Telemedicine Practice Guidelines

Against the rising need for practice of medicine sans physical consultation, especially in the current lockdown situation, the Board of Governors, Medical Council of India has adopted the “Telemedicine Practice Guidelines” (‘the Guidelines’). To provide statutory basis to the Guidelines, it was proposed that the same be included as an amendment to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 by insertion of Regulation 3.8 titled ‘Consultation by Telemedicine’. The draft notification of the proposed amendment was approved by the Ministry of Health and Family Welfare on 25.03.2020.

DEFINITION:

The Guidelines incorporate the World Health Organization’s definition of ‘Telemedicine’ which defines the term as:

‘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.’

ELEMENTS TO BE CONSIDERED:

As per the guidelines, the following seven elements that should be taken into consideration before any consultation:

  • Context

The Registered Medical Practitioners (RMPs) 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.

  • Identification of RMP and Patient

Telemedicine consultation should not be anonymous, both patient and the RMP need to know each other’s identity. An RMP should verify and confirm patient’s identity by name, age, address, email ID, phone number, registered ID or any other identification as may be deemed to be appropriate. Every RMP shall display the registration number accorded to him/her by the State Medical Council/MCI, on prescriptions, website, electronic communication (WhatsApp/ email etc.) and receipts etc. given to his/her patients.

  • Mode of Communication

The Guidelines recognizes video, audio and text based mode of communication for telemedicine consultation.

  • Consent

The Guidelines states that patient consent is necessary for any telemedicine consultation. The consent can be implied or explicit depending on situations.

  • Type of Consultation

The Guidelines identify two types of consults:

  1. First Consult where the patient is consulting with the RMP for the first time or  the patient has consulted with the RMP before but more than 6 months have lapsed since previous consultation or the patient has consulted for a different health condition earlier
  2. Follow-Up Consult where the patient is consulting with the same RMP within 6 months of previous consultation and for the same health condition.
  •  Patient Evaluation

The Guidelines state that RMPs must make all efforts to gather sufficient medical information about the patient’s condition before making any professional judgment and an RMP should use his/her professional discretion to gather the type and extent of patient information required to be able to exercise proper clinical judgment (history/examination findings/Investigation reports/past records etc.). If the RMP feels that the information received is inadequate, then he/she can request for additional information from the patient

  • Patient Management

 If the RMP comes to the conclusion that the condition of the patient can be appropriately managed via telemedicine, he/ she may proceed to:

  1. Provide Health Education as appropriate in the case; and/or
  2. Provide Counseling related to specific clinical condition; and/or
  3. Prescribe Medicines


OTHER FEATURES OF THE GUIDELINES:

  • Only RMPs entitled to practice telemedicine

As per the Guidelines, only RMPs are entitled to provide telemedicine consultation to patients from any part of India. It is also stated that an online program will be developed and made available by the Board of Governors to aid in familiarizing RMPs with the guidelines as well as with the process and limitations of telemedicine practice. Until such online program is notified, a RMP is to practice telemedicine by adhering to the provisions of the guidelines.

  • List of Medicines

Recognizing that there are certain limitations on prescribing medicines on consult via telemedicine depending upon the type of consultation and mode of consultation, the Guidelines incorporate a list of medications that further categorizes medications as per the suitability to be prescribed:

  1. List O: It will comprise those medicines which are safe to be prescribed through any mode of tele-consultation. They comprise of Medicines which are used for common conditions and are often available ‘over the counter’.
  2.  List A: These medications are those which can be prescribed during the first consult which is a video consultation and are being re-prescribed for re-fill, in case of follow-up.
  3. List B: Medication which RMP can prescribe in a patient who is undergoing follow-up consultation in addition to those which have been prescribed during in-person consult for the same medical condition.
  4. Prohibited List: An RMP providing consultation via telemedicine cannot prescribe medicines in this list. These medicines have a high potential of abuse and could harm the patient or the society at large if used improperly
  • Choice to both parties

The RMP can choose not to proceed with the consultation at any time. At any stage, the RMP may refer or request for an in-person consultation. Similarly, the patient also has the right to choose to discontinue the teleconsultation at any step/ stage.

  • Obligations on RMPs

Some broad obligations placed on RMPs practicing telemedicine are as follows:

  1. Principles of medical ethics, including professional norms for protecting patient privacy and confidentiality as per Indian Medical Council Act shall be binding and must be upheld and practiced
  2. RMPs would be required to fully abide by Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 and with the relevant provisions of the IT Act, Data protection and privacy laws or any applicable. Which means they have to implement reasonable security practices & procedures as prescribed under the Information Technology (Reasonable Security Practices & Procedures Sensitive Personal Data & Information) Rules, 2011
  3. RMPs are not permitted to solicit patients for telemedicine through any advertisements or inducements
  4. RMPs to maintain log/ record of telemedicine interaction, patients records, reports, document, images etc. utilized in consultation and prescription shared for the period as prescribed from time to time
  5. RMP should also give a receipt/invoice for the fee charged for providing telemedicine based consultation 
  • Guidelines for Technology Platforms

The guidelines also provide instructions to technology platforms which work across a network of RMPs and enable patients to consult with RMPs through the platform:

  1. Platforms to ensure that consumers are consulting with RMPs duly registered with National Medical Council or State Medical Councils
  2. Platforms shall conduct due diligence before listing any RMP on its online portal. Platform must provide the name, qualification and registration number, contact details of every RMP listed on the platform
  3. Platform is required to report any non-compliance to the Board of Governors.  
  4. Platforms based on Artificial Intelligence/Machine Learning are not allowed to counsel the patients or prescribe any medicines to a patient. Only a RMP is entitled to counsel or prescribe and has to directly communicate with the patient in this regard.

It is also stated that in case any specific technology platform is found in violation, Board of Governors may designate the technology platform as blacklisted, and no RMP may then use that platform to provide telemedicine

  • Misconduct and Penalties

The guidelines state that any actions that willfully compromise patient care or privacy and confidentiality, or violate any prevailing law are explicitly not permissible and would attract penalties under the Indian Medical Council Act, ethics and other prevailing laws. It is pertinent to note that this is in addition to addition to all general requirements under the MCI Act for professional conduct, ethics etc..

CONCLUSION:

For years, there was been lack of clarity in health consultation by virtual means of communication between doctors and patients. In August 2018, the Indian Medical Association had sought guidelines from the Medical Council of India on of telephonic medication and online consultations, while observing that the practice is illegal and unethical. Furthermore, in May 2019, the Karnataka Medical Council also advised doctors against engaging in online consultations stating that it ran contrary to the regulatory body’s code of ethics.[1] With the publishing of the Guidelines, the practice of telemedicine has received clarity and a procedural framework.

Furthermore, the Ministry of Health and Family Welfare has also launched a 24*7 National Teleconsultation Centre to answer queries relating to COVID-19. The Centre is to function as a multi-nodal telecommunication hub through which two-way audio- video and text communications can be exchanged from any part of the country as well as the world.

By

Revathi Murali, Abhay Nevagi & Associates

info@anevagi.com


[1] KMC warns doctors against online consultations

https://www.thehindu.com/news/national/karnataka/kmc-warns-doctors-against-online-consultations/article27130640.ece