A CRITICAL ANALYSIS OF THE GUIDELINES AND LEGALITIES OF TELEMEDICINE
This article has been authored by Ashwin Singh, a student at Symbiosis Law School, Pune
Telemedicine is essentially giving distanced medical care through the mode of technology. In India, such services can be hugely advantageous given the distance between residences and hospitals for a lot of people. The population and limited availability of doctors do make such services highly beneficial and often necessary. In 2018 in Deepa Sanjeev Pawaskar and Anr vs The State Of Maharashtra a doctor couple was held liable for medical negligence for prescribing medicines over the phone after the patient later died. That’s seen as a very negative judgment to the teleconsultation industry with a lot of doctors misinterpreting the judgment to mean that the Court has deemed such consultations, unconstitutional. While that was not the case, it did highlight how telemedicine had no legal backing.
The Indian Medical Association, pursuant to this, sought clear guidelines from the Medical Council of India (“MCI”) on the issue of telemedicine. The aim was of course to create a robust set of guidelines that makes telemedicine an effective industry. In March 2020, the Board of Governors of the MCI prepared the ‘Telemedicine Practice Guidelines’ (the guidelines) in consultation with NITI Aayog to address the lack of legislation for ethical telemedicine practice. In the wake of the pandemic, this has been vital as social distancing and staying at home are the norm. Hospitals are often crowded with COVID-19 patients as well. It, thus, becomes necessary for patients to get proper and ethical telemedical care and these guidelines seek to achieve that aim.
Prior Legal Framework
Prior to the introduction of the guidelines, there was no specific, singular law that actually dealt with the issue of telemedicine. The existing provisions were the Indian Medical Council Act, 1956(IMC Act), and Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. The guidelines themselves are a product of Section 20 and 33-A of the IMC Act gives the medical association of India the power to frame standards for professional conduct, etiquette, and code. The current guidelines were attached as appendix 5 to the 2002 Regulations. Information Technology Act, 2000 (IT Act) and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011, mainly govern the practice of medicine and the mode of preserving personal information and records of patients. It did not deal with telemedicine specifically.
Then, there is the Drugs and Cosmetics Act, 1940 (Drugs Act), and its rules formed subsequently, which also have no concrete directions on telemedicine. But in 2018, there was a discussion on draft rules being formed for the regulation of e-pharmacies. Numerous websites were coming up which enabled patients to get medicines delivered to them by entering their prescriptions and medical information, rather than visit brick and mortar pharmacies. Petitions were filed to ban these e-pharmacy websites as they were not following the due procedure under the Drugs Act and its rules. The case of Dr. Zameer Ahmad v. Union of India, saw the Delhi High Court injunct such e-pharmacy vendors, without a license, from carrying on a business. A single judge of the Madras High Court in Tamil Nadu Chemists and Druggists Association v. Union of India & Ors, held that the Centre is to notify the proposed Drugs and Cosmetics Amendment Rules, 2018 before promoting e-pharmacies but a division bench noted the benefits of e-pharmacies and the connections it provides patients with pharmacies, especially to elderly citizens. Thereafter, the draft Drugs and Cosmetics Amendment Rules, 2018 is still pending. Hence, there is no concrete set of laws even for e-pharmacies, which is one of the most important sectors right now in the pandemic especially since e-pharmacies are classified as essential services.
Hence, with the existing legal framework not covering a priority sector, the telemedicine guidelines are important as there is a need for stricter checks on the telemedicine industry. But are these laws perfect or constitutional?
Telemedicine Guidelines, and the Constitution
Accountability: The guidelines do hold doctors accountable for medical advice they give on e-platforms. According to the guidelines, the doctors can choose the mode of communication with their patients, either text, audio, video i.e., telephone calls, WhatsApp messaging, video calls, etc. But doctors have to identify themselves before every consultation and have to maintain the same standard of care in a teleconsultation as they would in an in-person consultation. While doctors have to collect patient records and have the patients identify themselves in the first consultation, they can be held for breach of patient confidentiality without the consent of the said patient. The legislature amended the IT Act to include Section 43-A and 72-A, which guarantee the right to compensation for unauthorized disclosure of personal data of the patient and provides the penalties for disclosing the subject’s data when performing contractual services, respectively.
Right to Privacy: The Supreme Court in K.S. Puttaswamy v. Union of India laid down that the right to privacy was a fundamental right under Article 21. For patients and practitioners, the recommendations lack clarity on privacy and data utilization. They put the whole burden of maintaining records of every interaction between doctors and patients on doctors. The rules do not currently set a time limit for retaining data or any limitations on how that data might be used in the future. The rules merely state that the practitioner must be aware of and obey data protection and privacy legislation. Privacy problems emerge since the practitioner is compelled to record data such as a patient's address and other ‘reasonable' identification. The standards define implicit and explicit consent, however, an individual's mere request for a telemedicine consultation is deemed implicit permission. Despite the amendments to the IT Act and the section in the guidelines about doctors being held accountable for a breach of confidentiality, patients are naturally worried about the data they have to give since data leaks in India are not an uncommon occurrence. The rules should go into further detail on obtaining and recording consent in a teleconsultation.
In the USA the ‘Health Insurance Portability and Accountability Act of 1996 gives individuals control of their health information and allows them to obtain a copy of their health records. European law recognizes a patient’s health as personal information and has more robust laws dealing with health data privacy. It would be beneficial that for a safer set of guidelines, lessons can be taken from foreign countries and their laws to set up a more efficient data protection system which will alleviate the skepticism that a lot of people have about these guidelines with respect to their privacy.
State vs Centre Subject: The 7th Schedule of the Indian Constitution is the marker of the separation of powers between the center and states. Entry 26 of List III (concurrent list) allows regulation of the medical profession. However nowhere does it talk of regulations of online platforms. The IMC Act itself does not give the medical council of India any authority over online platforms and thus an amendment to the Act may not be constitutional either. Entry 6 of List II (state list) talks about public health, hospitals, and dispensaries. The guidelines seek to regulate the medical profession but through online platforms. They seek to facilitate public health by connecting patients, act almost like virtual hospitals and e-pharmacies. Thus, the ‘pith and substance’ doctrine has to be applied in such a situation of overlap between the concurrent list and state list. If the pith and substance of these guidelines fall within Entry 6 of List II, then it will fall outside the legislative competence of the union government even if there is incidental overlap with Entry 26 of List III. Based, on the extent these guidelines deal with the doctor-patient relationship over virtual platforms, the pith and substance of it may very well fall within the state list.
Enforcement and Challenges of the Guidelines
As the telemedicine guidelines have been published as an amendment in the Code of Conduct, any non-adherence or violation of the guidelines makes the doctor liable for misconduct under the Code of Conduct. The aggrieved patient has the right to complain against the concerned doctor to the corresponding State Medical Council under which the doctor is registered. Upon being found guilty, the doctor could face consequences like getting reprimanded or a suspension of the registration. Suspension of registration effectively leading to a stop on his/her medical practicing career.
With the development in telemedicine, there arise medico-legal challenges with respect to consent, frauds, licenses, confidentiality, care, civil responsibilities, etc. It also requires specific infrastructure and training for the practitioners. The major concerns include uncertainty regarding liability for neglect, the confidentiality of online data availed, safety and care of the aggrieved.
As the doctor-patient relationship can be put under contractual obligations, violations also lead to the filing of a civil suit as the breach amounts to negligence. For filing a civil suit, there must be an expressed or implied contract between the doctor and patient for consultation including clear consent and knowledge for both parties. However, not much judicial and legislative examination has been done for doctor-patient relationships apart from the extent of privacy and confidentiality.
There also lies punishment in IPC for gross negligence which falls within criminal negligence. The common charges include death by negligence under section 304-A, endangering life or personal safety by hurt or grievous hurt under sections 337 and 338 respectively. Fine and imprisonment are included in the punishments as per relevant sections. There could also arise a vicarious liability for the employer-employee relationship specifically in the context of telemedicine. For example, non-sync between the doctor and the other healthcare provider, due to the lack of communication or misinterpretation might lead to a patient's deterrence.
The consideration of a patient as a consumer under the Consumer Protection Act also provides a remedy for the patient to seek compensation against deficiency in services by the service provider. In the case of Indian Medical Association v. V.P. Shanta, the medical services were also included within the ambit of CPA, provided that the service is charged and not the free one. The patient files a misconduct complaint against the doctor in the respective state medical council, non-decision within 6 months of the complaint-filing leaves upon the patient to request the MCI for an order to state medical council to refer to the complaint or send it to the ethical committee of the MCI. Consumers also have a right to appeal within 60 days upon non-satisfaction with the state medical council’s decision
The introduction of telemedicine guidelines is a very positive step in the development of the medical sector for India. This has brought a very effective and helpful option for the people who don’t really require to visit a hospital or clinic for the consultation, especially during the covid-19 pandemic. The inclination towards telemedicine and teleconsultation is showing the inculcation of modern medicine in India. Steps like identification by the doctor before consultation, a requirement of care as in-person consultation, addressal of liability upon negligence are noteworthy considerations used by the government. This is even an economically efficient way for the doctors as well as patients. Telemedicine has the potential of flourishing in the future with developments in legislation and the security of the stakeholders. However, considering today’s status, it is difficult to comment upon the fate and future of this sector considering gaps in the legal framework and the risks of data protection and confidentiality involved in telemedicine services.