REGULATION OF TELEMEDICINE AND ONLINE HEALTHCARE SERVICES

This article is written by Sejal Ben Patel of 2^nd Semester of University Law College, Utkal University, Bhubaneswar, an intern under Legal Vidhiya

Abstract

Online healthcare services including telemedicine consultation have become much frequent nowadays in this digital era. Online healthcare services have various utilities with a lot of benefits but along with all its benefits, it also has some challenges that need to be addressed. As everything has its own pros and cons, online healthcare services do have its pros and cons. Due to its frequent use, its challenges it needs some regulations to monitor safe use of this services. This article provides a comprehensive view of online healthcare services and telemedicine, its pros and cons, and various regulations.

Keywords

Online Healthcare Services, Telemedicine, Laws  

Introduction

In recent years, the healthcare industry has undergone a profound transformation with the advent of online healthcare services. The rise of online healthcare services can be attributed to advancements in technology, the increasing prevalence of digital connectivity and the growing demand for convenient and accessible healthcare solutions. From virtual doctor consultation to remote monitoring and telemedicine, these services leverage digital platforms to deliver healthcare remotely, transcending geographical barriers and traditional healthcare services. Online healthcare services enhance convenience for everyone be it patient and healthcare providers.

Telemedicine refer to the remote diagnosis and treatment of patients using telecommunication technology, such as video conferencing, phone calls, messaging, etc. It allows patients to consult from a distance with the healthcare providers. It enhances the efficiency of healthcare delivery. Telemedicine represents a transformative paradigm shift in healthcare delivery offering accessibility, efficiency and patient engagement. Telemedicine plays a crucial role in shaping future of medicine enabling healthcare providers to deliver high quality care to patients.   

Online Healthcare Services and Telemedicine

An online healthcare system refers to the use of digital technology to provide healthcare services remotely. It includes virtual doctor consultations, telemedicine appointments, and online prescription services, remote monitoring of patients and digital health records management.

Telemedicine is the use of technologies like information and communication in the field of heath care. It is remote diagnosis of patients by use of such technology.

Telemedicine has been defined by World Health Organization (WHO) as “the delivery of health care services by all health care professionals using information and communication technologies at a distance for the exchange of valid information for diagnosis, treatment, and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, where distance is a crucial factor.”[1]

Such services facilitate the access of health services to the population with limited supply and access to health services in their geographical area. Such services using technology has brought a new scope in the field of health care services.

Pros and Cons of Online Healthcare Services and Telemedicine

The healthcare industry has undergone a profound transformation with the advent of online health care services. Despite various benefits of online health care services it faces several challenges that need to be addressed.

Online health care services represent a transformative force in modern healthcare delivery, offering improved accessibility, convenience, etc. While challenges exist in the ongoing evolution in this field of online health care services.

Following are some of the benefits and challenges faced in online health care services:-

Benefits of Online Health Care Services

The advent of technology has revolutionized the healthcare industry, offering the convenience of accessing medical advice and treatment through online platforms. Online health care services offer numerous benefits; following are some of those benefits –

• Accessibility

They provide access to medical professionals and resources from anywhere with an internet connection, eliminating geographical barriers.

• Convenience

Patients can schedule appointments, consult doctors from the comfort of their homes, saving time and effort.

• Cost-effectiveness

Online consultations often have lower fees compared to in person visits, reducing health care expenses for patients.

• Timely care

Patients can receive medical advice and treatment promptly, without waiting for appointments or traveling to a clinic.

• Continuity of care

Online platforms facilitate ongoing communication between patients and healthcare providers, ensuring consistent monitoring and follow-up care.

• Expanded access to specialists

Online healthcare platforms connect patients with specialists who may not be available locally, widening the range of available expertise.

• Reduces exposure to infections

By avoiding crowded waiting rooms and minimizing in-person contact helps decrease the risk of exposure to contagious illness.

Challenges of Online Health Care Services and Telemedicine

While online healthcare services and telemedicine have brought numerous benefits, they also come with their own set of challenges that needs careful consideration. Following are some of the challenges of online healthcare services and telemedicine –

• Misdiagnosis or inadequate treatment

Without the physical examination and in-person interaction between healthcare professionals and patients, accurately diagnosing medical condition becomes challenging.

Like symptoms may be misinterpreted, crucial aspect in a patient’s medical history may be missed, leading to incorrect diagnosis and ineffective treatment plans. This can have serious consequences on patient’s health outcomes and safety.

• Data privacy and security

Concerns regarding data privacy and security pose significant challenge for online healthcare services. With the transfer of sensitive medical information over digital platforms, there is an increased risk of data breaches, unauthorized access, and potential misuse of patient data. Maintaining confidentiality and safeguarding patient privacy becomes a complex challenge in the online healthcare landscape, raising ethical and legal concerns about the protection of personal health information.

• Limited scope

Another significant challenge is limited scope for hands-on medical procedures and interventions. While online healthcare services and telemedicine consultations can facilitate remote diagnosis and treatment for certain conditions, they cannot fully replace the need for physical examinations, diagnostic tests, and medical procedures that require direct patient contact. This limitation restricts the range of healthcare services that can be effectively delivered online, particularly for complex medical conditions and emergencies.

• Digital divide

Digital divide refers to disparities in access to technology and internet connectivity. Not all patients have access to the necessary devices or reliable internet connections required for online healthcare services or telemedicine consultations. This digital divide disproportionately affects marginalized communities, including rural populations, low-income individuals, and older adults, limiting their ability to benefit from online healthcare services and exacerbating existing healthcare disparities.

• Technical glitches

Technical glitches are another significant challenge in these online healthcare services. The technical glitches or connectivity issues disrupt the flow of care and compromise the quality of communication between patients and healthcare providers. Technical issues such as audio or video lag, glitches, or poor image quality can disrupt the flow of communication and compromise the patient-provider relationship.

• Regulatory challenges

Online healthcare services and telemedicine consultations may face regulatory and licensure challenges across different jurisdictions. Healthcare providers offering telemedicine services may need to navigate complex legal frameworks and licensing requirements, particularly when providing care to patients located in other states or countries. Regulatory inconsistencies and bureaucratic barriers can hinder the seamless delivery of telemedicine services and limit its scalability.

While online healthcare services and telemedicine offers numerous benefits in terms of accessibility, convenience, and efficiency, it also presents several significant challenges that must be addressed. These include limitations in physical examination, disparities in access to technology, privacy and security concerns, technical barriers, and regulatory hurdles. Overcoming these obstacles will require collaboration between healthcare providers, policymakers, technology developers, and other stakeholders to ensure that such healthcare services realizes its full potential as a valuable tool in modern healthcare delivery.

Regulations of Online Healthcare Services and Telemedicine

Healthcare services in India have been significantly influenced by advancement in technology. Online healthcare services and telemedicine has emerged in the Indian healthcare reducing geographical barriers and expanding access to medical services. The rapid evolution of online healthcare services has necessitated regulatory frameworks to ensure patient safety, data privacy, and ethical practice. The regulations have undergone various significant evolutions driven by advancements in technology, changing healthcare needs and the imperative to adapt the changing scenario.

Telemedicine practice guideline[2]

The telemedicine practice guideline, 2020 was issued on 25^th March, 2020 by ministry of health and family welfare and the government of India, which was prepared in partnership with NITI Aayog.

These guidelines enable the Registered Medical Practitioners (RMP) to provide healthcare using telemedicine. A Registered Medical Practitioner (RMP) is a person who is enrolled in the state medical register or the Indian medical resister under the Indian Medical Council Act, 1956. These guidelines are made to serve as an aid and tool to enable RMPs to effectively leverage telemedicine to enhance healthcare services.

These guidelines give practical advice to doctors and encourage all health workers to use telemedicine as a part of normal practice.

These telemedicine guidelines help to realize the full potential of these advancements in technology for healthcare delivery.

Telemedicine guideline requires consideration of some elements before telemedicine consultation-

i) Telemedicine should be appropriate and sufficient as per context

ii) Identification of Registered Medical Practitioner (RMP) and patient is required.

iii) IT provides for the mode of telemedicine consultation. Primarily there are 3 modes: – Video, Audio and Text.

iv) The guideline provides that patient consent is mandatory for any telemedicine consultation. It can be implicit or explicit.  

v) It provides for exchange of information for patient evaluation. RMPs must gather sufficient medical information about the patient’s condition.

vi) It provides for patient evaluation with two types of consultation, first consult and follow-up consult.

vii) It provides for patient management that includes health education, counseling and medication.   

This guideline provides norms and protocols relating to physician-patient relationship; issues of liability and negligence, evaluation, management and treatment, informed consent, continuity of care, referrals for emergency services, medical records, privacy and security of the patient records and exchange of information, prescribing, and reimbursement, health education and counseling.

The Telemedicine guidelines should be used with the other coexisting national clinical standards, protocols, policies and procedures.

The Indian Medical Council Act, 1956[3]

The IMC Act of 1956 governs the conduct and misconduct of RMPs.

The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 governs various issues relating to patient doctor confidentiality, collection of personal data from patient, issue of consent. 

Drugs and Cosmetic Act, 1940, and Drugs and Cosmetic Rules, 1945[4]

This act regulates the permissible and prohibited drugs which can be prescribed in telemedicine consultation. It regulates the manufacture, sale, import, and distribution of drugs in India. Drug and Cosmetic Act requires all the drugs to be sold under license with some exception falling under schedule K of the Drugs and Cosmetic Rules.

The Information and Technology Act, 2000 and The Information Technology Rules, 2011[5]

Online healthcare services and telemedicine consultation involves a constant exchange of information between the patient and health professionals. The patient’s personal information such as medical history, mental condition, etc. is considered to be Sensitive Personal Data or Information (SPD). When a body corporate collects, stores, transfers, process any such information then it requires activating certain rules under Data Protection Rules.

The Data Protection Rules stipulate that the data should be collected and processed on the basis of and in accordance with the consent of the information provider. The Data Protection Rules requires the body corporate to have adequate security measures to ensure the safety of stored data.

National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023[6]

The regulation is made to regulate the professional conduct of Registered Medical Practitioner (RMPs). The regulation regulates various aspects such as professional conduct of RMPS towards each other, patients, duty toward general public, healthcare professionals. It provides guidelines for medication via telemedicine consultation, as per the regulation the RMPs are free to prescribe drugs for all condition with exception to the drugs mentioned under schedule X of the Drugs and Cosmetic Rules, 1945 such as anti-cancer drugs, morphine, codeine, and all other drugs that can cause addiction.

The regulation made it necessary for the doctors to create an electronic prescription for telemedicine consultations. The regulation states that telemedicine advice carries the same professional accountability as in person consultation.

Case Laws

Deepa Sanjeev Pawaskar & Anr. Vs The State of Maharashtra[7]

The above case involves the use of telecommunication as a medium of consultation. The Bombay High Court, a single judge bench comprising of Sadhana S. Jadhav., refused to grant anticipatory bail to doctor involved in the treatment of a patient who ultimately died and his husband field criminal complaints against doctor accusing of criminal negligence. Cesarean was conducted and the patient was discharged and then again admitted within 24 hours and a telephonic prescription of medicine was given without the presence of doctor. The doctor was not present at the time of discharge after the delivery of a child and had prepared the discharge papers of the deceased in advance, also on the readmission the doctor was not present, still directed the nurse to admit the deceased by giving prescription without diagnosis.

Priyanka Singh & Anr. Vs The State of Maharashtra & Ors[8]

In the case involving the death of late actor Sushant Singh Rajput, the prescription of clonazepam to him by a doctor came under contention in court after it was claimed that the drug was prescribed through teleconsultation.

Conclusion

Online healthcare services have a significant importance in today’s digital era with its various benefits and challenges evolving with an implication for patient, healthcare provider and society as a whole. Regulatory frameworks play a crucial role in addressing the challenges faced in online healthcare services. Online healthcare services and telemedicine in India offer promising solutions to bridge the gap between healthcare accessibility and the growing needs of the population. It has shown significant potential in enhancing access to quality healthcare, especially in remote areas improving convenience for patients and reducing cost. However to realize their full potential there is a need for continued regulation and digital literacy to ensure equitable access and care for all across the country. The emergence of online healthcare services and telemedicine in India represents a transformative shift in the healthcare landscape, offering convenience, accessibility, affordability to millions of individuals. By leveraging technology to connect patients with healthcare professionals remotely, this technology has the potential to revolutionize the delivery of healthcare. The success hinges on addressing regulatory challenges, ensuring data privacy and security and promoting digital literacy.

References

• Telemedicine & Law – An Indian Perspective| IIPRD https://www.iiprd.cpm/telemedicine-law-an-indian-perspective/#_ftn5
• Telemedicine Practice Guidelines, pdf https://www.mohfw.gov.in/pdf/Telemedicine.pdf
• The IMC Act, 1956 and The IMC Regulation, 2002
• Drugs and Cosmetic Act, 1940 and Drugs and Cosmetic Rules, 1945
• The IT Act, 2000 and The IT Rules, 2011
• National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 https://www.nmc.org.in/rules-regulations/national-medical-commission-registered -medical-practitioner-professional-conduct-regulations-2023-reg/
• Deepa Sanjeev Pawaskar and Another vs State of Maharashtra, Bombay High Court on 25^th July, 2018. https://indiankanoon.org/doc/160266477/
• Priyanka Singh And Anr vs The State Of Maharashtra And Ors https://indiankanoon.org/doc/159693158

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[1] Telemedicine & Law – An Indian Perspective| IIPRD https://www.iiprd.cpm/telemedicine-law-an-indian-perspective/#_ftn5 , last visited 24 April, 20204

[2] Telemedicine Practice Guidelines, pdf https://www.mohfw.gov.in/pdf/Telemedicine.pdf , last visited 24 April, 2024

[3] The IMC Act, 1956 and The IMC Regulation, 2002, last visited 24 April, 2024

[4] Drugs and Cosmetic Act, 1940 and Drugs and Cosmetic Rules, 1945, last visited 24 April,2024

[5] The IT Act, 2000 and The IT Rules, 2011

[6] National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 https://www.nmc.org.in/rules-regulations/national-medical-commission-registered-medical-practitioner-professional-conduct-regulations-2023-reg/  last visited 24 April 2024

[7] Deepa Sanjeev Pawaskar and Another vs State of Maharashtra, Bombay High Court on 25^th July, 2018. https://indiankanoon.org/doc/160266477/, last visited on 24 April 2024.

[8] Priyanka Singh And Anr vs The State Of Maharashtra And Ors https://indiankanoon.org/doc/159693158, last visited 24 April 2024

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