Contributed by: Samvad Partners
On February 6, 2018, doctors Sanjiv and Deepa Pawaskar helped Dyananda Polekar to deliver a healthy child. She was discharged on February 9, 2018 but the very next day, she began vomiting through the day. She was taken to the Pawaskar’s hospital that night. The Pawaskars were away for a conference and the staff nurse, after consulting with Dr. Deepa Pawaskar, advised the Polekars that there was no need to go to another hospital and that they could be treated there. Dr. Deepa provided telephonic instructions to the staff nurses, who administered medicines on this basis. Despite the insistence of Dyananda’s relatives that she be shifted to another hospital, the nurses informed them that they are in touch with the Polekars and were treating her under Deepa’s telephonic instructions. However, her health deteriorated rapidly and the next day, she expired. Her husband then filed a complaint before the police under S. 304 (culpable homicide) and S. 304A (death due to negligence) of the Indian Penal Code (IPC). The Pawaskars then filed an application for anticipatory bail which was heard by the Bombay High Court.
The Court looked into the matter and framed a specific issue, namely, “whether Prescription without diagnosis and hence resulting into death of the patient amounts to criminal negligence on the part of the doctors”. The assumption underlying this issue, of course, was that telephonic consultation could not amount to disgnosis. The Court found, inter alia that: (i) the Pawaskars directed the patient to be admitted in their absence; (ii) the medicines were administered on telephonic instructions and without (iii) the complainant wanted to admit his wife in another hospital and was dissuaded by the Pawaskars. On these grounds, the Court formed a prima facie conclusion that he Pawaskars were not merely guilty of criminal negligence under S.304A of the IPC, but of culpable homicide under S.304 of the IPC. On this basis, the Court denied the Pawaskars anticipatory bail.
This decision created waves throughout the medical community. In particular, its interpretation by some experts and media outlets cast a pall over telemedicine, one of the fastest growing areas of medical practice in India. With this decision, (Deepa Sanjeev Pawaskar And Anr vs The State Of Maharashtra, decision dated 25 July, 2018, hereinafter the Pawaskar decision) the practice of telemedicine was plunged from a grey area into the black.
2. Telemedicine in India
Telemedecine is the provision of clinical services to patients by medical practitioners over a distance. This is conventionally understood as being done through electronic communication. Telemedicine is of particular importance to India, with an average doctor-patient ratio of 1 doctor per 1,457 people and a rural doctor-patient ratio of 1 doctor per 25,000 people. The area of telemedicine is also highly significant to India’s burgeoning healthcare startup industry, which has more than 150 enterprises creating innovation in the health-care field. Companies like Practo, Lybrate and Mfine which provide platform services for doctors, rely extensively on telemedicine. However, recent regulatory changes in the law regarding telemedicine are of significant importance to online pharmacies as well, such as 1mg, Echo and AlixaRx, as they enable the prescription of medicines pursuant to a telemedicine consult and diagnosis. After the onset of the Covid-19 pandemic in India, the practice of telemedicine took on additional urgency, with telemedicine often being the only practical medium for many people to access healthcare and diagnostic services. Of course, after the Pawaskar decision, there has been significant concern through these industry over the future of telemedicine consults in India.
3. Recent Changes in the Law
However, the regulatory environment around telemedicine recently underwent a sea-change, emphasised by the Prime Minister’s address to the nation on March 27, 2020. In his address, the Prime Minister urged people to seek the advice of doctors and medical professionals through telephonic means during the impending lockdown. This was enabled legally by certain important legal developments:
a. On March 25, 2020, the Board of Governors in Supersession of the Medical Council of (MCI), in consultation with the Ministry of Health and Welfare (MoHW) amended the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 (IMC Code) to allow for the provision of diagnosis and treatment through telemedicine. The IMC Code is the equivalent of the Bar Council Rules on Professional Standards for Advocates for medical professionals, governing a range of aspects of a medical professional’s practice, including ethics, record-keeping, confidentiality, requirements to display registration numbers, intellectual property, advertising and dealings with the pharma and health care industries. The amendments to the IMC Code introduced clause 3.8 which permitted telemedicine consultations by Registered Medical Practitioners (RMP) in accordance with the Telemedicine Practice Guidelines 2020 (Telemedicine Guidelines). It is made clear in the amendments as well as in the Telemedicine Guidelines that this permission to conduct telemedicine is not applicable to the use of digital technology for conducting surgical or invasive procedures remotely, also called remote surgery.
b. On the same date, the Telemedicine Practice Guidelines 2020 were also notified.
c. On June 11, 2020, the Insurance Regulatory and Development Authority of India (IRDAI) issued guidelines advising insurers to allow telemedicine wherever consultation with a medical practitioner is allowed in the conditions of the policy contract.
With these important inclusions, the practice of telemedicine became legitimised and moved out of regulatory grey space.
4. The Telemedicine Practice Guidelines
4.1. Legal Applicability
At the outset, it is important to note that the Telemedicine Guidelines are not a purely legal document, but contain a number of technical provisions with significant legal ramifications. They are applicable to all Registered Medical Practitioners (RMPs), a term defined in the IMC Code as meaning any medical professional registered to practice in the National Register of Medical Professionals or in any State Register of Medical Professionals. The Telemedicine Guidelines are also applicable to telemedicine that leverages all channels of communication that leverages IT. As mentioned earlier, the Telemedicine Guidelines are not applicable to remote surgery. However, the Telemedicine Guidelines also make it clear that they are not applicable to consultations outside the jurisdiction of India. The impact of this latter exclusion and its implications on telemedicine consults following in-person visits by persons resident outside India is currently unclear.
One important element of the legal applicability of the Telemedicine Guidelines arises from the fact that they provide for an online training program in telemedicine required to be undergone by any RMP seeking to practice telemedicine. The online program is an essential prerequisite for the practice of telemedicine. However, the Telemedicine Guidelines also specify that all RMPs are required to complete the program within 3 years of its notification. In the interim, the Telemedicine Guidelines are to be followed in order for an RMP to be considered as practicing telemedicine in accordance with the IMC Code. Therefore, the Telemedicine Guidelines serve as not merely a technical guide to the practice of telemedicine, but also a legal guide to ensure that doctors practice telemedicine without running afoul of the IMC Code.
4.2. Important Terms
At the outset, it is important to understand certain important terms regarding actors in the Telemedicine Guidelines.
Registered Medical Professional - As mentioned earlier, an Registered Medical Practitioner (RMP) is a person enrolled in State Medical Register or the Indian Medical Register under the IMC Act 1956.
Caregiver - The Telemedicine Guidelines define a Caregiver as a family member, or any person authorized by the patient to represent the patient.
Health Worker - The Telemedicine Guidelines also define a Health Worker as being a nurse, allied health professional, midlevel health practitioner, auxiliary nursing midwife or any other health worker designated by an appropriate authority.
4.3. Classification of Telemedicine
The Telemedicine Guidelines also understand the classification of telemedicine on the basis of 4 factors:
(a) Mode – This is the medium over which the telemedicine consult is provided. The modes could be video, audio or text. However, over the course of the Telemedicine Guidelines, it is apparent that video consults are given preference for certain reasons.
(b) Timing – This is the timeline within which the interaction between the patient and the RMP is conducted. The consult could be in Real Time, i.e. with a simultaneous exchange of information (for instance via a video consult) or Asynchronous (such as with the exchange of emails).
(c) Purpose – This pertains primarily to the urgency with which the consult is provided, and is broadly categorised into Non-Emergency and Emergency consults.
(d) Individuals - This pertains to the actors involved in the telemedicine consult. The Telemedicine Guidelines identify 4 primary categories of consult:
Patient to RMP – Where the RMP and the patient interact directly
Caregiver to RMP – Where the RMP interacts with a Caregiver on behalf of the patient, whether the patient is there or not
RMP to RMP – Where one RMP consults with another regarding specific issued being faced by a patient
Health Worker to RMP – Where a Health Worker consults with an RMP regarding a patient
There are certain specific guidelines governing all 4 forms of person-to-person consult provided for under the Telemedicine Guidelines. However, for the purposes of this article, emphasis is placed on the Patient to RMP category of telemedicine consult.
4.4. Factors to Consider before beginning Consult
The Telemedicine Guidelines require an RMP to consider a number of factors while conducting a Telemedicine consult. These factors make up a significant portion of the legal requirements that underly the technical aspects of the Telemedicine Guidelines.
i. Context (whether appropriate)
The Telemedicine Guidelines require an RMP to use their professional judgment to decide if telemedicine is appropriate method of providing a diagnosis to the patient. They also emphasise that the RMP is required to uphold same standard of care as for in-person consult.
ii. Type of Consult
The RMP is required to determine whether the patient consultation falls within the category of a First Consult or a Follow-up Consult.
First Consult - A First Consult means that, either:
The patient is consulting with the RMP for first time, OR
The patient has consulted with the RMP earlier but for a different condition, OR
The patient has consulted with the RMP more than 6 months before for the same condition
The Telemedicine Guidelines specify that the First Consult is is preferably conducted via video, thereby enabling the RMP to make better judgments and provide better advice.
Follow-up Consult – A Follow-up Consult is when a patient consulting with the RMP within 6 months of the previous in-person consult in continuation of same health condition. However, it will not be considered to be a follow up consult if:
The patient is exhibiting new symptoms that are not in the spectrum of the same health condition, or
If the RMP does not recall the context of previous treatment or advice
Identification is an important element to consider under the Telemedicine Guidelines. Both, the patient and the RMP must know and be able to verify each other’s identity. The RMP should verify the patient’s ID through their name, age, address, email ID, phone number, registered ID or any other appropriate form of identification. There must also be in place a mechanism for the patient to verify the credentials and contact details of the RMP. The RMP is required to establish the patient’s identity at the beginning of the consultation. If the patient is requesting a Follow-up Consult, the RMP is required to be reasonably convinced that they are communicating with the same patient. The RMP can implement this by requesting the consult through the registered phone number or registered email id provided by the patient earlier. It is also possible that if the consult is being conducted through a healthcare technology platform, the patient can establish identity by using the same account on the platform.
The Telemedicine Guidelines require the RMP to consider the appropriateness of the technology over which the consult is taking place and determine whether video, audio or text is relevant. However, as mentioned earlier, video is given some emphasis due to its ability to allow the RMP to make visual identification of certain conditions.
Prior informed consent is also a significant factor under the Telemedicine Guidelines, as under the IMC Code as well. Consent must be obtained from the patient prior to the RMP beginning the telemedicine consult. Implied consent can be inferred if the patient initiates the consult. However, if the consult is initiated by a Health Worker, Caregiver or by another RMP, explicit consent must be obtained from the patient by the Health Worker, Caregiver or the RMP. This must also be verified by the RMP providing the telemedicine consultation. It is important to note that, under the Telemedicine Guidelines , consent can be recorded in ANY form – however it must be recorded.
Consent is not merely relevant at the time of initiating the telemedicine consult, but at all points of time. The patient has right to discontinue the telemedicine consultation at any time if they so choose.
Consent is not only important from the patient’s end, but from the RMP as well. The RMP can also choose not to proceed with the telemedicine consultation at any time. From the Frequently Asked Questions posted along with the Telemedicine Guidelines, it is also apparent that a patient cannot insist on the RMP providing specific advice if RMP chooses not to.
vi. Information for Evaluation
The RMP is required to use their professional judgment to decide how much information required is required from the patient in order to make a proper evaluation of their condition. The RMP can ask for additional information, including requiring that certain tests or other investigations be conducted. If the RMP requests the patient to conduct tests or obtain more information, the consult is considered paused and can be resumed after the relevant information has been obtained. The RMP must also determine if a physical examination is critical. If so, the RMP should not proceed until a physical examination has been arranged for. As with the IMC Code, the patient is responsible for the accuracy of information provided by them to the RMP.
vii. Patient Management
Patient management provides to the actions that the RMP can take after consulting with and evaluating the patient. The RMP is allowed to exercise three options:
Provide Health Education which extends to general advice on health promotion or disease prevention
Provide Counselling for the Patient’s Clinical Condition, which extends to specific advice relevant to the patient’s condition – This may also include advice for testing or making any other investigation
The RMP is also authorised under the Telemedicine Guidelines to prescribe medicines to the patient. The rules and parameters under which the RMP may prescribe medicines are outlined below.
4.5. Guidelines for Prescribing Medicines Through Telemedicine
What to Prescribe?
At the outset, it is important to note that, with the exception of Schedule X of the Drugs and Cosmetics Rules, 1945 Existing Schedules of Drugs not applicable to the Telemedicine Guidelines. The categories of drugs that may or may not be prescribed under the guidelines are broadly divided into three:
List O - Medicines that can be prescribed through any mode of tele-consult. This would include over-the-counter drugs for common conditions such as paracetamol, ORS and others. The Telemedicine Guidelines also specify that this includes medicines necessary for public health emergencies
List A – Consists of a category of drugs that may be prescribed through the first consult. The Telemedicine Guidelines specify that List A drugs must be prescribed only pursuant to a video consult. List A drugs can also be re-prescribed for a refill, during a follow-up consult. List A consists of an inclusive list, containing relatively safe medicines with low potential for abuse such as antifungal medication or refills for chronic diseases such as diabetes, hypertension etc.
List B – Consists of drugs that may only prescribed for patients doing a follow-up consult AFTER an in-person consult. These consist of add-on medications used to optimise existing conditions such as ACE Inhibitors
Prohibited List – The prohibited list consists of drugs that cannot be prescribed at all during a telemedicine consult. They constitute drugs with a high potential of abuse, or which could harm the patient or the society if used improperly. The drugs under Schedule X of the Drugs and Cosmetics Rules, such as amphetamines, barbiturates, ketamines, anti-cancer drugs etc are in this category. Additionally, any psychotropic substance listed in NDPS Act is considered to be in the Prohibited List.
Injectables – The FAQ to the Telemedicine Guidelines specify that injectable drugs can be prescribed by an RMP only when being consulted by another RMP. It is possible for an RMP to prescribe injectables to a Health Worker if the RMP is confident of the medical facility and the technical expertise of the Health Worker. One exception to this rule is if the injectables are follow-up medications which are available only as injections, for instance insulin shots.
How to Prescribe?
The Telemedicine Guidelines also require an RMP to issue prescriptions as per the IMC Code. A sample format for prescriptions is provided as an annexure to the Telemedicine Guidelines. The Telemedicine Guidelines allow the RMP to provide the prescription either as a digital copy of the signed prescription or as an e-Prescription to the patient via any messaging platform. The Telemedicine Guidelines also require that, if the RMP is transmitting the prescription directly to a pharmacy, they must ensure the Explicit Consent of the patient, and ensure that the patient is aware that they are entitled to get the medicines dispensed from any pharmacy of their choice.
4.6. Privacy and Confidentiality
The Telemedicine Guidelines require all RMPs to comply with the IMC Act and the IMC Code norms for medical ethics, privacy and confidentiality. Though the Telemedicine Guidelines mention that the RMP is to comply with privacy obligations under the Information Technology Act, 2000 and applicable data privacy laws, very little additional guidance is provided. This means that the provisions regarding confidentiality and data privacy are the sparsest in the Telemedicine Guidelines, providing little effective guidance to a medical professional on how to handle these increasingly relevant issues in a telemedicine consult. The Telemedicine Guidelines do specify that an RMP is not liable for breach of patient confidentiality if there is reasonable evidence that the patient’s privacy and confidentiality was compromised by a technology breach or by a person other than the RMP.
Record keeping is an important part of compliance with the Telemedicine Guidelines. The Telemedicine Guidelines require an RMP to keep the following records:
Log/record of the telemedicine interaction – This should be a complete log of the entire telemedicine consult, whether as a video file, audio file, text file or in a multimedia format.
Any patient records, reports, documents, images, diagnostics, data etc. (Digital or non-Digital) utilised in the telemedicine consultation
A record of any prescriptions provided to the patient under the telemedicine consult
4.8. Guidelines for Technology Platforms
An important aspect of the Telemedicine Guidelines consists of the section devoted to technology platforms providing assistance to RMPs in making telemedicine consults. This section is squarely aimed at providing clarity as well as specific liability for health-care startups that seek to enable telemedicine consults. There are broadly two primary obligations placed on RMPs when making a telemedicine consult:
Due Diligence: There are two elements of due diligence by the technology platform under the Telemedicine Guidelines. Firstly, the technology platform is obligated to ensure that patients consult with RMPs who are duly registered with National or State Medical Councils. To this end, the technology platform must provide the name, qualifications, registration number, and contact details of every RMP listed on the platform. Secondly, the technology platform itself is tasked with ensuring an RMP’s compliance with the Telemedicine Guidelines. If the technology platform notes any non-compliance by the RMP, it is required to report such non-compliance with the Board of Governors in Supersession of the MCI.
Use of Artificial Intelligence / Machine Learning (AI/ML): The Telemedicine Guidelines specify that AI/ML algorithms are specifically prohibited from counseling patients or prescribe medicines. The Telemedicine Guidelines allow AI/ML algorithms to be used to assist or support an RMP on patient evaluation, diagnosis, or management. However, the final prescription must be delivered by an RMP.
Grievance / Query Redressal Mechanism: The Telemedicine Guidelines require technology platforms to institute a mechanism to address patient grievances or to answer patient queries effectively. However, the modalities of such a mechanism have not been specified in the guidelines.
Blacklisting: Importantly, the Telemedicine Guidelines state that, if a technology platform violates any of the requirements placed on it under the guidelines, the violating platform may be blacklisted. This means that no RMP will be permitted to use the platform. As has been noted earlier, the IMC Act and IMC Code specifically govern medical professionals and can accordingly only impact medical professionals. However, it is clear that, while such a blacklisting provision places an obligation on medical professionals, its impact would be squarely on the technology platforms themselves.
While the Telemedicine Guidelines and the amendments to the IMC Code provide welcome clarity to the medical profession, and the healthcare and health-tech industry, there are a few lacunae and omissions in them which could be addressed to improve clarity .
Firstly, as mentioned earlier, there is insufficient clarity on the privacy and confidentiality practices to be followed by medical professionals when performing telemedicine consults and maintaining records under the Telemedicine Guidelines. While a general obligation to comply with ‘applicable laws’ exists, this is insufficient to address the specific problems and situations that a doctor, patient or technology platform may face when managing data privacy over telemedicine consults and records.
Secondly, there is presently limited clarity on the classification of dugs permitted for prescription through telemedicine. While the FAQ to the Telemedicine Guidelines state that the criteria for prescription is based on practical clinical pathways, this provides little additional clarity to doctors, which could make them wary of prescribing important lifesaving drugs under Lists A or B. It is important to note that the ‘lists’ as mentioned under the Telemedicine Guidelines are not lists at all, but merely categories of drugs with broad descriptions. While the IMC Code amendment and the Telemedicine guidelines make it clear that the lists are subject to amendment by the MoHFW and the MCI, the lack of clarity could reduce the confidence with which doctors could prescribe under the Telemedicine Guidelines.
Thirdly, an important lacuna in the IMC Code and the Telemedicine Guidelines relates to the legal validity of telemedicine consults for persons resident outside India. It is entirely possible that an NRI or a foreigner could come into India for an in-person consultation with a doctor and then seek to make a follow-up consult via telemedicine with the doctor. However, the IMC Code specifically excludes the applicability of the Telemedicine Guidelines to telemedicine consults outside India. In this scenario, the legal validity of such a legitimate follow-up consult is in question.
While, in general, the Telemedicine Guidelines have lifted telemedicine out of a legal grey area towards the white, there are still steps that could be taken to ensure that these guidelines enable medical professionals as well as health-care institutes and startups to provide telemedicine services effectively and with confidence.
Contributed by Samvad Partners
The above article has been authored by Mr. Rohan K George (Partner, Samvad Partners)