Guest Blog: Telemedicine Practice Guidelines – Trailblazing the darkness of COVID-19 pandemic!
Amidst the Indian COVID-19 pandemic, people are hesitant to physically visit their medical practitioners and are seeking Telemedicine consultation through various digital communication techniques.
Presently, we do not have any specific law or guidelines in India on the practice of telemedicine and the existing provisions under Indian Medical Council Act, 1956 ("IMC Act"), the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 2002) ("Ethics Regulations"), The Drugs & Cosmetics Act, 1940 and Rules 1945, The Clinical Establishment (Registration and Regulation) Act, 2010, Information Technology Act, 2000 ("IT Act") and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 primarily govern the practice of medicine and information technology.
Accordingly, this is an opportune time for the Ministry of Health & Family Welfare ("MoHFW") to issue specific 'Telemedicine Practice Guidelines' ("Telemedicine Guidelines")1 dated 25th March, 2020 enabling 'Registered Medical Practitioners' ("RMP") to provide 'Healthcare' using 'Telemedicine'. The Board of Governors, Medical Council of India ("MCI") has adopted the Telemedicine Guidelines2 which provide for overarching principles and a practical framework. These Telemedicine Guidelines have been included as an amendment to the Ethics Regulations by adding Regulation 3.8 titled as "Consultation by Telemedicine" in the said regulations and are included as Appendix 5.
Further, to the issuance of such Telemedicine Guidelines, the MCI has issued 'Frequently Asked Questions [FAQs] on Telemedicine Practice Guidelines' this month ie. April, 20203.
Some pivotal elements of these Telemedicine Guidelines are listed hereunder:
• Distinction between Telemedicine and Telehealth: In general, Telemedicine is used to denote clinical service delivered by a RMP while Telehealth is a broader term of use of technology for health and health related services including telemedicine.
Telemedicine: "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, rese arch and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities" (Definition by World Health Organization).
Telehealth: "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".
• RMP: A Registered Medical Practitioner is a person who is enrolled in the State Medical Register or the Indian Medical Register under the IMC Act.
• Application: These Telemedicine Guidelines are intended to aid such RMPs to effectively leverage Telemedicine to enhance healthcare service and access to all until an online course is developed and completed by RMPs within 3 years of notification.
They provide the norms and standards for patient consultation and include all channels of communication with the patient that leverage information technology platforms, including Video (Telemedicine facility, video on chat platforms), voice, Audio (Phone, VOIP, Apps etc), text & digital data exchange. They however exclude conduct of surgical or invasive procedures remotely, research and continuing education of health care workers, consultations outside India etc. Though Telemedicine consultation provides a safety net from contagious diseases, it cannot replace physical examination that may require palpitation, percussion etc. which requires physical touch and feel.
Telemedicine applications can be classified into four basic types, according to:
(i) Mode of communication: Video, Audio, Text based (chat based applications, general messaging etc.), asynchronous (email/fax etc.).
(ii) Timing of the information transmitted (Real time video/audio/text interaction, asynchronous exchange of relevant information i.e. transmission of summary of patient complaints and supplementary data).
(iii) Purpose of consultation (Non-emergency – first and follow-up and Emergency).
(iv) Interaction between the following:
(a) Patient to RMP i.e. connecting patients to RMP;
(b) Caregiver to RMP i.e. connecting caregivers to RMP;
(c) Health worker to RMP i.e. a health worker (Nurse, allied health professional or any other designated by authority) facilitating consultation for a patient with RMP and help take history, examine patient, convey findings, reinforce advice given by RMP to patient; and
(d) RMP to RMP i.e. discussion amongst RMPs on patient issues or to disseminate knowledge
• Telemedicine Guidelines:
(i) Telemedicine must be appropriate and sufficient as per context: The guiding principle is professional judgment of a RMP in order to decide whether a technology-based consultation is sufficient or an in-person review is needed without comprising on the quality. RMP must consider mode/technologies available and their adequacy for a diagnosis before choosing to proceed with any health education or counselling or medication. They must uphold the same standard of care as in an in-person consultation but within the intrinsic limits of telemedicine.
(ii) Necessary identification of RMP and the patient: There must be no anonymity and both RMP and patient need to know each other's identity. An RMP should verify and confirm patient's identity by name, age, address, email ID, phone number, registered ID or any other identification as may be deemed to be appropriate. The RMP must also ensure that there is a mechanism for a patient to verify the credentials and contact details of the RMP. The patient must be informed about the name and qualification of the RMP in the beginning of consultation. The prescription must specify the registration number accorded to the RMP by the State Medical Council or MCI.
(iii) Mode of Telemedicine: Various technological systems used to deliver Telemedicine consultation have their respective strengths, weaknesses and contexts in which they may be appropriate or inadequate in order to deliver proper care. There may be situations where a real time consultation may be preferred over asynchronous exchange of information, where visual examination may be necessary for diagnosis and in such cases RMP could recommend video consultation. Depending on the situation, an RMP may decide the best technology for diagnosis and treatment using his/her best judgment.
(iv) Patient Consent: It is necessary for Telemedicine consultation and can be implied or explicit depending on the situation. The consent will be implied when the patient initiates the consultation. An explicit consent will be necessary in the event a health care worker, RMP or Caregiver initiates the consultation and must be recorded in patients records.
(v) Exchange of information for patient evaluation: An RMP will use his/her professional discretion to gather the type and extent of patient information (history/examination findings/Investigation reports/past records etc.) required to be able to exercise proper clinical judgement. This information can be supplemented through conversation with a healthcare worker/provider and by any information supported by technology-based tools. If the RMP feels that the information received is inadequate, then additional information from the patient can be requested. If a physical examination is critical information for consultation, RMP should not proceed until a physical examination can be arranged through an in-person consult. Wherever necessary, RMP in his/her professional judgement shall recommend video consultation, examination by another RMP/Health care worker, in-person consultation.
The information required may vary from one RMP to another based on his/her professional experience and discretion and for different medical conditions based on the defined clinical standards and standard treatment guidelines. RMP shall maintain all patient records including case history, investigation reports, images, etc. as appropriate.
(vi) First consult vs Follow-up consult: First consult means (a) the patient consults with RMP for the first time; or (b) the patient has consulted with 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 different health condition. Follow-up consult means that 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 same health condition; and/or RMP does not recall the context of previous treatment and advice.
(vii) Patient Management: If the condition can be appropriately managed via telemedicine, based on the type of consultation, then the RMP may proceed with a professional judgement to:
• Provide Health Education as appropriate in the case; and/or
• Provide Counselling related to specific clinical condition (May include food restrictions, home physiotherapy etc to mitigate an underlying condition; and/or
• Prescribe Medicines in the professional discretion of RMP: It entails the same professional accountability as in the traditional in-person consult. If a medical condition requires a particular protocol to diagnose and prescribe as in a case of in-person consult then same prevailing principle will be applicable to a telemedicine consult. RMP may prescribe medicines via telemedicine only when RMP is satisfied that he/ she has gathered adequate and relevant information about the patient's medical condition and prescribed medicines are in the best interest of the patient. Prescribing of medicines without an appropriate diagnosis/provisional diagnosis will amount to a professional misconduct.
Specific restrictions: There are certain limitations on prescribing medicines on consult via telemedicine depending upon the type of consultation and mode of consultation. The categories of medicines that can be prescribed via tele-consultation will be as notified in consultation with the Central Government from time to time. The categories of medicines that can be prescribed are listed below:
List O These are safe to be prescribed through any mode of tele-consultation. They comprise of: (a) medicines which are used for common conditions and are available as 'over the counter' medicines eg paracetamol, cough lozenges, ORS etc.; and (b) medicines that may be deemed necessary during public health emergencies.
List A These can be prescribed during the first consult which is a video consultation and are being re-prescribed for re-fill, in case of follow-up. This would be an inclusion list, containing relatively safe medicines with low potential for abuse.
List B Is a list of medication which RMP can prescribe 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.
Prohibited List RMP cannot prescribe the same. These have a high potential of abuse and could harm the patient or the society at large if used improperly i.e. Medicines listed in Schedule X of The Drugs and Cosmetics Act, 1940 and Rules or any Narcotic and Psychotropic substance listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985.
The Annexure to the Telemedicine Guidelines provides a list of medicines in the respective lists of the aforesaid table.
• Issuance of prescription and transmission: If the RMP has prescribed medicines, RMP shall issue 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, 1940 and Rules. 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. Annexure 2 of the Telemedicine Guidelines provides a sample of the prescription format to be followed by RMP.
• General duties and responsibilities of a RMP:
Medical Ethics, Data Privacy & Confidentiality: RMP's must ensure compliance with the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 and with the relevant provisions of the IT Act including Data protection and privacy laws or any applicable rules notified from time to time for protecting patient privacy and confidentiality and regarding the handling and transfer of such personal information regarding the patient. Misconduct shall be construed in certain instances eg. Misusing patients images and data, prescribing medicines in restricted list, soliciting patients through advertisements or inducements. The penalties under IMC Act and other laws will apply.
Maintenance of digital trail/documentation of consultation: RMP's must (a) Maintain log/record of Telemedicine consultation; (b) Retain patient records, reports, diagnostics etc.; and (c) Maintain prescription records as required for in-person consultations.
Fee for Telemedicine consultations: Telemedicine consultations must be construed in the same way as in-person consultations from a fee perspective: RMP may charge an appropriate fee for the Telemedicine consultation and must provide a receipt/invoice for the fee charged for providing telemedicine consultation.
• Guidelines for technology platforms enabling Telemedicine:
Ensure that the consumers are consulting with RMP duly registered with national medical councils or respective state medical council and comply with relevant provisions.
Conduct 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.
Report any non-compliance to Board of Governors ("BoG"), in supersession to MCI who may take appropriate action.
Platforms based on Artificial Intelligence/Machine Learning are not allowed to counsel the patients or prescribe any medicines to a patient. Only a RMP is entitled to counsel or prescribe and has to directly communicate with the patient in this regard.
Ensure that there is a proper mechanism in place to address any queries or grievances that the end-customer may have.
In case any specific technology platform is found in violation, BoG, MCI may designate the technology platform as blacklisted, and no RMP may then use that platform to provide Telemedicine.
• Appropriateness: The Telemedicine Guidelines are a step in the right direction at the right time. They are intended to facilitate and provide access to the over-burdened staff at the hospitals and serve as a litmus lamp for certain RMP's whose professional practice has been adversely affected on account of the pandemic. The FAQs to the Telemedicine Guidelines are indicative only and not exhaustive.
• CoNTeC: The MoHFW recently launched COVID-19 'National Teleconsultation Centre' (CoNTeC)4 on 28th March, 2020 and made it operational at AIIMS with a view to connect the doctors across the country to AIIMS in real time for treatment of the COVID-19 patients on a 24x7 basis. This facility is launched at a time when doctors world over are using different protocols to treat COVID-19 patients and accordingly the goal of the facility is to at least connect the doctors in the country together to discuss amongst themselves the protocols undertaken and provide the best treatment accordingly.
India and its technology can play a pivotal role for providing medical assistance especially to the poor. Going forward, it is intended to connect all the medical colleges and AIIMS such that they can interact and help in the policy implementation for the country in the health sector.
The CoNTeC is a Telemedicine Hub established by AIIMS, New Delhi, wherein expert doctors from various clinical domains will be available 24x7 to answer the multifaceted questions from specialists from all over the country. It is a multi-modal telecommunications hub through which 2 way audio-video and text communications can be undertaken from any part of the country as well as the world at large. The modes of communication will include simple mobile telephony as well as two way video communications, using WhatsApp, Skype and Google Duo. The CoNTeC is also fully integrated with the National Medical College Network (NMCN) to conduct a full fledged Video Conference (VC) between the 50 Medical Colleges connected through the NMCN with its National Resource Centre located at SGPGI, Lucknow.
Similarly, Pune platform for COVID-19 response has launched 'COVID-Madat' with the support of Maharashtra State Innovation Society, a telemedicine helpline for people to tele-screen themselves for COVID related symptoms. Such helpline provides for cloud based automated self-screening and ICMR COVID protocol trained doctors to assist in screening.
Recently, Andhra Pradesh government also officially launched telemedicine facility named 'YSR Telemedicine' to attend to patients in remote areas. The doctors in the primary health centres in remote places will help patients in treatment and provide medicines through ANM's, Asha workers and village secretariat volunteers.
In India, Telemedicine may be a challenge in certain rural clusters and in cases where the mass is uneducated and accordingly government may consider strengthening and/or partnering with community clinics, local/CGHS dispensary, anganwadi workers and/or private for profit and not for profit providers5 to garner support at all levels of community.
• Tweaking: Certain provisions of the Telemedicine Guidelines may be tweaked to enhance the consultation experience from a customer perspective.
Why would a follow-up consultation not include a situation in which RMP does not recall the context of previous treatment and advice? The inability of the RMP to remember a consultation (which must actually be documented) should have no nexus with a follow-up where all patient records are maintained. It must be borne in mind that relaxing a scenario in which RMP may express his inability to recall may hint of an incorrect diagnosis or absence of a correct finding/prescription (irrespective of the fact that a follow up is discounted or not) and must accordingly be eliminated from follow-up exclusion.
There is no provision relating to seeking of a second opinion and accordingly a distinction between follow-up and second opinion may be included.
The RMP's can exercise professional discretion to gather the type and extent of patient information (history/examination findings/Investigation reports/past records etc.) basis the information received from the end customer. They also stipulate same professional accountability as in the traditional in-person consult. However, any breach of duty, if any of the RMP requiring high standard of duty of care may be questioned since RMP relies on the information received from the customer through mode of communication specified herein. The strengths and limitations of such communication techniques are also specified in these Telemedicine Guidelines.
Lastly, while these guidelines intend to curtail the liability of an RMP in case of breach of confidentiality if there is a reasonable evidence to believe that patient's privacy and confidentiality is compromised by a technology breach or by a person other than RMP (i.e. RMP can exercise only reasonable degree of care), they cannot restrain any prosecution against the RMP under specific laws such as the Information Technology Act, 2002 etc.
2. https://mciindia.org/MCIRest/open/getDocument?path=/Documents/Public/Portal/LatestNews/01- Public Notice for TMG -Website Notice-merged.pdf
3. https://mciindia.org/MCIRest/open/getDocument?path=/Documents/Public/Portal/LatestNews/Final_FAQ-TELEMEDICINE 6-4-2020..pdf
5. MoHFW Guidance Note captioned 'Enabling Delivery of Essential Health Services during COVID 19 Outbreak' dated 14th April, 2020
The author is a lawyer and a senior associate with Kapil Sapra and Associates
Disclaimer: The views expressed in the above article are solely those of the author/agency in his/her private capacity and DO NOT represent the views of Medical Dialogues.