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 tele-medicine 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 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 modes for telemedicine consultation 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 tele- consultation. The RMP should use her best judgement whether tele-consultation or in-person consulting is suitable in a given situation.
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.
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 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. 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 RMP is authorised to provide a photo, scan, digital copy of a signed prescription or e-prescription via email or through any messaging platform.
A sample format in which the prescription is to be issued is provided as an Annexure to the Guidelines.
First Consult and Follow-up Consult
The Guidelines distinguish between first consultation and follow-up consultation. First Consult means that the patient is consulting with the RMP for the first time or if more than 6 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 is when the patient is consulting with the same RMP within 6 months of his previous in-person consultation and the consultation is for care of the same health condition. 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.
Patient consent is mandatory for any telemedicine consultation and may be implied or explicit. If a patient initiates a telemedicine consultation, consent is implied. An explicit consent is needed if a health worker or an RMP or a caregiver initiates a 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 intent on phone/video to the RMP The RMP must record such consent of the patient in his patient records.
The Guidelines provide for specific rules in an emergency. In an emergency, the RMP is required to advice the patient for an in-person interaction with a medical practitioner at the earliest. In case of an emergency, the RMP may, advice first aid, counselling or facilitate referral for an in-person consultation.
Tele-consultation Through a Health Worker or a Care Giver
Consultations with an RMP may be facilitated by a Caregiver who could be a family member or any person authorised by the patient. A Caregiver can consult with the RMP in absence of the patient if the patient is 16 year or less or if the Caregiver has 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 provide for consultation by a Health Worker with an RMP seeking consultation from a patient in a 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. RMPs shall not publish photographs or case reports of the patients without permission, in any journal in a manner by which identity of the patient could be made out. The Guidelines refer to 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 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
An online course will be developed and made available by the Board of Governors so as to enable all the RMPs to be familiar with the Guidelines. However, the FAQs issued on the Guidelines indicate that all RMPs can tele-consult provided they follow the Guidelines.
Covid19 and Tele-medicine
With the Covid situation, the Guidelines are published timely and provides an impetus for healthcare industry, medical practitioners and public at large. The Guidelines may evolve over a period of time based on the actual experiences of RMPs and the patients pursuant to telemedicine communications. We also hope that the Government provides clear guidance on online delivery of medicine.