With the revolution of technology, telecom subscribers in India were 1172.44 million and internet subscribers were 718.74 million in December 2019 (TRAI, 2020). In developing country like India, where mental health care resources need to increase to overcome barriers of distance, telepsychiatry seems to be an evolving option. Though telepsychiatry practice is in a stage of infancy in India, studies from other countries support its use to effectively deliver mental health care services. The ongoing pandemic (COVID-19) has necessitated the uptake of telemedicine as an option for healthcare delivery.
The third Global Survey on eHealth by WHO in 125 of its member states showed that 34% had telepsychiatry (25% established ones). Telepsychiatry services in India were initiated in 2004 by the Schizophrenia Research Foundation (SCARF) in Chennai. SCARF used two models: the specialist–doctor–patient model and the mobile telepsychiatry model. In Chhattisgarh, the Jan Swasthya Sahyog group had initiated the synchronous mode of telepsychiatry for both outpatient and occasional emergency mental health services for the rural and tribal areas of Bilaspur and areas around; the patient end was handled by a resident doctor or a paramedic, who facilitated the conversation and maintained logistics. The asynchronous mode of telepsychiatry (details emailed to specialists in a tertiary care center) was effectively used in a project in Maharashtra for psychiatry services. A clinical decision support system/virtual psychiatrist model was developed and validated by the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, to assist general practitioners in inaccessible areas.– National Institute of Mental Health and Neurosciences, Extension for Community Healthcare Outcomes (NIMHANS-ECHO) Project provided a wide range of mental health care services: didactic lectures and case conferences, teleconsultations in district hospitals, Telementoring and Tele E-Learning through Virtual Knowledge Network—National Institute of Mental Health and Neurosciences.
Ethical and Legal Issues of Telepsychiatry
Ethical analysis of using telemedicine service will employ ethical principles to look at, say, how people are benefited by it, whether people have the autonomy to choose or withdraw from it, and so on. In this uncharted area of mental health care services in India, which deals with the confidentiality of information and security of patients, there is a considerable need to construct legal and ethical codes depending on the available evidence and the hurdles that emerge in the due course of time. However, ethical guidelines for providing mental health services “in person” have been available for a long time. Regarding the provision of health information online, ethical guidelines have been developed.–
The Legal Validity of Telepsychiatry in India
In India, “Telemedicine Practice Guidelines” were released by The Ministry of Health and Family Welfare (MOHFW), New Delhi. Regulation 3.8 with title “Consultation by Telemedicine” was added as an amendment to Indian Medical Council (IMC) (Professional Conduct, Etiquette and Ethics) Regulations, 2002. Subsequently, in collaboration with NIMHANS, the Telemedicine society of India and Indian Psychiatric Society published “Telepsychiatry Operational Guidelines” in May 2020.
Telepsychiatry operational guidelines in India stipulate that the registered medical practitioner (RMP) should abide by the Indian Medical Council Professional Conduct, Etiquette and Ethics Regulations, 2002. In addition, RMP should abide by relevant parts of Acts and rules related to information technology, namely, Information Technology Act (IT Act, 2000), 2000 (Amended in 2008); the Information Technology (Intermediaries Guidelines) Rules (IT Rules, 2011), 2011; the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011; applicable laws or rules for health data to ensure privacy and confidentiality of patients, which will be notified periodically. This shall be considered as a mandatory requirement and must be observed strictly in practice.
Psychiatrists should uphold and practice along the lines of laws, rules, and regulations of the place of work. The psychiatrist must follow the Mental Healthcare Act, 2017. Further, all legislations such as Narcotic Drugs and Psychotropic Substances Act (NDPS Act), 1985; Rights to Persons with Disabilities Act, 2016; Pharmacy Act, 1986; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and other relevant legislations about public health should be observed. It is important to note that current telemedicine practice guidelines have not included consultations outside India.
Competency and Practice
Psychiatrists intending to provide telepsychiatry services are required to undertake an online course on the subject, which shall be made available in three years. In the interim period, the proposed telemedicine practice guidelines have to be followed. Ethical norms laid by the IMC (Professional Conduct, Etiquette, and Ethics Regulation, 2002) must be followed by all RMPs including psychiatrists. During telepsychiatry consultation also, treating psychiatrist must observe laws, standard protocols, standard procedures, existing policies, Mental Healthcare Act, 2017, and Rules, 2018 as he/she does during face-to-face in-person care to ensure quality care delivery. The psychiatrist must mention the qualification, training, and experience in telepsychiatry.
Advertising
It is considered unethical to solicit patients directly or indirectly by physicians or institutions or organizations as per Chapter 6 of the IMC (Professional Conduct, Etiquette and Ethics) Regulations, 2002. Further, it prohibits use of methods/advertisements to draw attention to a physician’s name, qualification, skills, position, achievements, affiliations, awards in such a manner which will translate into enhancing physician’s own importance and draw more attention.
However, it has provisions for a medical practitioner to make formal announcements in print media while starting/changing type/succeeding to another type of practice, about temporary unavailability or about changing address or about charges. Further, it is considered unethical if a physician prints his/her photograph on letterhead or clinic’s or hospital’s display board, as it amounts to self-advertising as per Chapter 6 of the IMC (Professional Conduct, Etiquette and Ethics) Regulations, 2002. Similar acts on virtual platforms like in social networks and internet are also not acceptable.
It is the responsibility of technology platforms to make sure that patients get to see enlisted RMPs’ full names, relevant qualifications, medical council registration numbers, and contact details. Further, platforms also have to take care to enlist only those who are registered with national/state medical councils. For psychologists, the Rehabilitation Council of India (RCI) registration numbers have to be mentioned. Further, platforms are not permitted to carry marketing strategies such as rating or voting of doctor, publishing photographs or recommendations of a particular doctor, or publishing responses of patients/doctors.
However, in the context of telepsychiatry, clear guidelines need to be developed to address the following issues:
Whether to advertise only once or keep advertising?
Suggestion: to abide by the existing rules by MCI for practice in real time.
Where to advertise: With the availability of plenty of platforms for online consultations, whether advertisements have to be there on all platforms? Whether advertisements should be there on other platforms, social network sites, and on print and audiovisual media also?
Suggestion: Advertisements can be on the platforms in which the psychiatrists will be providing services. Social networks can be avoided for advertising. Print and audiovisual media can have advertisements only in circumstance as in the MCI.
On how many platforms one psychiatrist can enroll for practicing?
Suggestion: A psychiatrist can enroll in as many platforms as he/she wants to, but one should ensure that timings are different on different platforms.
What details about the psychiatrist should be available while advertising on online platforms—example, qualifications, professional position, affiliation, skills, achievements, specialties, photographs, videos, and testimonials by other patients and professionals?
Suggestion: These should be as per the existing rules by MCI.
Liaison with telemedicine platforms in terms of the uniform standard operating procedure to address liabilities, profit sharing, and referral patterns.
Suggestion: These should be explicitly stated, and preferably a memorandum of understanding can be made before entering into a contract with online platforms.
Responsibilities of Technology Platforms
Telepsychiatry platforms come under the ambit of the term “intermediary” as per IT Act, 2000 (amended in 2008). As per description in IT Act, 2000, “Intermediary, with respect to any particular electronic message means any person who on behalf of another person receives, stores, or transmits that message or provides any service with respect to that message.” In the context of telepsychiatry, the intermediaries will be various service providers such as telecom, internet, payment gateways, search engines, web hosting, and cyber shops, and electronic message will include records.
Rules for intermediaries have been outlined in IT Rules, 2011. The rules to be observed by intermediaries while discharging duties are terms and conditions about accessing or using intermediary’s resources and these terms and conditions must include privacy and confidentiality statements of all, including vulnerable population; should avoid copyright infringement; should abide by all existing laws; avoid misleading/impersonation; avoid threat to integrity and sovereignty of country and relation with other countries. Personal data of a person includes information related to biometrics, health, sexual orientation, financial details, bank account and card numbers, and passwords. The data available in public domain and under Right to Information Act, 2005, are exempted.
Technology platforms are prohibited from hosting health care delivery using artificial intelligence, that is, by machines or applications or software instead of real life direct communication with an RMP. However, newer technologies can be used to assist or support the clinician in various stages of evaluation and interventions but this whole process will be controlled by the RMP.
Social Media and Telepsychiatry Practice
Popular platforms such as WhatsApp, Facebook, and Skype can be used for telepsychiatry consultations as Telemedicine Practice Guidelines—2020 do not prohibit using these platforms for teleconsultation. However, adequate security and privacy of the patient and psychiatrist have to be ensured. A written, informed consent from the patient is mandatory for posting or sharing any details such as summary, pictures, audio recordings, and video recordings. However, psychiatrists should refrain from doing this and the patient should also be conveyed against recording or sharing details of the consultation process or content in any form in media or social networks.
Professional boundary crossings and violations are possible if the same personal account on social media is used for professional purposes also. One can avoid mixing personal and professional relationships on social media.
If a psychiatrist has his profile as a psychiatrist on social media in public domains then the person should identify self with the registered name and be cautious and responsible in posting or sharing any content as it will be followed by patients and may be viewed as an official opinion of the profession.
Just like in real life, psychiatrists should share a cordial relationship and have mutual respect in virtual interactions on public platforms.
Process of Consultation in Telepsychiatry
Consent
One of the foundations of ethical health services is informed consent. The informed consent in telepsychiatry can be implied consent or it can be explicit consent. If teleconsultation is initiated by the patient, then it will be considered as implied consent. If a psychiatrist initiates a telepsychiatry consultation, then it will require explicit consent from the patient. Consent needs to be taken in the form of video or audio. This has to be recorded in the patient’s record. Before initiating telepsychiatry service, the patient should be made aware about relevant operational aspects of telepsychiatry including advantages and disadvantages and available alternatives and specific details of the psychiatrist providing the service.
Capacity to consent has to be decided in the same manner as in the process of in-person consultation as per the Mental Healthcare Act 2017.
Jurisdiction of Territory and Specialization
As per telemedicine practice guidelines, teleconsultation can be provided to patient in any place in India. However, in certain states, registration to practice is under specific laws which have not been clarified. In circumstances where a previously seen patient intends for a telepsychiatry consultation from a foreign land, it has to be declined and informed that the current guidelines restrict this practice to jurisdiction in India only.
Just as in real-time consultation, in telepsychiatry also, psychiatrist must restrict oneself to the field of specialization and standard recommended evaluation and interventions as mentioned in Section 106 of the Mental Healthcare Act, 2017.
Identification
The patient’s identity has to be verified and confirmed before consultation and prescription. For identification, an identity card containing name, age, gender, address, phone number (email ID—optional) with a photograph will be ideal. A family member will be allowed during telepsychiatry consultation if the patient is consulting along with an adult/nominated representative; however, informed consent for the same must be obtained from the patient first, only then the identity of the nominated representative/adult has to be ascertained.
The First Consultation and Follow-up Consultation
First consultation and follow up consultations are defined by telemedicine practice guidelines. If a specified patient consults a specified psychiatrist for the first time or patient visits the specified psychiatrist after six months of previous consultation with same psychiatrist, then it is considered as first consultation.
If specified patient consults for the same condition and for continuation of care within 6 months of the past in-person consultation, it will be considered as follow-up consultation.
Electronic Health Records/Medical Records
The psychiatrists should maintain case record files of the patients and details of the services provided in the pro forma (Appendix A) provided by the MCI (2002) for at least 3 years from the date of starting treatment. In addition, it has to be ensured that these records are as per the current Telemedicine Practice Guidelines, 2020, and in lines with the requirement of the Mental Healthcare Act, 2017. This has to be explained to the patient also, as the patient will have the right to access their records as per Mental Healthcare (Rights of Persons with Mental Illness) Rules, 2018.
The records which need to be maintained as per telemedicine practice guidelines and telepsychiatry operational guidelines are all details of interaction including messaging/call/audio/video details and all digital/physical case-related documents including investigations/prescriptions/certificates.
Recording: Covert audio/video recording by anyone in telepsychiatry is illegal. Before going for any audio or video recording of telepsychiatry consultation, all parties involved in the process of teleconsultation must explicitly give consent.
Access to basic medical records: The patient has to submit a letter in a prescribed form to access basic medical records as outlined in the Section 25 of the Mental Healthcare Act, 2017. After receiving the patient’s written approval, records shall be made accessible only to the patient. The stored audiovisual content can only be released if the patient has authorized specifically for the same.
Prescription
For a telepsychiatry consultation, a prescription has to be issued by the psychiatrist as per the rules in Indian Medical Council regulations and Drugs and Cosmetics Act and Rules, and it has to be in a specified format (Appendix B) as suggested by the telemedicine practice guidelines, 2020. Prescription has to be given in a format convenient for the patient: hand-signed prescription can be photographed or scanned and it can be sent to patient by message or an email; if the platform has an option of e-prescription, then the same can be generated and the patient can download it. In the prescriptions, it is preferable to mention ICD or DSM code for diagnosis to avoid revealing the name of diagnosis to the pharmacist or others. Ethical and strict professional judgment has to be considered while documenting information or clinical features on prescription. If a prescription is planned to send to a pharmacy directly or planned to dispense medicines from pharmacy (own or affiliated) and get it delivered, then an explicit consent must be obtained from the patient, and in both situations the patient will get the prescription also.
The psychiatrist is entitled to professional discretion of prescribing medications via the telepsychiatry mode but will have the same accountability as in-person consult. Diagnosis and necessary evaluations, if necessary as per protocol, must be followed before issuing a prescription. The medications which will be prescribed in telepsychiatry will depend on the type and mode of consultation and categories of medications. These are as mentioned in the telepsychiatry practice guidelines, 2020.
Dispensing medicines by psychiatrist: From ethical and legal aspects, if a psychiatrist is dispensing drugs, it may bring in conflict of interest and trust issue from the patient’s point of view. So this remains a debatable issue. To stay away from the conflict of interest, one can consider refraining from selling medicines to own patients.
Proxy/Asynchronous Consultation
A healthcare worker conducts the consultation process on behalf of a psychiatrist and records the session, which will be viewed by the psychiatrist and prescriptions are sent in the name of treating psychiatrist. This will amount to unethical practice. However, video evidence of clinical features and seeking expert opinion by a physician are permitted.
Initiation of Telepsychiatry Consultation by a Family Member or a Healthcare Worker with the Patient
A person can authorize any person or a family member or a nominated representative (as per advance directive) to initiate telepsychiatry consultation. All such consultations can be with or without the patient, but all such consultations must be considered after an explicit consent by the patient. A child or adult can be a patient here.
For children (less than 16 years): Age and identity of patient and family member, document to establish the patient, and family member’s relationship have to be verified.
For adult patients: Age and identity of patient and family member, document to establish the patient, and family member’s relationship have to be verified. Initiate with capacity assessment, if capacity to consent is present, then consent has to be obtained via teleconsultation, which has to be documented. If psychiatrist feels that the capacity to consent is absent or patient is coerced, then in-person consultation has to be advised.
For follow-up patients, the advance directive has to be checked, in its absence, the same has to be documented and one has to proceed with obtaining consent from the nominated representative, which also has to be documented.
Initiation of Telepsychiatry Consultation by a Family Member Without the Patient
This can be considered during follow-up only.
First consultation: For all such consultations, in-person consultation is advised.
Follow-up consultation: For patients eligible for follow-up, in the absence of the patient, the follow-up should proceed with verifying documents of identity of the patient, family member, relationship, and authorization letter. In certain conditions like moderate to severe dementia with inability to consent, the psychiatrist can agree for telepsychiatry consultation without the patient.
Telepsychiatry Consultation Between a Healthcare Worker and a Psychiatrist
In circumstances such as community visit, camps, and specialized settings for specified populations like prisoners/beggars/orphans/destitute/persons with mental illness, a healthcare worker can initiate consultation.
As per the Mental Healthcare Act, 2007, the healthcare worker initiated mode of consultation can be used for assisting legal agencies also.
In emergency situations where there is threat by person to person’s own life or other’s life or to property, treatment can be provided by any RMP in community or health establishment, if there is informed consent from nominated representative (Section 94). Here, the person needs to be shifted to the closest mental health facility and emergency intervention will be limited to 72 hours; but in disasters it may extend up to 7 days.
Stopping or Referring for In-person Consultation During Telepsychiatry Consultation
This can be considered if the patient refuses to consent, lacks capacity to consent for treatment, in emergencies, if there is risk of harm to self/others, if patient is in conflict with law, or falls under Protection of Children from Sexual Offences Act, 2012, for certification.
Telepsychotherapy
Just like telepsychiatry, a psychiatrist can provide telepsychotherapy to any patient from any place in India. The core principles of traditional in-person psychotherapy will remain the same irrespective of the mode of communication. Considering the limitations of psychotherapy in virtual mode, few rules need to observed:
Detailed evaluation has to be done in a real-time interview before initiating telepsychotherapy. Informed consent must be obtained before initiation. Diagnosis is essential before initiating therapy.
A psychiatrist can do it simultaneously, or subsequently, with pharmacotherapy by himself/herself or can refer.
Patient’s ability to get engaged in teletherapy to be assessed before initiating.
The need of emergency care has to be assessed before each session, and in-person consultation must be suggested for emergencies.
The psychiatrist has professional discretion to entertain family member/s to be part of the therapy session.
Quality of care, ethics, laws have to be observed in the same manner as in face-to-face therapy.
All professional etiquette as per the requirement have to be observed.
All communications have to be documented.
The psychiatrist and patient can discontinue therapy or refer to another therapist at any time.
The patient can also discontinue or choose other therapist at any stage.
The potential drawbacks of e-therapy (in the context of psychotherapy) have been documented for a long time,: Communication of emotions over the internet is difficult. The psychiatrist/psychotherapist may have limited knowledge of a person’s culture, language, rituals, and certain factors that may play a role in illness and outcome. Consensus and uniformity are lacking in training e-therapists. Patients may find it difficult to identify psychiatrist with required qualifications, and an unlicensed person may advertise themselves as competent. How to proceed in case if a patient is a minor or how to identify that the patient is a minor? The psychiatrist/psychotherapist will not know who else is there along with the patient at the other end. Conversations can be intercepted and accessed by others. There is a risk of the psychiatrist or the patient forwarding messages to someone else. Using a shared computer for evaluation and intervention may allow a third person to access communication and transcripts if any. Technical and internet errors may interrupt the process.
Addiction Medicine and Telepsychiatry
Addiction medicine evaluation and interventions will warrant in-person physical examination, laboratory evaluation, physiological parameters evaluations, psychological evaluations, and at times continuous observations. Complications related to substance use disorders can vary depending on the substance used and may involve other specialists’ inputs. Medications to manage these conditions may also be under list C, which is prohibited. However, healthcare workers and existing remote facilities can be considered for delivering addiction medicine services.
Patient in Conflict with the Law
In all telepsychiatry consultations, the psychiatrist has to ask whether the patient is in conflict with the law. Psychiatrist can choose to advise person to come for in-person consultation or in-patient care for detailed evaluation, diagnosis, treatment, and certification. For issuing medical records or certificates, Mental Healthcare Act, 2017, should be followed, and the medical board should be consulted.
Ethical Challenges
With the corporate sector assuring proven, reliable, and cost-effective telepsychiatry and telehealth services being made available, there can be new ethical challenges such as follows:
Depersonalizing doctor–patient relationship: Technology may act as a more important tool for evaluation rather than professional skills. With the advent of algorithms for diagnosis and management, in the longer run, self-diagnosis and self-medication can be a risk.
Shifting and widening jurisdictions of practice: With patient clientele being across the globe, it may be good to have cross-border legislation to deliver the services, and regulation for international services can be considered.
Data and technical processing as per patients’ wish: Current guidelines focus on the storage of data from clinician’s perspectives. New regulations to have provisions to make data available to the patients need to be considered.
Adapting the informed consent to the new technologies: Modes for video recording of consent for consultations have to be developed and standardized for uniformity and legal requirements.
What if the user becomes suspicious about the technical process? Legislation should keep pace with technological innovations.
Upholding human dignity and rights in the midst of technology: These have been addressed in current practice guidelines; however, newer challenges may come up with an increase in the trend of telepsychiatry practice.
Health insurance and clear reimbursement policy: The insurance sector has to cover expenses like in-person consultations. Guidelines have to be framed for these.
Malpractice and Professional Liability
If a psychiatrist fails to render his professional services because of negligence or breach of his responsibility despite being in contract with patient for offering such services, then it amounts for malpractice. When a psychiatrist owes professional services to a patient but fails in the service which results in harm to the patient, then this harm which results from the failure from the end of the psychiatrist is termed as negligence.
Professional Misconduct
Professional conduct requirements are the same as mentioned in the MCI Act for professional conduct and ethics. Further, acts which breach patient’s privacy or confidentiality or care or existing laws for telepsychiatry will be considered as acts of professional misconduct. Few nonpermissible actions are as follows:
Patient is requesting in-person consultation but psychiatrist insists on telepsychiatry.
Misuse of patient’s personal and clinical data by the psychiatrist.
A psychiatrist prescribes prohibited or restricted medicines.
Indulging in unethical methods to solicit patients by advertisements.
The penalties for professional misconduct are defined as per the MCI Act.
Discussion
Existing principles for clinical, ethical, and legal aspects of patient care and practice have paved path for telepsychiatry and these are helping for transition from in-person consultation to teleconsultation. As telepsychiatry in finding foothold across the globe, specifically in India, experience needs to translate into research, which will help in refining guidelines and in framing specific legislations. The pros and cons need to be viewed with objective viewpoint so as to ensure better acceptance by psychiatrists and patients to find a safe transition path. Three pillars—beneficence, nonmaleficence, and autonomy—of professional ethics must be strengthened further with the aid of research and legal framework. Finally, it is the patient care at the core of telepsychiatry, and ethical and legal aspects should swivel around patient care.
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