NOTE ON TELEMEDICINE PRACTICE GUIDELINES 2020
The use of technology and digital platforms in India to facilitate healthcare services has become critical in recent times where social distancing measures have been recommended for protection of medical practitioners and patients alike. Until recently, there was lack of clarity on online medical consultations due to absence of a framework and/or guidelines on medical consultations through online platforms. In order to build impetus and provide clarity in the regulatory framework, the Ministry of Health and Family Welfare has issued the Telemedicine Practice Guidelines dated 25 March 2020 (“Guidelines”). The Guidelines specifically permit technology platforms to facilitate the practice of telemedicine by connecting registered medical practitioners (“RMPs”) with patients on their platform.
Part A: Telemedicine Explained
The Guidelines permit RMPs to provide consultation services through information and communication technologies. Depending on the mode of communication, the interaction with the patient can be on a real time basis (for instance video-calls) or asynchronous (for instance transmission of summary of patient complaints and supplementary data including images, lab reports and/or radiological investigations between stakeholders.). Therefore, RMPs have the flexibility to receive the data from the patient on a real time basis or as and when needed basis.
RMPs may provide consultation for emergency consultation or non-emergency consultation (first check-up and follow ups). In case of emergency consultation, the RMP must advise the patient to go for an in-person interaction with an RMP at the earliest. During the consultation, the RMPs may provide health education, counselling related to specific medical conditions and prescribe medicines. The RMP may prescribe medicines only if the RMP has enough information about the patient’s medical condition further to an appropriate or provisional diagnosis.
The categories of medicines which may be prescribed via teleconsultation will be notified by the Central Government from time to time. The categories which can be prescribed under the Guidelines are provided below:
List O: This list includes over the counter medicines and medicines notified by the Central Government during public health emergencies. List O medicines can be prescribed through any mode of tele-consultation. For example, paracetamol, cough supplements (lozenges), and chloroquine for malaria control for a specific endemic region notified by the Central Government.
List A: This list includes medicines which are considered relatively safe with low potential for abuse. List A includes medicines which can be prescribed during the first consult, which is diagnosis through a video consultation, or are being re-prescribed for re-fill, in case of follow-up (on any mode of communication). For example, ointments/lotion for skin ailments or local ear drops for first consult and follow-up medications for chronic illnesses for ‘re-fill’ such as metformin for diabetes.
List B: This list includes medicines which can be prescribed to a patient who is undergoing follow-up consultation in addition to those medicines which have been prescribed during in-person consultation for the same medical condition. For example, addition of sitagliptin to metformin for diabetes. Medicines that cannot be prescribed through teleconsultation include medicines that have high potential for abuse such as medicines in Schedule X of the Drug and Cosmetic Act and Rules or any narcotic and psychotropic substance listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985.
Part B: Key Takeaways for RMPs
Certification under the Guidelines: Prior to practicing telemedicine, an RMP will have to qualify on an online program within 3 years of its notification by the Board of Governors in super-session of the Medical Council of India. Meanwhile, the RMPs will have to follow the Guidelines.
RMP and Patient Identity Disclosures: The RMP is required to disclose his name and qualification to patient. The RMPs registration number should be disclosed on prescriptions, website, electronic communication (whatsapp/ email etc.) and receipts. Further, the RMP must provide a mechanism for a patient to verify the credentials and contact details of the RMP. The RMP must verify the patient’ identity (name, age, address, email address, phone number, registered identification or any other appropriate identification). Minors can avail teleconsultations only where the minor is consulting with an adult whose identity details have been verified.
Patient consent In case the patient initiates telemedicine, then the patient consent is implied by his actions. However, in case the consultation through telemedicine is initiated by another RMP, health-worker or caregiver, then the patient consent should be obtained from the patient in any form such as an email, text, audio or video message. For instance, the following text from a patient constitutes explicit consent - “Yes, I consent to avail consultation via telemedicine”.
Patient information: The RMP must obtain sufficient medical information for providing consultation through telemedicine. The details may include the patient’s history, past records, investigation reports and other additional information such as laboratory tests.
Prescription: RMP must also provide the patient with the digital copy of the signed prescription or e-prescription through e-mail or any messaging platform. In case the RMP transmits the prescription directly to the pharmacy then the RMP will have to obtain the explicit consent of the patient for taking the medicine at the pharmacy of his choice.
Maintenance of records and documentation: An RMP is required to maintain the following for such period as prescribed from time to time: log or record of telemedicine interaction such as phone logs, text records, video interaction logs patient records which includes explicit patient consent, case history, investigation reports, images, etc. prescription records in case prescription is shared with the patient Page Break Fees The RMP can charge fees for teleconsultation in the same manner as fees are charged for in-person consultation. The RMP must provide the patient receipt/invoice for the fees charged for teleconsultation.
Duties and liabilities of RMPs : RMPs are required to uphold the same professional and ethical norms applicable to in-person cases within the limitations of telemedicine. The RMPs are required to abide by professional norms related to patent privacy and confidentiality as per the Indian Medical Council Act, 1956. RMPs are specifically prohibited from insisting on telemedicine when a patient is willing to opt for an in-person consultation and soliciting patients for telemedicine through any advertisements or inducements.
Part C: Key Takeaways for Technology Platforms
Technology platforms must ensure that consumers are consulting with RMPs who are duly registered with national medical councils or state level medical councils. Accordingly, the technology platforms must conduct due diligence on the RMP prior to listing such RMP on its online portal. Technology platforms must provide the name, qualification and registration number, contact details of every RMP listed on the platform. Technology platforms based on artificial intelligence or machine learning cannot counsel patients or prescribe medicines to patients. The RMP would be required to directly communicate with the patient for counselling and prescription of medicines. However, artificial intelligence, machine learning, advanced data science-based decision support systems etc. may be used by the technology platforms to assist and support the RMP on patient evaluation, diagnosis or management. In such cases, the final counselling or prescription would have to be delivered directly by the RMP. Technology platforms must have a grievance redressal mechanism for customers. Technology platforms must report all non-compliances to the Board of Governors. In the event any technology platform is found in violation of the Guidelines, then the Board of Governors may blacklist. No RMP will be permitted provide telemedicine on a blacklisted technology platform.
Way forward
The Guidelines have clarified the roles, duties and responsibilities of each stakeholders in the telemedicine process, that is, the patient, caregiver, RMPs, health workers and technology platforms. Further, technology platforms may assist the RMPs to provide teleconsultations through their online applications and websites and build in appropriate mechanisms in their systems. Therefore, technology platforms may facilitate obtaining of patient consent, billing services, maintenance of records for the RMPs in order to provide seamless teleconsultation services. The Guidelines are a welcome clarification from the Government of India. While the notification of the Guidelines is appropriately timed given the current scenario, these Guidelines will play a tremendous role in reshaping India’s healthcare sector. In a country like India, where access to healthcare is a challenge, telemedicine has the potential to provide access to quality healthcare services to millions.