At a time when the world is facing a pandemic and mobility is not possible, the Telemedicine Practice Guidelines could not have come at a better time. While all Registered Medical Practitioners should be made aware of these guidelines and training be made mandatory, patients seeking advice must also be aware of the limitations of this service and also its benefits. We note that there is a salutary provision for consent in the guidelines of the patient which requires our particular focus as lawyers, Consent is informed consent. In addition, we must note that all other prevailing laws will apply to medical professionals which would otherwise apply to physical consultations. The key to understanding this regime is that the Registered Medical Practitioners will use her professional opinion to decide if this is a fit case for telemedicine or whether a physical examination is required.
[dropcap]T[/dropcap]HE life and times of quarantine bring with it unique work and unique methods of execution. Telemedicine Practice Guidelines were issued on March 25, 2020. Ever since I have been asked a fair number of queries by both medical practitioners and app-based businesses. In the process of addressing such queries, I have had the benefit of analysing Telemedicine Practice Guidelines with stellar remote assistance from my junior colleague Mr N. Sasank Iyer and my online intern Mr Shreesh Chadha.
However, no potential seeker of telemedicine asked me anything about these guidelines, hence, I decided to compose this piece, in 2 parts.
What is Telemedicine?
World Health Organization (“WHO”) defines telemedicine as under:
“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 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”
Does the Medical Council of India recognise these Guidelines?
Yes. In supersession of Medical Council of India (“MCI”), Board of Governors (“BoG”) of MCI has issued Telemedicine Practice Guidelines (“Telemedicine Guidelines”) on March 25, 2020. These guidelines enable Registered Medical Practitioners (“RMPs”) to provide health care using telemedicine. For the purpose of Telemedicine Guidelines, RMP is defined as a person who is enrolled in the State Medical Register or the Indian Medical Register under Indian Medical Council Act, 1956 (“IMC Act”).
Are RMPs entitled to provide Telemedicine consultation?
Yes. Telemedicine Guidelines mandate that RMPs are entitled to provide telemedicine consultation to patients from any part of India. The following chronology of events is significant to enable all those RMPs who would want to practise telemedicine get familiar with Telemedicine Guidelines, as well as, with the process and limitations of telemedicine practice:
- An online program will be developed and made available by BoG in supersession of MCI.
- 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 Telemedicine Guidelines need to be followed.
- Undergoing and qualifying such a course, as prescribed, will be essential prior to practise of telemedicine.
What is the legal sanctity of these Guidelines?
Yes, Telemedicine Guidelines have legal sanctity. Telemedicine Guidelines constitute Appendix 5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (“Ethics Regulations”). Ethics Regulations consist of dedicated chapters on Code of Medical Ethics, various duties and responsibilities of physicians, unethical acts, misconduct, punishment and disciplinary action. Ethics Regulations also consist of 4 appendixes. As it stands today, Telemedicine Guidelines exist in the form of an appendix to Ethics Regulations.
Are guidelines in the context of Telemedicine practice necessary?
Yes. Telemedicine Guidelines are an absolute necessity. In September 2005, the Ministry of Health and Family Welfare (“Health Ministry”) has taken initiative to constitute the National Task Force on telemedicine, which resulted in the rolling out of several projects. However, a lack of clear guidelines has posed RMPs with significant ambiguity and doubts have been raised on telemedicine practice.
In September 2005, the Ministry of Health and Family Welfare has taken initiative to constitute the National Task Force on telemedicine, which resulted in the rolling out of several projects. However, the lack of clear guidelines has posed Registered Medical Practitioners with significant ambiguity and doubts have been raised on telemedicine practice.
Till now, in India, there was no statutory instrument on telemedicine being practised through video, phone and internet-based platforms. The provisions which exist in prevalent statutory instruments including Ethics Regulations and even Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011 are insufficient in the context of telemedicine practice.
Telemedicine Guidelines affirm that telemedicine will continue to grow and be adopted by more health care practitioners and patients in a wide variety of forms, and these guidelines will be a key enabler in fostering its growth. Telemedicine Guidelines also affirm that where clinically appropriate, telemedicine is a safe, effective and valuable modality to support patient care. At the same time, Telemedicine Guidelines make it clear 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.
What is the scope of Telemedicine Guidelines?
Telemedicine Guidelines are designed to serve as an aid and tool to enable RMPs to effectively leverage telemedicine to enhance health care service and access to all. Telemedicine Guidelines cover norms and standards for RMPs to consult patients via telemedicine.
Rather progressively, Telemedicine Guidelines make it clear that telemedicine includes all channels of communication with the patient that leverage information technology platforms, including voice, audio, text and digital data exchange. Such an approach ensures flexibility and futurism without compromising on certainty and precision.
Telemedicine Guidelines make it clear 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.
Telemedicine Guidelines vaguely state that within the broad paradigm of telemedicine, Telemedicine Guidelines will be published under the IMC Act and are for privileged access only. (See Guideline 1.2 at page 10 of Telemedicine Guidelines).
What is excluded from the purview of Telemedicine Guidelines?
The following are specifically excluded from the purview of Telemedicine Guidelines:
- Hardware or software specification, infrastructure building and maintenance
- Data management systems involved, their standards and interoperability
- Use of digital technology to conduct surgical or invasive procedures remotely
- Other aspects of telehealth such as research and evaluation and continuing education of health care workers
- Consultations outside the jurisdiction of India
Such exclusions are also progressive in nature, as such exclusions ensure that Telemedicine Guidelines are a focused regime.
Telemedicine Guidelines specifically exclude aspects of telehealth such as research and evaluation and continuing education of health care workers from its scope.
Telemedicine Guidelines define telehealth as under (See page 5 of Telemedicine Guidelines):
“The delivery and facilitation of health and health-related services including medical care, provider and patient education, health information services, and self-care via telecommunications and digital communication technologies.”
However, Telemedicine Guidelines specifically exclude aspects of telehealth such as research and evaluation and continuing education of health care workers from its scope.
What are the stated purposes of Telemedicine Guidelines?
Telemedicine Guidelines make it clear that they should be used in conjunction with the other national clinical standards, protocols, policies and procedures. Telemedicine Guidelines lay down the following purposes:
- To give practical advice to doctors so that all services and models of care used by doctors and health workers are encouraged to consider the use of telemedicine as a part of normal practice.
- To assist the medical practitioner in pursuing a sound course of action to provide effective and safe medical care founded on current information, available resources, and patient needs, to ensure patient and provider safety.
- To realise the full potential of these advancements in technology for health care delivery.
- To 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
- health education
- To provide information on various aspects of telemedicine, including information on technology platforms and tools available to medical practitioners and how to integrate these technologies to provide health care delivery.
- To spell 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.
- To mitigate risks, drawbacks and limitations in the usage of technology for telemedicine services, through appropriate training, enforcement of standards, protocols and guidelines.
- To use Telemedicine Guidelines in conjunction with other national clinical standards, protocols, policies and procedures.
As much as telemedicine consultation provides safety to Registered Medical Practitioners from contagious conditions, it cannot replace physical examination that may require palpation, percussion or auscultation; that requires physical touch and feel. Telemedicine Guidelines appreciate this aspect, however, they note that newer technologies may improve this drawback.
What are the tools of Telemedicine?
As much as telemedicine consultation provides safety to RMPs from contagious conditions, it cannot replace physical examination that may require palpation, percussion or auscultation; that requires physical touch and feel. Telemedicine Guidelines appreciate this aspect, however, they note that newer technologies may improve this drawback.
RMPs can use any telemedicine tool which is suitable to carry out technology-based patient consultation. The tools could range from mobile apps to landline phones. The core principles of telemedicine practice remain the same, irrespective of the communication tool which is put to use. Telemedicine Guidelines classify these tools into the following categories based on:
- The mode of communication
- Timing of the information transmitted
- The purpose of the consultation
- The interaction between the individuals involved – the interactions could be RMP to RMP or RMP to patient
Each one of these categories has been further sub-classified. For example, the mode of communication category tools could be video-based (for example Skype) or audio-based (for example phone) or text-based. Text-based tools could be telemedicine chat-based (for example specialised mobile apps), general chat-based (for example WhatsApp) or asynchronous (for example email).
Telemedicine Guidelines mandate that multiple technologies can be used to deliver telemedicine consultation, the 3 primary modes being video, audio and text. Pertinently, Telemedicine Guidelines appreciate the fact that each one of these technology systems has peculiar strengths, weaknesses and contexts, in which they may be appropriate or inappropriate to deliver a proper diagnosis.
What are the Guidelines of Telemedicine?
Telemedicine Guidelines mandate that the professional judgment of an RMP should be the guiding principle for all telemedicine consultations. In other words, an RMP is well-positioned to decide whether a technology-based consultation is sufficient or an in-person review is required. Telemedicine Guidelines go on to prescribe that practitioners shall exercise proper discretion and not compromise on the quality of care. In fact, Telemedicine Guidelines go on to lay down 7 elements which need to be considered before beginning any telemedicine consultation, namely:
- Identification of RMP and Patient
- Mode of Communication
- Type of Consultation
- Patient Evaluation
- Patient Management
Registered Medical Practitioners can use any telemedicine tool which is suitable to carry out technology-based patient consultation. The tools could range from mobile apps to landline phones. The core principles of telemedicine practice remain the same, irrespective of the communication tool which is put to use.
Telemedicine Guidelines deal with these elements in detail (See Guideline 3.1 at page 16 to Guideline 3.7 at page 22). An illustrative list of important aspects is as under:
- RMPs must make all efforts to gather sufficient information about the patient’s condition before making any professional judgment.
- Telemedicine consultation should not be anonymous i.e., the patient and the RMP need to know each other’s identity.
- Patient consent is necessary for any telemedicine consultation. The consent can be implied or explicit depending on the circumstances. If the patient initiates the telemedicine consultation, then, the consent is implied. Explicit consent is needed if a health worker, RMP or a caregiver initiates a telemedicine consultation. Such consent can be recorded in any form. The patient can send an email, text or audio/video message. The patient can state her intent on phone/video to the RMP. The RMP must record this in her patient records.
- RMPs shall maintain all patient records including case history, investigation reports, images et cetera, as appropriate.
- Prescribing medications via telemedicine consultation is at the professional discretion of the RMP. It entails the same professional accountability as in the traditional in-person consultation. If a medical condition requires a particular protocol to diagnose and prescribe as in the case of an in-person consult, then, the same prevailing principle will be applicable to a telemedicine consult. Prescribing medicines without an appropriate diagnosis/provisional diagnosis will amount to professional misconduct.
Telemedicine Guidelines lays down the framework for practising telemedicine in 5 scenarios, namely:
- Patient to RMP
- Caregiver to RMP
- Health Worker to RMP
- RMP to RMP
- Emergency Situations
Telemedicine Guidelines lay down a detailed framework in respect of the 5 scenarios (See Guideline 4.1 at page 25 to Guideline 4.5 at 32).
If a medical condition requires a particular protocol to diagnose and prescribe as in the case of an in-person consult, then, the same prevailing principle will be applicable to a telemedicine consult. Prescribing medicines without an appropriate diagnosis/provisional diagnosis will amount to professional misconduct.
Telemedicine Guidelines mandate that RMPs should exercise their professional discretion for the mode of communication depending on the type of medical condition. For example, if a case requires a video consultation for examination, then, the RMP should explicitly ask for it.
Pertinently, Telemedicine Guidelines mandate that at any stage, the patient has the right to choose to discontinue the teleconsultation.
What is there in Part 2?
Guideline 3.7.1 at page 23 to Guideline 3.7.3 at page 24 of Telemedicine Guidelines list out duties and responsibilities of RMPs in general. Telemedicine Guidelines mandate that it is the responsibility of RMPs to be cognizant of the current Data Protection and Privacy laws.
Guideline 5 at page 33 of Telemedicine Guidelines list out guidelines for technology platforms enabling telemedicine.
These aspects will be dealt with in Part 2.
Arjun Natarajan is a Delhi-based advocate. The views expressed in this piece are personal.
[Full Disclosure: Arjun Natarajan has been advising and representing Telecom Regulatory Authority of India, since January 2018]