Telemedicine practice guidelines of India, 2020: Implications and challenges.

Telemedicine Guidelines of India, 2020 promises to pave a road map for regularization and diversification of teleconsultation services across the country. This guideline is the need of the hour, especially during the current coronavirus disease pandemic. All modes of communications (text, audio, video, etc.) between the service provider and user are included in the broad rubric of the guidelines. Scope, inclusions, exclusions, and restrictions are clearly specified in the guideline. Medications are grouped and listed for the specific type of consultation, and restricted drugs are notified. This guideline especially helps mitigate the gaps in legislation and reduces the uncertainty while providing a practical, safe, and cost-effective framework to improve healthcare service delivery in this article; the authors discuss the implications of this new guideline and the challenges during the implementation of teleconsultation services across the country. Copyright:

INTRODUCTION

On March 25, 2020, the Ministry of Health and Family Welfare, India, had released the “Telemedicine Practice Guidelines” for allopathic registered medical practitioners (RMPs). This guideline is prepared by the Board of Governors, Medical Council of India, in partnership with the National Institution for Transforming India (Aayog). This would be included in the Appendix V of 2002 Regulations on “Professional Conduct and Ethics” under the Indian Medical Council Act, 1956. This amendment is valid according to the National Medical Commission Act, 2019, Section 61 (Subsection-2). The document is accessible at https://www.mohfw.gov.in/pdf/Telemedicine.pdf. The guidelines enable the RMPs to deliver healthcare using technology. This document provides definitions, scope, and protocols with roles and responsibilities of the patients, RMPs, healthcare workers, and telehealth platforms. Although the guideline is for universal healthcare across India, it is reviewed here from the mental healthcare service delivery perspective.

SCOPE OF THE GUIDELINES

The guidelines include all the channels of communications (text, audio, video, etc.) and provide norms and standards for RMPs registered under the Indian Medical Council Act, 1956 (i.e., allopathic practitioners). The guidelines specifically exclude teleconsultations outside the jurisdiction of India. Tele-assisted/remote surgeries, research, and education of health workers are also excluded. The guidelines also exclude the specifications for hardware/software, infrastructure, and data management system standards. Seven elements are emphasized as cardinal while considering telemedicine consultations, namely, context, identification of RMP/patient, mode of communication, consent, type of consultation, patient evaluation, and management. Patients and RMPs are enabled to communicate using any mode of available information technology solutions. Synchronous and asynchronous communication modes are allowed, and both the first and follow-up consultations could be facilitated. Provisions for emergency acute care and mandatory in-person referrals following such consultations are specified.

The patient/caregiver could initiate consultations and terminate the same at any stage. Discretion to use the available means to collect necessary information is left with the RMP's judgment. RMPs are mandated to prescribe medicines only if there is a reasonable satisfaction about the adequacy of received information. Medicines are categorized for the specific type of consultation, namely, List O, List A, List B, and prohibited list. List O includes drugs that are available over the counter (e.g., paracetamol and antacids). List A includes drugs that are safe and without any abuse potential (e.g., eye drops/ointment, skin creams, and oral hypoglycemic agents). It is mandated by the guideline to have a video consultation before prescribing List A drug for the first time. Refill of List A drugs is, however, allowed routinely. List B includes add-on drugs that are used to optimize regimen for the existing illness (e.g., enalapril added to existing atenolol to manage hypertension). Prohibited list includes drugs listed in the Schedule X of Drugs and Cosmetics Act, 1945 and drugs in the Narcotic Drugs and Psychoactive Substances Act, 1985 (NDPS Act 1985) (e.g., benzodiazepines, phenobarbitone, and methylphenidate). Drugs such as phenobarbitone, clonazepam, and clobazam were added to List A in the recent modification of the guidelines (https://www.mohfw.gov.in/pdf/Modificationin MedicineListinTelemedicinePracticeGuidelines.pdf). Details about implied/explicit consent, data privacy, and maintenance of confidentiality are provided along with a sample format for the standard prescription.

CRITIQUE

The National Mental Health Survey of India, 2016 reports a huge treatment gap ranging from 75% to 93%.[1] In this context, the telemedicine initiative to improve the accessibility of healthcare is much appreciated by all the stakeholders. This is seen as a game-changer in the healthcare delivery. In addition, during the pandemic such as coronavirus disease 2019, the telemedicine services are crucial to reach the unreached. Telemedicine reduces in-person consultations and minimizes the risk of contagious illness spread during pandemics. This guideline enables accessibility, particularly when nonessential outpatient services are stopped. Although service providers were interested to provide teleconsultations, lack of such guidelines had led to inhibition and inertia from the health industry.[2] This guideline especially helps mitigate the gaps in legislation and reduces the uncertainty while providing a practical, safe, and cost-effective framework to improve healthcare service delivery.

Consultations for routine follow-up and continuous monitoring could be avoided since in-person visit is not mandatory. Proxy consultations with provision to initiate consultation by a caregiver are much appreciated and needed in psychiatric practice. Telemedicine helps reduce unnecessary travel cost and effort, especially for the rural people. This would also reduce the burden on secondary and tertiary hospitals. RMPs are allowed to consult patients across the entirety of the nation that enables fast, easy, and equitable access to all parts of the country. Any patient from any corner of the country could initiate and request consultation from the specialists in the field. This ensures universal access of specialist care which is a dream even in developed countries that has state/zone restrictions.[3] The Mental Health Care Act, 2017 (MHCA 2017) emphasizes rights-based approach and mandates the government to ensure that every citizen has accessibility to the mental health services. In a country such as India, where the health expenditure is just 1% of the gross domestic product, telemedicine is a potential option to successfully implement the provisions of the MHCA 2017.[4] This guideline offers legal protection to all the stakeholders and higher likelihood in maintaining patient records and monitoring medication adherence.

Although this guideline is envisaged to bring in a paradigm shift in the healthcare delivery, it has certain important limitations. The network connectivity is still poor in many regions of our country. People from remote/rural areas are not specifically updated with the current technology platforms, and this might hinder effective communication during video consultation which is stipulated essential to prescribe List A drugs. Even, the healthcare personnel's skills are limited in utilizing the available technology solutions. The guidelines mention that a special online education course would be formulated, and RMPs would be directed to finish the same within the next 3 years. This might enhance the digital literacy of RMPs and translate into effective promotion of telemedicine. On the other hand, text and audio consultations are feasible across the country but have their own limitations. RMPs might need to send prescriptions online, and the availability of internet services is essential at both ends. Even when the patient receives such prescriptions, the routinely prescribed psychotropics are seldom available in remote areas, and this might limit the benefits of teleconsultation. The guideline prohibits prescribing specific drugs (e.g., benzodiazepines [except clonazepam] and methylphenidate). This is intended to prevent the misuse. However, various other benzodiazepines are frequently used class of drugs for many indications in psychiatric prescriptions.[5] Benzodiazepines are included as scheduled drugs under the NDPS Act 1985 which restricts its use. This guideline further tightens prescribing benzodiazepines which are an issue of concern. Furthermore, benzodiazepines and stimulants such as methylphenidate are frequently used in addiction treatment. This restriction is viewed as a disadvantage for addiction management. The guideline also had not mentioned specifically about prescribing long-acting depot injectable over teleconsultation.

RMPs are provided with a wide spectrum of flexible opportunities that also have its challenges. Liberty provided in the guideline also implies certain additional responsibilities. RMPs are mandated with the following:

To use professional discretion to decide whether teleconsultation is suitable in the given circumstances

To decide the best possible mode of communicating with the patient

To uphold the same standard of care as an in-person consultation within the intrinsic limits of telemedicine

To confirm the identification and credentials of patient/caregiver

To obtain consent from the individuals and record this in patient's reports

To collect information through all available means and make sure that adequate information is available to make provisional diagnosis

To advice appropriate health education/counseling or investigations

To prescribe medicines only if there is a provisional diagnosis

To confirm the patient's age specifically before prescribing medicines

To prescribe medicines in the standard provided format and send it to the patient

To display their registration number provided by the appropriate council on websites, e-mails, prescriptions, and receipts/invoice given

To provide first aid/counseling during emergency consults and mandatorily advice for an in-person visit as early as possible

To maintain the trail of conversations and treatment records

To ensure patient's privacy and confidentiality to a reasonable degree

To provide reasonable evidence that data breach has happened secondary to compromised technology or other persons

To abort the consultation session and refer for in-person treatment based on professional judgment.

Although most of the mentioned responsibilities are same and applicable for in-person consultations as well, the challenges are to confirm the identification/credentials, to maintain records and privacy, and most importantly to provide the same standard of care as an in-person consultation. What is the “reasonable” degree of maintenance of privacy/confidentiality? Or what would be considered as “reasonable” evidence in case of breach of data? Penalties and punishment for misconduct and negligence would be similar to an in-person consultation provided under the existing laws. When patients and RMPs use third-party platforms for communication, problems might arise from many sources. How legitimate is it to consider telemedicine misconducts as similar to in-person grievances? These questions remain and need further clarification.

Challenges in implementation across the country are follows:

In India, health is a state subject. Although this guideline provides for RMPs to practice across the country, local state government regulations might be a potential hindrance

When a grievance arises from interstate teleconsultation, legal jurisdiction of such case proceedings is not clarified

If a patient/caregiver records the communication with RMP and if third-party telehealth software/platforms keep records of the private data and when these recordings are made available to public, ways to address such concerns are not elaborated

The guideline is also quiet about the insurance cover for teleconsultations and prescriptions

Software aggregators might enable options to give ratings/scores to specific RMPs by service users, and this might be used for promotions/advertisements. Although the guideline prohibits RMPs from advertising their telemedicine services, software aggregators might indirectly promote/advertise RMPs, and this is another limitation

Although online prescription is promoted, many parts of the country do not have access to e-pharmacy. Steps to regulate such online drug marts are not mentioned.

The complete list of drugs belonging to various categories in the guideline is not provided yet, and the place of different psychotropics in these lists is unclear. E-pharmacy regulations might improve the transparency and promote universal accessibility to medicines. Research and educating the healthcare workers are excluded from the scope of the guidelines currently and hopefully would be enabled in the future. Counseling the patients with basic nonpharmacological tips is included in the guideline. However, clarity on existing psychotherapy modules is missing and if at all could be provided by medical practitioners only. The guidelines acknowledge the risks, drawbacks, and limitations of telemedicine and wish to provide mitigations such as appropriate training and enforcement of standards/protocols. In addition, the guideline also specifies measures for technology platforms that enable telemedicine consultations. The use of artificial intelligence or machine learning applications to counsel or to prescribe medicines is strictly prohibited. However, how exactly these mitigations would be translated from paper to practice need to be seen.

GUIDELINES FROM THE PSYCHIATRISTS' PERSPECTIVE

Telemedicine guidelines provide immense opportunity to make the mental health services accessible across the country. The opportunities and challenges provided by the guidelines from the psychiatrists' perspective are summarized in Table 1.

Table 1

Telemedicine guidelines from the psychiatrists’ perspective

Mandatorily prescribed in the guidelines

Psychiatrists should abide by the provisions of the existing laws during telepsychiatric consultations

Psychiatrists should uphold the clinical standards, existing protocols, and policies similar to in-person consultations

Psychiatrists intending to practice telepsychiatry are mandated to complete the online training program within 3 years of government notification

Psychiatrists should ensure verification of patient identification and consent for consultation through caregiver if needed

Maintenance of basic medical record as prescribed in the law similar to in-person consultation

Collect adequate information to make a provisional diagnosis and prescribe medicines only after arriving at a provisional diagnosis.

Online prescription to be provided in the standard format and only with generic names

Mandatory referral for in-person consultation for emergency concerns

Lack of clarity in the guidelines

Psychotropic medications are not clearly categorized in the guidelines

Only clonazepam is exempted in the appendix for first consult use; however, in practice, other benzodiazepines are also routinely used

Prescription of long-acting injectable preparations online is not clarified

Psychiatrists may not be held responsible for breach of confidentiality if there is a “reasonable evidence” of technological issues - what constitutes reasonable evidence?

Insurance cover for the telepsychiatry services is unclear

When grievances arise out of teleconsultations across states, the jurisdiction of inquiry is unclear

When online aggregators (platform) collect the data, the ownership of data for further use is not clarified

How long should the outpatient records be maintained is not specified

Psychiatrists to avoid

Advertising their service through any platform

Insisting telepsychiatric consultation if the patient is willing to travel for in-person visit

Disclosing confidential patient information in public/social media

Recording the consultation without explicit consent

Prescribing drugs from the prohibited list

Research and evaluation using online platforms

Issuing certificates based only on teleconsultations

EXPERIENCE AT TELEMEDICINE CENTRE, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES

Telemedicine Centre, the National Institute of Mental Health and Neurosciences, had initiated collaborative care in psychiatry since January 2011.[6] Here, the collaboration is between the psychiatry specialists at Bengaluru and RMPs at remote areas in Karnataka. Such collaboration has resulted in increased accessibility of specialist care in remote areas.[6] Furthermore, telepsychiatry aftercare clinic for already registered patients was initiated in December 2016.[2] This service had led to feasible continuity of care using video consultation.[2] Further, collaborative neuropsychiatric consultations for patients in prison were also provided using telemedicine platform.[7] This telemedicine guideline provides much-needed road map to diversify the abovementioned services across the country.

CONCLUSION

This initial attempt by the authorities in regulating the telemedicine services is appreciated by all the stakeholders as an easy and cost-effective strategy to provide equitable access to healthcare. This is a simple, provider-friendly, and user-friendly guideline that lays important foundation to initiate the telemedicine services across the nation. Benefits definitely outweigh the risks involved in the practice. Although the guideline is for universal healthcare, specific limitations from psychiatric practice perspective are elaborated. The authors hope that further amendments to this guideline might shed light on these shortcomings and promote the translation of enumerated benefits from paper to the public. Both the service providers and users stand to gain significantly by embracing the telemedicine practice and thereby begin the transformation of public health care in India.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.