Regulation of Telemedicine Practices in India
- ByAdmin --
- 02 May 2025 --
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Telemedicine, the use of technology to provide healthcare remotely, gained significant momentum in India, especially during the COVID-19 pandemic.
With the rise in virtual consultations, a strong legal and regulatory framework became essential to ensure safety, privacy, and quality of healthcare services.
Key Regulations Governing Telemedicine in India
- Telemedicine Practice Guidelines, 2020:
- Issued by the Medical Council of India (MCI) and later adopted by the National Medical Commission (NMC).
- Laid down protocols for medical practitioners to follow while offering remote consultations.
- Enforced under the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002.
- Information Technology Act, 2000:
- Section 43A: Provides for compensation for failure to protect sensitive personal data.
- Section 72: Punishes breach of confidentiality and privacy.
- Forms the backbone for cybersecurity and privacy requirements in telemedicine.
- Drugs and Cosmetics Act, 1940:
- Regulates the prescription of drugs during teleconsultations.
- Doctors must comply with rules regarding online prescriptions.
Key Features of Telemedicine Practice Guidelines, 2020
- Modes of Communication:
- Telemedicine can be conducted via video, audio, text, or online platforms.
- Telemedicine can be conducted via video, audio, text, or online platforms.
- Patient Consent:
- Consent is implicit when a patient initiates a consultation.
- Explicit consent is required when the doctor initiates the consultation.
- Identification:
- Both doctor and patient must verify their identity at the beginning of consultation.
- Both doctor and patient must verify their identity at the beginning of consultation.
- Prescription Protocols:
- Only certain categories of drugs (List O and List A) can be prescribed during teleconsultations.
- Prescription of Schedule X drugs (narcotics and psychotropic substances) is prohibited via telemedicine.
- Only certain categories of drugs (List O and List A) can be prescribed during teleconsultations.
- Documentation:
- Doctors must maintain proper records of the consultation, similar to physical consultations.
- Doctors must maintain proper records of the consultation, similar to physical consultations.
- Ethical Standards:
- Same professional and ethical norms apply to telemedicine consultations as to physical ones.
Constitutional and Legal Backing
- Article 21 (Right to Life and Personal Liberty):
- Right to health is recognized under Article 21.
- Telemedicine ensures accessibility to healthcare as a part of this right.
- Article 19(1)(g) (Right to Practice Profession):
- Medical professionals are allowed to practice telemedicine under reasonable regulations.
- Medical professionals are allowed to practice telemedicine under reasonable regulations.
- Consumer Protection Act, 2019:
- Doctors providing teleconsultation services are also liable under the consumer laws for any deficiency in service.
Challenges in the Regulation of Telemedicine
- Data Privacy and Cybersecurity:
- Lack of a specific law on data protection (pending Digital Personal Data Protection Act, 2023) leaves gaps.
- Risk of data breaches during telemedicine consultations.
- Licensing and Jurisdiction:
- Currently, Indian doctors are allowed to provide teleconsultation only within India.
- Cross-border telemedicine practices remain legally uncertain.
- Quality Control:
- Ensuring the competence of doctors and authenticity of digital platforms is a major issue.
- Ensuring the competence of doctors and authenticity of digital platforms is a major issue.
- Malpractice and Accountability:
- Blurred lines over liability in case of misdiagnosis or technical failures during remote consultations.
Recent Developments
- Digital Health Mission:
- Under the Ayushman Bharat Digital Mission (ABDM), efforts are being made to create a digital ecosystem for health services, including telemedicine.
- Under the Ayushman Bharat Digital Mission (ABDM), efforts are being made to create a digital ecosystem for health services, including telemedicine.
- eSanjeevani Platform:
- The government’s national telemedicine service that has facilitated millions of consultations, setting an example for regulated telemedicine practices.
- The government’s national telemedicine service that has facilitated millions of consultations, setting an example for regulated telemedicine practices.
- Draft Guidelines on Online Pharmacies:
- Proposed by the Ministry of Health and Family Welfare to regulate e-pharmacies offering remote medical services.
Suggestions for Strengthening Telemedicine Regulation
- Enactment of Data Protection Law:
- Full implementation of the Digital Personal Data Protection Act, 2023 will provide a legal framework for data privacy.
- Full implementation of the Digital Personal Data Protection Act, 2023 will provide a legal framework for data privacy.
- Licensing Framework for Telemedicine Platforms:
- A separate regulatory body or licensing system for platforms offering telemedicine services could ensure quality assurance.
- A separate regulatory body or licensing system for platforms offering telemedicine services could ensure quality assurance.
- Awareness Campaigns:
- Educating both patients and doctors about rights, obligations, and best practices in telemedicine.
- Educating both patients and doctors about rights, obligations, and best practices in telemedicine.
- Cross-Border Frameworks:
- India should explore bilateral agreements for international telemedicine services.
Conclusion
Telemedicine is a transformative force for India's healthcare system, enhancing accessibility, especially in rural and remote areas.
However, ensuring a secure, ethical, and regulated telemedicine practice is essential to maintain public trust and uphold the right to health under the Constitution.
India's evolving legal framework must address current gaps while fostering innovation in this rapidly expanding field.
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