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Issuance Of Telemedicine Practice Guidelines In India: A Long Due Piece Of Regulation

Tahir Ashraf Siddiqui
1 April 2020 4:06 AM GMT
Issuance Of Telemedicine Practice Guidelines In India: A Long Due Piece Of Regulation
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Telemedicine Practice Guidelines providing the much needed statutory cover to the practice of medicine by employing means of communication ( as opposed to in-person consultation) has been issued on March 25, 2020 ("the Guidelines) by the Ministry of Health and Family Welfare, Government of India by way of an amendment through the addition of Regulation 3.8 titled as 'Consultation by Telemedicine'. The Guidelines are appended as Appendix 5 to the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation), 2002 issue under the Indian Medical Council Act, 1956. India has followed other jurisdictions such as the United States and European Union, Singapore, etc., which have their respective regulations governing the practice of telemedicine.

The promulgation of Telemedicine Practice Guidelines has met the longstanding the demand of the stakeholders in the health industry for the regulation of health consultation by virtual means between doctors and patients. This demand has been finally met as the Guidelines were notified on March 25, 2020, hastened by the COVID-19 outbreak. The increase in the number of novel coronavirus disease ("COVID-19") cases worldwide resulting in an unprecedented imposition of lockdown by the government has brought the focus on social distancing to control the epidemic, and it is only appropriate that the regulatory framework encourages people to use virtual platforms in cases where physical interaction is not essential to the treatment.

Before the issue of these Guidelines, there was no statutory framework/guidance/regulations on the practice of telemedicine which had caused doubts on the legality and the procedure of the practice of telemedicine in India due to which there was no guidance on standard processes and procedures to be followed in case of teleconsultation and telemedicine amongst the minds of the practitioners as well as patients The Guidelines also fill the gap between law and practice. In fact, there were ethical dilemmas in the practice of telemedicine itself as there was a strand of opinion, which categorized the entire practice of telemedicine as being without authority, and therefore illegal. With the issuance of these guidelines a long-standing demand of the Indian Medical Association of doctors to come with clear-cut guidelines on the important issues concerning telemedicine have been fulfilled.

These Guidelines recognize the significance and value of the practice of telemedicine in the times of pandemic and infectious diseases by reducing exposure of doctors, patients and medical staff to potential infections in non-essential cases through remote screening and consultation. The Guidelines, subject to limited and necessary regulation, allow liberal use of technology for accessing healthcare through all channels of communication with the patient that leverage information technology platforms, including voice, audio, text and digital data exchange.

Apart from the unique place to telemedicine in healthcare in the present times of the Covid-19 outbreak, the practice of telemedicine has other tangible benefits in regular access to healthcare on a routine day to day basis. Telemedicine reduces the costs on time, expenditure and cuts travel of long distances for consultation and treatment in cases where there is no necessity for physical access or in cases of follow-up consultation, etc. Telemedicine is also highlighted as a key enabler in the government policy to ensure provisioning of quality healthcare access through e-health.

DEFINITION OF TELEMEDICINE AND TELEHEALTH UNDER THE GUIDELINES:

The Guidelines have incorporated the World Health Organization's definition of telemedicine which defines the term as "the delivery of health-care services, where distance is a critical factor, by all health-care professionals using information and communications technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and the continuing education of health-care workers, with the aim of advancing the health of individuals and communities."

The Guidelines also define telehealth (by incorporating NEJM's definition) as 'the delivery and facilitation of health and health-related services including medical care, provider and patient education, health information services, and self-care via telecommunications and digital communication technologies.'

In general, telemedicine is used to denote clinical service delivered by a medical practitioner while telehealth is a broader term of use of technology for health and health-related services including telemedicine. The Guidelines provided the much-needed framework for regulating the conduct of all stakeholders: doctors, patients and technology platforms (website, apps hosting the profiles of medical practitioners) in the practice of telemedicine.

WHO CAN PRESCRIBE MEDICINES TO WHOM?

In terms of the Guidelines only a 'Registered Medical Practitioner', that is a person who is enrolled in the State Medical Register or the Indian Medical Register under the IMC Act 1956 can practice telemedicine in India. The position, is the same, as any medical professional entitled to practice medicine in India.

The Guideline recognize that the same professional and ethical norms and standards as applicable to traditional in-person care, within the intrinsic limitations of telemedicine as provided in the Guidelines are applicable to all RMPs for telemedicine.

Exclusions:

The Guidelines exclude consultations outside the jurisdiction of India and thus RMPS are only permitted to consult with patients situated inside India. Further, the Guidelines specifically exclude amongst others, use of digital technology to conduct surgical or invasive procedures remotely also other aspects of tele-health such as research and evaluation and continuing education of healthcare workers through telemedicine.

Proposed training and mandatory online course in offing for telemedicine practice:

The Guidelines exhorts all RMPs who seek to practice telemedicine to get familiar with the provisions of the Guidelines as well as with the process and limitations of telemedicine practice. The Guidelines also mention without elaborating in detail that at an online program will be developed and made available by the Board of Governors in this regard and all registered medical practitioners intending to provide online consultation need to complete a mandatory online course within 3 years of the notification. However, in the interim period, a RMP can practice telemedicine by adhering to the provisions of these guidelines. RMPs using telemedicine are required uphold the same professional and ethical norms and standards as applicable to traditional in-person care, within the intrinsic limitations of telemedicine.

IMPORTANT FEATURES OF THE GUIDELINES:

The Guidelines are comprehensive and lay emphasis on important aspects of the practice of telemedicine and provide important guidelines on physician-patient relationship, the standard of care and requirement of informed consent, mode of communication for different modes and types/stages of consultation, requirement for maintaining patient information record, party autonomy, guidelines on prescriptions of medicine including prohibited list of medicines, fee, medical ethics, data protection and privacy obligations, duties and liability of RMPs as well as technology platforms, professional negligence, misconduct, and penalties amongst others. The Guidelines also recognize the strengths as well as limitations and drawbacks of the telemedicine and aim to incorporate the best practices to harness the technology for providing better access to healthcare through telemedicine.

The salient aspects of the Guidelines are explained as under:

  1. Recognition of primacy of RMP's opinion and emphasis on context: The Guidelines gives primacy to the opinion of the professional judgment of a RMP as guiding principle for all telemedicine consultations as only the RMP is well positioned to decide in a particular case on whether a technology-based consultation is sufficient or an in-person review is needed. At the same time, the Guidelines suggest that a RMP must exercise discretion through proper application of mind in a particular case and never compromise on the quality of care. The RMPs are required to taking a holistic view of the given situation to decide whether a telemedicine consultation is appropriate in a given situation or an in-person consultation is needed in the interest of the patient since every patient/case/medical condition may be different. A RMP is also required to exercise her professional discretion for the mode of communication within telemedicine depending on the type of medical condition. For instance: if a case requires a video consultation for examination, RMP ought to explicitly ask for it.

  1. Identity Verification of Patients and RMP: The Guidelines bar anonymous telemedicine consultation and make identity disclosure and verification of both the patient and the RMP to each other a must for availing/providing the services. An RMP is required to verify and confirm the patient's identity by name, age, address, email ID, phone number, registered ID or any other identification as may be deemed appropriate. An RMP must also put in place a mechanism to enable a patient to verify her credentials and contact details.

  1. Mode of Communication: The Guidelines encompass the use of all modes of virtual communication and allow the parties to use any communication technology to avail and provide telemedicine consultations. The Guideline recognize that there are three primary modes: Video, Audio, or Text (chat, messaging, email, fax, etc.) for telemedicine and allows a RMP to use any technological carrying out technology-based patient consultation e.g. telephone, video, devices connected over LAN, WAN, Internet, mobile or landline phones, Chat Platforms like WhatsApp, Facebook Messenger, etc., or Mobile App or internet-based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc. However, the use of different applications are regulated for prescribing different medicines depending upon the context, seriousness, urgency and stage of consultation as each of these technologies have their respective strengths and weaknesses, in which, they may be appropriate or inadequate to deliver a proper diagnosis.

Significantly, the Guidelines have adequately factored in the strengths, benefits as well as limitations of different technologies. The Guidelines rightly recognize that "through telemedicine consultation provides safety to the RMP from contagious conditions, it cannot replace physical examination that may require palpation, percussion or auscultation; that requires physical touch and feel" and express hope that "newer technologies may improve this drawback". The Guidelines further mention that in the case of emergency consult, if the alternative care is not present, tele-consultation might be the only way to provide timely care and in such situations allows RMPs to provide consultation to their best judgement in such urgent situation, while advising RMPs to avoid telemedicine in such emergency care when alternative in-person care is available.

  1. Consent of Patient is a must: The Guidelines make a patient's consent necessary for any telemedicine consultation, which may be given impliedly or explicitly. In case, a patient initiates the telemedicine consultation, then the consent is implied but explicit patient consent is needed if a health worker, RMP or a caregiver initiates a telemedicine consultation. The Guidelines are flexible in so far as the explicit consent may be recorded in any form, that is, a patient can send an email, text or audio/video message stating his consent to the RMP (e.g. "Yes, I consent to avail consultation via telemedicine" or any such communication in simple words). The RMP is required to record the consent in his patient records.

  1. Party Autonomy at all stages: The Guidelines permit a RMP to decide to not proceed with the consultation at any time and may refer or request for an in-person consultation. Similarly, the patient also has the right to choose to discontinue the teleconsultation at any stage.

  1. Types of Consultation: The Guidelines recognize two types of patient consultations, namely, first consult and the follow-up consult.

The Guidelines define first consult to mean: (a) The patient is consulting with the RMP for the first time, or (b): The patient has consulted with the RMP earlier, but more than 6 months have lapsed since the previous consultation; or (c) the patient has consulted with the RMP earlier, but for a different health condition.

On the other hand, a follow-up consult has been defined to mean that the patient is consulting with the same RMP within 6 months of his/her previous in-person consultation and this is for the continuation of care of the same health condition. However, it is not a follow-up consultation if: (a) there are new symptoms that are not in the spectrum of the same health condition; and/or (b) RMP does not recall the context of previous treatment and advice; in which case it will be regarded as the first consult.

  1. Patient Assessment: RMPs are required to make all efforts to gather sufficient medical information (history/examination findings/Investigation reports/past records etc.) about the patient's condition before making any professional judgment. RMPs are also required to maintain all patient records including case history, investigation reports, images, etc. The Guidelines provide that the RMP depending upon his assessment and professional judgment may prescribe and provide: (a) Health education (which includes health promotion and disease prevention advice) appropriate in the case; and/or (b) counseling related to specific clinical condition; and/or (c) prescribe medicines.

  1. Directions regarding prescription of medicines: The Guidelines specifically provide that a RMP may prescribe medicines via telemedicine only when RMP is satisfied that she has gathered adequate and relevant information about the patient's medical condition. The Guidelines show the necessary sensitivity and due care required before prescription of medicines and require RMPs to refrain from prescribing medicines without applying their mind to the diagnosis. The Guidelines also clearly state that prescribing medicines without an appropriate diagnosis/provisional diagnosis will amount to a professional misconduct.

The Guidelines emphasize the limitations faced by telemedicine inadequate examination and bar an RMP in prescribing medicines in cases where a physical examination is critical for consultation, and provide that an RMP should not proceed until a physical examination can be arranged through an in-person consult. The Guidelines reiterate that wherever necessary, depending on the professional judgment of the RMP, he is required to recommend: (a) video consultation; (b) examination by another RMP/ Health Worker; (c) In-person consultation; thus impliedly stating that prescription of medicines without visual examination is to be avoided in important cases.

  1. List of Medicines: In furtherance of the importance attached to the adequate examination and due application of mind before prescription of medicines, the Guidelines provide a set of criteria which must be met before a RMP prescribes any medicines and impose certain limitations in this regard by categorizing the medicines under different lists based on their use, effect and potential for abuse, as under:

List O: The medicines in this list can be prescribed by any mode of tele-consultation and comprise of medicines which are used for common conditions and are often available 'over the counter'.

List A: List A medications can be prescribed during the first consult through video consultation (and not through any other means) and are being re-prescribed for re-fill, in case of follow-up. This list contains relatively safe medicines with low potential for abuse.

List B: This list contains such medicines which may be prescribed by RMP to patient who is undergoing follow-up consultation in addition to those which have been prescribed during in-person consult for the same medical condition.

Prohibited List: The substances mentioned in this list cannot be prescribed via telemedicine as such medicines have a high potential of abuse and could harm the patient or the society at large if used improperly. The drugs listed in Schedule X of Drug and Cosmetic Act and all such substances listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985 or rules framed thereunder come under this List.

The aforesaid Lists are provided as Annexure 1 to the Guidelines.

  1. Mandatory issuing of prescription and other safeguards: In all cases where the RMP has prescribed medicines, a RMP is required to issue a prescription as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. The RMPs are also require to ensure that the prescriptions are in compliance with the provisions of the Drugs and Cosmetics Act and Rules. A sample format of prescription is suggested in Annexure 2 of the Guidelines. It is also mandated that the RMP is required to provide a photo, scan, digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform. In order to avoid any profiteering and nexus between the pharmacies and RMP, the Guidelines require a RMP to take express consent of the patient permitting the RMP to get the medicines dispensed from any pharmacy of his/ her choice.

  1. Maintenance of digital trail/ documentation of consultation. The Guidelines make it incumbent on RMP to maintain all the records/ documents for telemedicine interaction (e.g. phone logs, email records, chat/ text record, video interaction logs etc.), patient records (reports, documents, images, diagnostics, data etc.) and prescription records.

  1. Fee for Telemedicine Consultation: The Guidelines provide parity between telemedicine consultations with in-person consultation and state that a telemedicine consultation should be treated the same way as in-person consultation from a fee perspective. An RMP is also required to give a receipt/invoice for the fee charged for providing telemedicine-based consultation.

  1. Medical ethics, data privacy & confidentiality: The Guidelines provide that the same standard of medical ethics, including professional norms for protecting patient privacy and confidentiality as per Indian Medical Council Act, 1956 shall be applicable to the RMPs. A RMP is required to fully abide by the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 and with the relevant provisions of the Information Technology Act, 2002, Drugs &Cosmetics Act, 1940 and Rules 1945, Clinical Establishment (Registration and Regulation) Act, 2010, Information Technology Act, 2000 and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011, and all other relevant law/rules as may be applicable to her.

The Guidelines also lay special emphasis on protection of a patient's privacy and confidentiality of the process and requires a RMP to follow all safeguards in the handling and transfer of personal information of a patient. However, a RMP is not held responsible for breach of confidentiality if there is a reasonable evidence to determine that the patient's privacy and confidentiality has been compromised by a technology breach or by a person other than RMP. At the same, the Guidelines mandate the RMP to take a reasonable degree of care while hiring any technology services.

  1. Ban on Advertisements: RMPs are not permitted to solicit patients for telemedicine through any advertisements or inducements.

  1. Misconduct and Penalty: The Guidelines are at pains to emphasize that any activities that wilfully compromise patient care or privacy and confidentiality, or violate any prevailing law are explicitly not permissible and shall be treated as misconduct. Some examples are specifically listed in the Guidelines to emphasize the importance of maintaining professional ethics, conduct and privacy of the patient. For instance: (a) RMPs insisting on telemedicine, when the patient is willing to travel to a facility and/or requests an in-person consultation; (b) RMPs misusing patient images and data, especially private and sensitive in nature (e.g. RMP uploads an explicit picture of patient on social media etc;(c) RMP prescribes medicines from the specific restricted list.

As per the Guidelines, penalties for any misconduct shall be imposed in terms of the provisions of Indian Medical Council Act, and other applicable laws as mentioned above.

  1. Guidelines for Technology Platforms enabling Telemedicine: The role of technology platforms (mobile apps, websites etc.) as the market place between the patient and the RMP enabling the patients to consult with RMPs through the platform is crucial and cannot be overemphasized. The Guidelines thus address the potential concerns arising out of such arrangement and provide detailed advisories to the technology platforms. The Guidelines direct the technology platforms to ensure the verification of credentials of the practitioners listed on the platform so that the patients are only dealing with such practitioners registered with national medical councils or respective state medical council. Thus, technology platforms are now required to conduct their due diligence before listing any RMP on its online portal and provide the name, qualification and registration number, contact details of every RMP listed on the platform, which promoted transparency.

Further the Guidelines also put an obligation on the technology platforms to report any non-compliance on part of RMP to the Board of Governors, who are empowered to take appropriate action in this regard. At the same time, the Guidelines also proscribe technology platforms to counsel the patients or prescribe any medicines to a patient. It is specifically made clear that only a RMP is entitled to counsel or prescribe and has to directly communicate with the patient in this regard. The Guidelines mention that while new technologies such as artificial intelligence, internet of things, advanced data science-based decision support systems etc. could assist and support a RMP on patient evaluation, diagnosis or management, the final prescription or counseling has to be directly delivered by the RMP .

A technology platform is also required to ensure that there is a proper mechanism in place to address any queries or grievances of a patient. If a technology platform is found in violation of these obligations prescribed by the Guidelines, the Board of Governor may blacklist such technology platform from providing telemedicine services.

ANALYSIS AND CONCLUSION:

Telemedicine is poised to play a complementary and supplementary role to in-person consultation. Apart from its unique role in delivering services to the individuals during the times of epidemics and emergencies, the Guidelines recognize the transformative potential of the telemedicine in providing access to quality healthcare especially in the grassroots level through mid-level provider/health worker by connecting patients remotely to doctors on especially designed platforms. Telemedicine also promotes better management and upkeep of records. The Guidelines have been designed to promote accountability and protect genuine interests and concerns of all stakeholders, including a RMP, patient, technology platform provided that they are in compliance with the suggested measures.

On a broader level, given India's unique challenges in providing healthcare to all its citizens, the important role of telemedicine is also emphasized in Indian government's policy documents regarding provisioning of e-health. The regulation of practice of telemedicine through these Guidelines create the necessary regulatory basis for creation of the necessary framework towards 'mainstreaming telemedicine in health systems will minimize inequity and barriers to access'.

These Guidelines by recognizing and regulating telemedicine pave the way for creation of a robust healthcare infrastructure in remote areas and harnessing of communication networks to provide effective and timely consultation by RMPs to patients in all nooks and corners of the country through well-designed networks. However, emphasis for such institutional incorporation is missing in the Guidelines. To that extent, the Guidelines require expansion or supplementation by incorporating provisions which provide institutional absorption within the mainstream healthcare system. For example: The mandatory provisioning of telemedicine units within a government hospital shall go a long way in mainstreaming telemedicine.

It is also important to plug the gaps which have arisen due to express exclusions of a few areas from the practice of telemedicine by the Guidelines. At present, certain aspects of telehealth such as research and evaluation and continuing education of healthcare workers is specifically left out of the Guidelines. As stated above, the education and evaluation of healthcare workers in e-health and telemedicine forms a core function in a public healthcare system seeking to leverage telemedicine for providing equal access to all. In that regard, it is crucial that separate guidelines and instructions formulating a well-designed policy and action plan regarding education and training of support staff including healthcare workers, in sync with these Guidelines, is put in place without delay, without which it shall be difficult to operationalize telemedicine in public healthcare system.

The Guidelines also expressly exclude cross-jurisdictional consults. The exclusion of global consultation from availing telemedicine requires a relook as borders should not come in the way of providing healthcare which is a universal right. Although there are obvious legal and ethical challenges in permitting global consultation to patients but India is a hub of global medical tourism and it is neither in the interest of the medical industry nor the patients outside India that they are deprived from employing the salient features of telemedicine. Doing that amounts to throwing the baby with the bathwater. Global teleconsultation ought to be permitted by adopting a more nuanced approach in addressing the unique and critical challenges at play in case of cross-jurisdictions consults by harnessing the existing global frameworks and issuance of separate guidelines in this regard at the earliest in tune with the best practices adopted by other jurisdictions in this regard.

To conclude, the laudable objectives of the Guidelines can only be served if the RMPs, the drivers of the telemedicine system, are trained in the letter and spirit to follow the provisions of these Guidelines. In this regard, as envisaged in the Guidelines, it is imperative that regulator comes up with a well-designed an online course incorporating the most efficient modules and practices of telemedicine across the world to train and sensitise the RMPs towards their role and responsibilities in the creation of a robust and lively telemedicine culture in India.

Tahir Ashraf Siddiqui is an Advocate- on- Record, Supreme Court of India and practices before courts in Delhi. He may be reached at tahir.nlu@gmail.com. Views are personal.

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