Telehealth laws still in nascent stages

The Covid-19 pandemic has severely impacted physical access to medical services. This has boosted the telehealth sector enabling easier, quicker and cheaper access to medical help. However, prevention of online frauds, ensuring patient consent, data privacy and fixing liability were pertinent issues that needed addressing. Therefore, the implementation of Telemedicine Practice Guidelines (TPG) under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 (PCEE Regulations) with effect from March 2020 was a welcome move.

TPG governs consultations and counselling through telecommunication between doctors and patients, caregivers or healthcare workers within India. Telemedicine modes include audio, video and text-based platforms like phone calls, SMS, emails, chats over Zoom, Whatsapp, Skype etc.

TPG governs only allopathic medicine and is permitted for both first-time and follow-up consultations. It can be initiated for non-surgical diagnosis and is restricted to first-aid in emergency cases. If telemedicine seems unviable, doctors need to insist on personal check-ups. Tele-consultations must be charged similar to in-person consultations and fee receipts must be provided.

TPG places additional responsibilities on doctors apart from adherence to medical ethics. Doctors need to assess the viability of teleconsultation and identify the apt mode basis diagnosis. Doctors are permitted to provide prescriptions and can directly transmit them to the pharmacy only with patient consent. Medicines permitted to be prescribed also vary with the mode and session of teleconsultation. For instance, OTC drugs can be prescribed over all modes, skin ointments after the first time video consultation, and diabetic drugs only in a follow-up session.

Consent is implied if consultations are initiated by patients. If initiated by health workers or caregivers on behalf of the patient, written explicit consent of the patient is compulsory. Minors or mentally disabled patients need to be accompanied by an adult to provide consent. Patients may choose to withdraw consent at any point in time.

Patient confidentiality and privacy are protected through adherence to the PCEE Regulations and the Information Technology Act 2000. Medical records are considered sensitive personal data in law and doctors are not permitted to disclose details unless sought by the law. They can be held responsible for data leaks unless proven that they had taken reasonable care and such leaks were due to a technology breach.

Apart from breach of patient confidentiality, doctors can be liable for various other acts of misconduct including insistence on telemedicine without patient consent, prescribing prohibited drugs, misusing patient images, soliciting patients for telemedicine.

Despite advances, Telehealth laws are in their nascent stage. For instance, TPG excludes ayurvedic and homeopathic practitioners. It also does not cover the liability of nurses and other tertiary players. Consultations with doctors or patients outside India fall outside its ambit. The maintenance of digital records through the electronic health record systems and their protection is not adequately governed.

Similarly, though telepsychiatry operational guidelines have been issued, they do not have any force in law. The Bombay High Court has however considered aspects of patient consent and drug prescriptions in mental care in the pending case of Sushant Singh Rajput’s death. There is confusion around e-pharmaceuticals as well. While the Madras High Court has permitted the sale of drugs online with prescriptions, the Delhi High Court has banned retail sales until the government enforces the amendment to the Drugs and Cosmetics Act 1940 regulating the e-sale of prescription drugs. Nonetheless, various apps continue to operate amidst such legal confusion. Hopefully, the coming days will see legally sound and safer access to medical care.

(The writer is an advocate based in Bengaluru)