Telemedicine Guidelines Released in India Notified and Gazetted

Highlights :

• Telemedicine Guidelines Released in India are Notified and gazetted by the Government of India
• They cannot be challenged in the court of Law
• It makes the diagnosis and treatment through telemedicine a reality in India

The Government of India Notified and gazetted the Telemedicine Guidelines that were released on 25th March 2020. What it means is that this framework is here to stay even after the current COVID-19 pandemic recedes. The intent of the government to move aggressively to prioritize healthcare so that Telemedicine can become an enabler is highly commendable. It now would make it possible to deliver healthcare to masses and to work towards affordable and universal healthcare.

While 25th March was a historic day when the guidelines were released by the BOARD OF GOVERNORS - In super session of the Medical Council of India under NitiAayog, 14th of May the guidelines have officially been notified and gazetted.

"Now that the Telemedicine Practice Guidelines (TPG) have been notified in the Gazette, eligibility requirements for practice of telemedicine will come to be in force, and a timeline of 3 years will be granted to the Registered Medical Practitioners (RMPs) to regularize their practice of telemedicine. Also, the RMPs and the portals will be required to work in absolute and strict compliance with the TPG, and ensure that the best practices in the domain become the norm, and there is almost no deviation from the hand holding provided therein." said Ms Bagmisikha from TMT Law firm. She is an Advocate who works in Healthtech IT space for regulatory requirements and an Executive Member of Telemedicine Society of India.

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Telemedicine in Healthcare

The India rural and remote population will be the ones to benefit the maximum in the long run and our health indices will improve as a result. This will be the true impact in the years to come if telemedicine is used innovatively and as an enabler. The technology framework is already in place with over 500 million smartphone users and 4G being available in most locations. The financial element will be serviced by the online payment gateways that have recently been made more easily available. The only missing piece is the e-pharmacies draft bill that has been long pending.

In India, so far there was no legislation or framework on the practice of telemedicine although some doctors and companies were using it as a form of practice. There were many grey areas like how to issue a prescription or how to charge a patient.

The existing provisions under the Indian Medical Council Act, 1956, the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 2002), Drugs &Cosmetics Act, 1940 and Rules 1945, Clinical Establishment (Registration and Regulation) Act, 2010, Information Technology Act, 2000 and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 do not mention the practice of telemedicine and only indirectly applied to any practice that was happening. The gaps in the legislation and the uncertainty of rules posed a risk for both the doctors and their patients.

Currently, there are some countries that have put legislative and regulatory requirements for telemedicine practice while in others there only guidelines available to practice telemedicine. All these guidelines were reviewed before the current Indian ones were released.

Telemedicine will continue to grow and be adopted by more healthcare practitioners and patients in a wide variety of forms, and these practice guidelines will be a key enabler in fostering its growth.

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Purpose of Telemedicine Guidelines

The purpose of these guidelines is to give practical advice to doctors so that all services and models of care used by doctors and health workers are encouraged to consider the use of telemedicine as a part of normal practice. These guidelines will assist the medical practitioner in pursuing a sound course of action to provide effective and safe medical care founded on current information, available resources, and patient needs to ensure patient and provider safety.

These telemedicine guidelines will help realize the full potential of these advancements in technology for health care delivery. They provide norms and protocols relating to a physician-patient relationship; issues of liability and negligence; evaluation, management and treatment; informed consent; continuity of care; referrals for emergency services; medical records; privacy and security of the patient records and exchange of information; prescribing; and reimbursement; health education and counselling.

These guidelines provide information on various aspects of telemedicine including information on technology platforms and tools available to medical practitioners and how to integrate these technologies to provide health care delivery. It also spells out how technology and transmission of voice, data, images and information should be used in conjunction with other clinical standards, protocols, policies and procedures for the provision of care. Where clinically appropriate, telemedicine is a safe, effective and valuable modality to support patient care.

Like any other technology, the technology used for telemedicine services can be abused. It has some risks, drawbacks and limitations, which can be mitigated through appropriate training, enforcement of standards, protocols and guidelines. These guidelines should be used in conjunction with the other national clinical standards, protocols, policies and procedures.

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Definition of Telemedicine & Tele-health in the Notification

The guidelines have used the WHO definition to define telemedicine as follows-

’The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for the diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.’

It defines Telehealth as - ’The delivery and facilitation of health and health-related services including medical care, provider and patient education, health information services, and self-care via telecommunications and digital communication technologies.’

The gazette allows a Registered Medical Practitioner [RMP] enrolled in the State Register or the National Register under the IMC Act 1956 to practice telemedicine but it does not allow –

• Consultations outside the jurisdiction of India
• It does not cover hardware or software, infrastructure building & maintenance, data management systems; standards and inter-operability
• Use of digital technology to conduct surgical or invasive procedures remotely.

To practice telemedicine

• RMPs should be familiar with the guidelines as well as with the process and limitations of telemedicine practice
• All RMPs to take a mandatory online course within 3 years of notification of the guidelines - this is to be developed by MCI
• All qualifying RMPs will need to undergo and qualify such a course before they are given license to practice

In all cases of emergency, the patient must be advised for in-person interaction with an RMP at the earliest. However, if this is not possible emergency consult for immediate assistance or first aid etc., maybe offered
In the next few months what would be required is the following -

• Training of doctors on how to practice safe telemedicine by making them familiar with the Guidelines that have been notified.
• Creating minimum standards required for hardware and software to be used for telemedicine practice
• Putting a robust ethical and legal document that will substantiate the already laid down guidelines
• Getting health insurance companies to reimburse telemedicine consultation.

With these guidelines in place, the pharma companies have suddenly started working with partners and advising doctors to use certain apps. There is a need for pharma companies to use restraint when promoting such apps that they develop or endorse. One of the dangers for doctors is that the pharmaceuticals can track their prescriptions through these apps.

Many of the existing big players also are abusing privacy laws and sometimes spamming their customers with messages. They send repeated reminders to use services that the customers are not interested in or sending them information that is not relevant to their health condition.

The use of telemedicine as an enabler is important in the complex Indian healthcare ecosystem and all stakeholders should look at its long term benefits and use it prudently and not abuse the technology.

References:

1. Telemedicine Practice Guidelines Enabling Registered Medical Practitioners to Provide Healthcare Using Telemedicine - THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4] BOARD OF GOVERNORS IN SUPER SESSION OF MEDICAL COUNCIL OF INDIA NOTIFICATION New Delhi, the 12th May, 2020 No. MCI-211(2)/2019(Ethics)/100659 - (https://www.medindia.net/indian_health_act/Telemedicine-Guidelines-Gazetted-and-notified.pdf)
2. BOARD OF GOVERNORS - In supersession of the Medical Council of India - (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)

Source-Medindia