07 July 2020
Tech Platforms that enable Telemedicine Practice, are required to adhere to, or be compliant with, certain laws and regulations that may be applicable to them, depending upon the functions performed by such Tech Platforms, in enabling Telemedicine practice. The following article seeks to be a basic guide on the same.
The applicability of the Information Technology Act, 2000 (hereinafter referred to as the “IT Act”) is referred to in another post, and not covered in this one.
The Notification of the Telemedicine Practice Guidelines (“Telemedicine Guidelines” / “Guidelines”), as part of Appendix 5 of the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 (“MCI Code”) has made: (a) the practice of the medical profession; and (b) provision of medical care over technology platforms, legal and regulated. These guidelines will impact a cross section of stakeholders that would be integrated or affiliated with Telemedicine in India, in one way or the other. The regulated stakeholders are Medical Professionals (“MP”), Registered Medical Practitioners (“RMPs”), Patients, Caregivers and Technology Platforms. These guidelines have been prepared by the Ministry of Health and Family Welfare in partnership with NITI Aayog.
A Technology Platform (“Platform” / “Tech Platform”) may be a website/mobile app or any other virtual medium used to enable Patients to consult with MPs.
To state that the Guidelines are more restrictive/regulative of and over the MPs rather than the Tech Platforms/aggregators/facilitators, would be to state the truth (more on this in a later post). However, the Telemedicine Guidelines itself should be read in conjunction with other applicable laws, rules and regulations. The Guidelines are a guiding document, which lay out the primary principles, i.e. the contours within which, telemedicine practice in India is to be followed. The specific requirements with respect to medical practices are still regulated by already existing laws and regulations.
1. The Indian Medical Council Act, 1956 (“MCI Act”) and the MCI Code
While the MCI Act administers and enforces regulations regarding the medical profession (including registration, license to practice and educational qualification / standards), the MCI Code laws down the professional and ethical standards to be followed by doctors in their interaction with patients, pharmaceutical companies and within the profession. Tech Platforms are mandated to perform their due diligence, and ensure that the MPs providing services via their platform are compliant with both, the MCI Act and the MCI Code. Ideally, such Tech Platforms should integrate the process of verifying the RMPs on their Platform, and ensure that the relevant details of a particular RMP are visible to customers/patients on their Platform.
2. The Drugs and Cosmetics Act, 1945 (“D&C Act”) and Rules made thereunder
The Guidelines impose restrictions on what drugs/medicines can be prescribed by MPs, depending on the underlying condition of the Patient and the mode of consultation (i.e. audio, visual, text based et al.)
While Platforms do not need to take responsibility on the type of drugs being administered on their Platform (as the MPs are primarily responsible for the same), the Tech Platforms have been given a general responsibility to report any malpractice to the Medical Council of India (“MCI”), and thus would have to ensure internal checks and compliance by the MPs with the restrictions on drug prescription.
The D&C Act and the Rules made thereunder also require the prescriptions to be signed by the MP, in a particular format. When such prescriptions are provided online, they must be digitally signed in accordance with the IT Act. The Tech Platform is to enable a framework where doctors may digitally sign the prescription as per the IT Act, and send the same to the patients, or directly to pharmacies (after obtaining explicit consent of such patient).
3. Telecom Commercial Communication Customer Preference Regulations, 2018 (“TCCP Regulations”)
Platforms would be regulated by the TCCP Regulations, and it would apply in such communications they make to those to whom they provide their services, i.e. MPs and Patients/customers. These would regulate the promotional, marketing and transactional messages that Tech Platforms would send to the stakeholders.
4. Consumer Protection Act, 2019 (“CPA”)
The CPA would be more applicable on RMP’s than on the Platform, as courts have recognized that medical services are something that fall within the ambit of regulation of consumer protection legislation in India. The Platforms liability would only arise if it is in some way associated with the actual providing of medical care to consumers, and is actively involved in substituting the role of a MP on the Platform. Thus Platforms should avoid substitution of medical advice through the Platform.
5. Corporate Laws and Foreign Exchange Management Act, 1999 (“FEMA”) Compliances
The Platform would be subject to laws of India that regulate the functioning of an LLP, Pvt. Ltd. Co., Public Co. or a Sole Proprietorship et al. Accordingly, any corporate/commercial activity taken by it may be subject to such regulation, which would include raising funds, either domestically or from foreign sources, and accordingly would be subject to compliances under FEMA.
One of the most significant impacts (post COVID19) on the medical industry will be this the shift from hospital-based services to telemedicine and virtual care. When implementing the tech solution for providing telemedicine based services, the Tech Platforms must evaluate the exact nature of services they offer vis-à-vis the laws mentioned above, as it would impact the liability that may be applicable to them. Moreover, as MP’s and Patients become more use to medical care offered via Telemedicine platforms, the Tech Platforms themselves would have to ensure that the appropriate disclaimers are made to the MP’s and Patients.
 Indian Medical Association v. V. P. Shantha and Ors AIR 1996 SC 550
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