Consultation with a doctor over the phone is not novel for most of us. Many of us have, at some time or the other, interacted with doctors over phone, WhatsApp and through other such means of communication. The importance of using information and communication technology to provide healthcare services in a country with a population of over 1.3 billion is not lost on policy makers, who have, now and again, highlighted India's commitment to adopt digital technology to fulfil its healthcare needs. Now, with challenges posed by COVID-19, the need for greater utilisation and faster adoption of digital communication technology for delivery of healthcare services is felt more than ever.
Responding to this need, on 25 March 2020, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 ("2002 Regulations") were amended by the Board of Governors (acting in supersession of the Medical Council of India) to explicitly permit teleconsultation by doctors registered under the Indian Medical Council Act, 1956 ("Amendment"). Teleconsultation is a component of telemedicine and as the name suggests, it refers to consultations being provided by doctors through use of information and communication technology (like audio and video devices, chat platforms like WhatsApp and Facebook Messenger or other applications and websites).
To give clarity regarding the protocol for such consultations, 'Telemedicine Practice Guidelines' ("Guidelines"), prepared in partnership with the NITI Aayog, were also released and included in the 2002 Regulations. In April 2020, the Board of Governors also released certain indicative FAQs based on the Guidelines ("FAQs").
While even prior to COVID-19, the need for greater adoption and use of teleconsultation was undisputed, its legal permissibility was less clear. To make matters worse, a Bombay High Court decision in 2018 casted doubts over the permissibility of prescribing treatment without an in-person consultation. In the absence of any clear guidelines, doctors did not adopt teleconsultation enthusiastically and in most instances, teleconsultations were limited to a rather rudimentary form of family doctors providing consultations to known patients.
However, COVID-19 has precipitated action and, policy makers and regulators have now provided much-needed clarity in the form of the Amendment and Guidelines. Taking a cue from this enactment, the regulatory bodies for Homeopathy and Ayurveda, Siddha and Unani practices have also announced their respective Telemedicine Practice Guidelines for Homeopathy, Ayurveda, Siddha and Unani practitioners. Though differing in terminology, the ethos and terms of the Guidelines for all medical practices remains the same. The Dental Council of India, however, is yet to adopt any guidelines, implying that dentists are not explicitly permitted to offer teleconsultations.
The nomenclature of the Guidelines (Telemedicine Practice Guidelines), however, is a little misleading. While Telemedicine includes within its ambit delivery 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, the Guidelines are limited to teleconsultations (which is a component of Telemedicine). The Guidelines provide "practical advice to doctors" in "pursuing a sound course of action to provide effective and safe medical care founded on current information, available resources, and patient needs to ensure patient and provider safety." In addition, the Guidelines also provide limited "practical advice" for technology platforms enabling teleconsultation, i.e., the intermediaries. We briefly explore the 2002 Regulations and the Guidelines and their impact on three key players viz. the doctor, the intermediary and the patient.
Doctors – additional protocols to be followed
The Guidelines contain, as promised, some helpful practical advice, laying out some procedural protocols for the doctors to fulfil. Some of these have been discussed here.
As the patient-doctor interaction transcends through new modes of interaction, it also gives rise to differing levels of accountability for doctors. The first step towards ensuring such accountability is to eliminate anonymity and to this end, the Guidelines require that the doctors and the patients verify, albeit electronically, each other's identity and credentials, including the registration details of a doctor.
Initiation of teleconsultation and its impact on the restriction on solicitation:
As per the Guidelines, a teleconsultation can be "initiated" by a patient, a doctor, a caregiver of a patient, or a health worker. The Guidelines also cover any consultation between two or more doctors. Consent of a patient has been given paramount importance and the doctor is required to ensure that the patient has consented to teleconsultation. The doctor is, in fact, not permitted to continue teleconsultation if the patient insists on an in-person consult. The Guidelines also recognise differentiated consent requirements. For situations where a patient initiates the consultation, the consent is implied, while for situations where a doctor, a caregiver of the patient (for instance, a family member), or a health worker (for instance, a nurse), initiates teleconsultation, explicit consent of the patient is required. The Guidelines also prescribe the procedure for follow-up consultations, which are defined to include consultation for the same condition.
While the Guidelines provide very detailed guidance on some issues, they fail to clarify the contours of teleconsultation being initiated by the doctor. Existing regulations and the Guidelines prohibit solicitation and advertisements by doctors. Initiation of teleconsultation by a doctor is likely to be at odds with this prohibition and it may be seen as solicitation in certain circumstances. It is likely that initiation of a follow-on consultation with an existing patient would be permissible. It is also equally obvious that doctors should not be able to call up patients at random, to check if they are in need of a teleconsultation. However, in certain other situations, initiation of teleconsultation by a doctor without an explicit request from a patient may create confusion and uncertainty. For instance, can a doctor, without a request from an existing patient, initiate teleconsultation, if such patient usually comes every month for a walk-in consultation? More clarity on what initiation by a doctor implies, and circumstances in which it would be seen as solicitation would reduce apprehensions for doctors in initiating a teleconsultation.
Protocol for prescriptions and the enigma of e-Prescription:
The Guidelines provide three distinct lists of medicines that can be prescribed through teleconsultation. The first list or List O, includes Over-the-Counter drugs such as paracetamol, lozenges, common-cold medicines etc., which can be prescribed through any teleconsultation. The second list or List A is restricted to medicines which can be prescribed only where the teleconsultation is provided through video mode. This includes ointments for skin ailments, ear drops, and follow-up medication for re-fill in case of chronic illness such as, hypertension or diabetes. Such re-fill is permitted for a maximum period of 6 months after which an in-person visit is mandatory. The third list or List B is applicable for follow-up add-on medications, i.e., additional medications to optimize management for chronic illness such as, hypertension or diabetes. The Guidelines specifically prohibit prescription of any drugs included in Schedule X of the Drugs and Cosmetics Act, 1940 and narcotic and psychotropic substances listed in the Narcotic Drugs and Psychotropic Substances Act, 1985. For AYUSH practitioners, the only restriction applicable is a prohibition on prescribing narcotic and psychotropic substances.
With consultation moving to an online platform, the Guidelines also lay down the procedure for issuing and transmitting such prescription (including directly to a pharmacy or a laboratory), with patient's consent). The doctor can provide a photo, scan, a digital copy of a signed prescription or an 'e-Prescription' to the patient via email or any messaging platform. Currently, the legal framework, including the Pharmacy Practice Regulations require that a prescription should be signed. This creates some ambiguity on the meaning of an e-Prescription. For instance, would an image of a handwritten signature or signature with an electronic pen on an electronically generated prescription suffice? Currently, the only form of digital and electronic signatures legally acceptable in India are those which are in conformity with the requirements under the Information Technology Act, 2000 ("IT Act"). The FAQs also indicate that a digital signature would be necessary and as such, a scan of a handwritten signature or a signature made with an electronic pen may not suffice as e-Prescription. Since, the requirements under the IT Act are fairly cumbersome, and are typically used for making certain filings with government authorities, all doctors may not have or end up using digital and electronic signatures. The uncertainties may effectively eliminate the e-Prescription option, requiring doctors to share either scans or photos of hand-signed prescriptions. Clarity on what can be considered as a valid e-Prescription would be very helpful to make the process of teleconsultation more seamless.
Doctor's standard of care:
The doctor's standard of care towards the patient does not change while advising through teleconsultation, hence, the doctor is also required to uphold the "same professional and ethical norms and standards as applicable to traditional in-person care." This also implies that the doctor has the responsibility to determine whether effective consultation can be rendered through teleconsultation. Where in the professional judgment of the doctor, teleconsultation is not appropriate, the Guidelines require them to refuse and terminate teleconsultations. However, it is unclear how such professional judgment would be assessed in claims of malpractice or negligence initiated under the Consumer Protection Act, 1986 and other applicable statutes against the doctor providing teleconsultation. In such cases, Courts and regulatory bodies may use well established principles and place reliance on independent expert testimony, where required.
Online training for doctors:
In a welcome initiative, to acquaint the doctors with the standard operating procedures of teleconsultation along with its limitations, the regulatory bodies for different branches of medicines are in process of developing an online course. Once developed, completion of this program within three years from the date of its introduction will be mandatory for a doctor to continue providing teleconsultation.
Impact on cross-border healthcare:
The Guidelines have bridged the geographical distance between a patient and a doctor. However, the geographical limit of the applicability of the Guidelines itself is restricted to India. This has an impact on cross-border healthcare which is left in a regulatory black hole. This not only covers a simple everyday situation where an Indian resident patient happens to be outside the country, and wants a consultation with a trusted, known Indian doctor through teleconsultation but also, on medical opinions obtained by Indian doctors from foreign doctors.
Intermediaries - Navigating the troubled waters
Guidelines for the intermediaries:
Unlike the traditional practice of medicine, teleconsultation also involves the intermediary i.e., a technology platform which facilitates the communication between the patient and the doctor(s). Such a platform would facilitate the transmission of messages and communication, exchange of data and patient information and may also provide for the transfer and disbursement of money for such consultation.
The Guidelines provide that they specifically cover those technology platforms which work across a network of doctors and enable patients to consult with them through the platform. The Guidelines state that the intermediaries are "obligated" to ensure that patients interact only with doctors who are registered with the applicable regulatory bodies viz., the Indian Medical Council for doctors practicing western medicine, the Central Council of Homeopathy Medicine for doctors practicing homeopathy and the Central Council of Indian Medicine in case of doctors practicing Ayurveda, Siddha and Unani.
In addition to this, intermediaries are also required to conduct their "due diligence" before listing a doctor on their platform. The intermediaries are also obligated to inform the relevant regulatory bodies if any non-compliance by the doctors is "noted". The Guidelines require the intermediaries to ensure that patients have a mechanism for grievance redressal. The Guidelines also prohibit use of artificial technology for providing teleconsultations as only doctors can provide teleconsultations.
Need for clarity on scope of intermediaries covered by the Guidelines:
The requirements laid down for an intermediary make absolute sense when one thinks from the perspective of an intermediary providing specific teleconsultation services for a doctor and a patient such as, Practo. However, the regulatory landscape and obligations on the intermediaries get murkier if one starts thinking of teleconsultation provided through platforms such as WhatsApp, Google Hangouts or Zoom. These platforms are generic in nature and cater to various kinds of communication. The Guidelines may lead to an absurd scenario where Google, WhatsApp or Zoom would need to start complying with obligations such as, ensuring that only registered doctors are using the platforms, verifying their registration details and conducting due diligence on them. While the Guidelines do state that they "specifically covers (sic) those technology platforms which work across a network" of doctors and enable patients to consult with them through the platform, the implication of "work across a network" is not clear. The FAQs also provide no guidance in this regard. Greater clarity in the Guidelines, limiting their applicability to specialised intermediaries would have avoided such stringent requirements which are near impossible for generic intermediaries to comply with.
Non-compliance by doctors, uncertainty for intermediaries:
The intermediary is required to inform the concerned regulatory body if any non-compliance by doctors is "noted" by the intermediary. Interestingly under the IT Act and the Information Technology (Intermediaries Guidelines) Rules, 2011 ("Intermediary Guidelines"), the obligation to take action against illegal conduct is placed on the intermediary only when it receives "actual knowledge" of such conduct. Judicial decisions have provided some meaning to the trigger of "actual knowledge" for different intermediaries, however the word "noted" is bereft of any guidance. It is hence, not clear if this requires constant active monitoring by the intermediary (which may impinge a doctor-patient confidentiality) or, whether it implies non-compliance being brought to the specific notice of the intermediary by the users of their platform. A clarification in this regard would be very helpful for the intermediaries.
The obligation on the intermediary to inform the regulatory bodies of any non-compliance coupled with the obligation to ensure that patients have mechanism for grievance redressal on the platform, may also lead to a situation where the intermediary receives complaints of various nature – ranging from misconduct to medical negligence. There is no guidance in the Guidelines or the FAQs on the nature of non-compliance that the intermediary is required to report. It is also unclear if this would include complaints of medical negligence, which may require an understanding of the field of medicine which most intermediaries may not have. Absent the same, regulatory bodies may find themselves flooded with various frivolous complaints that the intermediaries will, to comply with their obligations, forward to them. Elaborating on the scope of the non-compliance that would require action by the intermediary would greatly assist in ensuring compliance. Since for cases of medical negligence in teleconsultation the patient will continue to have recourse to legal actions before courts, it may be worthwhile to exclude, complaints regarding the adequacy, appropriateness or sufficiency of the teleconsultation, from the scope of non-compliances that requires action by the intermediary.
Patients – convenience v. caution
For patients, the permissibility of teleconsultation would provide increased and more convenient access to healthcare. It will also be highly useful in cases of emergencies where a doctor may guide a caregiver or a patient to take some immediate first aid-steps till such time in-person care can be provided.
A patient's rights in teleconsultation:
While opting for a teleconsultation, a patient needs to be mindful of her rights. Teleconsultation may lead to increased incidents of fraud. The Guidelines require adequate identification of the doctor along with the registration number. Where patients opt for teleconsultation with an unknown doctor, they should take care to verify details.
Since patient's consent is necessary for any teleconsultation as such, success of teleconsultation depends on how successfully patients can overcome the barrier of trusting a doctor over a phone or a video call. One factor that may help build a patient's trust is that, they will have recourse to the same legal mechanism that is available in cases of medical negligence on account of an-in person consult.
The Guidelines also give doctors the prerogative to terminate the teleconsultation if in their professional judgement it would not be sufficient and appropriate. Patients would be well-advised to heed to the doctor and not insist on teleconsultation if it's not considered appropriate by the doctor.
Usage of prescriptions:
The Guidelines and the FAQs also provide some very helpful clarifications for patients regarding prescriptions. While there are potentially some limitations on the use of e-Prescriptions, as discussed earlier, it is clear that patients would be able to use scanned copies or photos of prescriptions and these would have to be honoured by the pharmacies and laboratories. They can also ask their doctor to directly send the prescription to the pharmacies and laboratories. This is a significant step in encouraging use of technology in healthcare.
Implications for data protection:
Another issue that arises for patients, is the protection of their personal data, that will inevitably be shared through the intermediaries. Currently, a bare structure of protection is provided through the Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011. A more wholistic data protection regime is likely to inspire more confidence in patients about adequate safeguards for their personal data. This may lead to greater adoption of telecommunication, especially among those patients who are protective about their personal data. The draft Personal Data Protection Bill, 2019 is currently being considered by the Joint Parliament Committee. Given the pendency of the Bill, the proposed Digital Information Security in Healthcare Act (DISHA), by the Ministry of Health and Family Welfare has been put on hold. Adequate protection for health data in the draft Personal Data Protection Bill, 2019 and eventual passage of DISHA may provide a more wholistic regime for protection and governance of health data.
Regulators – Welcome step with a need for dynamic action
With the exigencies created due to COVID-19 and the practical advice provided by the Guidelines one can hope for faster adoption of teleconsultation by doctors and patients. Regulatory authorities can assist this by addressing some of the lacunae in the Guidelines identified in the article. Once a concrete patient-doctor relationship gets established based on the path set out by the Guidelines and the prevalence of the same increases, more legal and procedural lacunae are likely to surface. It is imperative for the authorities to continue addressing such voids through additional guidance or clarifications to create a robust telemedicine framework.
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