Telemedicine Practice Guidelines and Telepsychiatry Operational Guidelines, India—A Commentary

Abstract

Recent advancements in technology, access to smartphone, and gains achieved in increased internet speed and data transfer have expanded the scope of health care service delivery through the digital platforms. In India, telemedicine services remain poorly adopted and integrated due to various barriers. The important reasons are lack of legal and administrative clarity in using technology for service delivery and inertia from health service providers to adopt newer developments. However, during coronavirus disease (COVID-19) pandemic, these equations are changing. The Telemedicine practice guidelines released in March, 2020, and Telepsychiatry operational guidelines released in May, 2020, appear to remove these barriers and promote equitable access to health care. In this article, the authors discuss the scope of these guidelines.

Telemedicine encompasses the delivery of health care services using information and communication technologies.¹ This involves collecting information from the person, making a diagnosis, and managing the illness in virtual mode.² Mental health service delivery in India is hampered primarily by inadequate human resources and inequitable distribution of available resources. As capacity building is time-consuming, telepsychiatry could be used to address the poor accessibility issue efficiently.³ The call to utilize technology so as to increase the reach of medical services has been there since a long time; however, many barriers prevented its uptake—some of these barriers were skepticism from clinicians, inadequate data on cost-effectiveness, and administrative and legal concerns.^{3, 4} Recently, the Medical Council of India released the Telemedicine practice guidelines.¹ The Indian Psychiatric Society (IPS) and Telemedicine Society of India (TSI) in collaboration with the National Institute of Mental Health and Neurosciences (NIMHANS) released Telepsychiatry operational guidelines in May 2020.⁵ These recent guidelines help to remove the administrative and legal concerns present in practicing telemedicine. Also, available data suggests telepsychiatry is more economical than the existing standard in-person clinical care,⁶ and it is acceptable and feasible.⁷

In this context, the telemedicine initiative from the government is much appreciated by all the stakeholders. During the lockdown phase of the pandemic, most services deemed to be nonessential were closed and it was a huge challenge even to get access to routine health care services. The timely release of the guidelines helped to dispel the administrative and legal concerns among clinicians, and they have been able to embrace telemedicine like never before. Recent reports show that telepsychiatric services are gaining popularity and getting implemented in many countries.^{8, 9} National Mental Health Survey of India (NMHS 2016) reported a huge treatment gap ranging from 75% to 93%.¹⁰ Mental Healthcare Act (MHCA 2017) mandated the government to ensure every citizen has access to the mental health services. In India, with the public expenditure on health only around 1% of the gross domestic product (GDP), telemedicine could be a potential option to implement provisions of the MHCA.^{11, 12} In this overview, the authors, discuss the scope of the Telemedicine practice guidelines, March 2020 and Telepsychiatry operational guidelines, May 2020.

Telemedicine Practice Guidelines

Board of Governors in supersession of the Medical Council of India released the Telemedicine practice guidelines for registered medical practitioners (RMPs) on March 25, 2020.¹ The guidelines enable the RMPs to deliver health care using technology. The purpose of the guidelines is to offer clear, practical advice to the RMPs about using technological advancements in medical practice. The guideline is an important first step in organizing the telehealth services across the nation. Scope, definitions, norms, protocols, and framework to implement telemedicine services are outlined in this guide. The roles and responsibilities of patients, RMPs, health workers, and telehealth platforms while administering telemedicine services are clearly delineated.

The guidelines enable RMPs to utilize audio, video, text, apps, email, social media, fax, or any other available communication platform to interact with other RMPS, health workers, patients, and their caregivers. This reduces the ambiguity and entitles RMPs to explore the innovative digital options to reach the stakeholders. For service users, telemedicine provides better access to care, minimize travel-related expenditure, and safety from contagious diseases. The guidelines allow both initial and follow up consultations through telemedicine services. Both synchronous and asynchronous communication modes could be utilized to deliver service. The guidelines describe the strengths and limitations of different modes of communication. The professional discretion of judgment to use the available means rests with the RMP. Additionally, practitioners are instructed not to compromise on the quality of care. RMPs are expected to uphold similar ethical norms and professional standards as applicable to the routine in-person clinical care.

RMPs are mandated to verify and confirm the identity and age of the patient before proceeding with the teleconsultation. Types of consent and means of availing the consent for online consultation are described. First and follow-up consultations are categorized clearly. Guidelines for consultation between two RMPs, between RMP and health workers, and between RMP and caregiver are provided. Drugs are categorized into different lists (List O, A, B, and prohibited) for a specific type of consultation. Steps to handle emergencies in teleconsultations are specified. RMPs are directed to mandatorily refer the patient for immediate in-person consultations if clinical emergency is identified. There is a separate section providing guidelines/directions for the software aggregators and telehealth platforms. The guidelines exclude the provisions for remotely assisted surgeries, research, and education of health care workers. Also, the guideline does not provide for the consultation outside the jurisdiction of India through telemedicine. A standard format for issuing a prescription is provided.

This guideline reduces ambiguity in health care delivery but has certain important limitations. When a grievance arises out of an inter-state telemedicine consultation, the legal jurisdiction of the trial is unclear. For example, RMP registered with a particular state medical council could treat patients across all the states in the country. When grievances arise out of such consultations, the patient/caregiver might face hardships in approaching the legal system since the jurisdiction is not clarified. Provision and management of health care is specific to each state, and the local regulations might hinder the effective translation of telemedicine guidelines services. The poor network connectivity in many regions of the country might restrict effective communication. Video-based consultation is stipulated essential to prescribe certain listed drugs, and this may not be feasible at all times. For example, benzodiazepines are frequently used class of drugs for various indications in psychiatry.¹³ This guideline restricts prescribing benzodiazepines further, which may be a cause of concern. RMPs are likely to face practical challenges in maintaining the digital trail of records, privacy, and confidentiality secondary to difficulties in the transition from manual to digital records and the possibility of data leak from the software aggregators. When the role of technology platforms (e.g., WhatsApp, zoom, and Skype) is unclear, managing the privacy and confidentiality of the communication becomes problematic. Enabling education and research using technology would be the ideal next step. Though this initial attempt by the governing body has certain limitations, it is indeed the essential step in regulating the telemedicine services. This initiative has received widespread appreciation from the service providers as a friendly and effective strategy to provide equitable access to health care.

Telepsychiatry Operational Guidelines

In May 2020, IPS and TSI in collaboration with NIMHANS, Bengaluru, published the Telepsychiatry operational guidelines—2020.⁵ This is a telepsychiatry resource guide intended for psychiatrists practicing in India. The guidelines focus primarily on the video-based telepsychiatry services, unlike the telemedicine guidelines that included audio and text-based consultations as well. The guidelines aim to empower psychiatrists across the nation to initiate and implement telepsychiatric services. The guide emphasizes that the psychiatrist should be observant of the provisions of laws (MHCA 2017, especially) pertinent to the practice of medicine and mental health. Psychiatrists should also uphold professional clinical standards while practicing telepsychiatry, similar to the traditional in-person psychiatry practice.

The guidelines outline the medico-legal issues that may arise during the online consultation and lay specific suggestions to avoid such concerns. The guidelines reiterate that the professional should avoid advertisements about the practice in social media and online platforms. A framework for setting up telepsychiatry services with hardware and software technology standards is outlined. The guide advises choosing telemedicine software, which is simple, user friendly, and effective. Clear suggestions are provided to maintain the basic medical record in either physical or virtual form. In accordance with the existing laws, a structured format is provided that would help to maintain patient health records for first and subsequent visits. The need to obtain explicit consent from the patient before recording the consultation is emphasized. Importantly, the step-by-step operational procedure to be followed before, during, and after telepsychiatry consultation is elaborated in detail. The guidelines also provide a specific format for caregiver-initiated consultations. The caregiver initiating a psychiatric consultation is common in our country.¹⁴ This provision in the guidelines would avoid unnecessary professional and legal dilemmas while rendering the needed service and streamlines the provisions of the Telemedicine practice guidelines.

The guidelines specify the clinical scenarios where the telepsychiatry consultation needs to be stopped, and the concerned person is to be referred for in-person assessment and management. The role of a psychiatrist during the collaborative telepsychiatric consultation between a psychiatrist and a health worker is explained. The importance of availing adequate information and arriving at a provisional diagnosis before prescribing psychotropic medications is reiterated. The guidelines classify the available psychotropic medications into groups/List O, A, B, and C in accordance with the Telemedicine practice guidelines. This simplifies and enables the psychiatrist to choose a specific drug for the denoted purpose. Telepsychotherapy is also encouraged after initial in-person detailed assessment. A set of guiding principles are provided for practicing telepsychotherapy. Appendices to the guidelines contain pro formas for a new consultation, follow-up visit, necessary consent forms, therapy report form, a formal authorization letter from the patient for caregiver-initiated consultations, and standard prescription format.

Future Directions

Innovative application of available technology in mental health service delivery might reduce the huge treatment gap. Several mental health regulatory authorities could be brought online for addressing the grievances quickly and effectively. Such innovations might bring in transparency and accountability. The inclusion of research and training in the guidelines would provide the necessary scope to evaluate the telepsychiatry practice. Perspectives from the service provider and the user may be assessed for better implementation of the guidelines. Research in virtual physical examination, which is currently not in the provisions of the guidelines, may instruct and educate the practitioners for future adaptation. Recent developments in wearable devices that monitor heart rate and rhythm, activity levels, and sleep quality, and adherence-monitoring applications might be integrated for better clinical practice. Telepsychiatry services could be used to monitor, mentor, and supervise the implementation of national and district mental health programs.

Conclusion

The release of the telemedicine and telepsychiatry guidelines has come as a timely measure during this COVID pandemic as it will help to reach the unreached during the restrictions. These are not to be seen as an alternative to lack of human resources but an essential first step in ensuring the equitable distribution of available resources. These guidelines might provide impetus in taking health service delivery to service user’s doorstep. Especially when nonessential out-patient services are stopped and transport facilities are curtailed, the guidelines mainly help to mitigate the uncertainties in the legislation and make the process simpler. These guidelines pave the way for providing a safe, user-friendly, and cost-effective framework to improve health care service delivery. Psychiatrists are enabled to consult patients across the country, promoting fast and equitable access to all parts of the country. The guidelines offer legal protection to all the stakeholders and a higher likelihood of maintaining patient records. Successful translation of the guidelines’ vision to clinical practice is the essential way forward.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.