
sufficient guarantees to implement appropriate technical and organisational measures in such a manner that processing will meet the
requirements GDPR and ensure the protection of the rights of the data subject (art. 28 GDPR)

Providing adequate guarantees regarding international data Mandatory

LR3
transfers in case of Non-EU country location Specific
Compliance to apply methodologies for data protection by design Mandatory

LR4
and by default as required by Art. 5 and 25 GDPR Specific
Ensure Data Protection by design and by default Compliance to that applied methodologies of data protection by
design and by default are in line with the Guidelines of the European Mandatory
LR5
Data Protection Board and the specific Guidelines of the national Specific
data protection authorities of the procurers' countries.
Ability to apply a risk-based analysis methodology that meets the

LR6 standards required by the GDPR to quantify and map acceptable
levels of risk in a processing operation.
If feasible, provide a short description of the provision of

LR7 pseudonymisation techniques and encryption of personal data that
could andor will be implemented.
Security of Information Processing & Business Describe compliance to the measures to ensure the continued Essential
continuity measures LR8 confidentiality, integrity, availability and resilience of processing
Specific
systems and services that are intended to be implemented.
Describe what planned measures will implement to ensure the

LR9 ability to restore availability and access to personal data quickly in
the event of a physical or technical incident.
Compliance to the risks presented by the processing as a result of

LR10 the accidental or unlawful destruction, loss or alteration of data that
are transmitted, stored or processed, or the unauthorised disclosure

of or access to such data in order to assess the level of security

applied
Compliance to implements measures to ensure that persons

LR11 authorised to access data only process them in accordance with the
instructions provided
Ensure compliance with the obligations of the ePrivacy Directive on Essential

Mobile Applications LR12
user permissions and cookies/fingerprints Specific
Table 6 Legal and Regulatory requirements

2.4.1. Other requirements
Other requirements
CHARACTERISTICS
Requirement
Desirable
Affordability and competitiveness: The solution itself and its

CBR1
elements shall be affordable and highly competitive in the market.
Cost of ownership: The solution developers shall provide the

CBR2
solution at low total costs of ownership.
Business plan and strategy: The ROSIA solution developers shall Essential
Commercialization and Business Plan
provide a business plan strategy describing the approach for Illustrative
CBR3
commercializing the solution (including market expansion plans,
business models, etc.)
Commercialization plan: The solution developers shall provide a

CBR4 commercialization plan including the market analysis, risk
management, principles for licensing, pricing, distribution, etc.)
Bidders should provide a change management plan, describing the Functional

Change management CM1 proposed approach to facilitate the deployment of the pilot Essential
operation phase and the acceptance by all participants. Illustrative
Table 7 Other requirements

2.4.2. Change management
Bids are to include a change management programme to support the successful

implementation of the new care pathways in each validation site in Phase 3.
Such a change management programme has to include preliminary plans for implementing
solutions, training all stakeholders involved in the solution deployment, and comprehensive
monitoring and review points.
At the very least, the following areas should be addressed:
• Integrated care: scheduling of the shared care plan and the clinical pathways defined
by each procurer for the selected pathologies.
• Model change training for all professionals involved in the validation phase.
• Global monitoring and evaluation of the activities and services throughout the
duration of the pilot. Identification and measurement of key indicators.
• Training and support for patients and family/care networks.
2.5. A use case to illustrate the ROSIA model implementation.
A person living with chronic spinal injury (Ted use case)
Ted is 55 years old and is a farmer in Rathdaggan, close to the Blackwater River and 42 Km
away from Cork. He lives with his wife Anne (50), a teacher in a catholic school in nearby
Fermoy (16 Km away) and his three children, Paul, Sinead and Eamon (8, 13, 27). Ted is a very
active man who works all day on the farm, with crops and cattle. Ted has a history of
cardiovascular disease and manages it with dietary changes, medication, and some light
exercise. Farm work also requires daily care of facilities, repairs, and improvements, etc. It
also involves travelling to fairs, purchasing seeds, cattle, materials, etc. It is almost a 24/ 7 job
requiring being ready for emergency scenarios, e.g., having to respond to a call that cows have
escaped a field during the night, or he finds out late in the evening the tractor engine has a
problem and has to repair it.
On a routine day with no such scenarios, Ted likes to spend some evenings with friends in the
pub in Fermoy. Other evenings he goes horse riding, and often he is just playing or watching
TV with the children. In addition, Ted is passionate about hiking in nature. Ted uses social
media regularly and owns a smartphone and a tablet, but is not “tech-savvy” (e.g. limited use
of these items).
The onset of Spinal Cord Injury
One afternoon Ted was repairing the barn roof when he accidentally slipped from the ladder.
The family immediately called an ambulance and took Ted to the emergency department in
Cork University Hospital. Ted had emergency surgery in the hospital. After the surgery, the
doctor told the family Ted had a spinal cord injury (complete thoracic paraplegia) and would
therefore need rehabilitation. Rehabilitation services in Ted’s local area were unable to
provide a suitable rehabilitation service to meet the extent of Ted’s rehabilitation needs. The
surgeon informed Ted and the family that they would be referred for admission to The
National Rehabilitation University Hospital (NRH), in Dublin, 200km away.
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Inpatient Stay in NRH
After an initial assessment, a care plan including long- and short-term goals was tailored for
Ted with an estimated length of stay at the NRH for 12 weeks. Ted progressed well through
this phase of rehabilitation, but after discharge, he still needed local rehabilitation.
Unfortunately, this local rehabilitation was problematic because of the lack of availability of
community services, and Ted and his family could not afford a private service. As a result, Ted
will not be able to regularly attend the face-to-face rehabilitation appointments and support
services. However, it is confirmed that Ted has access to broadband at home, he owns a tablet
and smartphone, and he is a medium level user of technology. Therefore, Ted is an excellent
candidate to use the ROSIA services, and when offered, Ted and his family agree.
In his final week of discharge, Ted met some outpatient rehabilitation staff for an in-person
review. Goals were set with the interdisciplinary team (IDT) and entered the onboarding
procedures of the ROSIA platform.
Preparation for Discharge
Before discharge from the hospital to the home, all care teams supporting Ted in the
community are assigned to Ted’s case, and all relevant information is made accessible in the
ROSIA Open Platform for, i.e., the specialist rehabilitation team, local hospital, and community
team to understand Ted’s history better. Before discharge, a comprehensive assessment is
completed in place, and a personalised Shared Care Plan and goal setting. Finally, the
multidisciplinary care team prescribes Ted to use three different apps from the ROSIA
Catalogue to offer the decided rehabilitation plan, communication channel, review and follow-
up frequency and alerts. The first one is an app to keep better track of his CVD and to
coordinate better between the people involved in the circle of care. Second is the ROSIA NRH
Connect* app (*invented name for the use case), where Ted has access to messages, video
calls, plans, goals, appointments, prescribed medicine, education, and instructions. The ROSIA
NRH Connect app also links to select social media information sources, including peer to peer
support groups co-organised by his local care team. They feed information from the health
authorities to the peer-support groups informing about, e.g., free education, training plans,
tips and new research results.
Finally, he is getting a specialised exergaming app with a built-in training plan, virtual health
coach, and monitoring of his exercises via sensors and using an augmented reality camera to
help him perform the movements better. The app is paid using a kind of no-cure - no pay
model but has proven to be highly successful in achieving excellent results for other patients
in a similar situation.
All new local ROSIA Open Platform Clinician users like Ted are given training in using the ROSIA
Open Platform, with access to timely support. ROSIA portal is easy to use, as patients can
access the ROSIA Open platform backend services using a simple internet browser. They can
access them on any device with a browser, including their smartphones. It makes
communication and care transitions between Ted, the local care team and the NRH easier. All
procedures and internal workflows about what each member in the care team have to do and
the agreed coordination around Ted are available for the care team.
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ROSIA appointments are booked (before discharge) using the Appointment Management
service, and both Ted and his clinicians can see his subsequent appointments. Specific ROSIA
training devices are provided, and apps selected (such as co-morbid CVD self-management,
one app to help access the different community services and a peer-to-peer network, where
he also can see wheelchair accessible trails). Finally, Ted is prescribed the training app and the
app service provider is notified of the new patient and arranges for delivery and training in
the use of the AR/VR exergaming app and the sensor devices.
The app provided to Ted has already been tested and certified for use in the ROSIA Catalogue
(as all other apps available in the service), and passed the different requirements for patient
safety, usability, and data privacy. The app uses the modern ROSIA open API and
documentation (freely available for all to utilise to develop services for the ROSIA platform
that have spread rapidly to many regions in the EU countries). The developers of Ted’s app
used the ROSIA Developer modern APIs to connect their service easily into the ROSIA Open
platform services so that the Care team can see data, including communication services from
all the different apps in one unified platform, and Ted can be prescribed the app most suitable
to his needs.
Discharge Home
Discharge from NRH to a home environment with referral to a local public health nurse for
follow up of a healed pressure injury.
Ted was provided with a home exercise programme (HEP) on discharge from the inpatient
setting, and outpatient staff offered additional advice and education before his first
appointment.
Ted was shown the peer support section on the ROSIA Portal via his iPad, including a subgroup
of farmers with SCI. In addition, Ted’s wife can access the SCI family section of peer support
on the platform. It’s linking to the social media groups via the channel manager so that NRH
can supply official verified news and tips to all members of the peer-to-peer support network.
Once at home, Ted starts using the ROSIA Catalogue services and can see his Shared Care Plan
goals and other information in the ROSIA Patient portal. He can access a tailored rehabilitation
programme to continue with his rehabilitation, to be as independent as possible at home as a
first step. He would like to be able to self-care and self-manage his conditions as much as
possible in the future using the services offered via the ROSIA platform.
Ted uses a new Augmented Reality virtual coaching app for his iPad and gets Interactive
feedback from a virtual personal coach. The virtual coach is getting sensor data from his new
wearables when training. Using AI, the virtual coach advises/gives feedback regarding, e.g.,
quality of movement, the velocity of movements, no. of repetitions, etc., tailored to Ted from
the biofeedback. His exergaming app sends data about completeness and progress towards
the goals to the ROSIA Open Platform using the developer layer API, and Ted can see all his
data in the NRH Connect App.
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Ted regularly needs to give feedback on his progress in the ROSIA apps. He has been assigned
questionnaires using the ePROM editor (SCI QoL, Vital signs); ePREM (SF-36) built from
protocol editor using general and personal thresholds to measure his progress. Some of the
data is automatically retrieved from his exergaming app, and some he needs to fill out
manually. He is taking his Blood pressure every morning using the front camera of his
smartphone in the Remote patient monitoring app he got. The NRH team designed 2x ePROM
standard questionnaires and assigned them for the patient to fill out at specific times, e.g.
twice a week and biweekly. He is reminded if he forgets, and the care team can also see
notifications for missing the timeframe set for the ePROM’s. The Care team will get
notifications for non-compliance if Ted misses the questionnaires. A care team member will
contact Ted to make sure he is kept motivated if he does not perform his daily tasks. This
alerting has proven to be vital to keep his motivation high.
In the ROSIA NRH Connect app Ted can:
• See his shared care plan and achievement towards his goals and his improvement over
time
• See his replies to all questionnaires.
• See His training data outcome from the exergaming app.
• Access his training and meal plans and instructions.
• See all messages and access his peer-to-peer support groups on social media.
• See his medication schedule in the Shared Care Plan. Ted’s GP can communicate with
the rehab team to discuss medications prescribed by using the ROSIA portal services.
The pharmacist can provide educational materials through the App that even has
applied nudging features and reverse reminders from his smart pillbox, e.g. increased
medication adherence.
• Modify the times for the exercises and score them based on effort and comfort. Based
on this score, the following exercises are modified accordingly automatically in the
exergaming app.
• See the notes/messages from his care team when the exercises, questionnaires or
treatment is reviewed from his care team.
• Receive and request video consultations.
• Take and send notes or messages to the care team. In case of emergency, Ted is
instructed to contact the regular emergency services.
The care team involved, including the leading rehabilitation team at the hospital, social
services, community care and the liaison coordinator, can see all the information in a
structured and easy to read interface. It has an easy overview via dashboards to his data from
all the three different apps he was prescribed. His CVD Self-management app, the exergaming
app for Spinal cord injury, and the NRH ROSIA Connect App for all patient users using the
telerehabilitation services. Ted can also see all his data by logging into the ROSIA portal on a
browser on any device using his National eID.
The ROSIA platform facilitates the communication between Ted and the care team, and
between members of the care team. They receive alerts when they get messages and can
track if the messages sent have been read and responded to.
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When they process Ted’s self-reported ePROM and ePROM data in the ROSIA Open Platform
through the portal browser access, they can acknowledge and send a receipt to Ted that they
have reviewed the data. If his data is outside thresholds, it shows as red and yellow
notifications; the responsible care team member can make necessary interventions and
schedule video consultation with Ted and one or more of the Care team.
Data and information are safe and secure in the platform, and every member of the care team
can only access the data based on their role. Ted can always see who has accessed his data.
He can even decide to consent and withdraw consent to share his personal data securely and
anonymously for research to 3rd parties. Ted decides to support three different research
requests, one from his exer-game app service, one public research project from NRH, and one
from a pharmaceutical company. Ted likes that the data-sharing service from a 3rd party uses
some technology where his identity and data are kept private.
Pressure Injury
Ted notices the healed pressure injury is red again. Following his shower in the morning, he
takes a photograph and sends a message to his NRH team for review and advice via the ROSIA
platform using the NRH Connect app. They liaise with the local public health nurse who has
been given access to the platform, who reviews the images whilst on a video call with the NRH
staff. They contact Ted to discuss the plan and advise him to stay off it/lie prone until it’s
healed, and the public health nurse arranges a home visit. An alert/medical update clinical
note is attached to Ted’s file to inform the other team members of this change in
activity/status.
The physiotherapist provides new information on positioning and exercises whilst confined to
bed, and he is assigned a new questionnaire from the ePROM. Ted's NRH Connect app
immediately shows the new questionnaire in Ted’s list. The occupational therapist provides
new information on graded return to sit and recommends specific equipment to
hire/purchase when returning to sitting. The social worker in NRH supports Ted, arranges
teleconsultation appointments, and encourages engagement with the ROSIA peer support
groups. Psychology arranges a meeting for Ted to address his mood and adjustment post-
discharge. Psychology observes that Ted has not been eating due to his mood/prolonged bed
rest, and Ted consents to a dietitian referral. The dietitian provides information and education
on strategies to promote wound healing and change meal types to avoid feeling too full when
lying prone. Ted uses the ROSIA NRH Connect app to send data regarding changes in
positioning, inform about mood changes and his diet over the next four weeks using the HADS
ePROM mood questionnaire and the diet questionnaire, and is encouraged to eat specific
snacks at certain times of day.
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Ted sends regular photos to the NRH team and the local public health nurse to guide their
collaborative management plan wound care. He gets instructed to use a card with QR code
with his case number, and a ruler, he needs to put next to his wound photo to guide the local
wound nurse and specialist to better evaluate the wound. The photos are analysed using AI to
help guide the nurse in the deterioration of the pressure wound. Ted gradually returns to
sitting for short periods and transferring independently and using shower chair again under
IDT guidance. Ted’s lower limb spasms have worsened over time – NRH team requests a urine
sample from the local public health nurse; a video consultation appointment was arranged for
a medication review; recommendations were made and forwarded to Ted’s GP in addition to
routine blood work and arrange other routine follow up locally. Ted’s medication list is
updated in the ROSIA platform that is updated using the new national medication card service
API. Now everyone can see the actual medicine list, changes and the patients can order new
prescriptions directly, and it is sent to either the GP or specialist doctor in NRH in charge.
Ted has most of his reviews and follow-up appointments virtually through the ROSIA platform.
He finds them helpful and makes it easier to have regular reviews with his care team either in
the community or hospital. He still appreciates face-to-face visits but recognises the benefits
of saving some unnecessary travel.
Because of the ROSIA services, Ted feels he is more capable of his care and has more say in it.
He feels his care is better coordinated because everybody involved is updated with all the
relevant information. The care team feels the quality of the care offered to Ted is better using
the ROSIA solution. On the one hand, they can access all the information in an easy to read
and structured dashboard. On the other hand, they see the value of the alerts and internal
communication channels. He can communicate with all the care team members; they can also
raise questions to the members with more expertise to improve their capacity and feel safer
when they have questions.
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3. Final remarks
3.1. Expected results per phase
ROSIA PCP is willing to unlock the telerehabilitation market by purchasing the development of
a technological innovation ecosystem, enabling service providers to provide telerehabilitation,
and self-management & self-care of rehabilitation at home, at scale.
Consequently, the main focus of ROSIA PCP is to develop its ecosystem; to develop the ability
of its Open Platform to implement integrated care models (defined by each of the procurers
according to their current needs); to ensure the seamless integration of the shared care plan
with the services in its Catalogue; and to develop the ability to flexibly configure and collect
KPIs.
The core value of the R&D process relies on CH4 (ROSIA Open Platform), CH5 (ROSIA
developers layer), and CH6 (ROSIA Catalogue). Consequently Phases 1 and 2 will be focused
on developing the ROSIA Ecosystem.
However, the final purpose of this development is implementing ROSIA's telerehabilitation

care model, defined in CH1 (Telerehabilitation), CH2 (Integrated Care), CH3 (Patient
empowerment) and CH7 (Value Based Healthcare). For this reason, Phase 3 will include a full
proof of concept by populating the catalogue with services that empower patients, targeting
a given set of pathologies. These services should be integrated with the aid of the SDK and the
data sharing layer. Furthermore, the proof of concept should assist in validating the tools that
define the integrated care model and the KPIs for each of the implementation sites.
To facilitate the development of such a solution, no limits have been set on subcontracting,
and the services to be integrated in the validation phase are not limited to those provided by
the members of the consortium.
A detailed description of what is expected in each phase has been provided in TD1.
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3.2. Expected outputs
ROSIA's Value-Based Healthcare model will identify the most appropriate outcomes and KPIs
to measure the impact of the services integrated in its Catalogue. These KPIs are to be
consistent and allow automatic collection of the data required to measure them.
Identifying these indicators will help generate a baseline for future PPIs and deployments of
services through Value-Based Procurement.
The table below should be interpreted as an example of expected outcomes and KPIs. The
impact assessment framework will be developed before pilot execution and will not affect the
evaluation of bidders nor payments in the current PCP.
VBHC Outcomes and KPIs
Stakeholder Outcome Indicator
• Survival rate (%)

• Hospitalization (%)
• Repeat operations after
• Better medical outcomes
complications (%)
• Reduction of hospitals
• PROMs
visits
• Unplanned admissions, and
• Fewer chronic and acute
deviation from treatment plan
conditions
(%)
• Patients’ access to
• PREMs
information and new
communications channels • Patients involved in decision-
making processes (%)
• Reduction of patients’
social inequalities • Depression (%)
Patients
• Increased patients’ • Anxiety (%)
personal freedom and • Sleep disturbance (%)
choice
• Airflow limitation (%)
• Increased patients’
• Mental issues (%)
inclusiveness
• Lifestyle/Behavioural change
• Increased patient
(%)
involvement
• Sustainability of health (%)
• Better informed patient
• Reduced exacerbations and/or
• Active role in decision
acute episodes (%)
making
• Reduced complications (%)
• Impact on treatment
adherence
• Higher patient satisfaction • Clinic consultation time per

Providers
rate patient (number)
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• Better care efficiencies • Duration of the treatment

• Maintainability and plan
technical service support • Reduction of hospital
• Support on administration admissions (%)
• Alignment and support • Team for remote supervision
with reimbursement (number)
structures (no lost income) • Team for
• Strategic fit for provider emotional/psychological
and support of strategy support (number)
• Improved workforce • Dedicated contact person who
satisfaction supervises the patient and is
known to the patient (%)
• Improved quality of care
by comparing performance • Average number of patients
and learning cycle involved
processes • Workforce satisfaction (%)
• Optimization of care • Time-driven activity-based
• Increased care capacity costing (%)
• Patient wait time
• Staff-to-patient ratio
• Integrated teams (number)
• Communication line between
integrated teams (number)
• Risks reduction
• Medical Loss Ratio (%)
• Strong costs control
• Claim Settlement Cycle Time
• Investments focused on (Medical) (%)
needs
Payers • Provider Contracting Cycle
• Increased coverage of Time
reimbursement
• Patient Medical Outcomes
• Contracting based on Benchmarks Reached (%)
results rather than volume
• Alignment of prices, • Volume of services (%)

product and services with • Degree of medical outcomes
patient outcomes included in their business plan
• Price negotiation KPIs (%)
• Risk-sharing agreements • Volume of agreements with
Suppliers payers and suppliers (%)
• Innovations and new
therapy • Innovation rate (%)
• Continuous development • Volume of patients treated
of services, products and (%)
solutions alimented by • Volume of bundled payments
consisted data agreements (%)
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• Higher rate of products • Volume of patients treated

scalability (%)
• Marketing on products • Volume of patients’ medical
based on value rather than relevant outcomes improved
volume, showing improved (%) (e.g. acute episodes,
outcomes relative to costs complications, personalized
treatments, patient health
literacy, patient comfort and
convenience, treatment
adherence, survival rate,
wellbeing, sustainability of
health)
• Patients’ involvement in
services creation (%)
• Lower costs
• Positive environmental
impact by reduced
travelling and/or less
resource utilization
• Socially responsible
product value chain
adopted • Quality of Life (QoL) (%)
• Contribution to • Mortality rate (%)
development of health and
Society • Morbidity rate (%)
social care solutions
• Availability of new • Overall National Healthcare
solutions for providing Costs Reduction (%)
self-managed
telerehabilitation
• Reduced healthcare
pending
• Geographic
implementation of
standards of care
Table 8 VBHC Outcomes and KPIs
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List of images
IMAGE 1 ENABLERS, CHALLENGES, AND CORE FACTORS FOR INTEGRATED CARE ADOPTION ............................ 14
IMAGE 2 ROSIA MODEL BUILDING BLOCKS .......................................................................................................... 32
IMAGE 3 HEALTHCARE INTEROPERABILITY STANDARDS ...................................................................................... 35
IMAGE 4 ROSIA MODEL 2.0: CONCEPTUAL ARCHITECTURE FOR A NOVEL SELFCARE TELEREHABILITATION
MICROSERVICE CLOUD NATIVE PLATFORM .......................................................................................................... 37
IMAGE 5 ROSIA MODEL V2.0 IDENTIFIED PERSONAS ........................................................................................... 38
IMAGE 6 ROSIA MODEL V2.0 SERVICE DELIVERY CHANNEL.................................................................................. 38
IMAGE 7 ROSIA MODEL V2.0 SERVICE CATALOGUE ............................................................................................. 39
IMAGE 8 ROSIA MODEL V2.0 REGULATORY COMPLIANCE & CERTIFICATIONS .................................................... 40
IMAGE 9 ROSIA MODEL V2.0 DEVELOPER & GOVERNANCE ................................................................................. 41
IMAGE 10 ROSIA MODEL V2.0 HEALTHCARE INTEROPERABILITY FABRIC ............................................................ 42
IMAGE 11 ROSIA MODEL 2.0 ROSIA OPEN PLATFORM ......................................................................................... 42
IMAGE 12 ROSIA MODEL 2.0 ROSIA CLOUD PLATFORM ....................................................................................... 43
IMAGE 13 ROSIA HEALTHCARE INTEROPERABILITY LAYER (IN SANDBOX MODE) ................................................ 43
IMAGE 14 THE RVB MODEL ................................................................................................................................... 46
96 Public
List of tables
TABLE 1 SUMMARY OF THE CURRENT CARE PROCESS PATHWAY AND USER EXPERIENCE BY CONDITION ......... 22
TABLE 2 COMMON NEEDS RELATED TO COMMON CHALLENGES ........................................................................ 30
TABLE 3 REQUIRED REGULATIONS AND CERTIFICATIONS .................................................................................... 41
TABLE 4 COMMON CHALLENGES .......................................................................................................................... 54
TABLE 5 ROSIA REQUIREMENTS ............................................................................................................................ 81
TABLE 6 LEGAL AND REGULATORY REQUIREMENTS ............................................................................................. 84
TABLE 7 OTHER REQUIREMENTS........................................................................................................................... 85
TABLE 8 VBHC OUTCOMES AND KPIS .................................................................................................................... 95
97 Public
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TD2 - CHALLENGE BRIEF

ABBREVIATIONS AND ACRONYMS

ABI Acquired Brain Injury

ACHI Australian Classification of Health Interventions

API Application Programming Interface

APS Authenticated Persistent Session

ARM Application reference model (ARM)

ATNA Audit Trail and Node Authentication

BAA Business Associate Agreement

BRM Business reference model (BRM)

BSP Basic Security Profile

BYOD Bring Your Own (medical) Device

BYOD Bring Your Own Device

CAPAs Corrective and preventive actions

CDA Clinical Document Architecture

CDG Continua Design Guidelines

CDVC Care Delivery Value Chain

CHO Community Health Organisation

CHUC Centro Hospitalar e Universitário de Coimbra

COPD Chronic Obstructive Pulmonary Disease

CRPD Convention on the Rights of Persons with Disabilities

CSP Cloud Service Provider

CVDs Cardiovascular Diseases

DEC Device Enterprise Communication

DEN Document Encryption

DMP Data Management Policy

DPIA Data Protection Impact Assessment

EHR Electronic Healthcare Record

EMR Electronic Medical Record

ePREM Patient Reported Experience Measures

ePROM Patient Reported Outcome Measures

FHIR Fast Healthcare Interoperability Resources

FIDO Fast Identity online

GBDS Global Burden of Disease Study

GDPR General Data Protection Regulation

HCP Health Care Professional

HEP Home Exercise Programme

HIMSS Healthcare Information Management Systems Society

HIS Healthcare Information System

HL7 Health Level 7 International

HTTP Hypertext Transfer Protocol

IACS Instituto Aragonés de Ciencias de la Salud

ICD International Classification of Disease

ICT Information and Communication Technology

ICU Intensive Care Unit

IDT Interdisciplinary Team

IoMT Internet of Medical Things

IPUs Integrated Practice Units

IRM Information reference model (IRM)

ISO International Standards Organisation

ISO/IEEE 11073 ISO/IEEE 11073 Personal Health Data (PHD) Standards

ITU International Telecommunications Union

JSON JavaScript Object Notation

MDR Medical device regulatory

MDS Minimum Data Set

MSF Most Significant Changes Questionnaire