Telemedicine Practice Guidelines: Step Forward for Effective Regulation of Healthcare over Distance
Advancements in technology have various implications, socio-legal and otherwise which need to be taken into account and dealt with through proper regulation. The paradigm shift that has been brought about in various industries, including healthcare and medicine, as a consequence of rapid digitization, is a testament to how there is an urgent need for the integration of a proper legal framework into the whole system.
One of the core aims of Information and Communications Technology (“ICT”) is bridging the gap of distance thereby increasing convenience of how individuals lead their lives. The concept of ‘Telemedicine’ is a fairly recent one and if simply put refers to healing at a distance.[i] Despite having its fair share of advantages, telemedicine has its shortcomings too, especially in a developing country such as India which need to be rectified through proper policy framing.
With the objective of consolidating gaps in legislation and eliminating uncertainty in rules of consultation between medical practitioners and patients, the Medical Council of India in partnership with NITI Aayog formulated the Telemedicine Practice Guidelines, 2020 (“Guidelines”) which were released by the Ministry of Health and Family Welfare on the 25th of March and the same forms the crux of this discussion.[ii]
Telemedicine- The Next Step in Healthcare
For dealing with various issues that exist in providing health care services remotely through using various digitalized products and services, it is pertinent to understand the concept of Telemedicine, its importance and the urgent need to properly regulate its administration.
As per the Guidelines, Telemedicine may be defined as,[iii]
“The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for the diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.”
This definition has been approved by the WHO as well and reflects the issues that this innovation aims to solve, i.e. ensuring access, equity, quality and cost-effectiveness in the less developed regions of the world and in the instant case, in India.
Importance of Telemedicine
The present-day telemedicine makes use of existing computing devices such as smartphones, wearable biosensors, etc. belonging to either the patient or physician to gather clinical information and data and is very simple to use without any special training/education.
These modern practices help in cutting down travelling expenses as well as incidental medical costs, saving time and ensuring a lesser disruption in the daily responsibilities of both the doctors as well as patients, especially those residing in rural areas. Telemedicine plays a significant role in those circumstances where there is no need for the patient to physically see the Registered Medical Practitioner (“RMP”), i.e. for routine checkups or continuous monitoring.
In the light of the novel Coronavirus and other such infectious diseases, telemedicine assumes even greater significance since it helps in reducing physical contact and protects the practitioners along with the associated health workers. Such remote screening of patients by doctors is very necessary in the case of such a pandemic.
Telemedicine Regulation: The Way Ahead
The purpose of these guidelines is to render practical advice to medical practitioners and integrate telemedicine into normal practice. These set of rules are designed to ensure that the correct course of action in providing effective and sound medical care is adopted by doctors.[iv]
The guidelines provide protocols and procedures relating to patient-physician relationship and subsequent privacy and confidentiality issues, health education and counselling, the standard of care during the evaluation, prescription of drugs, penalties for negligence and so on. This section deals with an elaborate discussion on these norms and protocols.
Information, Confidentiality and Data Privacy
The telemedicine guidelines state that the consultation between the patient and the medical practitioner cannot be anonymous, i.e. both the parties should be able to identify and verify each other’s identities.[v] The guidelines place a duty on part of the doctor to confirm and verify the identity of the patient by asking the patient’s name, age, address and contact details, before providing teleconsultation to the patient. At the same time, the guidelines place an added obligation on the medical practitioner to make their identity known to the patient, before the start of the consultation. [vi]
It must also be noted here that while in cases of an in-person consultation, it is not a general scheme for the doctors to keep and maintain the health records of patients. However, in case of teleconsultation, the present set of guidelines make it mandatory for the medical practitioner to maintain and keep the records of the interaction with their patients and other relevant documents (such as prescriptions).
The health data of an individual falls within the definition of sensitive personal data as can be inferred by the legislative intent behind the Personal Data Protection Bill, 2019,[vii] as well as the Information Technology Rules, 2011. A registered medical practitioner is under an ethical obligation to protect the privacy of the patient and maintain confidentiality as per the provisions of the Indian Medical Council Regulations, 2002.[viii] Moreover, since this consultation takes place over an electronic platform, the protection of the Information Technology Act, 2000 is also extended in this regard. Sections 43A and 72A of the said Act prescribe punishment for failure to maintain reasonable security standards relating to sensitive personal data[ix] and for disclosure of any information of such nature to unauthorized parties,[x] respectively.
Thus, the guidelines seek to regulate the acts of the practitioner and ensure that no such information must be shared or transferred that may disclose the identity of the patient, without his/her prior consent.
Generating Awareness and Imparting Health Education
For any technological innovation to be successful, a certain level of understanding is required by the users. In the case of telemedicine, such a familiarity with technology is increasing with leaps and bounds, with e significant rise in the number of Indians using smartphones and/or computers and having access to the internet.[xi] Consultation has been enabled through messaging and video-conferencing platforms (such as WhatsApp, Facebook, Google Duo, Skype, etc.) thereby making it a very simple process as it does not require any special training on part of the concerned parties.
In the case of devices such as Remote ECG Kits, hearing aids, wearable Biosensors making use of AI and so on which may be required for constant monitoring of certain patients (suffering from organ ailments), practitioners are required to impart complete information regarding their working.
As per these Guidelines, the doctors are permitted to provide instructions relating to health preservation and disease prevention which may include but are not limited to diet plans, physical activity regimens, mosquito control, hygiene practices, etc.[xii]
These provisions ensure that there is full disclosure of relevant medical information and proper clinical counselling to the patients, thus increasing their faith, belief and awareness with regards to this innovative and recent approach to healthcare and medicine.
There is also a provision for prescribing certain drugs (as provided for by these Guidelines under four lists in consonance with related statutes such as the Drugs and Cosmetics Act and Rules, Narcotic and Psychotropic Substances Act, 1985 and the MCI Code of Ethics Regulations, 2002) in a manner which ensures that there is no health risk faced by the patients in the absence of physical support of a medical professional.[xiii]
A Solution to the Medical Negligence Conundrum
The Telemedicine Guidelines expressly state that registered medical practitioners 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.”[xiv]
A doctor has to maintain the same standard of care during teleconsultation as he/she is required to meet, in an in-person consultation. Therefore, if medical negligence is alleged against him/ her, the medical practitioner cannot seek the protection from the liability on the grounds that the consultation took place through an electronic medium.
In 2018, the judgement of the Bombay High Court in the case of Deepa Sanjeev Pawaskar v. State of Maharashtra,[xv] cast a shadow on the legitimacy of telemedicine in India. In this case, two doctors were held liable for criminal negligence resulting in the death of the patient, while under their care. The Court held that the patient died due to treatment prescribed over the telephone without proper enquiry and diagnosis, thereby constituting criminal negligence.
This however created a lot of uncertainty as regards to the legitimacy of different modes of administering healthcare in the country. The decision of the Court was misconstrued by associations of healthcare practitioners across the country so as to hold the practice of telemedicine itself as illegal in its entirety.[xvi] It must be understood here that the mere fact that medicines were prescribed to the patient over the telephone was not the rationale behind the judgement of the Court but instead incidental to it. It can, therefore, be said that the telemedicine guidelines are not in contravention of the judgement of the Court but, are rather, reinforced by it.
The guidelines assert that a registered medical practitioner may prescribe medicines via telemedicine to a patient only when the practitioner is satisfied that he has acquired all the relevant and adequate information about the patient’s medical condition.[xvii] This would mean that if there exists a specific set of requirements that need to be met, as regards to diagnosis and prescription in case of an in-person consultation, the same standards must be ensured in teleconsultation as well. Non-fulfilment of these standards by the doctor would amount to professional misconduct and may result in the medical practitioner losing his/her registration with the State Medical Council.[xviii]
Consolidation of Gaps in the Legislative Framework
One of the biggest issues that were faced by medical practitioners in practising telemedicine was uncertainty with regards to different methods of teleconsultation, the legality of medical advice given via virtual means and rules of the standard of care to be adopted during such a process. These gaps pose risks for both practitioners as well as patients.
These guidelines have been published as an amendment to the MCI Code of Ethics Regulation, 2002. Therefore, not conforming to them would amount to misconduct and subsequent suspension from the State Medical Council if the guilt on the basis of patient grievance is confirmed.[xix]
By ascribing appropriate punishment for failure to discharge any duty on the medical professional’s part on the basis of an existing legal framework, the Guidelines have ensured that there is no undue increase in the bulk and complexity of the same. This ensures a better implementation and enforcement of law and affirms the faith of all concerned stakeholders.
The drafting and implementation of the Telemedicine Practice Guidelines, amidst the lockdown in place due to the pandemic, marks the dawn of a new era for the medical industry in India. It would be fitting to say that the Law has finally drawn alongside the realities and obligations of contemporary times.
The guidelines have provided a legal reinforcement to the consultation of patients by the doctors through electronic means, thereby providing remote access to medicine. It is no longer required for the patients to wait for long hours to consult a doctor for the smallest of problems.
It can be aptly said that the union of Information Technology and Medicine holds many a boon and ensures that no individual is deprived of medical attention just because of a distance barrier. Law, being ever-pervasive is required as a regulatory mechanism and the absence of its clarity leads to the cropping up of several grey areas which are often disadvantageous to the parties concerned. The 2020 Guidelines carry the key to the effective and beneficial management of the different facets of Telemedicine.
[i] EM Strehle & N Shabde, One hundred years of telemedicine: does this new technology have a place in paediatrics?, 91(12) Archives of Disease in Childhood 956, 959 (2006).
[ii] Vinod Joseph & Protiti Basu, Telemedicine Guidelines – A Review, Mondaq (May 05, 2020), https://www.mondaq.com/india/healthcare/928698/telemedicine-guidelines–a-review-.
[v] supra note iii at Guideline 3.2.1.
[vi] supra note iii at Guideline 3.2.4, 3.2.5.
[vii] The Personal Data Protection Bill, 2019.
[viii] Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Gazette of India, pt. VII sec. 14 (Apr.6, 2002).
[ix] §43A, Information Technology Act, 2000.
[x] §72A, Information Technology Act, 2000.
[xi] TECHINSIGHT – At 502.2 million smartphone users, it’s time for smartphone brands to turn towards services in 2020, Technology-Analytics Research Consulting- techARC (Jan. 30, 2020), https://techarc.net/techinsight-at-502-2-million-smartphone-users-its-time-for-smartphone-brands-to-turn-towards-services-in-2020/#page-content.
[xii] supra note iii at Guideline 3.7.2.
[xiii] supra note iii at Guideline 3.7.4.
[xiv] supra note iii at Guideline 1.3.2.
[xv] 2018 SCC OnLine Bom 1841.
[xvi] Thulasiraj Ravilla, A long term vision for universal eye care, The Hindu BusinessLine (Jun. 18, 2019), https://www.thehindubusinessline.com/opinion/a-long-term-vision-for-universal-eye-care/article28067008.ece.
[xvii] supra note iii at Guideline 3.7.4.
[xix] Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Gazette of India, pt. VIII sec. 2 (Apr.6, 2002).
Co-authored by Abhigyan Tripathi & Rishabh Chhabaria, students of Rajiv Gandhi National University of Law, Punjab. This blog post is part of the blog series on ‘Digital Healthcare in India’ as organised by RSRR in collaboration with Nishith Desai Associates.