MCI notifies new rules and guidelines for consultation by tele-medicine

The Medical Council of India vide notification no. CG-DL-E-14052020-219374 has notified the Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2020. These regulations shall deemed to have been effective from 25th March 2020 which is the date on which the Central Government has accorded approval to these Regulations.

Consultation by Telemedicine

Consultation through Telemedicine by the Registered Medical Practitioner under the Indian Medical Council Act, 1956 shall be permissible in accordance with the Telemedicine Practice Guidelines. Telemedicine Practice Guidelines are designed to serve as an aid and tool to enable Registered Medical Practitioners to effectively leverage telemedicine to enhance health services and access to all in India.

Telemedicine Practice Guidelines are not applicable to the use of digital technology to conduct surgical or invasive procedure remotely.

A Registered Medical Practitioner is entitled to provide telemedicine consultation to patients from any part of India. 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.

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 practice of telemedicine.

Definitions

Telemedicine: 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.

 Telehealth: 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.

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.

Registered Medical Practitioner: A Registered Medical Practitioner [RMP] is a person who is enrolled in the State Medical Register or the Indian Medical Register under the Indian Medical Council Act 1956.

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 health-care workers
  • Does not provide for consultations outside the jurisdiction of India

RMP may use any telemedicine tool suitable for carrying out technology-based patient consultation e.g. telephone, video, devices connected over LAN, WAN, Internet, mobile or landline phones, Chat Platforms like WhatsApp, Facebook Messenger etc., or Mobile App or internet based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc. Irrespective of the tool of communication used, the core principles of telemedicine practice remain the same.

Important rules and guidelines:

  • 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.
  • Every patient/case/medical condition maybe 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 follow-up 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.
  • Telemedicine consultation is 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. The RMP should ensure that there is a mechanism for a patient to verify the credentials and contact details of the RMP.
  • For issuing a prescription, the RMP needs to explicitly ask the age of the patient, and if there is any doubt, seek age proof. Where the patient is a minor, after confirming the age, tele consultation would be allowed only if the minor is consulting along-with an adult whose identity needs to be ascertained.
  • An RMP should begin the consultation by informing the patient about his/her name and qualifications.
  • 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.
  • Multiple technologies can be used to deliver telemedicine consultations. All these technology systems have their respective strengths, weaknesses and contexts in which they may be appropriate or inadequate in order to deliver proper care.
  • Primarily there are 3 modes: Video, Audio or Text (chat, images, messaging, email, fax etc.). Their strengths, limitations and appropriateness as detailed in Section 2 need to be considered by the RMP.
  • 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.
  • Patient consent is necessary for any telemedicine consultation. The consent can be Implied or explicit depending on the following situations:
    • If, the patient initiates the telemedicine consultation, then the consent is implied (In an in-person consultation, it is assumed the patient has consented to the consult by his/her actions. When the patient walks in an OPD, the consent for the consultation is taken as implied. Like an in-person consultation, for most of the tele-consultations the consent can be assumed to be implied because the patient has initiated the consultation).
    • An Explicit patient consent is needed if a Health worker, RMP or a Caregiver initiates a Telemedicine consultation.
    • An Explicit consent can be recorded in any form. Patient can send an email, text or audio/video message. Patient can state his/her intent on phone/video to the RMP (e.g. “Yes, I consent to avail consultation via telemedicine” or any such communication in simple words). The RMP must record this in his patient records.
  • 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
  • RMP shall maintain all patient records including case history, investigation reports, images, etc. as appropriate.
  • 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
  • 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.
  • 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
  • Principles of medical ethics, including professional norms for protecting patient privacy and confidentiality as per IMC Act shall be binding and must be upheld and practiced.
  • Registered Medical Practitioner 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 rules notified from time to time for protecting patient privacy and confidentiality and regarding the handling and transfer of such personal information regarding the patient. This shall be binding and must be upheld and practiced.
  • Registered Medical Practitioners will not be held responsible for breach of confidentiality if there is a reasonable evidence to believe that patient’s privacy and confidentiality has been compromised by a technology breach or by a person other than RMP. The RMPs should ensure that reasonable degree of care undertaken during hiring such services.
  • Fee:Telemedicine consultations should be treated the same way as in-person consultations from a fee perspective: RMP may charge an appropriate fee for the Telemedicine consultation provided. An RMP should also give a receipt/invoice for the fee charged for providing telemedicine-based consultation.
  • Maintaining Digital Trail/ Documentation Of Consultation: It is incumbent on RMP to maintain the following records/ documents for the period as prescribed from time to time:
    • Log or record of Telemedicine interaction (e.g. Phone logs, email records, chat/ text record, video interaction logs etc.).
    • Patient records, reports, documents, images, diagnostics, data etc. (Digital or non-Digital) utilized in the telemedicine consultation should be retained by the RMP.
    • Specifically, in case a prescription is shared with the patient, the RMP is required to maintain the prescription records as required for in-person consultations.
  • RMP should exercise his/her professional discretion for the mode of communication depending on the type of medical condition. If a case requires a video consultation for examination, RMP should explicitly ask for it
  • The RMP can choose not to proceed with the consultation at any time. At any step, the RMP may refer or request for an in-person consultation
  • At any stage, the patient has the right to choose to discontinue the teleconsultation
  • RMP should confirm patient identity to his/her satisfaction by asking patient’s name, age, address, email ID, phone number or any other identification that may be reasonable
  • Telemedicine consultation should be initiated by the patient and thereby consent is implied
  • 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:
    • ” 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
  • Penalties: AS per Indian Medical Council Act, ethics and other prevailing laws/
  • Restrictions: There are certain limitations on prescribing medicines on consult via telemedicine depending upon the type of consultation and mode of consultation. The categories of medicines that can be prescribed via tele-consultation will be as notified in consultation with the Central Government from time to time. The categories of medicines that can be prescribed are listed below:
    • List O: It will comprise those medicines which are safe to be prescribed through any mode of tele- consultation. In essence they would comprise of medicines which are used for common conditions and are often available ‘over the counter’. For instance, these medicines would include, paracetamol, ORS solutions, cough lozenges, Cough/ Common-cold medications (such as combinations of Acetylcysteine, Ammonium Chloride, Guaifensen, Ambroxol, Bromhexene, Dextromethorphan) Syrup Zinc Supplements: Iron & Folic Acid tablets, Vitamin D, Calcium supplements etc and medicines that may be deemed necessary during public health emergencies. This list includes usually prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivititis etc. and Re-fill medications for chronic diseases such as Diabetes, Hypertension, Asthma etc. This list includes ‘add-on’ medications which are used to optimize an existing condition. For instance, if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an ACE inhibitor such as Enalapril For instance, Anti-Cancer drugs; Narcotics such as Morphine, Codeine etc. It also includes medications notified by Government of India in case from time to time on an Emergency basis such as Chloroquine for Malaria control for a specific endemic region, when notified by Government
    • 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. This would be an inclusion list, containing relatively safe medicines with low potential for abuse Is a list of medication which RMP can prescribe in a patient who is undergoing follow-up consult, as a refill. E.g. Ointments/Lotion for skin ailments: Ointments Clotrimazole, Mupirocin, Calamine Lotion, Benzyl Benzoate Lotion etc; Local Ophthalmological drops such as: Ciprofloxacillin for Conjunctivitis, etc. Local Ear Drops such as: Clotrimazole ear drops, drops for ear wax etc. Follow up medications for chronic illness such as Hypertension: Enalapril, Atenolol etc Diabetes: Metformin, Glibenclamide etc Asthma: Salmetrol inhaler etc
    • List B: Is a list of 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. On follow-up, medications prescribed as ‘Add-on’ to ongoing chronic medications to optimize hypertension: Eg, add-on of Thiazide diuretic with Atenolol; Diabetes: Addition of Sitagliptin to Metformin Etc
    • Prohibited List: An RMP providing consultation via telemedicine cannot prescribe medicines in this list. These medicine have a high potential of abuse and could harm the patient or the society at large if used improperly. Medicines listed in Schedule X of Drug and Cosmetic Act and Rules or any Narcotic and Psychotropic substance listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985

Copy of notification: CG-DL-E-14052020-219374

-Adv. Tushar Kaushik 

Leave a Reply

Your email address will not be published. Required fields are marked *