DIAL-A-DOCTOR-A-look-at-the-Telemedicine-Practice-Guidelines-2020

The Ministry of Health and Family Welfare (“MoHFW”), on March 25, 2020, issued the Telemedicine Practice Guidelines (“Guidelines”) providing Registered Medical Practitioners (“RMPs”) with guidelines to treat patients remotely by using the telemedicine tools at their disposal.

Concepts such as telemedicine have gained prominence pursuant to the rapid development of information technology and the need to service the requirements of patients who may not be able to visit healthcare facilities, or have little to no access to the same. Such services involve the transfer of medical information and expertise through telecommunication and computer technologies and aim to facilitate diagnosis, treatment and management of patients. Currently, in India, platforms such as ‘practo’ and ‘DocOnline’ exist which facilitate online medical consultations albeit in a restricted manner given stringent regulatory controls on the practice of medicine. Though such platforms would help to deliver widespread healthcare services, there exist several concerns that exist about the medicolegal implications of telemedicine relating to registration, licensing, insurance, quality, privacy and confidentiality issues, as well as other risks associated with electronic health care communication.

A primary concern in the Indian healthcare sector is the lack of quality healthcare services in the rural regions of the country and the large distances that need to be travelled by rural people to avail healthcare services. This is of particulate concern in the remote and rural regions of the country.

In addition, disasters and pandemics, such as the COVID-19, pose several unforeseen challenges to the healthcare framework of the country. A rising global concern is the lack of healthcare professionals to deal with these and risks to healthcare providers who are at the forefront dealing with the infected patients. Thus, in such situations, telemedicine services are in a unique position to help mitigate such a grave healthcare crisis, by not only ensuring quality services are available widely but also by reducing the chances of healthcare professionals being infected themselves.

Historically, in the absence of any guiding framework or regulations which govern the practice of telemedicine, there were several concerns regarding the registration, licensing, liability, quality, privacy and confidentiality issues, as well as other risks associated with such telemedicine services. There was significant hesitation on part of the courts in allowing medical consultation vide telecommunication mediums owing to grave concerns such as medical negligence and in larger public interest. Interestingly, the Bombay High Court in its judgement in Deep Sanjeev Pawaskar and Anr. v. State of Maharashtra[1], has held the applicants in this case (the two doctors) liable for medical negligence in lieu of the medical consultation/ advice provided though telephonic medium. This judgement has acted as a strong deterrent to the practice of telemedicine in India, with doctors being gravely concerned about the medicolegal/ liability implications of such service. Consequently the Indian Medical Association (“IMA”) while acknowledging the role of telemedicine has clearly held that the practice of telemedicine has grave ethical dilemmas[2]. Thus, the IMA has requested the Medical Council of India to lay down clear cut guidelines for the doctors for the practice of telemedicine in India.[3]

These long pending guidelines, will serve as an important tool to enable accessibility of healthcare services to the general masses of the country.Telemedicine could come as a great boon to India as its basic characteristics are quite well suited to deliver healthcare services across the large geographical expanse of the country. Telemedicine will increase timely access to appropriate interventions including faster access and access to services that may not otherwise be available[4].

Salient features

  • Definitions – The Guidelines lay down the definitions of the terms ‘Telemedicine’, ‘Telehealth’ and ‘Registered Medical Practitioner’.
  • Scope and Exclusion – It is clearly stated that the Guidelines will be published under the Indian Medical Council Act, 1956 (“IMC Act”) and the same will be applicable to only RMPs (as defined under the IMC Act) and will act as an aid and tool to enable RMPs to effectively leverage telemedicine.
  • Types – Telemedicine applications have been segregated into four different types, based on – (a) mode of communication, (b) timing of the information transmitted, (c) the purpose of the consultation and (d) the interaction between the individuals involved.
  • Professional and Ethical standards – The Guidelines clearly stipulate that 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[5]. Additionally, it also states that RMPs who intend to practice telemedicine will have to undertake an online course for the same.[6]
  • Guidelines for telemedicine in India
    1. Context – an RMP is to exercise his/ her professional judgement and discretion to determine whether the particular case being presented by the patient is appropriate for a telemedicine consultation or whether the same mandates an in-person consultation.
    2. Identification of RMP and Patient – it is very crucial to establish the identity of both the RMP and the patient. The RMP has seek all the information from the patient as may be deemed appropriate to establish the identity of the patient. Furthermore, the RMP shall make available to the patient his/ her credentials and contact details.
    3. Mode of Telemedicine – with the advent of information technology there are several tools that may be used to cater to telemedicine services. The Guidelines categorize such tools/ modes into three major categories – video, audio or text, and elaborates on the characteristics and drawbacks of each mode of telemedicine.
    4. Patient consent – patient consent is extremely crucial in any telemedicine consultation and the same may be express or implied. If the patient initiates the consultation then the consent is implied and if a health worker, caregiver or RMP initiates the consultation then the express consent of the patient is to be made known.
    5. Exchange of Information for patient evaluation – though the guidelines give an indicative framework of the kind of information that is to be sought from a patient, we see that ultimately the onus is placed on the RMP to gather sufficient medical information about the patient’s condition before making any professional judgment. The RMP is to also maintain records of such patient information.
    6. Types of Consultation – the Guidelines segregate the types of consultations in two types – first consultation and follow-up consultation, and also lays down the ambit of the same.
    7. Patient Management – if the RMP is of the opinion that the condition exhibited by the patient can be adequately managed by telemedicine then he/ she may (a) provide health education, and/ or (b) provide counselling of a particular clinical condition, and/ or (c) prescribe medicines.On prescribing medicines, the Guidelines emphasize that the same is at the professional discretion of the RMP and would entail the same professional accountability as in traditional in-person consultation. The RMP can only prescribe drugs mentioned in Lists O, A and B and cannot prescribe medicines enlisted in the Prohibited List vide telemedicine consultation. Additionally, while issuing the prescription the RMP is to abide by the provisions of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 and the Drugs and Cosmetics Act, 1940 and Rules.
    8. The Guidelines also highlight the duties and responsibilities of the RMP regarding medical ethics, data privacy and confidentiality. Penalties have been prescribed in case of violations.
  • Framework for Telemedicine – The Guidelines provide for interactions: (a) patient to RMP, (b) caregiver to RMP, (c) health worker to RMP, (d) RMP to RMP and (e) emergency situations.
  • Guidelines for Technology Platforms enabling Telemedicine – The Guidelines also provide for a set of recommendations/ advice to be followed by technology platforms which enable such telemedicine services. These recommendations include due diligence to be carried out by such platforms, reporting requirements in case of any non-compliance and blacklisting of such technology platforms in case of violation.
  • Special Responsibilities of Board of Governors (“BoG”) – The Guidelines lay down certain powers at the disposal of the BoG in supersession of the medical council of India, such as the power modify any drug list contained in the Guidelines, issue advisories and amend the Guidelines in the larger public interest.
  • Medical Misconduct- The Guidelines absolve the liability of the RMP in relation to any breach of confidentiality on account of technology breach (with reasonable evidence of the same) or any other person other than the RMP. However, the RMPs will still be held accountable for any willful action which compromises patients care and privacy or violate any prevailing law.

Conclusion and Observations

  • The Guidelines provide a much needed framework for the practice of telemedicine in India by clarifying an covering concerns related to liability, consent, confidentiality and negligence. Furthermore, they have specific exclusions and emergency circumstances where such telemedicine consultation would not be applicable.
  • It is however pertinent to highlight certain observations about the said Guidelines –
    1. The definition of ‘Telemedicine’ which has been borrowed from the definition stipulated by International Consultation Group set up by the World Health Organisation, fails to clearly set out the ambit of telemedicine consultations as it does not highlight the requirement of ‘timely access’ to healthcare facilities (which becomes critical factor in providing primary resolution in case of an emergency situations) and is an essential reason for resorting to such telemedicine consultation.
    2. We see that while highlighting the requirement of technology platforms in conducting a due diligence on the RMPs before listing them, the Guidelines fail to elaborate upon the scope of such a due diligence and neither do they stipulate a ‘reasonable’ threshold for the same.
    3. Though the Guidelines under 5.3 stipulates the reporting requirement in case of a non-compliance, they fail to state elaborate on what would be considered as non-compliance and liability for the same.
    4. Due to the nature of their profession, medical professionals owe a duty of care to their patients. And any act or omission deviating from the duty of care, may result in tortious liability on the grounds of medical negligence. In order to make a claim of medical negligence, it must be proven that there is a usual and normal practice, that such practice was not followed and the RMP adopted a course of action which no similarly placed professional of ordinary skill would have taken, had they been acting with ordinary care. The law in India in this regard sets standards and thresholds fairly high as the burden of proof to show negligence on part of the professional is difficult.
    5. Further, it is evident from the Guidelines that they provide a wide scope for exercising discretion by the RMPs, without prescribing the standards to be considered while exercising the discretion (even while the same imposes restriction on the nature of medication that can be prescribed). This exercise of discretion increases the potential exposure of RMPs to the possibility of negligence on their part. There is an additional element of risk involved due to substantial reliance on digital medium for transmission of private information. In such an event, the RMP will be required to take additional precautions to ensure that the standards of duty of care as prescribed is met. Further, as the RMP relies more on the information provided by the consumer themselves, it remains to be tested whether the high standards of duty of care (and therefore for a breach of such duty), as established for traditional medical practices, would be affected.
    6. It is pertinent to note however, that while the Guidelines attempt to restrict the liability of an RMP in cases of technological breaches, the same may not absolve/restrain any prosecution against the RMP under special statutes such as the Information Technology Act, 2002, Consumer Protection Act, 1986, etc.

[1] Criminal Anticipatory Bail Application No. 513 OF 2018.

[2]https://www.newindianexpress.com/cities/bengaluru/2018/sep/17/telemedicine-has-no-legal-backing-fraternity-calls-for-regulation-1872965.html

[3]https://www.business-standard.com/article/pti-stories/ima-seeks-clear-cut-guidelines-on-telemedication-from-mci-118080801080_1.html

[4] https://www.mohfw.gov.in/pdf/Telemedicine.pdf

[5] https://www.mohfw.gov.in/pdf/Telemedicine.pdf.

[6] The said online course will be developed and notified by Board of Governors in supersession of Medical Council of India. The RMPs will need to undertake the said course within three years of the same being notified. Till the time such an online course is being developed, the practice of telemedicine will be guided by the said Guidelines.

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Photo of Ashwin Sapra Ashwin Sapra

Partner in the General Corporate Practice at the Delhi Office of Cyril Amarchand Mangaldas. With a specialist focus on intellectual property, pharmaceuticals / medical devices regulatory and compliance affairs, Ashwin has an extensive domestic and international experience of 19 years providing advice on…

Partner in the General Corporate Practice at the Delhi Office of Cyril Amarchand Mangaldas. With a specialist focus on intellectual property, pharmaceuticals / medical devices regulatory and compliance affairs, Ashwin has an extensive domestic and international experience of 19 years providing advice on matters relating to intellectual property, drug and medical device regulatory and compliance affairs, transactional affairs, anti corruption and anti kick back laws, litigation and dispute resolution. He can be reached at ashwin.sapra@cyrilshroff.com

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Partner in the Dispute Resolution Team at the Mumbai office of Cyril Amarchand Mangaldas. Ankoosh focuses on arbitrations (domestic and international),  corporate/commercial litigation, real estate disputes and private client pratice related litigation. He can be reached at ankoosh.mehta@cyrilshroff.com

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Senior Associate in the Dispute Resolution Practice at the Mumbai office of Cyril Amarchand Mangaldas. Aviral advises on white collar crime and civil litigation, including arbitrations and dispute advisory. He can be reached at aviral.sahai@cyrilshroff.com

Photo of Jashaswi Ghosh Jashaswi Ghosh

Associate in the Pharmaceutical, Healthcare & Life Sciences Practice at the Delhi office of Cyril Amarchand Mangaldas. Jashaswi has graduated from Gujarat National Law University, in 2018 and specializes in regulatory compliance, advisory work and litigation pertaining to the pharmaceutical and health-care industry.

Associate in the Pharmaceutical, Healthcare & Life Sciences Practice at the Delhi office of Cyril Amarchand Mangaldas. Jashaswi has graduated from Gujarat National Law University, in 2018 and specializes in regulatory compliance, advisory work and litigation pertaining to the pharmaceutical and health-care industry. He also has experience corporate laws and litigation having worked in the general corporate and disputes teams in the firm’s Mumbai Office. He can be reached at jashaswi.ghosh@cyrilshroff.com