Ethics in IT related to

Health Care in FP7

EUROPEAN COMMISSION
Directorate L - Science, Economy &
Society
Unit L3 - Governance &Ethics
 What is Different in FP7?
A major change in FP7, compared to earlier
programs, is that the ethics review will be carried
out on the proposal that is originally submitted
with no additional information requested on
ethical questions after scientific evaluation.

You need to look at introducing, at the outset,

the ethical perspective into the working structure
of your research consortium?
Introducing the Ethical Perspective
Consortia should consider including a
specific Work Package on Ethics
If it is included it should be monitored by
an Ethical Committee which has at least
one external expert as a member
The Ethical issues should be considered in
every Work Package
How are Ethics related to ICT and
eHealth?

They should ensure that the full potential

of ICT, including the Internet, can be used
by all to manage their own health and also
the health of those under their care
bearing in mind the risks involved
 Obligations of Information
Providers

Quality of content on the Internet

Users Privacy must be protected
The site must be trustworthy
Standards must be maintained
Best practice must be used
Feedback must be meaningful
 Credibility
The main prupose of the site should be
stated e.g.
– Purporting to offer Advice
– Used for Education
– Sales of Goods or Services
The site should identify those, if any, with
a Financial Interest
 Honesty
Information must be straight forward and
not capable of Misinterpretation in any way
Any Claims must be backed up with proofs
The Purpose of each individual piece of
Content must be Identified
 Quality
Totally Accurate
– Basis of Information must be clear
– Information not directly produced should be verified
– All alternatives identified
Easy to Understand
– Written in simple language
– Accessible by All
Current
– Up to date
 Informed Consent
If Personal Data is being collected then
the subject must be informed and their
consent sought
They must be able to have their
information removed at any time
For more details see Data Protection Act
and consult the person responsible in your
own organisation for Data Protection
 Privacy
All data held must be kept in a Confidential
Manner
Data should be encrypted
Data must be available for review and
correction by the Data Subject
If possible it should be Anonymised
 Professionalism
Professionals should also abide by thie
own Professional Ethics
Limitations should be clearly explained
Policy on Incidental Findings must be
made clear
Treatment must not be Compromised
 Affiliations
If the Project is Linked to Other Sites there
must be a plan to Ensure those Sites meet
all of the above Criteria.
 Accountability
Feedback should be Accepted
There should be a clear Policy on how to
give Feedback with ease
The site should display the Ethical Policies
clearly
 Ethical Communication
If communicating – Use personal communication
if possible
Individualise records – “no cut and paste” from
other records
Audit all changes to electronic documents
Establish relationship with patient not with the IT
Ensure patients know reasons for use of IT
Close alliance between Data Protection and
Ethics
 Electronic Records
They should be used solely for the purpose that
they are collected for – in the case of Health
Care for providing integrated high quality health
care
They should contain a record of diagnosis and
treatment
They should be used for education of other
health professionals and for communicating with
others involved in the care of the patient
 Consent
Consent must be obtained and must be
informed
If unable to give consent – disability etc.
may be given by someone else.
Information should only be available on a
“need to know basis”
Must not be disclosed
Must be kept secure
 Areas of Concern(1)
Confidentiality and Privacy of electronic
data
Selection and use of informatics tools in a
clinical setting
Who should use the tools
Role of System Evaluation
Obligations of Systems developers,
maintainers and vendors
 Areas of Concern(2)
Use of Computers to track clinical
outcomes to guide future practice
Under the Data Protection Act – Data
should only be retained for as long as is
necessary. This can cause problems if the
patient recovers but then relapses after
the data has been erased. This does not
happen with a paper record. So a
judgement is required on retention of data
 Appropriate Use
Laboratory Systems have been shown to
improve care and save in cost and time
Clinical Expert Systems should only be
used to support the human decision maker
Ethical software use must be aligned with
the production of favourable outcomes
Humans are still superior to computer
systems – at the moment!!!
Appropriate Users and Educational
Standards
As with other tools in Health Care users
must be trained to use them
The appropriate level of training must be
correlated with the question in hand
e.g. Expert Systems for diagnosis
– Used for support for clinicians
– Education for medical and nursing students
Not used by patients, administrators etc.
 Designers of Systems
Must realise the consequences of errors
Must care about the uses of the system
Value the reduced suffering from use of
their systems
Must maintain standards
Must do the above over and above the
desire to gain maximum profit
 Evaluating Software(1)
Does the system work as designed?
Is it used as anticipated?
Does it produce the desired results?
Does it work better than the procedures it
replaced?
Is it cost effective in both monetary and
time terms?
How well have the individuals been trained
to use it?
 Evaluating Software(2)
What are the anticipated long term effects
on how departments interact?
What are the long term effects on the
delivery of medical care?
Will the system have an impact on control
in the organisation?
To what extent do effects depend on
practice settings?
 Research

Data can be used for personal research

If anonymised can be used for research by

others

Must be extra careful with genetic data

 Social Ethics

Safeguarding of data for use by

– Administrators
– Governments
– Researchers
– Insurers
 Summary (1)
Computers should not overrule properly
trained professionals
Health Care Professionals who use
informatics tools must be properly trained
in the use of each and all of the tools used
Balance between protecting access and
making data available through education
and security policies
 Summary (2)
The tools themselves must be carefully
evaluated and validated not just in terms
of performance but also
– Efficiency
– Accuracy
– Influence on working environment
 Summary (3)
Ethical obligations are important not just
for health care professionals but also for
– System developers
– Maintenance personnel
– Supervisors
Ethical use of technology should always
be addressed
 References
http://europa.eu.int/comm/european_group_ethics/docs/avis13_en.pdf
Electronic Records – Ethical Guidance – Donald Draper and Michael Rigby
http://www.i-r-i-e.net/
Medical Informatics – Shortliffe et al. Chapter 7 – Goodman and Miller
Andersen – The role of ethics in information technology decisions: a case-
based approach to biomedical informatics education.
Int J Med Inform. 2004 Mar 18;73(2):145-50. Review.
Curtain – Ethics in informatics: the intersection of nursing, ethics, and
information technology.
Nurs Adm Q. 2005 Oct-Dec;29(4):349-52.
Anderson J.G. and Goodman K.W. – Ethics and Information Technology –
A Case-based approach to a Health Care System in Transition – 2002
Explicit Right to Personal Privacy under Article 8 of European Convention for the
Protection of Human Rights & Fundamental Freedoms (ECHR)
 References Cont’d
Data Protection Directive 95/46/EC – Data Protection Acts 1988 & 2003
Electronic Privacy Directive 2002/58/EC – EC Electronic Privacy
Regulations 2003 (SI 535/2003)
New Eurosocap Guidelines highlighted -
http://www.eurosocap.org/Downloads/European-Standards-on-
Confidentiality-and-Privacy-in-Healthcare.pdf
eHealth Code of Ethics – eHealth Initiative 2000