The requirement of telemedicine was starkly visible during the current COVID-19 pandemic and the resultant lockdown. It significantly helped in reducing hospital visits, waiting periods, and long travel to and from the hospital. Other benefits of telemedicine include timely and faster access to healthcare services, convenience, cost-saving, and adequate documentation of health records. Until recently, there was no legislation or guidelines on how telemedicine could be practiced in India. In view of the current pandemic, the Government of India has timely come up with the Telemedicine Practice Guidelines on 25^th March 2020.  This guideline forms a part of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, and is numbered Appendix-5. With this, there is now some legitimacy attached to the service and the guidelines would pave the way for statutory legislation on the same lines in the future.

Evolution of Telemedicine in India

From the constitution of a Telemedicine Taskforce in the year 2005 by the Ministry of Health and Family Welfare, India has gradually progressed in telemedicine by budgeting for it, setting up various institutions, connecting Regional Cancer Centers with peripheral centers across India through the ONCO-NET India Project and networking of states and district headquarters and premier institutes as part of Integrated Disease Surveillance Project (IDSP).  The Government has further facilitated it through the establishment of the National Rural Telemedicine Network, mother, and child tracking system (MCTS), the establishment of National Telemedicine Network, National and Regional Resource Centers etc. Various indigenous software has also been developed to provide telemedicine solutions.

Scope of the Telemedicine Practice Guidelines, 2020

The Telemedicine Practice Guidelines introduced on 25^th March 2020 provide norms and protocols pertaining to physician-patient relationship; issues of liability and negligence; evaluation, management, and treatment as well as informed consent. The provisions also deal with continuity of care; referrals for emergency services; medical records; privacy and security of the patient records and exchange of information; prescription; health education and counseling. These guidelines also provide information on technology platforms and telemedicine tools available to medical practitioners and how to integrate them into these technologies.

Guidelines for Registered Medical Practitioner

• Information Exchange: A Registered Medical Practitioner (“Doctor”) is empowered by these guidelines to provide telemedicine consultation to patients from any part of India, and the same professional norms, ethics, and standards apply. All physical examinations cannot be done via video/audio/text messages. Therefore, it is left to the Doctor’s professional judgment as to whether he/she can provide a technology-based consultation or an in-patient consultation. In addition, doctors are restrained from providing telemedicine when the physical examination is critical for consultation. Doctors are also mandated to uphold the same standard of care as in-patient consultation. Both Doctors and patients are required to provide their identification to the other as may be deemed appropriate.   Since prescriptions are based on the age of the patient, a Doctor is required to explicitly ask for the age, and if necessary, seek proof thereof.  In the case of a minor, teleconsultation can only be done when the minor is accompanied by an adult whose identity is also required to be verified.
• Informed Consent: Patient consent is mandatorily required for a telemedicine consultation. Consent is implied when telemedicine is initiated by the patients themselves. If it is initiated by a health worker, another Doctor, or caregiver, explicit consent of the patient must be procured and recorded.  Health education, counseling, and prescription of medicines can be done through telemedicine. If a caregiver is not present with the patient and does not have authorization, Doctors cannot provide telemedicine consultation. In the case of a health worker, he/she should have obtained informed consent from the patient to obtain consultation from Doctor.
• Prescription of Drugs: The guidelines categorize drugs into four lists, List O (over the counter medications), List A (can be prescribed during the first consultation and has relatively low potential of abuse), List B (when an in-patient consultation is already done, and drugs have to be prescribed in follow up consultation), Prohibited Drugs (high potential for abuse). Doctors cannot prescribe prohibited drugs. Doctors can only prescribe List A drugs if the consultation is done through video as it involves the first consultation. If the gap between two successive consultations is more than 6 months or if the consultation is for a different health condition, it would be construed as a first consultation. Signed prescription or e-prescription can be sent to the patient digitally (or to the pharmacist after the explicit consent of the patient).
• Confidentiality, Privacy and Data Protection: Doctors are required to abide by their professional conduct regulations, IT Act, Data protection and privacy laws in India, and other applicable rules. The guidelines specify a certain inclusive list of actions constituting misconduct by Doctors such as insisting on telemedicine when a patient is willing to travel, misusing patient data, prescription of medicine from the restricted list, and solicitation of telemedicine. Further, doctors will not be held responsible for breach of confidentiality if there is a piece of reasonable evidence to believe that patient’s privacy and confidentiality has been compromised by a technology breach or by a person other than the Doctor. However, doctors should ensure that a reasonable degree of care is undertaken during hiring such services. Penalties for violation would be as per the IMC Act, ethics, and other prevailing laws.
• Documentation: Doctors are required to maintain digital trails and documentation of the telemedicine consultation such as logs of telemedicine interaction; patient records, reports, diagnostic data, etc., utilized during telemedicine consultation, and prescriptions for such period prescribed from time to time. Fees for telemedicine consultation should be treated in the same way as in-patient consultation, and a fee receipt should be provided to the patient.

Guidelines for Technology Platforms

It is the responsibility of technology platforms such as websites, mobile apps, etc., assisting in telemedicine services to:

1. Ensure that the telecommunication is with a Doctor who is duly registered with the national or state medical councils.
2. Conduct Due Diligence before listing Doctors in online portals. The technology platform should provide the name, qualification, registration number, and contact details of every Doctor.
3. Report any non-compliance to the Board of Governors of MCI.
4. Ensure that Artificial intelligence or machine learning is not utilized to counsel patients. However, such technologies can be used to assist Doctors in inpatient evaluation, diagnosis, management, and prescription.
5. Ensure that the technology platform has a proper mechanism to address the queries and grievances of patients.

Any violation by the Technology Platform would lead to blacklisting of them by the Board of Governors or MCI, and thereafter, no Doctor shall use such a platform to provide telemedicine services.

Conclusion

In the wake of the coronavirus pandemic and the heavy toll it is taking on the healthcare sector across the world, the telemedicine guidelines had to be brought in to limit hospital visits and avoid the transmission of diseases significantly. The guidelines are designed to regulate unauthorized use and assist Registered Medical Practitioners to provide their services in an uninterrupted manner and to remote locations.  The provision for blacklisting technology platforms that do not abide by these guidelines is a welcome step to ensure due care from their end and was necessary to inculcate faith in these platforms. However, it is unjust on the part of the Government of India to only empower doctors who practice modern medicine to provide telemedicine services and not bring practitioners of Indian Medicine under its ambit.  As the definition of Registered Medical Practitioner in the guidelines state, it is only for doctors enrolled in the State Medical Register or Indian Medical Register as per the Indian Medical Council Act 1956.  Practitioners of Ashtang Ayurveda, homeopathy, Siddha, Unani, Tibb, or Sowa-Rigpa who are registered under other enactments have been overlooked.

That said, several initiatives by the Government of India on providing greater bandwidth connectivity, optical fiber connectivity, and National Knowledge Network connecting more than 800 institutions including medical institutions would encourage Telemedicine and Telehealth significantly. With people across the country in isolation and quarantine, Telemedicine is a viable alternative for patients to get immediate medical attention for minor health issues. With the assistance of technologies like fitness trackers, smartwatches, and plasters that are capable of monitoring heart rate, breathing rate, body temperatures, and generating ECG reports, it is time to harness Telemedicine for faster and timely access to healthcare services.