INTRODUCTION

In the era of social distancing, the concept of “digital health” is gaining traction. The World Health Organization (“WHO”) has also emphasised the importance of digital health in its guidelines on introducing digital tech-based setup into the health system in 2019.[1] In India, quality healthcare has always faced geographical, demographical, and economic challenges. There is a need to revamp the healthcare sector to cater to the needs of patients, particularly relating to digital health.

Telemedicine is the remote delivery of healthcare services, such as health assessments or consultations, with the use of telecommunications technology. In India, the Government has successfully introduced initiatives in telemedicine, such as eSanjeevni and SeHAT, which have provided more than 3 crore teleconsultations until now.[2] The Government has also introduced the ‘Guidelines for Tele-Medicine Services in Ayushman Bharat Scheme’ to roll out telemedicine services based on the hub and spoke mode, where patients have access to specialist doctors in bigger cities (hub) through smaller rural clinics equipped with teleconsultation facilities (spoke).[3]

REGULATIONS GOVERNING TELEMEDICINE

The following are some of the legislations that are applicable to telemedicine:

• National Medical Commission Act, 2019 (“NMC Act”)

The National Medical Commission has replaced the Medical Council of India in 2020 through the NMC Act. Likewise, the draft Registered Medical Practitioner (Professional Conduct) Regulations, 2022[4] (“Draft RMP Regulations”), upon notification, shall take over the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. The Draft RMP Regulations contains Guidelines for Practice of Telemedicine in India (2022) which oversees the consultations conducted through telemedicine resources.

• Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (“IMC Regulations 2002”)

The IMC Regulations 2002 (which are in force until the Draft RMP Regulations are notified), under Appendix 5, contains the Telemedicine Practice Guidelines 2020 (“TPG Guidelines”).[5] The TPG defines telemedicine, telehealth, and a registered medical practitioner (“RMP”), along with details on the application of telemedicine, the guidelines specific to the framework of telemedicine, and the roles and responsibilities of a RMP. It categorises medicines into List O (over-the-counter medications), List A (first-consult medications) and List B (follow-up medications) that can be prescribed by doctors via teleconsultation. The TPG Guidelines also refer to a prohibited list of medicines that cannot be prescribed through teleconsulting.

• Information Technology Act, 2000 (“IT Act”), the Information Technology (Intermediaries Guidelines) Rules, 2011 (“Intermediary Rules”) and the Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011 (“Data Protection Rules”)

The IT Act read with the Data Protection Rules and the Intermediary Rules governs and regulates the collection of sensitive personal information by teleconsultation intermediaries who facilitate the interaction between the service provider and the patient and are not directly involved in the provision of the services.

Other relevant legislations on telemedicine include the Drugs and Cosmetics Act, 1940 and the related Drugs and Cosmetics Rules, 1945, the Clinical Establishment (Registration and Regulation) Act 2010, the Unsolicited Commercial Communications Regulations, 2007, the Telecom Commercial Communication Customer Preference Regulations, 2010, the New Telecom Policy, 1999, and the Electronic Health Record Standards, 2016 which requires registration of telemedicine service providers.

FEATURES OF THE TPG GUIDELINES

• Duties of RMP: RMPs should maintain the same standard of care as in-person consultation, mandatorily identify patients during the first consultation, display RMP’s registration number, ensure confidentiality of patient’s personal data, and only prescribe medicines as mentioned under the TPG guidelines. If the RMP thinks it is inappropriate to continue with teleconsultation as per the symptoms, they should request an in-person consultation.[6]
• Medium of Teleconsultation: Through mobile or landline phones, chat platforms like Whatsapp, or other digital platforms like emails, skype, etc.[7]
• Accuracy of Information: The onus of providing accurate information rests on the patient.[8]
• Caregiver: For children below 16 years of age or incapacitated patients, the caregiver shall be authorised to take consultation on their behalf.[9]
• Prescription: The RMPs should mandatorily share the digital or scanned copy of the duly signed prescription with the patient.[10]

REGULATORY CONCERNS

With emerging technologies, telemedicine is plagued by several liability concerns such as doctor’s liability, duty and quality of care, misdiagnosis, data security, and patient confidentiality. Some major concerns include:

• Lack of clarity on data usage: As per the TPG guidelines, the responsibility to maintain records of all communication with the patients is on the RMP. No time limit has also been specified for storing the data, nor have any limitations have been prescribed on further use of such data.
• Inability to make a fully informed opinion: The doctor who has not personally examined the patient may not be able to render a fully informed opinion resulting in an inaccurate reading. Under the TPG guidelines, prescribing medicines without appropriate diagnosis shall amount to professional misconduct. However, the law is not clear about the liability that may arise due to any misrepresentation by the patient and its subsequent consequences.
• Telemedicine service providers: The liability of the telemedicine service providers, i.e., the entities who provide the platform which connects the patients and the RMPs is unclear under the TPG Guidelines. Even the usage of third party telemedicine applications may make the personal information of the parties involved vulnerable to exploitation.
• Applicability issues: The TPG guidelines apply only to the RMPs. Also, there is a lack of clarity in the legal framework regarding the cross-jurisdictional mechanism of teleconsultations. The TPG guidelines specifically exclude any consultation conducted outside the territory of India. There is no clear indication regarding on whom the liability will rest in case a teleconsultation is conducted by a cross-jurisdictional medical professional who is not covered under the TPG guidelines.
• Grievance redressal mechanism: There is a need for a strong grievance redressal mechanism to address basic issues such as long waiting times, no response from specialists or doctors, etc.
• Privacy issues: The Government has come out with certain draft policies such as the draft Data Health Management Policy, 2022[11] and the draft Digital Information Security in Healthcare Act, 2018[12] to ensure the confidentiality of digital health data. However, these have not been notified yet. Until the Digital Data Protection Bill 2022 comes into force, all the draft policies and guidelines shall remain without any force of law.

CONCLUSION

Globally, the trend of telemedicine began more than a decade ago, but in India, it is still in its nascent stage. Telemedicine can be looked at as a step towards facilitating the availability of quality medical assistance even in remote areas and thus, improving the healthcare system. However, the protection of sensitive data of patients and providing a hassle-free experience to patients by regulating the functioning of telemedicine providers should remain the priority. Stringent checks at various stages would assure its safety and would gradually build the patient’s trust.

Overall, a positive transition in the healthcare system can be potentially expected by harnessing such advanced technologies to reach every corner of the country and provide impeccable medical support.

Please reach out to Praveen Raju and Renuka Abraham for queries.

[1] “WHO Guidelines on Recommendations on Digital Interventions for Health System Strengthening” (World Health Organisation) <https://apps.who.int/iris/bitstream/handle/10665/311941/9789241550505-eng.pdf?ua=1> accessed 3 Feb. 2023.

[2] “Health Ministry’s flagship telemedicine service – “eSanjeevani” records 3 Crore teleconsultations” (Ministry of Health and Family Welfare, 25 Mar. 2022) <https://pib.gov.in/PressReleasePage.aspx?PRID=1809569> accessed 3 Feb. 2023.

[3] “Guidelines for Tele-medicine Services in Ayushman Bharat Scheme” (Ministry of Health and Family Welfare, 29 Aug. 2019) <https://nhm.gov.in/New_Updates_2018/NHM_Components/Health_System_Stregthening/Comprehensive_primary_health_care/letter/Telemedicine_Guidelines.pdf> accessed 3 Feb. 2023.

[4] “Registered Medical Practitioner (Professional Conduct) Regulations 2022” (National Medical Commission, 23 May 2022) <https://www.nmc.org.in/MCIRest/open/getDocument?path=/Documents/Public/Portal/LatestNews/NMC%20RMP%20REGULATIONS%202022%20Draft%20Final%20YM.pdf> accessed 3 Feb. 2023.

[5] “Telemedicine Practice Guidelines 2020” (Ministry of Health and Family Welfare, 25 Mar. 2020) <https://www.mohfw.gov.in/pdf/Telemedicine.pdf> accessed 3 Feb. 2023.

[6] Clauses 3.7 & 4.1, Telemedicine Practice Guidelines 2020.

[7] Clause 4.1, Telemedicine Practice Guidelines 2020.

[8] Sub-sub clause (4.1.1.2 (4)), Telemedicine Practice Guidelines 2020.

[9] Clause 4.2, Telemedicine Practice Guidelines 2020.

[10] Sub-sub-sub clause 3.6.4.2, Telemedicine Practice Guidelines 2020.

[11] “Draft Data Health Management Policy 2022” (Ministry of Health and Family Welfare, Apr. 2022) <https://abdm.gov.in:8081/uploads/Draft_HDM_Policy_April2022_e38c82eee5.pdf>  accessed 3 Feb. 2023.

[12] “Digital Information Security in Healthcare Act 2018” (Ministry of Health and Family Welfare, 21 Mar. 2018) <https://www.nhp.gov.in/NHPfiles/R_4179_1521627488625_0.pdf> accessed 3 Feb. 2023.