Authored By: Rishabh Manihar & Sarvotham M Naik
With Covid 19 affecting the world the need for telemedicine has been felt more than ever in the past. Although the judgement of Bombay High Court in Deep Sanjeev Pawaskar and Anr. v. State of Maharashtra was seen as a roadblock for practicing telemedicine in India, the pandemic has shown the necessity for the same. Thus, Ministry of Health and Family Welfare with Niti Aayog has released guidelines on telemedicine on March 25, 2020. The present article makes an effort to understand the guidelines and analysis the practical challenges in implantation of the same. It also attempts to give insight interplay of telemedicine with other legal aspects and plausible changes which might result in effective implementation of telemedicine in India.
Key Takeaways of Guideline
On 25 March, 2020 the Ministry of Health and Family Welfare in partnership with Niti Aayog issued Telemedicine Practice Guidelines. This guideline envisaged the concept of Telemedicine and Telehealth in India. It provides for patient consultation through technology based platform. It classifies the consultation in two categories namely First Consultation and Follow Up Consultation between patient and Registered Medical Practitioner (RMP), Patient and RMP through Caregiver, Health worker and RMP, Two RMPs. These RMPs shall disclose their registration number to patient while verifying and confirming the patient’s identity by any ID proof (guideline 3.2). All patient records including case history and personal data shall be maintained by RMPs while ensuring privacy and confidentiality of patient if not; RMPs will be liable for breach of it. Also, the guideline provides for implied consent in case patient initiates consultation. However, express consent is must when Health worker, RMP or Caregiver initiate consultation (guideline 3.4). In the opinion of the doctor, if the treatment is possible through telemedicine, it should be done through Health education or Counselling or Prescription of medicine and if it is not possible through telemedicine, it should be done through in person consultation.
However, prescription of medicine depends on mode or nature of consultation because List “O” medicine can be prescribed for any emergency, whereas List “A” medicine can be prescribed for video consultation. However List “B” medicine can be prescribed for any mode but in follow up consultation only. It also enlisted category of prohibited medicine which can’t be prescribed by RMPs (guideline 3.7).
Challenges and The Way Ahead
- Definitional Challenge:
Definition of telemedicine as provided guideline is narrow as it only covers distance as critical factor however, it should have included time as also critical factor for example patient resides nearby RMP and patient requires immediate relief during odd hours or late night if patient consult with RMP over telephonic conversation, then time is critical factor in such situation not distance as patient resides near to RMP.
- Training of RMPs
The guideline provides for Mandatory training of RMPs for a period of 3 years for getting engaged in online consultation however, it does not suit the present situation of Covid-19 which is one of the primary motive for formulation of guideline and this intention can be gathered from definition of telemedicine provided in guideline where distance is the sole critical factor and due to nationwide lockdown movement is restricted. Therefore, this three year mandatory training will cause hindrance in the present situation. Therefore there is a need of interim waiver of such training. However, training would equip RMPs with right skill sets which can be beneficial for the success of telemedicine in long run.
- Consent of Patient
Consent is an essential factor in Data Protection Bill as well as medico legal requirement while treating a patient; failure to do so is a tort and crime and the same was taken care in guidelines. However, there are certain drawbacks which should have been taken into consideration. It gives deemed authorisation to caregiver for consulting with RMPs when patient is not present with caregiver. However, it does not give clarity on the consent of the patient in emergency situation.
In addition to this, it does not lay down situation in which patient will give consent while he/she is of unsound mind as those persons are not competent to give consent. Also, it does not provide that consent should be free as guideline merely provides for either implied or explicit consent of patient. In case consent is not free and any liability arises, then there is no responsibility of either party as there is not valid consent which is essential for telemedicine process.
Consent is an important element for maintaining privacy as RMPs is taking record of data of the patient and guideline does not deal with consent procedure for this privacy related concerns also.
- Discretionary Power of RMPs
This guideline has given wide power to RMPs for treatment of patient while exercising their professional discretion as per their medical ethics. However, the guideline does not put restriction or provide limitation for exercising such discretionary power and it also gives right to RMPs to choose to consult at any point of time. Therefore, this wide discretionary may lead to arbitrary exercise of these powers which is against the medical ethics and there is no liability or sanction provided in guideline if the RMPs fail to comply with the professional ethics.
- Unfair Practices of RMPs
Telemedicine can have negative effect if RMP’s are involved in unfair practices or if any person misrepresents his/ her qualifications. A strong screening system is required since many cases of harm would come to light only after the damage would have already been caused. Hence Medical Council of Indian needs to be the most active participant in the entire process.
- Intermediary Platform and Data Privacy
The guidelines aim to connect the patient with the medical practitioner through different virtual platforms. Although the burden of protection of the privacy of the patients is put on the Medical Practitioners, no such responsibility is put on the technology platforms.
The need for protection of privacy has been emphasised by the Hon’ble Supreme Court and efforts have been made to translate the same into action in technology sector. In furtherance of this the Personal Data Protection bill 2019 (PDP bill) was introduced.
The information relating to physical, physiological and mental health condition has been classified as sensitive personal data as per rule 3 of Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011as well as its allied rules and section 3(36) of the PDP Bill 2019. A special obligation is placed on intermediaries (the platform providers) to protect the same. It is important to ensure these platforms are not collecting the data since the same could amount to breach of the privacy. Similarly, it is also not clear about the privacy obligations and the data allowed to be shared to the second RMP.
- Critical Analysis
This guideline requires the platforms providing telemedicine to ensure that only registered practitioners are allowed to provide consultation. While the obligation is put on the platforms to ensure the validity and qualification of the practitioners, the responsibility is put on the platforms without any exceptions. This becomes problematic in cases where there is misrepresentation or forging of documents by the practitioner for which the platforms would have to suffer unnecessarily. Hence, it would bebetter if the enlistment of the practitioners on platforms is done through the Indian Medical Council.
The guidelines also miss out the regulation of instances of telemedicine where consultation takes place not through platforms which are exclusively meant for providing services but through general mode or platforms of communications. This is important since the medical practitioners can conduct Follow-up consultation through private communication where it becomes difficult to regulate owing to hardships in identification of communications especially on audio mode of communication like a phone call.
One of the positive moves included in guideline is manner of inclusion of Artificial Intelligence. The guidelines prevent incorporation of AI with exclusion of human intervention. This ensures that AI is incorporated in a manner in which it assists RMP but simultaneously places responsibility on RMP and the platforms to prevent its misuse.
The guidelines also make it clear that the role of platforms is not merely that of intermediary but also a consumer-service provider by specifying that the platform should have mechanism to address grievance and queries of the users (guideline 5.6). So, disputes related to deficiency of services can also be brought against the platforms.
The guidelines allow the RMP to get a second opinion from another RMP in treating the patient. However, the former RMP continues to treat the patient and is held responsible for the recommendations given to the patient. Although it is correct to place such liability on the RMP who treats the patient, the RMP providing second opinion should also be held liable in cases where the former RMP has acted exclusively on the suggestions of the latter.
Telemedicine has a greater impact on the health sector through its greater reach and shifting paradigm to digital health sector. It will further revolutionize medical education. In addition, telemedicine also further assists in reducing the cost of consultation from specialist RMPs. This initiative seeks to take medical services to the nooks and corners of the country but for the entire process to work efficiently, certain basic infrastructure is required. Additionally, in rural places an extra effort is also required in teaching the masses about the usage of technology and creating awareness about their rights specially right to privacy.
Regulation of Telemedicine falls between telecommunication and health services hence there is requirement of a special regulatory body which is well equipped both in terms of technology and in medical sciences.
It would be better if the government could integrate the present program with other initiatives like Digital India and Health insurance so that the services become accessible to every section of the society without any economical or geographical constraints.
It is important to address the factors like bearing of operation costs of the communication platforms since advertisements from the RMPs are prohibited on such platforms. Further, there is also requirement for licensing regime for communication platforms for ensuring service quality and regulating their operations.
The authors are currently fourth-year students at Gujarat National Law University, Gandhinagar.