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Telehealth Newsletter
Official Newsletter of Tamil Nadu Chapter of Telemedicine Society of India
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What is New? This month the National Medical Commission (nmc.org.in) has released the draft version 2 of the Telemedicine Practice Guidelines on its website. The version two is part of the new Professional Conduct regulation which will now be called National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2022. Please click here to view and send your comments. The last date is 22nd June 2022. The telemedicine section specifically starts from Page 64 of this PDF document. The important elements of the guidelines are well summarised by Bagmishika Puhan in this newsletter and makes an easy point of reference. I do hope TSI soon holds a consensus meeting to send in the comments. Other than that we carry a piece on Speech and hearing from Dr. Vidya Ramkumar. An area of high impact where tele-practice has an important role. Thank You |
National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2022. – Consultation Document
Bagmisikha Puhan
Associate Partner, TMT Law Practice.
Siddhant Gupta
Associate, TMT Law Practice
Preamble
Draft document for public consultation has been released this month by National Medical Commission (NMC) regarding Professional Conduct Regulations (2022) and includes Telemedicine Practice Guidelines Version 2 for Registered Medical Practitioner. This is likely to have far reaching changes in way doctors practice both physical and remote tele-consultations.
The disciplines of medicine and clinical practice have undergone a complete facelift, to cater to the marginalized and underprivileged populace, with telemedicine and teleconsultation measures. The issuance of the Telemedicine Practice Guidelines, 2020 (TPG) brought upon standardization and regulation of the telemedicine industry, a hitherto adverse proposition for the regulatory authorities.
Highlights of the Draft Regulation regarding Professional Conduct Regulations (2022) including Telemedicine Practice
The issuance of the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2022 (Draft Regulations) to update the erstwhile Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 was essential, to update the regulations in view of the novel digitized modes of patient interaction and consultation.
Practice – The Draft Regulations specifically exclude RMP (under NMC) from practicing more than one system of medicine. RMPs are not allowed to practice another system of medicine simultaneously. The certificates so issued by an RMP must contain the details of the training, duration, skills/ competency, and the work done. The onus of establishing the veracity lies on the RMP.
Digitize Patient Records: In addition to impositions at the level of the healthcare institutions, every self-employed RMP must completely digitize patient records within 3 years from the date of publication of the regulations, in absolute compliance with the applicable laws of India and as per the proforma laid down by NMC.
Social Media: The Draft Regulations prescribe the key principles, behavioral obligations upon an RMP on social media. It is pertinent to note that the NMC Regulations do not prescribe any definition for “social media”, and we may be constrained to the definitions provided under IT Act and allied rules, to rely upon the definition of social media.
Training of RMPs: The Draft Regulations make considerable modifications to the TPG and prescribe Continuous Professional Development (CPD) training to RMPs desirous of conducting telemedicine practice in India; the earlier prescribed timeline of seeking a course certification within a period of 3 years from the date of notification of the TPG 2020, has been done away with. It now stresses on how the RMPs must familiarize themselves with the guidelines, as well as appreciate the shortcomings of the practice of telemedicine.
Establishing Relationship & Consent: The TPG now mandate an RMP to commence a consultation with provisioning an introduction [details of name, qualifications, area of specialty] and the location of their affiliate medical establishment. The Draft Regulations further require an RMP to obtain the patient signature or thumb impression with the date of the signature, on the informed consent document shared with the patient. Explicit consent must be recorded in any form – physical, audio, video, graphics, electronic, text – this must be stored by the RMPs. A template with respect to informed consent has also been provided within the draft regulations.
Follow Up Appointments: The specifics of a follow-up consultation have also been amended, wherein the patient may seek an appointment for a follow-up consultation after the expiration of 6 months, provided that the RMP has advised the patient to seek an appointment with him, between the period of 6-12 months from the date of the initial consultation. There is an additional leeway provided to the platforms for affording “follow-up consultations” to the same patient, where the newly assigned RMP / available RMP is comfortable in comprehending the patient’s medical condition after having been provided with adequate information (details of the condition and reports of all relevant investigations) by the patient. We see reliance being placed upon the professional judgment of the RMP who is available. The retention timelines for online consultation remains unchanged from what has been already prescribed for in-patient and out-patient records.
Duties of RMPs: The ethical considerations and duties imposed upon RMPs for practice of telemedicine specifically call out the primary RMP as the one responsible for the care and coordination of the patient, with the distant medical team/ professionals at 1.1.(2). The amended TPG clarify on the range of advisories which may be provided by an RMP during a tele-consult, and allow for advice on immunization, exercise, personal and household hygiene practices, mosquito control and so on.
At Annexure 3, the renewed TPG provide template that must be adhered to by the platform, as a patient information sheet. This includes the information which is already captured within the terms and conditions, and consent form (in some cases) of platforms which own, operate and manage teleconsultation platforms.
Prescription of Drugs: Further, the amended TPG now permit the RMP to prescribe any drugs, depending on the type of consultation, [with the exception of Schedule X drugs] during a tele-consult, basis their professional opinion and judgment.
Telemedicine service providers: The amended TPG now requires telemedicine service providers to establish protocols for referrals to emergency services, a hitherto unregulated aspect of clinical examination and practice in the erstwhile TPG. Further, RMPs must not participate in telemedicine platforms that provide ratings by patient or others including reviews, advertisements, and promotions of RMPs any means. As a consequence, it will become incumbent upon the digital platforms to remove such reviews, ratings that may be associated with a particular RMP listed on their platform.
The Draft Regulations do not merely require the platforms to conduct due diligence of the RMPs qualifications and registrations, but now specifically require that the onus of ensuring all the information regarding the RMP and all their qualifications that have been mentioned on their portal have been authenticated and are registered with the National Medical Register or their respective State Medical Councils is wholly placed on the owners and administrators of the technology platform.
Advertisement of Services: There is a clear embargo on advertisement of any RMPs, and promotion, including by means of manipulation of algorithms, search engines, etc.
Artificial Intelligence: The Draft Regulations reiterate that AI/ ML based counseling and prescription is not permissible; additionally, they clearly state that any correspondence in this regard with the patient shall be delivered directly by the RMP. The Draft Regulations continue to use the same template for prescriptions during online consultations.
Section that Lack Clarity – Unfortunately, the document still does not speak of interoperability, which has been spoken about since the first iteration of Electronic Health Records Standards were released in 2013, by MoHFW. We can only assume that the same is left to be determined by the Ayushman Bharat Digital Mission scheme.
Overall the current document is an improvement on the somewhat outdated Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations of 2002. All the stakeholders are invited to send their expert comments by 22rd June 2022 to National Medical Commission (www.nmc.org.in). The complete document is available on the site. Use this link to access the document-
Legal challenges with issuing prescriptions through teleconsultations
Anay Shukla
Founding Partner, Arogya Legal – Health Laws Specialist Law Firm
Eshika Phadke
Associate, Arogya Legal – Health Laws Specialist Law Firm
The ability of doctors to offer remote consultations has been legitimized after the notification of the Telemedicine Practice Guidelines, 2020 (“Telemedicine Guidelines”).
The Telemedicine Guidelines provide a framework for doctors on how to offer consultations: doctors are at liberty to select whether or not to consult via a teleconsultation, what mode of teleconsultation to adopt, whether to switch to another mode or in-person consultation midway, how to ensure that sufficient information is collected to arrive at a diagnosis (including ordering laboratory or diagnostic tests). After arriving at a diagnosis, doctors may even issue prescriptions to the patients.
On the same lines, the ability of a doctor to issue prescriptions is not unfettered: the Telemedicine Guidelines have categorised medicines that four broad categories – List O, List A, List B and the Prohibited List. Depending on the type and mode of consultation, doctors may issue prescriptions subject to the restrictions for that category. Non-adherence to the restrictions that have been specified for the lists would be treated as professional misconduct under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.
List O medicines can be prescribed following a first-time or follow-up consultation. These are the commonly prescribed drugs that are often over-the-counter drugs such as paracetamol. medications for coughs or common colds, supplements, etc.
List A medications can only be prescribed following a first-time consultation if it is a video consultation. These include ointments and lotions for skin ailments, local ophthalmological drops or ear drops, drugs used in psychiatric practice, etc. These are the drugs that typically require the doctor to undertake a visual inspection of the patient before arriving at a diagnosis as per standard treatment guidelines. Medications for chronic conditions such as diabetes, asthma and hypertension also fall under this list, provided that the diagnosis was made at an in-person consultation, and the doctor has last seen the patient regarding the same condition less than six months prior to the teleconsultation.
Doctors may prescribe re-fills of the same medication or add-ons for the ongoing treatment. The add-ons fall under List B.
The lists are not exhaustive, but indicate the rationale behind the categorisation so that doctors may apply it while issuing prescriptions. Doctors should bear in mind that they are ultimately responsible for the prescriptions, and they should err on the side of caution while issuing prescriptions. They should keep in mind the standard treatment guidelines for the condition while ascertaining what list a drug is likely to fall under and what mode of consultation would be appropriate. If any visual examination is required, a video consultation or in-person consultation should be requested. If a physical examination is typically necessary to arrive at a diagnosis, the doctor should not issue a prescription based on a teleconsultation. If a drug is to be administered only under medical supervision (such as injectables or abortion pills), a prescription cannot be issued to a patient directly, but may be issued during a consultation with another doctor or health worker. In some situations, a video consultation or in-person consultation may not seem necessary to a doctor, but the doctor should bear in mind that it is required under the law.
If a patient refuses to comply with the instructions given by the doctor regarding the mode of consultation, the doctor must record the non-cooperation in their notes and end the consultation without issuing a prescriXJption.
A violation of Telemedicine Guidelines at the hands of a doctor may amount to professional misconduct. Hence, it is paramount that prescription related decisions are based on sound medical and legal rationale.
References:
Telemedicine Practice Guidelines, 2020
Frequently Asked Questions on Telemedicine Practice Guidelines
Understanding the implementation of telepractice in speech and language services for children and adults using a mixed-methods approach
Ms. Varsha Shankar
PhD Research Scholar, Department of Speech, Language and Hearing Sciences,
Sri Ramachandra Institute of Higher Education and Research (DU), Chennai – 600 116.
Email – varshashankar@sriramachandra.edu.in
Dr. Vidya Ramkumar
DBT/Wellcome Trust India Alliance
Intermediate Fellow in Clinical and Public Health Research
Associate Professor, Department of Speech, Language and Hearing Sciences,
Sri Ramachandra Institute of Higher Education and Research (DU), Chennai – 600 116.
Email – vidya.ramkumar@sriramachandra.edu.in
Dr. Shuba Kumar
Samarth, Research for Change, Chennai – 600 004.
Email – shubakumar@samarthngo.org
Review of Telepractice in speech-language pathology (SLP) & Semi-structured interviews (SSI)
In recent years, telepractice in speech-language pathology (SLP) has emerged as a solution to overcome the challenges of access in the delivery of healthcare. Telepractice in SLP has been explored for over a decade, yet there is a significant knowledge gap with respect to factors influencing the implementation and sustaining telepractice. We aimed to identify implementation factors that influence the provision of telepractice in SLP services.
The current study consisted of a scoping review and semi-structured interviews (SSI). Articles that described telepractice in SLP were included if it was implemented for two or more years, providing screening, diagnostic or rehabilitative services to individuals of all age groups with speech and language difficulties across the world. Literature from January 2010 – April 2021 published in the English language were considered. Data from studies was extracted on: project description, geographical distribution, the focus area of service delivery, method and model of telepractice service delivery. Barriers and facilitators were identified and grouped under five domains identified from telemedicine implementation frameworks (technical aspects, organizational aspects, patient perspectives, economical aspects, and ethical legal aspects).
The SSIs were conducted for five authors who provided consent. Data was analysed using a hybrid method (Swain, 2018), which included
i) Deductive template of codes and themes derived from our scoping review and
ii) Data-driven inductive approach that was carried out following data collection.
We then applied the principles of thematic analysis as described by Clarke & Braun (2012).
Data was extracted from 11 studies that were mapped to nine projects in telepractice in SLP.
Telepractice in SLP was implemented in five projects from the USA; two in Australia; and one each in Norway and Canada.
Five of the nine projects reported service delivery to be on-going or routine. The broad focus areas identified included diagnostics and evaluation, therapeutics and comprehensive assessment, management and follow-up care services. Synchronous/ real-time telepractice methods were always used for the provision of diagnostic testing or when providing therapy services using video conferencing. The ‘professional-facilitator-patient’ model was used most commonly followed by the ‘professional-patient’ model.
Barriers: for long-term sustainability included
a. Inadequate initial capital investment,
b. Lack of reimbursement and payment options,
c. Low internet speed and bandwidth,
d. Resistance and hesitancy to use telepractice from the patient’s end,
e. Lack of organizational policies and uniform regulations. Organisational aspects had substantial influence on implementation.
Funding, administrative and infrastructure support were key elements that emerged as a part of organisational support from this study.
Findings of the study –
A. We found that telepractice services that received public-funding reported better sustainability. Availability of critical infrastructure such as internet also depends on political will of administrators.
B. Having a dedicated team of professionals and technicians with clear roles and responsibilities, and inclusion of systematic planning facilitated implementation.
Unique Proposition of the Study – The strength of the current study lies in the unique method of using a mixed-methods approach (combining a scoping review and semi-structured interviews) to get a deeper understanding of the barriers and facilitators influencing the provision of telepractice services in SLP.
Conclusion:
The findings from this study can guide the planning of future telepractice based services in SLP. Telepractice implementation research and reporting in the LMIC context is limited and no study fulfilled the inclusion criteria. Outcome reports from LMIC will be valuable considering the demand for such services in these regions.
In general, telepractice in SLP was not explicitly guided by implementation science or framework. The use of implementation frameworks ensures systematic planning and feasibility assessment to inform the scale-up of implementation. Therefore, it would be worthwhile for program implementers to consider these aspects when exploring telepractice services.
Full article Published in : Wellcome Open Research, 7, 46.
Telemedicine – News from India & Abroad
India
Unlocking the Power of Digital Health – Mansukh Mandaviya at Davos
Digital health is a great equaliser and enabler to support Universal Health Coverage and Sustainable Development Goals and can help ensure accessibility and affordability of health service delivery. India is implementing a national framework for digital health.
Under Ayushman Bharat (Long Live India) Digital Mission, India has embarked on digital transformation of healthcare in India. The focus is on creation of a longitudinal Electronic Health Record for more than 1.3 billion people of India. Health Minister Mandaviya said ‘We have already issued more than 220 million Unique Health IDs along with health facilities and provider registry’.
India also is utilising digital health interventions for its national program management. Reproductive & Child Healthcare IT platform tracks more than 120 million pregnant women for their ANC, PNC check-up, delivery planning and over 90 million children for immunization. Health Management Information system regularly collates data regarding health programmes from more than 200,000 health facilities.
Source: https://pib.gov.in/PressReleseDetailm.aspx?PRID=1828349
International
Artificial Intelligence Benefits Psoriatic Arthritis Patients
PredictAI, a new machine-learning tool developed by researchers, speeds up the diagnosis of psoriatic arthritis (PsA) by up to 4 years, potentially preventing irreversible joint damage and deteriorating function for sufferers…..Readmore
New App Detects COVID by Hearing Sound of Cough
A new app, called ResApp, detects COVID-19 infection by just the sound of a cough. The app, which uses machine learning to analyze cough sounds, could detect Covid with 92 percent accuracy, Daily Mail reported……Readmore
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Telemedicine Practice Guidelines – A Foundation Course for RMPs by TSI Faculty
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https://tsitn.org/tpg-course/
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