1.

Introduction

Telemedicine is thought to have begun with the use of ancient hieroglyphs and scrolls to convey
information about health-related events1. However, as the 19th century began with the
development of the telephone and television, it was thought that the first real-time video
telemedicine consultation had taken place at the University of Nebraska, using interactive
telemedicine to transmit neurological examinations2. The internet's emergence has
favoured healthcare and telemedicine worldwide, resulting in rapid healthcare innovation. 3

1.1Malaysia’s Telemedicine Landscape

In Malaysia, the initiative to deploy online healthcare services (OHS) began in 1997 with the
development of Malaysia's Telemedicine Blueprint4 .The government has incorporated it within the
Multimedia Super Corridor (MSC) initiative, which focuses on telecommunications, information, and
multimedia technologies with the goal of reshaping the healthcare structure 5. Unfortunately, the
author argued that such an idea may have been ahead of its time because neither the Internet nor
technologies like the Internet and artificial intelligence (AI) were commonplace at the time.

The development of telehealth was observed in 2015, when a group of doctors and entrepreneurs
in Malaysia established a Telemedicine Development Group, later renamed Digital Health Malaysia
(DHM), which covers everything from data management to healthcare delivery and how the system
improves the service6. By 2017, Malaysia’s OHS market booming as the public becomes more aware
and rising health service demand, putting new and creative health tech providers to acquire market
share such as Doctor2u ,Bookdoc and Naluri7.

1.2 OHS during Covid-19

Through a study done in 2022, OHS emerged as a viable and sustainable approach for Covid-19
precaution, prevention, and treatment by allowing medical professional to communicate with
patient remotely thus saving time and contagious patient to remains confined8. The role of OHS
providers became more prominent when OHS was established as a strategy in mitigating disease
spread by minimising patient displacement to hospital leave and allocating hospital capacity to
critical patients . For examples BookDoc who became the official digital healthcare platform for

1
Hurst EJ. Evolutions in telemedicine: from smoke signals to mobile health
solutions. J Hosp Librariansh 2016;16:174–85.
10.1080/15323269.2016.1150750
2
Zundel KM. Telemedicine: history, applications, and impact on
librarianship. Bull Med Libr Assoc 1996;84:71–9
3
Ayesha Amjad,Piotr Kordel and Gabriela Fernandes, A review on Innovation in Healthcare Sector( Telehealth)
through Artificial Intelligence (2023) Sustainability page 1
4
Telemedicine Flagship Application malaysia’s telemedicine blueprint MOH 25 July 1997
5
M.H. Mat Som, A.N. Norali and M.s.A Megat Ali, ‘ Telehealth in Malaysia – An Overview’ 2010 ISIEA page 660/
6
https://www.theedgemarkets.com/article/cover-story-bringing-future-healthcare-malaysia#:~:text=In
%202015%2C%20they%20began%20organising,the%20scope%20of%20their%20work. Accessed date
4/5/2023 Cover story: Bringing the future of healthcare to Malaysia ,Tan Zhai Yun
7
Inception Report OHS Regulatory Framework 4th May 2020 alpha catalyst Consulting sdn bhd page 50
8
Raheleh Ganjali, Mahdie Jajroudi, Azam Kheirdoust, Ali Darroudi and Ashraf Alnattah , ‘ Telemedicine
solutions for clinical care delivery during COVID-19 pandemic: A scoping Review (2022) Front Public Health
Ministry of Health (MOH) in combating COVID-199 as well as Doc2US that had created a Covid-19
task force to help the public gain adequate information about the disease spread and management 10
whereby indirectly reduce patient-doctor contact.

2.Challenges of Telemedicine

Private online healthcare services have flourished in Malaysia as a result of the industry's rapid
adoption of technological innovations, most notably in the form and structure of new services and
business models. It is becoming increasingly obvious that the policies and regulations governing
healthcare that were enacted during the analogue era may be inadequate. Uncertainty arises for
healthcare professionals, platform providers, and patients alike when the law is ambiguous or leaves
gaps in its coverage.

2.1 Business Model

Malaysia now has several business models in place for offering OHS, including telemedicine, e-
pharmacy, information and booking, wellness, homecare, and dental care. These OHS providers are
constantly evolving and upgrading their services, merging diverse models into a single service centre.

The author see such diverse and complex ecosystem of business model consist of platform
providers, network provider, technology company, HCP and consumers required various
interministerial collaboration for example MOH, Ministry of Finance, Malaysia Productivity
Corporation and Department of Protection of Personal Data in building an integrated approach of
framework when highlighting regulatory concern in those model. These brought a legit argument for
platform providers whether deciding on prescriptive versus descriptive requirement with different
business models and the consequential cost of prescriptive requirement.

Therefore, the Malaysian government appointed Futurise as Public Policy Advisor to the ministries
and industries to lead National Regulatory Sandbox as an initiative to expedite regulatory
intervention, deploy innovation and technology solutions, and establish new innovation ecosystems
for OHS Regulatory Lab 11.

Essential, according to the author, for the government to have continuous stakeholder engagement
with platform providers in order to identify criteria required in constructing acceptable business
models as the input will determine the entity of regulatory method.

However, apart of the diversity industrial players had construct on, the author are looking on a
deeper issues that been face by the policy makers in drafting such regulation where the next
discussion would raised the dilemma on HCP.

9
https://www.scmp.com/country-reports/business/topics/malaysia-business-report-2017/article/2125202/
bookdoc-redefines South China Morning Post accessed date 4/5/2022 ‘BookDoc redefines Malaysian Health
care access at the touch of a button
10
https://www.doc2us.com/pressrelease/doc2us-hails-doctors-and-hcps-to-join-covid-19-telemedicine-task-
force-1 DOC2US accessed date 4/5/2023
11
Azrita Kadir, Futurise, Ministry of Helath (KKM) and Futurise Announce Major Milestone with the Launch of
Online Health Service Regulatory Lab (OHS RegLab) for Malaysian Healthcare Industry
https://www.futurise.com.my/press-release-2022-1 23 feb 2022
2.2 Telemedicine Practitioner

2.2.1 Cross Border practitioner

Current scenario in Malaysia, verification of practitioner’s identity, registration of license and

certification to practice is hard to identify as the service are being rendered online and nobody can
validate who is giving out the services.

Telemedicine Act 1997 (Act 564) sets out several requirements for telemedicine practitioners to be
registered with the Malaysian Medical Council and to comply with professional standards of
practice and to maintain patient confidentiality. In addition , S3 (1)(b) of Act 564 allow foreigner HCP
to practice even outside Malaysia when giving services to patient in Malaysia. However , though the
act was gazetted in 1997 but it was not yet enforced till now. Making pursuant to s16 of Medical Act
1971 to be more reliable by law, where a Temporary Practicising Certificate (TPC) is issued to enable
a foreign registered medical practitioner to practice in Malaysia for the purpose of teaching, conduct
research fellowship training and clinical attachment.

Furthermore,In the form provided by MMC required the attach doctor to provide address location
residing in Malaysia which leading the author to assume that the foreign doctor need to reside in
Malaysia in order to practice . From the statement above, the author argue both act contradicting
each other on the issue of foreign doctor practice. It seems that Malaysian Medical Council (MMC)
had put a stand that allowing TPC on foreigner only for educational purposes and not for those
seeking working income.

The next debate of cross border practice will pertain on the ethical issue of putting liability when a
misconduct or negligence occur to a patient where the doctor located outside Malaysia. When the
criminal offence occur outside of Malaysian jurisdiction, conviction and upholding penal code would
become a hampering factor in providing efficacy and quality of OHS to patient. Though S3 of Penal
Code 1997 (Act 574) , allow punishment of offences commited beyond but may be tried within
Malaysia and S4(1)(c) of Act 574 that imply any offence commited by any person against a citizen of
Malaysia, but rather the author sees that it require international agency collaboration to bring the
criminal to justice and such tedious process would take longer time than usual , leaving the victim
with tremendous negative impact to live with.

2.2.2 Indemnity Insurance

At the time of writing, the avaibility of insurance provider for liability protection on telemedicine is
yet unknown. The author believe that indemnity insurance play a strong role in safeguarding HCP
especially on private sector where negligence case could cost up to millions per case. Without the
revision of coverage in insurance policy, moving forward to empower digital health and improve OHS
would remain the talks in the air.
2.3 Data and record

2.3.1 The data user and data processor

Health data under Personal Data Protection Act 2010 (PDPA) is not specifically defined but such data
would be consider as sensitive personal data as its consist information as to the ‘physical or mental
health or condition of a data subject’12. The author foresee the issues especially on the roles of data
users13 and data processors14. There is a need to see what data is required to fullfill a particular
healthcare service as there could be misuse of data as they may ask access to more data than
necessary. Despite HCP have to abide to Code of Professional Conduct 2019 , government are lacking
authority body that able to have online surveillance and access to the practice whenever necessary.

Besides that, PDPA act also required data user to be register 15and to follow the code of practice
under this act16. These figuratively increasing the amount of work involved in several registration
processes required under different acts in addition such as Medical Act 1971 , Private Healthcare
Facilities and Services Act (Act 586) .

S 40 of PDPA act also required HCP to understand the rights in processing sensitive personal data.
Particularly on s 40 (1)(b)(ii)(A)

2.3.2 Cross-Border Data

Data privacy and protection via OHS is another issue need to be address especially on data storage
location. As much as the difficulty in putting a liability for whom to be responsible either the patient,
HCP, platform provider or the technology company when there are leak of data, not to mention
adding the severity of the problem when the data cross-transfer to a foreign country in a way putting
nation at risk. Despite the avaibility PDPA act in Malaysia, so far there are no regulations for
localisation rules where the data must stay in the country . China on the other hand through Data
Security Law of the People’s Rebulic of China enforced on September 2021 complemented by its
Personal Information Protection Law that come into effect November 2021 with Cyberspace
Administration of China (CAC) as its authority body provide measurement of security assessment in
cross-border data transfer where the focus are on data localisation17.

The author believes, without an act or regulation that govern data privacy on cross-border, OHS in
Malaysia may be at risk of multiple international cyber attack that could potentially put Malaysia’s
national security jeopardize.

12
S4 Interpretation ‘sensitive personal data’ PDPA Act
13
S4 PDPA act “data user” means a person who either alone or jointly or in common with other persons
processes any personal data or has control over or authorizes the processing of any personal data, but does
not include a data processor;
14
S4 PDPA act “data processor”, in relation to personal data, means any person, other than an employee of the
data user, who processes the personal data solely on behalf of the data user, and does not process the
personal data for any of his own purposes;
15
S 14 PDPA Act Registration of data user
16
S23 Code of Practice PDPA act
17
Article 37 of Chinese Cybersecurity Law
2.3.3 Informed Consent

Consent is consider a data and needed to be recorded when providing a medical treatment.
Botrugno in his legal work, focuses on the importance of the explaination that must be clear and
unambigous to obtain consent from the patient.18 A literature review on telemedicine challenges
revealed that most of the the studies mention ethical and technical difficulties in informed consent 19.
The author opined that the difference in the purpose of each study impacted the structure,content
and format of the informed consent. The lack of uniformity leads to multiple consents with different
approaches exposing the vulnerability and validity in OHS.

However,in contrast to consent virtually, the long standing stigma of healthcare environment when
dealing with patient in a physical clinic , HCP often consider that the act of patient walk into the clinic
is a presumed consent for allowing doctor-patient relationship. The author on the other hand, stand
that during a virtual consultation, a valid and informed written consent at each consultation session
are necessary in safeguarding the HCP as well as patient. Moreover the author believe that platform
provider should hold the responsibility to ensure that patient’s written consent in such must be
reproducible whenever required by HCP as the dynamic of virtual consultation in each session might
change when physical contact are not available during body examination.

Other than that, the author agreed that current relevant guideline such as Code of Professional
Conduct and Malaysian Medical Council Guideline: Consent for Treatment of Patients by Registered
Medical Practitioners are adequately sufficient to ethically guide the HCP .

2.4 E-pharmacy

Pharmacies are venturing into the domains of e-commerce and e-health to provide reliable online
pharmaceutical services (Orizio et al., 2011) According to online observations, numerous online
pharmacy platforms provide patients with alluring offers20. Small and medium-sized pharmacies that
use e-commerce platforms lack appropriate e-pharmacy platforms with pharmaceutical service
features, such as visual consultation, e-prescription applications, and online medication adherence
programmes, compared to large chain pharmacies.

2.4.1 E-prescription

18
Botrugno C. Telemedicine in daily practice: Addressing legal challenges while waiting for an EU
regulatory framework. Health Policy Technol 2018;7:131–136
19
Giulio Nittari, Ravjyot Khuman, Simone Baldoni, Graziano Pallota, Gopi Battineni, Ascanio Sirignano,
Francesco Amenta and Giovanni Ricci, ‘ Telemedicine Practice : Review of the Current Ethical and Legal
Challenges’ (2020) Telemed J E Health p 1427-1437
20
Amran Abu Bakar,Samuel Ting Chua Yew, Siew Chin Ong and Guat See Ooi, ‘Barriers for implementation of E-
Pharmacy policy: Viewa of Pharmacy Authorities, Public Institutions and Societal Groups (2022) Pertanika J Soc.
Sci. & Hum. p43
Doc2Us became the first OHS provider to launch digital signature enhanced e-prescription in
Malaysia that fully complies with Malaysia Digital Signature Act 1997 (DSA)21.The use of both
recognised e-prescriptions with digital signature can fullfill the requirement of confidentiality,
identity authentication, non-repudiation and intergrity of information22. A medical practitioner can
readily select the sort of medications needed to be administered to a patient at the prescriber
level23. With a few clicks, the doctor can generate an e-prescription for repeat supplies, reducing
prescription errors.As illegible hand-written prescriptions are no longer necessary, dispensing errors
have been drastically reduced at the pharmacy level24.

Despite the positive impact ,the current pharmacy regulations are still insufficient to encourage
community pharmacist to invest in e-pharmacy services and are deemed unfriendly requirement
where its required to comply with DSA that is costly toward small and medium-size pharmacies
leaving only giant-franchise pharmacy to monopoly the market sorting unhealthy competition 25.

Another concern raised in e-prescription are when S15 and S16 of Poison Act 1952 (Act 366) only
provide details on sales of poison by wholesale and retails. These provision seems to provide
provision that cover the sale but not on the delivery of the drug . The author consider the mode of
delivering medication is important as it could hamper the quality and safety of the medicine if
necessary precaution taken lightly. Furthermore, as traceability are one of the guiding principle of
healthcare provision26, track and trace item deliver it also an element of standard of care in e-
pharmacy. Ensuring such notion to be applied without a proper legislation would worsen the stigma
around community pharmacist. Realizing the deficit, some of Malaysia’s giant e-pharmacy provider
had taken the iniatiative to innovate and merging services in order to provide standard delivery
service by signing a MOU with postage delivery provider such as GDEX27 and etc .

2.4.2 Issuance and dispensing

Since health data in Malaysia are not centralize between government and private sector, access to
history and previous medication would contribute to prescription error. Ideally, the author would
suggest the issuance of e-prescription must be restricted access to partner pharmacies only and
dispensing of medication should also be restricted to licensed pharmacist where track record can be
recheck and duplication medication error as well as abuse of prescription could be avoided for
example when the medication prescribed falls within the category of Group B poison that need to
follow as described in S21(2) Poison Act 1952 thus upholding the standard of care.

Not to mention, on the basis of argument in para 2.2.1 regarding foreign HCP that reside outside
Malaysia, the author cannot overlook on the provision in S2 of Act 366 in regards to prescription and
dispensing where the act define registered medical practitioner as those who registered under
Medical Act 1971. This interpretation brings the author to argue that any issuance of prescription for
21
https://healthcaretoday.com.my/doc2us.html#:~:text=HEALTH%20SERVICES%20LOCATOR-,DOC2US%20%2D
%20THE%20FIRST%20TO%20LAUNCH%20DIGITAL,ENHANCED%20E%2DPRESCRIPTION%20IN
%20MALAYSIA&text=Doc2Us%20digital%20signature%20enhanced%20e,being%20dispensed%20by%20a
%20pharmacist.
22
Ibid n 21
23
Ibid 21
24
Ibid 21
25
Ibid n20
26
WHO, Policy paper on traceability of medical products ( WHO ,2021) Geneva p 1-52
27
The Star- GDEX ties up with DOC2US, Alpro for medicine delivery tracking https://gdexpress.com/the-star-
gdex-ties-up-with-doc2us-alpro-for-medicine-delivery-tracking/
the purpose to be dispense in Malaysia by practitioner who are not register with MMC are consider
invalid and against the law.

2.5 Advertising and Promotion

Yet another flaw in the current regulatory structure where the author find out that S 4A of Medicine
(Advertisement and Sale) Act 1956 (Act 290) only allowed medical advertisement on to four
healthcare fasilities which are private hospital, clinic, radiology clinic and private medical laboratory.
Though S7 of Act 290 gave source of power for Medicine Advertisement Board to have the authority
for approval of advertisement, the uncertainty of where the OHS lies on may create a greater
ambiguity in future when legal issue arise. However to denied the influence of digital marketing
nowadays and the need of online advertisement to promote bisness expenditrure and economic
growth would deem as irrelevant as well28. Yet, safeguarding the trust and ethical conduct of HCP
when the possibility of the platform to be construed as an advertisement or promotion of HCP’S
skill,knowledge,qualification and services for the purpose of professional advandtage and / or
obtaining patients.

Therefore,threshold is met as the problem discussed above required comprehensive revision of Act
290 to overcome the shortcoming of unregulated advertisement involving digital health platform.

28
Yogesh K. Dwivedi (More than 3 authors) Setting the Future of digital and social media marketing research :
Perspectives and research propositions 59 (2021) International Journal of Information Management 1-37.