Ms. Atishaya Kaushal, Advocate
(9891952134/atishayakaushal@gmail.com)
Telemedicine Practice Guidelines, 2020
On 20th March, 2020, the Board of Governors in supersession of MCI in partnership with Niti Aayog framed these guidelines.
Purpose:
The purpose of these guidelines is 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. These guidelines will 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.
These telemedicine guidelines will help realize the full potential of these advancements in technology for health care delivery. It provides 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. These guidelines will 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. It also 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. Where clinically appropriate, telemedicine is a safe, effective and a valuable modality to support patient care. Like any other technology, the technology used for telemedicine services can be abused. It has some risks, drawbacks and limitations, which can be mitigated through appropriate training, enforcement of standards, protocols and guidelines.
The purpose of these guidelines is 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. These guidelines will 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.
These telemedicine guidelines will help realize the full potential of these advancements in technology for health care delivery. It provides 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. These guidelines will 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. It also 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. Where clinically appropriate, telemedicine is a safe, effective and a valuable modality to support patient care. Like any other technology, the technology used for telemedicine services can be abused. It has some risks, drawbacks and limitations, which can be mitigated through appropriate training, enforcement of standards, protocols and guidelines.
Relevant provisions:
1.1.1 Definition of Telemedicine
World Health Organization defines telemedicine as “The delivery of health-care services, where distance is a critical factor, by all health-care professionals using information and communications technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and the continuing education of health-care workers, with the aim of advancing the health of individuals and communities.”
World Health Organization defines telemedicine as “The delivery of health-care services, where distance is a critical factor, by all health-care professionals using information and communications technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and the continuing education of health-care workers, with the aim of advancing the health of individuals and communities.”
1.1.2 Definition of Telehealth
NEJM Catalyst defines telehealth as “The delivery and facilitation of health and health-related services including medical care, provider and patient education, health information services, and selfcare via telecommunications and digital communication technologies.” In general, telemedicine is used to denote clinical service delivered by a Registered medical practitioner while telehealth is a broader term of use of technology for health and health related services including telemedicine.
NEJM Catalyst defines telehealth as “The delivery and facilitation of health and health-related services including medical care, provider and patient education, health information services, and selfcare via telecommunications and digital communication technologies.” In general, telemedicine is used to denote clinical service delivered by a Registered medical practitioner while telehealth is a broader term of use of technology for health and health related services including telemedicine.
1.1.3 Definition of Registered Medical Practitioner (RMP)
For the purpose of this document a ‘Registered Medical Practitioner’ is defined as a person who is enrolled in the State Medical Register or the Indian Medical Register under the IMC Act 1956
For the purpose of this document a ‘Registered Medical Practitioner’ is defined as a person who is enrolled in the State Medical Register or the Indian Medical Register under the IMC Act 1956
1.2. The guidelines are meant for RMPs under the IMC Act 1956
The guidelines cover norms and standards of the RMP to consult patients via telemedicine.
EXCLUSIONS:
The guidelines specifically explicitly exclude the following:
EXCLUSIONS:
The guidelines specifically explicitly exclude the following:
- Specifications for hardware or software, infrastructure building & maintenance
- Data management systems involved; 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 healthcare workers.
- Does not provide for consultations outside the jurisdiction of India·
There is no doubt that the Guidelines have expanded the scope of clinical care via technology.
1.3.1 A Registered Medical Practitioner is entitled to provide telemedicine consultation to patients from any part of India
1.3.2 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
1.3.3 To enable all those RMPs who would want to practice telemedicine get familiar with these Guidelines as well as with the process and limitations of telemedicine practice: An online program will be developed and made available by the Board of Governors in· supersession of Medical Council of India. 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 the practice of telemedicine.
Guidelines for Telemedicine in India:
The professional judgment of a Registered Medical Practitioner 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. Practitioners shall exercise proper discretion and not compromise on the quality of care.
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 Registered Medical Practitioner 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. Practitioners shall exercise proper discretion and not compromise on the quality of care.
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 Registered Medical Practitioners should exercise their professional judgment to decide whether a telemedicine consultation is appropriate in a given situation or an in-person consultation is needed in the interest of the patient. They should consider the mode/technologies available and their adequacy for a diagnosis before choosing to proceed with any health education or counseling or medication. They should be reasonably comfortable that telemedicine is in the patient’s interest after taking a holistic view of the given situation.
Complexity of Patient’s health condition Every patient/case/medical condition may be different, for example, a new patient may present with a simple complaint such as headache while a known patient of Diabetes may consult for a followup with emergencies such as Diabetic Ketoacidosis. The RMP shall uphold the same standard of care as in an in-person consultation but within the intrinsic limits of telemedicine.
There may be situations where in order to reach a diagnosis and to understand the context better; a real-time consultation may be preferable over an asynchronous exchange of information. Similarly, there would be conditions where an RMP could require hearing the patient speak, therefore, a voice interaction may be preferred than an email or text for a diagnosis. There are also situations where the RMP needs to visually examine the patient and make a diagnosis. In such a case, the RMP could recommend a video consultation. Considering the situation, using his/her best judgment, an RMP may decide the best technology to use to diagnose and treat.
Our introductory chapter on “clinical diagnosis” assumes relevance and analogy here.
Patient consent is necessary for any telemedicine consultation. The consent can be Implied or explicit depending on the following situations:
1. If, the patient initiates the telemedicine consultation, then the consent is implied
2. An Explicit patient consent is needed if: A Health worker, RMP or a Caregiver initiates a Telemedicine consultation.
3. Patient’s Information - An RMP would use his/her professional discretion to gather the type and extent of patient information (history/examination findings/Investigation reports/past records etc.) required to be able to exercise proper clinical judgement.
This information can be supplemented through conversation with a healthcare worker/provider and by any information supported by technology-based tools.
If the RMP feels that the information received is inadequate, then he/she can request for additional information from the patient. This information may be shared in real time or shared later via email/text, as per the nature of such information. For example, an RMP may advise some laboratory or/and radiological tests to the patient. In such instances, the consult may be considered paused and can be resumed at the rescheduled time. An RMP may provide health education as appropriate at any time. –
Telemedicine has its own set of limitations for adequate examination. If a physical examination is critical information for consultation, RMP should not proceed until a physical examination can be arranged through an in-person consult. Wherever necessary, depending on professional judgement of the RMP, he/she shall recommend:
- Video consultation –
- Examination by another RMP/ Health Worker ;
- In-person consultation –
The information required may vary from one RMP to another based on his/her professional experience and discretion and for different medical conditions based on the defined clinical standards and standard treatment guidelines. - RMP shall maintain all patient records including case history, investigation reports, images, etc. as appropriate.
First Consult means The patient is consulting with the RMP for the first time; or· The patient has consulted with the RMP earlier, but more than 6 months have lapsed· since the previous consultation; or The patient has consulted with the RMP earlier, but for a different health condition·
Follow-Up Consult(s) means The patient is consulting with the same RMP within 6 months of his/her previous inperson consultation and this is for continuation of care of the same health condition.·
However, it will not be considered a follow up if: There are new symptoms that are not in the spectrum of the same health condition;· and/or RMP does not recall the context of previous treatment and advice·
Prescribing Medicines 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 consult. If a medical condition requires a particular protocol to diagnose and prescribe as in a case of in-person consult then same prevailing principle will be applicable to a telemedicine consult. RMP may prescribe medicines via telemedicine ONLY when RMP is satisfied that he/ she has gathered adequate and relevant information about the patient’s medical condition and prescribed medicines are in the best interest of the patient.
Prescribing Medicines without an appropriate diagnosis/provisional diagnosis will amount to a professional misconduct
There is a list of drugs that can be or cannot be prescribed.
Issue a Prescription and Transmit
If the RMP has prescribed medicines, RMP shall issue a prescription as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations and shall not contravene the provisions of the Drugs and Cosmetics Act and Rules. A sample format is suggested in Annexure 2
If the RMP has prescribed medicines, RMP shall issue a prescription as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations and shall not contravene the provisions of the Drugs and Cosmetics Act and Rules. A sample format is suggested in Annexure 2
RMP shall provide photo, scan, digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform
In case the RMP is transmitting the prescription directly to a pharmacy, he/ she must ensure explicit consent of the patient that entitles him/her to get the medicines dispensed from any pharmacy of his/ her choice
Misconduct
It is specifically noted that in addition to all general requirements under the MCI Act for professional conduct, ethics etc. while using telemedicine all actions that wilfully compromise patient care or privacy and confidentiality, or violate any prevailing law are explicitly not permissible. Some examples of actions that are not permissible:
It is specifically noted that in addition to all general requirements under the MCI Act for professional conduct, ethics etc. while using telemedicine all actions that wilfully compromise patient care or privacy and confidentiality, or violate any prevailing law are explicitly not permissible. Some examples of actions that are not permissible:
RMPs insisting on Telemedicine, when the patient is willing to travel to a facility and/or· requests an in-person consultation
RMPs misusing patient images and data, especially private and sensitive in nature (e.g.· RMP uploads an explicit picture of patient on social media etc)
RMPs who use telemedicine to prescribe medicines from the specific restricted list·
RMPs are not permitted to solicit patients for telemedicine through any advertisements· or inducements
Framework for Telemedicine
This section lays out the framework for practicing telemedicine in 5 scenarios:
1. Patient to Registered Medical Practitioner
2. Caregiver to Registered Medical Practitioner
3. Health Worker to Registered Medical Practitioner
4. Registered Medical Practitioner to Registered Medical Practitioner
5. Emergency
Emergency
In all telemedicine consultations, as per the judgment of the RMP, if it is an emergency situation, the goal and objective should be to provide in-person care at the soonest. However critical steps could be life-saving and guidance and counseling could be critical. For example, in cases involving trauma, right advice and guidance around maintaining the neck position might protect the spine in some cases. The guidelines are designed to provide a balanced approach in such conditions. The RMP, based on his/ her professional discretion may o Advise first aid o Counseling o Facilitate referral In all cases of emergency, the patient MUST be advised for an in-person interaction with a Registered Medical Practitioner at the earliest
Emergency
In all telemedicine consultations, as per the judgment of the RMP, if it is an emergency situation, the goal and objective should be to provide in-person care at the soonest. However critical steps could be life-saving and guidance and counseling could be critical. For example, in cases involving trauma, right advice and guidance around maintaining the neck position might protect the spine in some cases. The guidelines are designed to provide a balanced approach in such conditions. The RMP, based on his/ her professional discretion may o Advise first aid o Counseling o Facilitate referral In all cases of emergency, the patient MUST be advised for an in-person interaction with a Registered Medical Practitioner at the earliest
I would say the Guidelines have articulated the willingness of the regulators to at least try an alternate mode of clinical diagnosis. The riders and exclusions no doubt are a reassurance, that even in the time of the pandemic, patient care, health, and well being remains a top priority in any legislative document or code.
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