Medicine may be considered a noble profession, but it is still not immune to legal issues. Amid calls for stricter laws to protect doctors against violence, there is also a need to understand the medico-legal aspects of healthcare delivery so that doctors are not indicted on certain charges.
According to the expert panel of our latest Practo Connect webinar – hosted exclusively for doctors, by doctors – the best way to handle medico-legal issues is by preventing them in the first place.
“There has been a paradigm shift in the legal aspects of medical practice over the last few decades,” says Prof SV Joga Rao, Advocate, Healthcare Consultant, Founding Faculty Member and Visiting Professor at National Law School of India University, Bengaluru. “Its ambit has significantly expanded, making its awareness a priority today,” he adds.
Agrees Prof Suresh Bada Math, Head of Telemedicine Center at National Institute of Mental Health and Allied Neurosciences (NIMHANS), Bengaluru, “Given the role of telemedicine in shaping healthcare delivery, it is important that doctors understand the legal provisions binding digital practices well.”
Guidelines for telemedicine in India
The Telemedicine Practice Guidelines (TPG) was released on March 25, 2020 through the Board of Governors of Medical Council of India (MCI) in partnership with NITI Aayog. But there is no consensus yet on whether TPG should be classified as guidelines, regulations or rules under the National Medical Commission (NMC) Act, 2019, and whom it should be directed towards.
“Given that the healthtech ecosystem is vast and involves a lot of players – from doctors and owners of medical establishments to aggregators and internet service providers – many are pondering whether introducing an independent legislation instead is the right approach,” says Prof Math.
As of now, TPG is intended only for healthcare professionals, and is simply meant to serve as guidelines on how they should conduct themselves on a telemedicine platform. These guidelines are seen in conjunction with existing laws governing healthcare, including Consumer Protection Act 2019, Drugs and Cosmetic Act and Medical Termination of Pregnancy Act, among others.
“This means that laws that are applicable for in-person consultations are also applicable in telemedicine,” he says.
Legal complications in virtual healthcare delivery
The new Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021 impacts software companies operating in healthcare. According to the Intermediary Guidelines, aggregators in this industry must support and facilitate regulation.
“If a complaint is lodged by a patient on a digital medium, aggregators are expected to acknowledge it within 24 hours,” says Prof Math, adding, “They also have to respond appropriately within the following 15 days.
Furthermore, as per the Code of Ethics Regulation 2002 – broadcasting to patients by doctors (directly or indirectly) – through any digital means (including social media) can be considered a violation.
“So healthcare professionals cannot advertise their work,” says Prof Math, adding, “there are some exemptions on starting a new practice, or making a formal announcement in the press regarding resumption of another practice, etc. But medical practitioners must be careful about making the distinction between publicity, providing information and advertisement.”
Another important matter is the regulation on prescribing medicines during online consultations.
“These medicines are currently split into four categories – A, O, B and Prohibited,” says Prof Math. “A is considered relatively safe, with low potential for abuse, and can be administered through video mode for the first consultation. O is over-the-counter medicines that may be deemed necessary during public health emergencies. B can be prescribed during follow-up online consultations for the same medical condition a patient has been seeing a doctor in-person for the past 6 months at least. The last category includes medicines listed in Schedule X of Drug and Cosmetic Act, 1940 and Rules 1945, and has serious abuse potential,” he elaborates.
Legal complications in in-person healthcare delivery
Even before the emergence of telehealth practices, the medico-legal aspects of healthcare delivery entailed legal, ethical and regulatory issues and implications concerning healthcare establishment and infrastructure (registration and license), nature of services, doctors and service providers, care and treatment, among others.
The legal framework for in-person healthcare delivery includes the Clinical Establishments (Registration and Regulation) Act, 2010, which has become an enforceable legislation in some states. However, several others have enacted their own legislation too, notably Karnataka Private Medical Establishments Act, 2009, and Tamil Nadu Private Clinical Establishments (Regulation) Act, 1997.
“When it comes to healthcare establishments, either the relevant state legislation or the Clinical Establishments Act is expected to be followed,” says Prof Rao. “Accordingly, registration is mandatory for these establishments in the respective state,” he adds.
According to him, additional laws are also applicable, depending on the nature of services rendered by the establishment. This could include Medical Termination of Pregnancy (MTP), transplantation surgeries, mental health or diagnostic services, among others.
The legal and ethical liability across the following categories – medical negligence, informed consent, and confidentiality – must also be understood well.
“In India, there are many courts empowered to adjudicate medical legal liability,” says Prof Rao. These courts can award compensation, imprisonment or fine, temporary or permanent suspension of licence, closure of healthcare establishments, etc, but there are significant defences too. This includes medical record documentation and patient communication, which must be followed at all times by doctors and medical establishments.
“Medical profession has its own ethical parameters and code of conduct, and healthcare workers may be at high risk for litigation,” says Prof Rao. “Thus, being aware about medico legal aspects of their practice and how they can perform their duties ethically can safeguard themselves – as well as their patients – against risks,” he adds.
Join us every month as we partner with leading industry and doctor associations for our educational webinar series, Practo Connect. Watch this, as well as previous webinars, here.