Hetero Group of Companies gets an acceptance from the Drug Controller-General of India (DCGI), as they have given the permission for the generic version of Gilead’s Remdesivir for the treatment of COVID-19 patients in the country as it gives a positive result. They have also agreed on manufacture and selling oral antiviral drug Favipiravir, under the brand name FabiFlu, for treatment of mild to moderate COVID-19 patients in India.
Covifor will be made available to only hospitals for giving medication to only COVID-19 patients. The drug makers acquainted that Each 100 mg (injectable) medicine will be charged between Rs. 5,000 to Rs. 6,000 and the drug is to be dispensed only after getting the consent of the patients. However it should be under the observation of a healthcare practitioner.
Devang Bansal, a Second year Law student at National Law University, Jodhpur, analyzes the telemedicine practice guidelines and its implications during Covid crisis.
With the release of guidelines on the practice of Telemedicine by the Medical Council of India in partnership with NITI Aayog, the issue has been generating considerable interest. These guidelines are incorporated under Appendix 5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. It filled the legislative void on the issue and laid down a fundamental framework for the regulation of Telemedicine in the country. Telemedicine is set to become a vital factor in the dispensation of healthcare, and the release of guidelines is a welcoming step, particularly in the times of restriction on physical movement due to the COVID-19 pandemic. This article analyses the legal and policy issues arising out of these guidelines.
Tele-medicine is essentially the delivery of health care services, where distance is a critical factor by health care professionals using information & communication technologies. The issues in the guidelines that must be considered to ensure that no malpractice takes place are as under:
The formation of a Doctor-patient relationship is important because it forms the foundation of the legal obligation and liability between the doctor and the patient The guidelines allow for consultation over video, voice, and text-based platforms which include platforms such as WhatsApp, Facebook, Skype, Emails etc. No prior Doctor-Patient relationship is needed to start the telemedicine consultation. Even first-time consultation can be done by text or voice-based mode of communication.
Telemedicine in India, while still in its relative infancy, necessarily alters the context of the traditional face-to-face Doctor-Patient trust-based relationship. The lack of face-to-face interaction in text/voice modes of Telemedicine is seen as a barrier to the adequate development of this relationship as visual cues are not obtained in these modes. Given the high stakes, serious consideration should be given to mitigate any potential negative impacts on this relationship. For example, The Texas board decided to limit telemedicine consultation where a pre-existing fiduciary Doctor-Patient relationship is prevalent. Thus, allowing consultation based solely on a patients description on a text/voice-based mode of communication may result in a false sense of fiduciary relationship considering the socio-economic and demographic factors such as low education level and problems in penetration of internet and internet connectivity in remote areas of our country.
Standard of care
The guideline stresses on the practitioners to use their professional judgment to decide whether a telemedicine consultation is appropriate in a particular situation. The practitioner using Telemedicine shall uphold the same professional and ethical norms & standards as applicable to traditional in-person care. Prescription of medicine without an appropriate diagnosis will amount to professional misconduct.
In medical practice, the standard of care is judged in light of knowledge available at the time of the incident, And omission to do routine investigation constitutes a deficiency in service. As Telemedicine is a new concept, no judicial precedents or established medical custom or routine is present. Accordingly, the standard of care and precautions to be practiced is not yet known, and professional judgment on a case to case basis over the new technology will be the guiding light.
Privacy & Security of patient records
The guidelines put the onus on the practitioner to be cognizant of the data protection laws applicable, and that practitioner will not be held responsible for breach of confidentiality if there is reasonable evidence to believe that patient’s privacy and confidentiality has been compromised by technology breach or by a person other than the practitioner.
It has been held that a doctor-patient relationship is a professional matter of confidence based on fiduciary relationships and, therefore, doctors are morally and ethically bound to maintain confidentiality. Telemedicine consultations add more volume of data like medical video and images, medical forms, prescription, and other sensitive information stored on the web than the traditional physical visits. The approach to absolve the practitioner from liability in case of a technology breach or when done ‘by any other person’ might lead to data breaches. This approach is evasive and might lead to abuse. In this regard, it is suggested that the onus is put on the practitioner to use the suitable platform protecting the data records.
A technological platform enabling Telemedicine
Under the guidelines, the technological platforms (mobile app, websites, etc.) due diligence is performed in listing & providing professional and contact details. The guidelines prohibit Artificial Intelligence/Machine learning platforms like chatbots to advise patients but can be used in assisting & supporting the RMP in diagnosis & evaluation.
However, the guidelines are silent on the issue of whether the technology platforms can induce patients for solicitation by way of discounts, advertising, and other such methods. The guidelines lack clarity and fail to provide sufficient norms to regulate technical platforms. As legal status has been given to the use of Artificial Intelligence/machine learning to assist the practitioner, these guidelines will further interest the private players in the market.
It is recommended that current guidelines regarding no need of pre-existing Doctor-Patient relationship and allowing for first time consultation over text and voice-based mode of communication should be reconsidered. Otherwise, the guidelines might lead to severe negligence and misconduct, especially considering the socio-economic & demographic factors of our country. Also, clarity on the issue of whether inducement by technological platforms for solicitation is permitted or not is required. The directions regarding the privacy and integrity of patient records are evasive & ambiguous in the current nature and might hinder the interests of the patient.
The COVID-19 crisis is such a situation, where diagnosis and treatment of other diseases are taking a toll, and therefore Telemedicine is becoming more relevant than ever. Restrictions on physical movement are likely to become a part of our lives in the coming times. Telemedicine has enormous potential in a country like India, where the doctor-patient ratio is low, and resources are concentrated on the cities. In the current form, the guidelines fail to recognize the demographic factors of our country, such as low education level, the problem in internet penetration, and connectivity in remote areas. While the issuance of guidelines is a welcome step, but without legislative policy designed to suit the infrastructural and demographic factors of our country, severe negligence concerns and fraud are likely to arise.
Devang Bansal is a Second Year Law Student at National Law University, Jodhpur