Navigating the Role of Regulations in Telemedicine: Bridging the Gap between Innovation, Quality of Care and Patient Protection

 INTRODUCTION

Telemedicine is defined 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] It has been shown that telemedicine is quite useful, specifically in underserved populations, where there is a lack or insufficiency of clinical treatment in, for example, remote locations. Indeed, telemedicine and telehealth services, tried and tested to be reliable and cost-effective, are today very widely available in both the developed and developing world.[2] Although the term "telemedicine" was self-promotional, it came into being in India in the year 1999, and the country's government started realizing its potential in 2000. In the year 2001, ISRO introduced the country's first SATCOM-based telemedicine network.[3] It connected Apollo Hospital in Chennai to Apollo Rural Hospital in the hamlet of Aragonda in Andhra Pradesh.

The Department of Information Technology jointly co-supervises telemedicine services in the country with the Ministry of Health and Family Welfare, abbreviated as "MOHFW." A National Telemedicine Portal was developed by the Indian Ministry of Health and Family Welfare's Telemedicine Division to support the implementation of a new e-health project. This plan suggests the establishment of a National Medical College Network, interlinking all the medical schools in the country for its e-Education purpose, with a main National Rural Telemedicine Network focusing on e-Healthcare delivery.[4]

In a nation like India, which has 139 crore people, telemedicine is unquestionably a beneficial tool. Better healthcare may be available to individuals who reside in rural locations. In addition to saving time for physicians and patients, it is also cost-effective. The physicians' reach is also expanded as a result. As the instrument is used more often, patients and medical professionals alike must be aware of the rules and regulations that apply to telemedicine.

CRITICAL ANALYSIS

Telemedicine may also be described as the delivery of medical advice via technology. It is basically a complicated fusion of medical practice and information technology. Patients who need immediate access to physicians have benefited greatly from it. Telemedicine is regulated in just a small number of countries worldwide, while being essential for the development of the health and medical fields. The Telemedicine Act of 1997 was only passed by a select few nations, including Malaysia. Face-to-face visits are limited if the therapy may be provided through telemedicine, according to the Telemedicine Development Act of 1996, which was passed by the state of California. Until the COVID-19 epidemic caused the government to release the rules to practice telemedicine, there was no specific or special legislation or regulatory guideline dealing with the practice of telemedicine in India.[5]

In 2018, the Bombay High Court ruled in Deepa Sanjeev Pawaskar v. State of Maharashtra, which affirmed the need of a suitable legal framework for telemedicine. [6]Since the patient was hospitalized without the presence of physicians and medications were administered per telephone instructions, a medical pair was found guilty of criminal negligence in this instance. Additionally, there was not a doctor present. The patient finally passed away as a result of the staff developing a new plan for a doctor, and the practitioner was held accountable for taking the chance of behaving recklessly and without thought to the consequences.[7]

India presently has no laws that expressly address telemedicine. Despite dealing with information technology, the Information Technology Act of 2000 did not address any problems pertaining to healthcare. This has caused many individuals to doubt if telemedicine is acceptable in India for decades. The lack of a telemedicine-specific regulation, however, should not be taken to imply that the practice of telemedicine is forbidden in India. The "Telemedicine Practice Guidelines" were published by the Indian government in March 2020 and are now part of Appendix 5 of the 2002 Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulation. This offers a framework for telemedicine practice.[8]

[Image Sources: Shutterstock]

A framework for telemedicine-based healthcare service delivery is provided by the Telemedicine Practice Guidelines. The topics they address include things like patient safety, informed consent, privacy and security, clinical standards, and technological needs. These recommendations place a strong focus on the necessity for healthcare professionals to make sure that telemedicine services are given safely, effectively, and to the same levels of quality as in-person treatment. The recommendations also stress the significance of patient autonomy and confidentiality, as well as the need for suitable training and oversight of medical professionals who provide telemedicine services. In addition, they provide advice on the legal and regulatory requirements for telemedicine practice as well as the choice of technological platforms.[9]

The 'Telemedicine Practice recommendations' are not unenforceable simply because they are recommendations rather than legislation. Since the legal concerns relating to telemedicine are still in their infancy, the court and legislature have established a framework in the form of "guidelines" that must be observed until new legislation and laws are created and approved. There are currently very few case judgments in Indian Courts that deal with telemedicine.

In the recent high-profile case against the death of deceased actor Sushanth Singh Rajput, a doctor's prescription of clonazepam to him was contested in court based on the claim that the medication was procured through a teleconsultation. However, since clonazepam is on the forbidden list, the purported acquisition of the substance was declared unlawful, according to the Telemedicine Practice Guidelines.[10]

COMPARATIVE ANALYSIS  

Ø  Indian Telemedicine Laws

The National Institution for Transforming India (NITI Aayog), India's top planning organization, and the Board of Governors of the Medical Council of India (MCI), the country's former medical education regulator, prepared the guidelines to close a significant legal and regulatory gap in telemedicine. The suggestions include texting, audio, and video as three different ways to communicate and outline the requirements for practitioners to use each, along with any restrictions.

According to the background information for the guidelines, the goal of these recommendations is to give doctors useful advice so they can start incorporating telemedicine into their routine practice. They also give them a sensible course of action for providing efficient and secure medical care based on the most recent knowledge, resources available, and patient needs to ensure patient and provider safety, to be used in conjunction with national clinical standards.[11]

The guidelines fully outline the standards, norms, and practices that any Registered Medical Practitioner (RMP) who has registered with the State Medical Register or the Indian Medical Register in accordance with the Indian Medical Council Act must adhere to while engaging in telemedicine in India. These communications can be video, audio, or text-based and can be used for information exchange in real time or in synchronous modes for first consults or for follow-up appointments. Within three years of the guidelines' publication, RMPs must complete an online training course provided by BoG.[12]

Ø  Australian Telemedicine Laws

There are currently no laws or norms governing telemedicine in Australia. Telemedicine is subject to the same laws and norms that already apply to the delivery of healthcare. However, several regulatory and business bodies in the medical field have published guideline documents on the provision of services via telemedicine. For instance, the Australian Health Practitioner Regulation Agency (AHPRA), a government institution responsible for overseeing the country's medical professionals, has published telemedicine instructions for practitioners on its website. All qualified health professionals may use telemedicine, per AHPRA advice, provided it is secure, clinically appropriate for the healthcare being provided, and suitable for the patient. [13]

The AHPRA advice further emphasizes that telemedicine services may be provided over the phone and using publically available video conferencing software and applications without the need for specialized equipment. Free versions of applications (i.e., non-commercial versions), according to the AHPRA guidance, may not adhere to applicable security and privacy laws, and practitioners must make sure that the telecommunications solution they select satisfies their clinical needs, the needs of their patients or clients, and privacy laws. The Medical Board of Australia has published online "guidelines for technology-based patient consultations" in addition to the present "Good Medical Practice: A Code of Conduct for Doctors in Australia." Another publication from the Royal Australian College of General Practitioners (RACGP) is a "guide to conducting telephone and video consultations in general practice."[14]

 

 

CONCLUSION AND SUGGESTION  

The effective adoption and regulation of telemedicine services depend on legal and ethical telemedicine issues. To assure the provision of safe, effective, and high-quality healthcare services, the developing area of telemedicine necessitates the construction of solid legal and ethical frameworks. The incorporation of telemedicine services has the potential to significantly increase patient access to healthcare in underserved or distant locations and to lower healthcare expenditures. In many nations, including India, concerns relating to patient privacy, informed consent, liability, and licensing remain unsolved.

Although India has made tremendous progress in increasing access to healthcare via telemedicine, more uniform and stronger legal and ethical frameworks are still required to guarantee patient safety and privacy. In order to provide legal foundations for telemedicine, the Indian government has taken several actions, such as creating regulations for the practice of telemedicine. On matters like patient consent, data privacy and security, licensing and liability, and the protection of vulnerable groups, more work must be done.[15]

Policymakers must give top priority to the creation of thorough legal and ethical frameworks that meet the difficulties of telemedicine in order to assure the responsible and ethical application of the technology. All parties involved in the development of these frameworks, such as patients, healthcare workers, and legal professionals, should work together. Additionally, healthcare professionals must make sure that all telemedicine services are provided in accordance with accepted ethical norms and uphold the highest levels of care.

To ensure that their services are current and compliant with the changing legal and ethical landscape, healthcare providers who offer telemedicine services should all undergo ongoing training and ethical review. Additionally, training programs on these topics should be incorporated into medical education.[16]

Finally, even though telemedicine has advanced significantly in countries like India and others, more study is still required to fully comprehend the moral and legal implications of telemedicine. The efficiency of current legal and ethical frameworks and any holes that need filling should be the main topics of this study. To ensure that all facets of telemedicine are addressed and that their concerns and views are properly heard, the study must also be conducted in partnership with stakeholders from other industries.

In conclusion, telemedicine has the power to drastically alter the way healthcare is delivered and raise millions of people's standards of living. Its effective implementation relies on the creation of moral and legal frameworks that protect patient confidentiality, safety, and quality of treatment. The creation of such frameworks must be given top priority by legislators, and healthcare professionals must make every effort to uphold accepted ethical standards. The promise of telemedicine may be realized in a way that benefits all of us by working together.[17]

Author: Apurva Ranjan, in case of any queries please contact/write back to us at support@ipandlegalfilings.com or   IP & Legal Filing.”

REFERENCES

1.      What is Telemedicine? Chiron, https://chironhealth.com/telemedicine/what-is-telemedicine/

2.      Fong B, Fong ACM, Li CK. Telemedicine technologies: information technologies in medicine and telehealth, 2010.

3.      Dr Sandeep Singh, Telemedicine in India, DocOnline, https://www.doconline.com/forbusiness/blog/telemedicine-india

4.      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/.

5.      Kirit Javali, 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-virtualscorona-provides-impetus-to-telemedicine-guidelines-in-india-legal-challenges-going-forward/

 

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[1] What is Telemedicine? Chiron, https://chironhealth.com/telemedicine/what-is-telemedicine/

[2] Fong B, Fong ACM, Li CK. Telemedicine technologies: information technologies in medicine and telehealth, 2010.

[3] Dr Sandeep Singh, Telemedicine in India, DocOnline, https://www.doconline.com/forbusiness/blog/telemedicine-india

[4] 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/.

[5] Kirit Javali, 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-virtualscorona-provides-impetus-to-telemedicine-guidelines-in-india-legal-challenges-going-forward/

[6] Deepa Sanjeev Pawaskar v. State of Maharashtra, (2018) SCC OnLine Bom 1841

[7] A Critical Analysis of The Guidelines and Legalities of Telemedicine, Indian Review of Advanced Legal Research, https://www.iralr.in/post/a-critical-analysis-of-the-guidelines-andlegalities-of-telemedicine

[8] Board of Governors in Supersession of the Medical Council of India. Telemedicine practice guidelines. (2023), https://www.mohfw.gov.in/pdf/Telemedicine.pdf.

[9] Board of Governors in Supersession of the Medical Council of India. Telemedicine practice guidelines. (2023), https://www.mohfw.gov.in/pdf/Telemedicine.pdf.

[10] Priyanka Singh and Anr vs the State of Maharashtra and Ors, Bombay High Court on 15 February, 2021, https://indiankanoon.org/doc/159693158/.

[11] Nishith Desai, Telemedicine in India the Future of Medical Practice, https://www.nishithdesai.com/Content/document/pdf/ResearchPapers/Telemedicine-in-India.pdf

[12] Aishani Singh, India: Telemedicine & Law – An Indian Perspective https://www.mondaq.com/india/healthcare/944860/telemedicine--law--an-indian-perspective

[13] Shantanu Mukherjee† and Vatsala Sood, The Regulation of Telemedicine: A Global Comparative Analysis, https://www.scconline.com/blog/post/2021/12/24/the-regulation-of-telemedicine-a-global-comparative-analysis/

[14] Elizabeth J Halcomb, Telehealth use in Australian primary healthcare during COVID-19: a cross-sectional descriptive survey, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9826926/

[15] Giulio Nittari, Telemedicine Practice: Review of the Current Ethical and Legal Challenges, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757597/

 

[16] Satvik N. Pai, Understanding the Medico-Legal Aspects of Telemedicine in India, https://www.cureus.com/articles/173699-understanding-the-medico-legal-aspects-of-telemedicine-in-india#

[17] Sharma, Luv K.; Rajput, Meena, Telemedicine: Socio-Ethical Considerations in the Indian Milieu, https://heinonline.org/HOL/Page?handle=hein.journals/medlgjr77&id=62&collection=journals&index=