As the world gradually embraces technology’s role in reshaping various sectors, India also dives into the digital transformation of its healthcare industry. Its rapid advancement, however, makes it imperative to understand the legal provisions and regulations governing digital health practices. Hence, our team of legal experts at SimranLaw, a prestigious law firm in Chandigarh, India, peels back the complexities of this sphere of legislation to provide you with an in-depth understanding of these regulatory mechanisms.
Currently, India does not have a comprehensive legislation for digital health. However, the Union Ministry of Health and Family Welfare (MoHFW) released the National Digital Health Blueprint (NDHB) in 2019 that envisions a framework for the integration of digital technologies in health care services.
a. The Information Technology Act, 2000 (IT Act) – it governs electronic contracts, data protection, and cybersecurity issues which are relevant to digital health practices.
b. The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 – outlines ethical codes for medical practitioners, including those engaged in telemedicine.
c. The Drugs and Cosmetics Act, 1940 – regulates the sale of drugs, which extends to online pharmacies.
2. The Telemedicine Guidelines
In March 2020, Telemedicine Practice Guidelines were released, enabling registered medical practitioners to consult with patients remotely. It provides specific do’s and don’ts for healthcare professionals engaged in telemedicine services, thus forming the backbone of telehealth legal provision in India.
3. Data Privacy and Protection
The Personal Data Protection Bill, 2019 (PDP Bill), currently pending in Parliament, is expected to provide comprehensive data protection legislation. With its passing, digital health platforms would be required to implement enhanced safety measures complying with patients’ data security and privacy.
4. Regulation of Online Pharmacies
In 2018, the draft Drugs and Cosmetics Amendment Rule was released to regulate e-pharmacies, underscoring requirements for registration, the prohibition of certain drugs sale online, and conditions regarding data privacy.
Draft rules for the sale of drugs by e-pharmacy under section 67K and 67L of The Drugs and Cosmetics Rules, 1945, were also proposed.
5. Relevant Case Laws and Judgments
a. Martin F. D’Souza vs Mohd. Ishfaq (2009) – The Supreme Court recognized that telemedicine could be practiced in India. However, it stated that negligence could not be ignored in cases where a doctor did not physically review the patient.
b. Ankur Kumar vs State of Uttar Pradesh (2018) – The Allahabad High Court held that an e-pharmacy could be deemed as a traditional ‘shop’ under the Factories Act, 1948, and hence should comply with the relevant regulations.
The rapidly evolving digital health environment in India demands a robust legal framework. As legal experts from SimranLaw, we emphasize the importance of staying aware and compliant with existing regulations while anticipating future legal shifts in this dynamic field. As the landscape of digital health continues to morph, practitioners must brace for changes while operating within the gamut of law to ensure their practices’ legality and ethicality.