The Medical Council of India (“MCI”) has legitimized the practice of telemedicine by registered medical practitioners, giving a significant relief to doctors and patients amid the current scenario of COVID-19 pandemic where face-to-face consultations are difficult.
The Government of India has prepared a new set of “telemedicine practice guidelines” in collaboration with NITI Ayog and has notified the same under the Indian Medical Council (Professional Conduct, Etiquette, and Ethics Regulation, 2002), on March 25th 2020 (“guidelines”). With the advent and practice of telemedicine, doctors can now provide remote consultations, remote diagnosis, treat patients through different modes of telecommunications such as video, audio (phone), emails or texts and Mobile apps (WhatsApp, Hangout, Skype, Facebook messenger etc.).
Telemedicine provides an optimal solution for not just providing timely and faster access, it also reduces financial costs associated with travel. It also reduces the inconvenience/impact to family and caregivers and other social factors and particularly in cases where there is no need for the patient to physically see the RMP e.g. for regular, routine check-ups or continuous monitoring. Telemedicine can greatly reduce the burden on the secondary hospitals. It can also provide rapid access to medical practitioners who may not be immediately available in person.
These guidelines provides norms and protocols relating to physician-patient relationship, issues of liability and negligence, evaluation, management and treatment; informed consent, continuity of care, referrals for emergency services, medical records, privacy and security of the patient records and exchange of information, prescribing and reimbursement; health education and counseling.
An Overview of the Telemedicine Practice Guidelines
As per the guidelines framed, “telemedicine” is the delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication 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 and only a Registered Medical Practitioner (“RMP”) who is enrolled with the State Medical Register or the Indian Medical Register under the Indian Medical Council Act,1956 can offer telehealth services.
Types of Consultations
These guidelines provides for the different types of patient consultations, namely, first consult and the follow-up consult.
First Consult is where the patient is consulting with the RMP for the first time; or The patient has consulted with the RMP earlier, but more than 6 months have lapsed since the previous consultation; or The patient has consulted with the RMP earlier, but for a different health condition.
Follow-Up Consult(s) means the patient is consulting with the same RMP within 6 months of his/her previous in person consultation and this is for continuation of care of the same health condition. However, it will not be considered a follow up if:
- There are new symptoms that are not in the spectrum of the same health condition; and/or
- RMP does not recall the context of previous treatment and advice.
It has also been stated that for Non – Emergency consult, the first consultation between doctor (RMP) and patient need not be an in-person consultation, and doctors in India can provide the first consultation to patients located in any State remotely through teleconsultation.
Emergency consult for immediate assistance or first aid etc., where in case alternative care is not present, tele-consultation might be the only way to provide timely care. In such situations, RMPs may provide consultation to their best professional judgment. Telemedicine services should however be avoided for emergency care when alternative in-person care is available, and telemedicine consultation should be limited to first aid, life-saving measure, counseling and advice on referral. In all cases of emergency, the patient must be advised for an in-person interaction with an RMP at the earliest.
Issue of Prescription and Transmit
For issuing a prescription, the RMP needs to explicitly ask for the age of the patient, and if there is any doubt, the RMP can ask for the patient’s age proof. Where the patient is a minor, after confirming the age, tele consultation would be allowed only if the minor is consulting along-with an adult whose identity needs to be ascertained.
An RMP should begin the consultation by informing the patient about his/her name and qualifications. If the RMP has prescribed medicines, RMP shall issue a prescription as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations and shall not contravene the provisions of the Drugs and Cosmetics Act and Rule. The RMP shall provide photo, scan, digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform. In case the RMP is transmitting the prescription directly to a pharmacy, he/ she must ensure explicit consent of the patient that entitles him/her to get the medicines dispensed from any pharmacy of his/ her choice.
These guidelines specifically state that in a Telemedicine consultation both the patient and the RMP need to know each other’s identity. Going forward, all doctors who provide teleconsultation will have to display their registration number accorded to him/her by the State Medical Council/MCI, in all communications exchanged with the patient – for example, in emails or WhatsApp messages, on prescriptions, website and on fee receipts. The RMPs have to verify the patient’s identity by name, age, address, email ID, phone number, registered ID or any other identification as may be deemed appropriate.
Patient Consent:
The guidelines state that the patient consent is necessary for any telemedicine consultation. The consent can be implied or explicit depending on the situation. If the patient initiates the telemedicine consultation, then their consent is implied. However, if a Health worker, RMP or a Caregiver initiates a Telemedicine consultation then an explicit patient consent is required. The RMP must record the patient consent in his patient records.
Modes of Telemedicine:
In situations where in order to reach a diagnosis and to understand the context better; a real-time consultation may be preferable over an asynchronous exchange of information. Similarly, there would be conditions where an RMP could require hearing the patient speak, therefore, a voice interaction may be preferred than an email or text for a diagnosis. There are also situations where the RMP needs to visually examine the patient and make a diagnosis. In such a case, the RMP could recommend a video consultation. A decision on whether a remote consultation or in – person consultation is appropriate is left to the doctor’s discretion by exercising his/her‘s professional judgment without compromising the quality of care in the best interest of the patient.
Apart from direct RMP and patient consultation, the telemedicine consultations can be held between a caregiver and a RMP, RMP to RMP, health worker and RMP.
Mandatory Online Training for all RMPs:
All RPMs will have to complete a mandatory online course in telemedicine administered by the MCI’s board within 3 years of its notification to provide remote consultations. Since an online course may take a while to develop, doctors can examine patients remotely in the interim but must abide by the guidelines. Thereafter, undergoing and qualifying such a course, as prescribed, will be essential prerequisite to practice telemedicine consultation.
Permissible Drug list and Specific Restrictions:
The Government of India has also imposed certain specific restrictions on the type of medications that can be prescribed based on the type and mode of consultations.
‘List O’ comprises of those medicines which are safe to be prescribed through any mode of tele-consultation. It encompasses medicines which are used for common conditions and available over-the counter drugs and that may be deemed necessary during public health emergencies.
‘List A’ comprises of relatively safe medicine with low potential for abuse. These medications can be prescribed during the first consultation over video consultations and are being re-prescribed in a follow-up consultation for a re-fill.
‘List B’ is a list of medication which RMP can prescribe to a patient who is undergoing follow-up consultation in addition to those which have been prescribed during in-person consult for the same medical condition.
Meanwhile, The Government of India has also listed out certain drugs that cannot be prescribed through telemedicine. This includes drugs listed under ‘Schedule X’ of the Drugs and Cosmetics Act of 1940 and its Rules, and any narcotics and psychotropic substance listed in the Narcotics Drugs and Psychotropic Substances Act of 1985.
The guidelines states that it is incumbent on part of the RMP to maintain the digital trail/records/ documentations and prescriptions of the patient consultation for the period as prescribed from time to time
Fee for Telemedicine Consultation
The RMP may charge an appropriate fee for the Telemedicine consultation provided and he/she should also give a receipt/invoice for the fee charged for providing telemedicine based consultation.
Guidelines for Technology Platforms enabling Telemedicine
These telemedicine guidelines also address technology platforms that enable telemedicine services. It specifically states that such platforms can list a doctor only after conducting their due diligence verifying the doctor’s credentials before listing any RMP on its platform. Importantly, the guidelines allow the use of artificial intelligence and machine learning tools to assist and support RMP in patient evaluation, diagnosis or management, the final prescription or counseling has to be directly delivered by the RMP.
Exclusions:
The guidelines explicitly exclude the following:
- Does not provide for consultations outside the jurisdiction of India.
- Specifications for hardware or software, infrastructure building & ma
- Data management systems involved; standards and interoperability.
- Use of digital technology to conduct surgical or invasive procedures remotely.
- Other aspects of telehealth such as research and evaluation and continuing education of healthcare workers.