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Paper Details
Paper Code: AIJACLAV3RP132023
Category: Research Paper
Date of Submission for First Review: March 9, 2023
Date of Publication: December 29, 2023
Citation: Sankalp Mirani, “Telemedicine In India: A Critical Analysis on the Regulatory, Legal, & Ethical-Consideration of Telemedicine", 3, AIJACLA, 113, 113-119 (2023), <https://www.aequivic.in/post/telemedicine-in-india-a-critical-analysis-on-the-regulatory-legal-ethical-consideration-of-tel>
Author Details: Sankalp Mirani, BALLB (Hons.), Maharashtra National Law University, Mumbai
Abstract
The ethical and legal implications of telemedicine are subject to a lot of debate. The obligations and prospective obligations of medical practitioners, the need to protect patient privacy, and the secrecy of medical records are some of these, and the legal issues surrounding cross-border consultations. It also describes the refund of telemedicine expenses. Telemedicine enables the transmission of cross-border health information. Cross-border telemedicine services have been introduced, especially in specialized areas such as long-distance radiology, but the jurisdiction and registration issues have not yet been fully resolved. This can be true for many of the legal and ethical aspects of telemedicine in general, but it is also true for healthcare professionals who use telemedicine carefully to minimize the possibility of forensic complications. The practice of employing electronic signals and information transmission to deliver medical care over long distances is known as telemedicine. Intuition for many people who want medical care today looks up the internet. In a technical sense, anyone outside the company may access the database. Information is included so that can verify the protection and confidentiality of your personal data. It's very difficult. Ethical issues arise especially during the data protection phase. As a result, there are two sides to this equation: the intended use of technical methods, and the potential hazards. Morally, it is respected.
Keywords
Confidentiality; Ethical Consideration; Regulatory Consideration; Telemedicine
Introduction
Telemedicine can be described as “the use of technology (computers, video, phone, messaging) by a healthcare professional to provide diagnosis and treatment to patients in a remote location.”[1] However, due to the Covid 19 pandemic, which calls for the need of quarantine and social distancing, telemedicine had gained momentum in India, especially during the second wave. Even though Telemedicine has become a popular term even in urban areas, it was originally beginning 1999 in India, and the potential of telemedicine was recognized by the government in 2000. In 2001, the ISRO launched the country's first SATCOM-based telemedicine network.[2] It linked the Apollo Rural Hospital in the hamlet of Aragonda in the Chittoor district of Andhra Pradesh with the Apollo Hospital in Chennai.
Telemedicine services in the country are jointly overseen by the Department of Information Technology and the Ministry of Health and Family Welfare (abbreviated "MOHFW"). In order to implement a new initiative on e-health, the Telemedicine Division of the Ministry of Health and Family Welfare (MOHFW) of India has created a National Telemedicine Portal. This initiative includes the creation of a National Medical College Network (NMCN) for connecting medical schools nationwide with the goal of e-Education and a National Rural Telemedicine Network with the goal of e-Healthcare delivery[3].
Telemedicine is certainly a useful tool in a country like India with a population of 139 crores. It can provide those who live in rural areas with better healthcare. It is cost effective and saves the time of patients in addition to the doctors. It also helps the doctors widen their reach. With the increase in use of the tool, the medical professionals in addition to the patients need to know what laws and regulations telemedicine is subject to.
Legal Consideration of Telemedicine in India
Telemedicine is essentially a complex blend of medical practice and information technology which can also be defined as imparting medical consultation via technology. It has been very advantageous to patients in need of urgent access to doctors. Even though it is vital for the advancement of the health and medical arena, telemedicine is regulated in only a few nations throughout the world. Malaysia is among the few countries that has enacted the Telemedicine Act of 1997. The Telemedicine Development Act of 1996, enacted by the state of California, restricts face-to-face visits if the treatment may be offered via telemedicine.[4]
Until the COVID-19 epidemic which caused the government to release the rules to practise telemedicine, there was no specific or special legislation or regulatory guideline dealing with the practise of telemedicine in India.
Prior Legislative Framework
Since there was no special law, all existing legislation in India dealing with medicine and information technology would absolutely adhere to Telemedicine. A review of the Guidelines' many components also reveals that RMPs and Telemedicine must adhere to several laws that pertain to medical practitioners in India.[5]
In India, rules such as the 1940 Drugs and Cosmetics Act and the 1945 Drugs and Cosmetics Rules[6] are relevant to the medical industry. The Clinical Establishments (Registration and Regulation) Act, 2010[7] (also known as "the Clinical Establishments Act"), The Indian Medical Council Act, 1956[8], and The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002[9].
The laws that regulate information technology include: IT Act, 2000[10], IT (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011[11] and IT (Intermediaries Guidelines) Rules, 2011.[12]
All these laws collectively regulated the medical practice and the safeguarding of private information of the patients. To perform medicine in India, one must be a licenced medical professional and provide a valid prescription that complies with the Drugs and Cosmetics Rules, 1945.A handwritten prescription with the signature of a qualified medical practitioner is usually provided. A prescription is legal in telemedicine even if it is signed using digital signatures[13] and the electronic documents are permitted as evidence in a court according to the Evidence Act of 1872 because of the IT (Amendment) Act of 2008.[14]
Even though in 2003, The Recommended Guidelines and Standards for Telemedicine Practise in India were produced by the Department of Information Technology of the Ministry of Communications and Information Technology, but since these rules were non-binding, as the name implies and all these existing laws were neither comprehensive nor sufficient in addressing RMPs' and patients' concerns during telemedicine consultations, [15] there felt the need for proper legislation to regulate this advancing field.
The 2018 judgment of Bombay High Court in Deepa SanjeevPawaskar v. State of Maharashtra[16]supported this need for an adequate framework for the legality of telemedicine. In this case, husband and wife which were doctor by profession were held liable for criminal negligence since it was ordered that the patient be hospitalized without the presence of doctors, and drugs were given according to telephonic orders. Furthermore, there was no on-site medical practitioner. The patient eventually died as the staff formed a different strategy for a doctor due to which the practitioner was held liable as he took the risk of acting recklessly and without regard for the repercussions.[17]
Telemedicine Practice Guidelines
The MOHFW announced the Telemedicine Practice Guidelines[18] (“Guidelines”) on March 25, 2020, in a landmark step that would allow Registered Medical Practitioners (RMPs) to deliver treatment via telemedicine. These guidelines were inserted as Appendix 5 of the Ethics Regulations of 2002[19] issued by the Indian Medical Council (“The Ethics Regulations”).[20]
The fundamental ideas as well as a practical structure are included in these guidelines. While the fundamental tenets would apply to any future guidelines, the other focuses on the immediate necessity in the light of the COVID-19 pandemic. It was agreed to provide the “Telemedicine Practice Guidelines” a legal foundation. As a result, “The Ethics Regulations” of 2002, have been amended to incorporate Regulation 3.8 headed "Consultation by Telemedicine"[21] in the aforementioned Regulations.
The Medical Council under the aegis of India’s Board of Governors, with the prior approval of the Indian Union Government, also issued new regulations on May 12, 2020, named Indian Medical Council (Professional Conduct, Etiquette, and Ethics) (Amendment) Regulations, 2020[22] which included both the fundamental principles and the practical structure.[23]
The key features of these guidelines include that RMPs would be able to offer telemedicine to patients in any part of India while adhering to the same ethical and legal criteria as conventional in-person treatment.[24] The RMP and the patient should recognize one another's identities, and the telemedicine practice should not be confidential.[25] The principles of Medical Ethics, Data Privacy, and Confidentiality are also discussed in the guidelines, which must be followed throughout the procedure.[26]
However, there are certain legal issues that may emerge during the delivery of telemedicine consultations which are as follows:
Relationship between RMP and Patients
Patients place their faith in healthcare providers and rely on them when seeking care. The scope of the IT Act, 2000 is rather restricted in the context of the aforementioned telemedicine rules, and it doesn't deal specifically with how technology is used in the practise of medicine. However, the use of telemedicine may be subject to various provisions of the aforementioned Act. The IT Act has made electronic records and digital signatures legal.[27] The IT Act has given proper attention to the preservation of records, their ownership, recognition, delivery (time and location), and receipt, and thus its major objective is to offer legal legitimacy to contractual agreements through electronic transactions. A doctor-patient relationship will almost probably develop as a result of the aforementioned factors. Furthermore, the aforesaid electronic record might be utilized to show the relationship in a court.
Misconduct in the Digital Space
When a doctor–patient relationship has been created, it is the doctor's job to offer the level of care and medication that is expected from such a professional.
The RMP in charge will regard any violation of the Telemedicine Act as a misconduct matter. As a result, if the RMP's misbehaviour is proven, they may be punished, or their license may be revoked or cancelled.
Other liabilities under the law may also arise such as liability in civil negligence, liability in criminal negligence, misconduct under the Consumer Protection Act of 1986[28] and Vicarious liability.[29]
Regulatory Considerations in India
Registration
If a person is listed in the State Medical Registry or the Indian Registry of Medicine, they are considered Registered Medical Practitioners (RMPs), as defined by the Scientific Council Rule of 1956. The state medical boards need medical providers to register with them (SMCs). The Indian medical registration is updated with names. once the Medical Council of India (MCI) receives state medical documents and verifies them (if necessary). These health professionals are then permitted to practice in India. Nonetheless, several jurisdictions, through their state appropriate medical bodies, permit healthcare professionals to get a license to practice in their respective states. In terms of telemedicine, it's unclear if a medical professional licensed in one state can provide care somewhere else in the country without further authorization. Notwithstanding the premise that the MCI's Ethics Committee had concluded that a medical practitioner doesn't need to register with more than one SMC, no modification to the IMCA had been made to this effect.[30]
Several medical specialties, including radiology, dermatology, anatomy, ophthalmology, and others, are considered to be advanced in their use of ICT tools, while others are still in the initial phases. Guidelines support and promote cooperation among RMPs/specialists who utilize IT to treat, manage, and prevent illness. Tele-radiology is the capacity to transport radiographic images from one location to another. Tele-pathology employs technology to send image-rich pathology findings across remote places for treatment, teaching, and research. Tele-ophthalmology provides people in rural locations with availability of eye doctors, as well as monitoring, diagnosis, and surveillance of ocular conditions.
Phases in telemedicine
The aforementioned steps are followed for telecommunication –
Consultation for the first consult – The patient requests the online consultation, for example, by making a video or audio conversation with an RMP, or by sending a message or email with a medical issue. The RMP agrees to arrange the consultation. The preliminary appointment shows that the patient meets with the RMP for the first session; however, more than Six months have passed since the earlier consultation or the patient's earlier consultation with the RMP for a different health issue.
Identification and consultation of the patient - RMP must verify the patient's identification in order to access their material by requesting their names, birthdates, addresses, email addresses, and cellphone numbers. or any other suitable identification.[31]
Evaluation of the patient - The RMP must identify the patient's position quickly based on proper data, as well as if urgent attention is required. The RMP employs its medical skills to assess if urgent treatment is required. If the patient's condition necessitates prompt attention, first aid / immediate treatment advice is provided, as well as referral data if necessary.
Patient evaluation - I The RMP may ask the patient to provide pertinent information regarding complaints and, if applicable, information about any past treatments for the same problem. The patient is responsible for the truthfulness of the data he or she gives the RMP. If the RMP believes the data provided thus far is inadequate, he or she may request the patient for further information. This data can be sent instantly or afterwards by email/text, depending on the nature of that information. After the extra data has been collected, the consultation can be rescheduled (this may consist of lab radiological testing).
Supervision of the patient - If the ailment could be appropriately controlled by telemedicine, the RMP may use his or her skilled judgment to deliver health education as suitable in the case, guidance on particular medical symptoms, such as recommendation on fresh investigations to be performed prior to the next appointment, or particular medical care by prescribing medications as outlined in List O. Additional drugs (as listed in List A) may be administered if the teleconsultation is being conducted through video.[32]
Technique for Telecommunication
RMP could use any telemedicine platform suited for conducting virtual patient consultations, including mobile, videoconferencing, Internet, landline phones, messaging platforms including Facebook messenger, WhatsApp, etc., or mobile applications or web digital telemedicine portals, or Data transmitting systems like Skype, e-mail, etc. Telemedicine consultations can be provided using a variety of techniques. Audio, video and message are the three main mediums. All of those approaches have their own set of advantages and shortcomings, as well as situations wherein it may or may not be suitable to make a thorough diagnosis.[33]
Inside the inherent constraints of telemedicine, RMPs employing it must adhere to the identical ethical and professional rules and expectations that apply to conventional in-person treatment. A web - based program would be established and made accessible by the Governing board inside the MCI's supersession to allow all RMPs who choose to practice telemedicine to familiarize themselves with such rules along with the method and restrictions of telemedicine practice. Within 36 months of receiving notice, both licensed health professionals who intend to provide online consultations must finish an obligatory training course. During the interim period, the requirements indicated in such Guidelines should be followed. Then, before telemedicine may be performed, it will be necessary to complete and pass a prescribed curriculum.
Prescribed Norms of Telemedicine
Consultation - The RMP should make a decision whether or not to use text, video, or audio as a mode of interaction. The RMP should implement medical discretion when conducting telemedicine consultation and must advocate in-person consultation if it appears that it is required. In most cases, emergency treatment or assessment should be carried out in person, although the RMP could continue through telemedicine diagnostics if it is timely and required in its expert assessment. RMPs have the option to stop prescribing and revert to in-person consultations at any moment, and patients have the same option.
Prescription - The Central Govt may, periodically, provide alerts concerning medical items which may be prescribed by virtual consultation, as well as any limits that may be applicable, in the accompanying classifications: List O: teleconsultation-safe medical medicines, like those used for certain diseases (paracetamol, ORS) List A: Medications which may be provided after the initial video appointment and prescribed to re-fill in the event of a follow-up visit. List B: Drugs that can be recommended for the same health issue to a patient who has a next appointment, supplementary to those administered after the in-person appointment.
Confidentiality - Any data shared by the client is confidential, and the RMP is obligated to exercise reasonable care by using means to maintain the confidence of such knowledge. RMP is obliged to submit all details and keep a complete track of all documentation or materials utilized during the examination and treatment of the patient.
Cost - RMP could charge the appropriate fee, and online consultations will be conducted in the identical manner as traditional consultations. RMP shall provide an invoice for the amount paid against telemedicine consultation.[34]
Conclusion
Despite its lack of infrastructure facilities, India's quality hospitals employ cutting-edge medical equipment; more crucially, India has a world-class digital infrastructure that enables quick and cost-effective data exchange. As a result, the country is a fertile environment for tele-healthcare providers. Telemedicine is helping to close the healthcare gap in India. With a click of the device, the most respected, well-trained doctors can now treat patients in far-flung, faraway corners of the country. Patients who live far away can receive excellent medical treatment and care because of good digital infrastructure.
There is still a need for specific legislation governing telemedicine or virtual consultations. It is being governed by a combination of medical practice and information technology laws in addition to the practice guidelines issued in the year 2020.
India provides for regulatory considerations for telemedicine as well to ensure proper access which includes registration of medical practitioners and steps that need to be taken and tools for telecommunication. It also consists of the principles of telemedicine which are: the mode of consultation would be chosen by the RMP, maintenance of secrecy of the patient by the RMP and charging of appropriate consultation fee.
However, there are certain legal and ethical issues which creates a barrier in the advancement of telemedicine. The requirement of the moment is to meet standards, computer security, and privacy. Informed consent, the doctor–patient relationship, patient rights, misconduct, and confidentiality are all major medicolegal and ethical issues that must be addressed. The digital gap, or unequal access to technology based on numerous geographic and societal variables, is a key impediment to telemedicine development and it needs to be addressed.
Telemedicine's future has a lot of promise. Notwithstanding these obstacles, the expansion of telemedicine since the start of the current COVID-19 pandemic has been spectacular, and it is likely to continue to grow with greater Vigor in the future.
[1]Chiron, What is Telemedicine?, https://chironhealth.co m/telemedicine/what-is-telemedicine/. accessed 20 July 2023.
[2]Dr Sandeep Singh, Telemedicine in India, DocOnline,( Feb.18, 2020) https://www.doconline.com/for-busines s/bl og/telemedicine-india,
[3]Vinoth G. Chellaiyan, et al. Telemedicine in India: Where do we stand? 8, JFPMC, 1872–1876, (2019). https://www. ncbi.nlm.nih.gov/pmc/articles/PMC6618173/.
[4]KiritJavali, Season of Virtuals: Corona provides impetus to Telemedicine Guidelines in India – Legal challenges going forward, SCC Online (May 20, 2020), https://www. scconline.com/blog/post/2020/05/22/season-of-virtuals-corona-provides-impetus-to-telemedicine-guidelines-in-india-legal-challenges-going-forward/ .
[5]Aishani Singh, India: Telemedicine & Law – An Indian Perspective, mondaq (June. 02, 2020), https://www.mondaq.com/india/healthcare/944860/telemedicine-law-an-indian-perspective?login=true.
[6] The Drugs and Cosmetics Act, 1940.
[7]The Clinical Establishments (Registration and Regulation) Act, 2010.
[8] The Indian Medical Council Act,1956.
[9] Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.
[10]The Information Technology Act,2000.
[11]Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011.
[12]The Information Technology (Intermediaries guidelines) Rules, 2011.
[13]The Information Technology Act, 2000 § 5.
[14]Kirit, supra note 4.
[15]SeemaJhingan, India: Legal And Regulatory Framework For Digital Health – Telemedicine Practice Guidelines, mondaq( Apr. 08, 2020), https://www.mondaq.com/india/ healthcare/915292/legal-and-regulatory-framework-for-digital-health-telemedicine-practice-guidelines
[16]DeepaSanjeevPawaskar v. State of Maharashtra, (2018) .SCC OnLine Bom 1841.
[17]A critical analysis of the guidelines and legalities of telemedicine, Indian Review of Advanced Legal Research (Aug. 22, 2021), https://www.iralr.in/post/a-critical-analysis-of-the-guidelines-and-legalities-of-telemedicine
[18]The Medical Council of India, Telemedicine Practice Guidelines, (Issued on March 25, 2020).
[19]Supra note 8.
[20]Seema, supra note 15.
[21]Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Reg. 3.8.
[22]Indian Medical Council (Professional Conduct, Etiquette, and Ethics) (Amendment) Regulations, 2020.
[23]Kirit, supra note 4.
[24]Supra note 18.
[25]Ibid.
[26]A critical study of the legal framework of telemedicine practice in India, TECH & IP LAW POLICY REVIEW ( Sep. 14, 2020), https://www.tiplpr.com/post/a-critical-stud y-of-the-legal-framework-of-telemedicine-practice-in-india.
[27]The Information Technology Act, 2000 § 4 & 5.
[28]The Consumer Protection Act, 1986.
[29]Aishani, supra note 5.
[30]Sunil Nandraj, et al, Regulation Of Health Care Delivery In India A Landscape Study, Health Systems Transformation Platform, https://www.hstp.org.in/wp-content/uploads/2021/08/Regulation-of-Health-Care-Delivery-in-India_-A-Landscape-Study_HSTP-2021.pdf.
[31]Nishith Desai Associates Telemedicine in India The Future of Medical Practice?, (Oct. 2020)https://www.nish ithdesai.com/fileadmin/user_upload/pdfs/Research_Papers/Telemedicine-in-India.pdf.
[32]Nathaniel M. Lacktman, Understanding Telehealth https://accessmedicine.mhmedical.com/content.asp x?b ookid=2217§ionid=187795865.
[33]SakshiShairwal, Regulations around telemedicine in India, Lexology, (Dec 6. 2021) https://www.lexology.com/library/detail.aspx?g=8f247a2f-04e1-4c48-b5 cc-5b629350b652.
[34]Khyati Basant, Regulation of telemedicine in India, iPleaders, (Nov. 6, 2020) https://blog.ipleaders.in/regulation-telemedicine-india/#:~:text=Consultation%2D% 20The%20RMP%20must%20decide,if%20the %20same%20seems%20necessary.