Season of Virtuals: Corona provides impetus to Telemedicine Guidelines in India –  Legal challenges going forward

The practice of telemedicine is fundamentally an intricate combination of ‘the practice of medicine’ with ‘information technology’.

There is no doubt, several studies, seminars and workshops have taken place over a period of time to examine the feasibility of providing medical consultation through technology popularly known by ‘Telemedicine’. The Corona crisis has undoubtedly pushed the envelope further and forced the Government in bringing out the Telemedicine Guidelines (as discussed below) which has been long pending demand of the medical fraternity.

Very few countries in the world have legislated on Telemedicine. Malaysia is one such country which has a Telemedicine Act, 1997. In the USA, the State of California, provides for the Telemedicine Development Act of 1996 which prohibits face-to-face visit if the service can be provided through telemedicine.

So what does Telemedicine mean:  ‘healing from a distance’. WHO[1] has adopted the following description of telemedicine: ‘The delivery of health care services, where distance is a critical factor, by all healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of healthcare providers, all in the interests of advancing the health of individuals and their communities.’

The main purpose of telemedicine and virtual consultation is to facilitate access to healthcare to all sections of the society within India by providing faster, cheaper and better communication for treatment and especially for those who are in distant areas and lack any means of transport.

The existing laws relating to the medical profession are as follows:

Undoubtedly all the existing laws relating to both ‘medicine’ and ‘information technology’ in India would apply to Telemedicine.

Medical related legislations

  • Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules, 1945;
  • The Indian Medical Council Act, 1956, The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002;
  • Clinical Establishments (Registration and Regulation) Act, 2010 (‘the Clinical Establishments Act’).

Information technology’ law

  • Information Technology Act, 2000;
  • Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011;
  • Information Technology (Intermediaries Guidelines) Rules, 2011.

The Information Technology Act, 2000[2] (“the IT Act”) contains provisions for safeguarding the security and privacy of information exchanged using means recognised under the IT Act. All companies registered under technology or providing technology services are governed by the IT Act.

Under these laws, only a person who is a registered medical practitioner and provides a valid and legal prescription under the Drugs and Cosmetics Rules, 1945, is allowed to practice medicine in India. A registered medical practitioner generally provides a handwritten prescription with his signature on it. In the case of telemedicine, a prescription is valid even if it is provided by the way of digital signatures as per Section 5 of the Information Technology Act, 2000. Through the IT (Amendment) Act, 2008[3], electronic records are admissible as evidence in a court under the Evidence Act, 1872.

Lack of clear guidelines previously

A 2018 judgment of the High Court of Bombay in Deepa Sanjeev Pawaskar v. State of Maharashtra[4] had created uncertainty and ambiguity for registered medical professionals, raising doubts on the practice of telemedicine about the place and legitimacy of telemedicine because an appropriate framework does not exist.

In the said casethe patient was directed to be admitted in the absence of doctors and medicines were administered on telephonic instructions. Additionally, there was no resident medical officer. An alternative arrangement for a doctor was made by the staff when the condition of the patient started deteriorating. The Bombay High Court held that it was criminal negligence, which is defined as gross negligence so extreme that it is punishable as a crime. It is further stated that the element of criminality is introduced not only by a guilty mind but by the practitioner having run the risk of doing something with recklessness and indifference to the consequences.

Until recently, there were no exclusive legislation or guidelines on the practice of telemedicine through video, phone, Internet based platforms (web/chat/apps etc).

Telemedicine Practice Guidelines

The demands of the medical fraternity were somewhat fulfilled. On 25-3-2020, the Board of Governors (in supersession of the Medical Council of India) framed the Telemedicine Practice Guidelines[5] (“the Guidelines”) which was added as Appendix 5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulations, 2002[6] (“the Ethics Regulations”).

These guidelines include both the overarching principles and a practical framework. While the overarching principles would be common to all future guidelines, the latter specifically tries to address the current need in the wake of COVID-19 outbreak. It has been decided to provide statutory basis to the “Telemedicine Practice Guidelines”. Accordingly, the same has been included as an amendment to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, by adding Regulation 3.8 titled as “Consultation by Telemedicine” in the said Regulations.

On 12th May 2020, the Board of Governors, Medical Council of India with the previous sanction of the Central Government of India, passed new regulations called “the Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2020”[7]. These Regulations include both the overarching principles and a practical framework. 

Some of the main features of the Telemedicine Guidelines are as follows:

A, The Guidelines lay down the definitions of the terms ‘Telemedicine’, ‘Telehealth’ and ‘Registered Medical Practitioner ’(“RMP”);

  1. They help realise the full potential of advancements in technology and provide practical advice to the registered medical practitioners by encouraging the use of telemedicine as a normal practice;
  1. They provide norms and protocols relating to physician-patient relationship; issues of liability and negligence; evaluation, management and treatment; informed consent; continuity of care; referrals for emergency services; medical records; privacy and security of the patient records and exchange of information; prescribing; and reimbursement; health education and counseling;
  2. Spells out how technology and transmission of voice, data, images and information should be used in conjunction with other clinical standards, protocols, policies and procedures for the provision of care;
  3. Hospitals, clinics and companies will need to ensure that their doctors receive the mandatory online training. RMPs using telemedicine shall uphold the same professional and ethical norms and standards as applicable to traditional in-person care, within the intrinsic limitations of telemedicine.
  4. All registered medical practitioners intending to provide online consultation need to complete a mandatory online course within 3 years of its notification.  In the interim period, the principles mentioned in these guidelines need to be followed. Thereafter, undergoing and qualifying such a course, as prescribed, will be essential prior to practice of telemedicine.  This would involve additional compliance and costs. An interim waiver seems to have been provided to the RMPs in view of the prevalent situation caused by the Covid-19 pandemic.

In addition to the Guidelines, the RMPs, hospitals, clinics and companies will need to comply with all other applicable requirements including data privacy obligations.

Exclusions in the Guidelines

The Guidelines explicitly excludes the following: 

  • Specifications for hardware or software, infrastructure building and maintenance
  • Data management systems involved; standards and interoperability
  • Use of digital technology to conduct surgical or invasive procedures remotely
  • Other aspects of Tele-health such as research and evaluation and continuing education of healthcare workers
  • Does not provide for consultations outside the jurisdiction of India

Framework for Telemedicine as per the Guidelines

The framework for practicing telemedicine is there in 5 scenarios:

1. Patient to RMP;

2. Caregiver to RMP;

3. Health Worker to RMP;

4. RMP to RMP;

5. Emergency Situations.

Main Guiding Principle for Teleconsultations 

Seven elements need to be considered before beginning any telemedicine consultation:

1. Context 

2. Identification of RMP and patient

3. Mode of Communication

4. Consent

5. Type of Consultation

6. Patient Evaluation

7. Patient Management

The professional judgment of a RMP should be the guiding principle for all telemedicine consultations: An RMP is well positioned to decide whether a technology-based consultation is sufficient or an in-person review is needed. The RMP should exercise proper discretion and not compromise on the quality of care.

Legal Challenges that may arise while providing telemedicine consultations

We live and breath technology from the time we get up until we retire for the day. Technology provides user friendly solutions but also brings with it challenges, risks, drawbacks and limitations like anything else.

Telemedicine involves a constant exchange of information between the patient and the service provider. The patient’s personal information, such as medical history and physiological conditions, is considered sensitive personal data or information (‘SPDI’ under the Data Protection Rules).  When a corporate body collects, stores, transfers or processes such information, certain requirements under the Data Protection Rules are triggered. Over a period of time as is one is aware diagnostic labs all across the country assess medical tests through the medium of technology, something even as routine as blood tests as well. The diagnostic labs become the custodian of these medical records of the patients and most of the labs these days provide records through emails. 


Similarly, hospitals, polyclinics and individual practitioners would need to consider adopting virtual consultations as part of their practice, in the present times now that some guidelines are in place. However, they should ensure they follow the guidelines strictly. It can be mitigated through appropriate training, enforcement of standards, protocols and guidelines.

The scope for telemedicine abuse is possible and some key medico-legal and ethical issues[8] would arise while practicing telemedicine and virtual consultation.  As the telemedicine practice evolves, issues would arise from time to time.  I have highlighted only a few of them here briefly.

Relationship of RMP and Patient

Patients trust healthcare professionals while seeking treatment and confide in them. In the light of the aforesaid telemedicine guidelines, the scope of the Information Technology Act, 2000 is somewhat quite limited and it does not specifically deals with the practice of medicine through technology. However, there are some provisions in the said Act which may apply on the application of Telemedicine. Sections 4 and 5 of IT Act have given legal recognition to the electronic record and digital signatures.

The IT Act has also amended the Evidence Act, 1872 thereby making the electronic record admissible in evidence. Section 2(1)(t) of the IT Act defines “electronic record” as data, record or data generated, image or sound stored, received or sent in an electronic form or micro film or computer generated micro fiche.

The IT Act identifies three parties to the electronic record/message: the originator [Section 2(1)(za)], the addressee [Section 2(1)(b)] and the intermediary [Section 2(1)(w)]. The originator is the sender, the generator of any electronic message; whereas, the intermediary is a facilitator to receive, store, or transmit or provide any service with respect to that message and the addressee is the recipient of that message.

Retention of electronic records, their attribution, acknowledgment, dispatch (time and place), and receipt have been given due recognition in the IT Act and hence, its main purpose is to give legal recognition to contractual obligation through electronic transaction.

The above circumstances will certainly give rise to a doctor-patient relationship. Further, the said relationship can be proved in the court of law through the above electronic record (e.g. exchange of e-mails, patient’s medical (electronic) record, online prescription by doctor, etc.).

Virtual Malpractice

Once the doctor–patient relationship is established, it is the responsibility of the doctor to provide due care and treatment, which is expected from the professional in the given circumstances.

Any violation made under the Telemedicine will be considered as a misconduct at the hands of the concerned RMP. As such if the misconduct is proved, the RMP may be reprimanded or have their registration suspended or cancelled.

Duty of care

The RMP  won’t be exempt from liability or prosecution from statutes affecting the RMP such as the Information Technology Act, 2002, and the Consumer Protection Act, 1986, etc. The RMP will be required to take stringent precautions to ensure that the standards of duty of care as prescribed is met since due to substantial reliance on digital medium for transmission of private information, the same would involve an element of risk for the RMP. Any act or omission deviating from the duty of care, may result in tortious liability on the grounds of medical negligence.
The ‘duty of care’ must be established in all telemedicine encounters to clarify responsibility(s) for the patient/caregiver as well as other involved healthcare providers. Healthcare professionals should clearly define their roles and responsibilities regarding the various aspects and extent of treatment.

Confidentiality & Privacy

The IT Act and other regulations on data privacy shall
be applicable on the RMP providing tele-consultation. 

All information shared by the patient shall be confidential and the RMP is required
to undertake reasonable degree of care in usage of platforms for maintaining such confidentiality.
RMP is required to log all details and maintain full record of the patient with respect to any documentation or information used for the consult and the prescriptions.

The right to privacy has been an integral part of medical ethics since time immemorial and is supported by various codes including the International Code of Medical Ethics.  Every individual has a right to privacy even in telemedicine. The onus for safeguarding this information has to be on the medical practitioner.

Conclusion

There is much hope for the future of telemedicine. With rapid advances in technology, telemedicine will become easier and more widely accepted in coming years.

The Guidelines do provide a much needed framework for the practice of telemedicine in India by providing the necessary clarifications and covering concerns relating to liability, consent, confidentiality and negligence. Hospitals and Polyclinics would need to ensure an house internal compliance committee similar on the lines of the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 to address issues of regulation concerning telemedicine based on the guidelines. 


* (Barrister) Advocate, Supreme Court, Partner at Jafa & Javali, Advocates, New Delhi.

[1] WHO. A health telematics policy in support of WHO’s Health-For-All strategy for global health development: report of the WHO group consultation on health telematics, 11–16 December, Geneva, 1997. Geneva, World Health Organization, 1998.

[2] Information Technology Act, 2000

[3] Information Technology (Amendment) Act, 2008

[4] 2018 SCC OnLine Bom 1841 

[5] Telemedicine Practice Guidelines  

[6] Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulations, 2002 

[7] Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2020 

[8] “Telemedicine and virtual consultation: The Indian perspective”, National Medical Journal of India, (Year 2018), Vol. 31, Issue  4, Pages 215-218


Image Credits: DeccanHerald.com

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