Telemedicine Practice Guidelines
The Indian Government has issued the Telemedicine Practice Guidelines (“Guidelines”) for enabling the Registered Medical Practitioners (“RMPs”) to provide health care services using the various telecommunication and digital communication technologies. RMP is defined to mean a person who is enrolled in the state register or the national register under The Indian Medical Council Act, 1956 (“IMC Act”). Under IMC Act, an RMP has to be an individual, who has completed the “Recognized Medical Qualification”. In India there was no legislation or guidelines on the practice of telemedicine through video, phone, internet-based platforms like web / chat / apps etc. and the issuance of the Guidelines is a major step forward in the healthcare domain in India, especially during Covid situation. Publishing the Guidelines has certainly cleared the air on the legality of telemedicine in India.
The Guideline are detailed and cover various modes of communication that can be used by the RMPs to provide health care services to the patients, such that the RMP shall uphold the same standard of care as in an in-person consultation. While there are advantages of each mode of communication, there are disadvantages as well. The Guidelines require obtaining consent from the patients, the manner in which a prescription is to be issued by the RMP, medicines which can be prescribed by an RMP based on the different modes of communication and the nature of consultation (i.e. first consultation or follow-up consultation or emergencies).
The Guidelines specifically excludes amongst other things the use of digital technology to conduct surgical or invasive procedures remotely. It would have been good if the Guidelines did provide for data management systems etc. But perhaps, these might be included in draft bill for Digital Information Security in Healthcare Act (DISHA). We had earlier written about DISHA , the future direction of digital health information in India and about the Data Ownership, Security, Consent for health data. Doctor consultations outside India jurisdiction:
The Guidelines do not permit for consultation outside India. Practically, those consultations will be through the medium of audio, video, text based and hence the aim of the Guidelines is to exclude such consultations. IMC Act, clause 12 also details “Recognition of medical qualifications granted by medical institutions in countries with which there is a scheme of reciprocity”.
Tools for Telemedicine
The Guidelines has identified the modes for telemedicine consultation and the primary modes are video, audio and text. The modes can include telephones, video devices, chat platforms (like WhatsApp, Facebook messenger) or email, fax or special apps developed for teleconsultation. The RMP should use her best judgement whether tele-consultation or in-person consulting is suitable in a given situation. Specific guidelines have been set out for Technology Platform enabling telemedicine consultations.
The Guideline are detailed and cover various modes of communication that can be used by the RMPs to provide health care services to the patients, such that the RMP shall uphold the same standard of care as in an in-person consultation.
Responsibilities of the RMP
Apart from the many responsibilities under the IMC Act and these Guidelines, the RMP should be reasonably comfortable that telemedicine consultation is in the patient’s interest. The RMP can also decide on the mode of technology (video, audio, chat) to diagnose and treat a patient. By way of maintenance of records, the RMP is required to maintain the log or record of telemedicine interaction (e.g. phone logs, email records, chat/ text record, video interaction logs etc.). The RMP is also required to retain patient records, reports, documents, images, diagnostics, data (Digital or non-Digital) etc. utilized in the telemedicine consultation. The time period for which such records have to be maintained are not specified in the Guidelines and it is only mentioned that the records are required to be maintained for the period as prescribed from time to time.
Misconduct by the RMPs
The general requirements under the IMC Act relating to professional misconduct, ethics will be applicable in case of a telemedicine consultation. The Guidelines further provide that all actions that wilfully compromise patient care or privacy and confidentiality or violate any prevailing law are not permissible. Such activities can be in the nature of the RMP misusing the patient images and data (especially private and sensitive data) by uploading any explicit picture of the patient on social media. Further, the RMPs are not permitted to solicit patients for telemedicine consultations through any advertisement or inducements. The penalties for any misconduct by the RMP will be as per the IMC Act and other prevailing laws.
Medicines that can be prescribed in telemedicine
The Guidelines prescribe norms and rules for the issuance of prescriptions by RMPs. If an RMP has prescribed medicines pursuant to telemedicine consultation then the RMP is required to issue a prescription as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation (“IMC Regulations”). The IMC Regulations prescribe that a physician shall write his name and designation in full along with the registration particulars on his prescription letter head and the same rules also apply to prescriptions issued pursuant to a telemedicine consultation. The RMP is authorised to provide a photo, scan, digital copy of a signed prescription or e-prescription to the patient via email or through any messaging platform. The Guidelines also allow the RMP to transmit the prescription directly to a pharmacy but in such cases the RMP is required to ensure the explicit consent of the patient that entitle the RMP to get the medicines dispensed from a pharmacy of the choice of the RMP.
However, it is clarified that the RMP may prescribe medicines via telemedicine only when the RMP is satisfied that adequate and relevant information has been gathered about the patient’s medical condition and that the prescribed medicines are in the best interest of the patient. For issuing a prescription, the RMP is required to explicitly ask the age of the patient and in case of doubt the RMP should require an age proof of the patient. As in the case of in-person consultations, the RMP is required to maintain a record of the prescriptions issued pursuant to a telemedicine consultation. A sample format in which the prescription is to be issued is provided as an Annexure to the Guidelines.
The IMC Regulations prescribe that a physician shall write his name and designation in full along with the registration particulars on his prescription letter head and the same rules also apply to prescriptions issued pursuant to a telemedicine consultation.
First Consult and Follow-up Consult
The Guidelines draw a distinction between a first consultation and a follow-up consultation with an RMP. First Consult means that the patient is consulting with the RMP for the first time or if more than 6 (six) months have elapsed since the previous consultation or if a patient has consulted with the RMP earlier but for a different health condition. Follow-up Consult means the when the patient is consulting with the same RMP within 6 months of his previous in-person consultation and the consultation is for the continuation of care of the same health condition. A consultation will not be considered as a follow-up consult if there are new symptoms and / or the RMP does not recall the context of the previous treatment and advice. The process of consultation and the nature of drugs that can be prescribed by an RMP depends on if the consultation is a first consult or a follow-up consult.
Identity and Consent
The RMP is required to verify and confirm the patient’s identity by name, age, address, email address, phone number, registered ID or any other identification as deemed appropriate. The RMP is also required to ensure that there is a mechanism for a patient to verify the credential and the contact details of the RMP. For the purposes of identification, the RMP is required to begin the consultation by informing the patient about his name and qualifications. The RMP is required to display the registration number accorded by the State Medical Council on prescriptions, website, electronic communication (WhatsApp/ email etc.) and receipts etc. issued by the RMP to the patients.
Consent from a patient is mandatory for any telemedicine consultation and the consent may be implied or explicit. If a patient initiates a telemedicine consultation, then consent is implied and an explicit consent if needed if a health worker or an RMP or a caregiver initiates a telemedicine consultation. An explicit consent from a patient can be recorded in any form either by way of an email, text or audio/video message and the 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 such consent granted by a patient in his patient records.
The Guidelines also prescribe the process for consultation by a Health Worker with an RMP seeking consultation from a patient in a public or private health facility.
The Guidelines provide for specific rules in case of an emergency situation. In all cases of an emergency, the RMP is required to advice the patient for an in-person interaction with a Registered Medical Practitioner at the earliest. However, in case of an emergency situation, the RMP may, based on his professional discretion, advice first aid, counselling or facilitate referral for an in-person consultation. The FAQ on the Guidelines clarify that in case of an emergency if the RMP asks for immediate referral for in-person consultation but if a patient insists for tele-management, then the RMP should record his statement regarding the advice given regarding referral for an in-person consultation. The FAQ also clarify that in case of an emergency the patient may call an RPM for medical advice but a patient cannot insist for an advice if the RMP chooses not to reply or to give any specific advice.
Tele-consultation Through a Health Worker or a Care Giver
Under the Guidelines, the consultations with an RMP may be facilitated by a Caregiver. A Caregiver could be a family member or any person authorised by the patient to represent him. The Caregiver may either be present with the patient during consolation or the Caregiver may consult the RMP on behalf of the patient and in the absence of the patient. A Caregiver can consult with the RMP in absence of the patient if the patient is a minor (16 year or less) or if the Caregiver has a formal authorisation or verified document establishing his relationship with the patient and / or has been verified by the patient in a previous in-person consultation. The Guidelines also prescribe the process for consultation by a Health Worker with an RMP seeking consultation from a patient in a public or private health facility. A Health Worker can be a nurse, an allied health professional, mid-level health practitioner, or any health worker designated by an appropriate authority.
Privacy in telemedicine consultation
The RMP as part of telemedicine consultation are required to abide by the principles of medical ethics. Thus, in keeping with the provisions of the Ethics Regulations, RMPs shall not publish photographs or case reports of the patients without their permission, in any medical or other journal in a manner by which their identity could be made out. The Guidelines makes a reference that the Information Technology Act, 2000, the data protection and privacy laws regarding the handling and transfer of information regarding the patients or any other applicable rules in relation to protecting patient privacy as notified from time to time will have to be complied with by the RMPs. It is to be seen if the proposed DISHA and the proposed Personal Data Protection Bill, will all provide for a cohesive compliance structure. It is clarified that the RMPs will not be held responsible for breach of confidentiality, if there is reasonable evidence to prove that the patient privacy and confidentiality has been compromised by a technology breach or by a person other than the RMP.
Online Course on Practice of Telemedicine
The Guidelines provide that an online course will be developed and made available by the Board of Governors so as to enable all the RMPs intending to practice telemedicine to be familiar with the Guidelines and that the RMP will be required to complete the course within a period of 3 (three) years from the date of notification of these Guidelines. However, the FAQs issued on the Guidelines indicate that all RMPs can tele-consult provided they follow the Guidelines. Thus, the Guidelines create an uncertainty in relation to the online course and further notification in this regard will help introduce clarity on the subject.
COVID-19 and Tele-medicine
With the Covid situation, the Guidelines are published timely and provides an impetus for healthcare industry. The Guidelines may evolve over a period of time based on the actual experiences of RMPs and the patients pursuant to telemedicine communications.
For further queries for Telemedicine Practice Guidelines kindly refer the link given below: www.mciindia.org/MCIRest/open/getDocument?path=/Documents/Public/Portal/LatestNews/Final_FAQ TELEMEDICINE%20%206-4-2020..pdf
Composed by Sharda Balaji, Managing partner, NovoJuris Legal