Summary - Telemedicine Practice Guidelines
Doctor friends,
Telemedicine guidelines now allow you to do everything. Just be careful; Liability is on you now, so:
Technology Requirement:
Relevant Clause by Clause Summary - Telemedicine Practice Guidelines - 25 March 2020
This constitutes Appendix 5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation, 2002Definition:‘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 for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.'
With telemedicine, there is higher likelihood of maintenance of records and documentation hence minimalizes the likelihood of missing out advice from the doctor and other health care staff. Conversely, the doctor has an exact document of the advice provided via tele-consultation. Written documentation increases the legal protection of both parties. <Interpretation>: Keeping Electronic Medical Records is now mandatory.
help patients adhere better to their medication regimens and manage their diseases better. Telemedicine can also enable the availability of vital parameters of the patient available to the physician with the help of medical devices such as blood pressure, blood glucose, etc management.
Unnecessary and avoidable exposure of the people involved in delivery of healthcare can be avoided by using telemedicine and patients can be screened remotely.
India’s digital health policy advocates use of digital tools for improving the efficiency and outcome of the healthcare system and lays significant focus on the use of telemedicine services, especially in the Health and Wellness Centers at the grassroots level wherein a midlevel provider/health worker can connect the patients to the doctors through technology platforms in providing timely and best possible care. <Interpretation>: Telemedicine Guidelines have to be read in conjunction with and will be governed under the ambit of India's Digital Health policy i.e. NDHM, NDHB Standards, EHR Standards and MDDS Standards for Health.
However, there has been concern on the practice of telemedicine. Lack of clear guidelines has created significant ambiguity for registered medical professionals, raising doubts on the practice of telemedicine. The 2018 judgement of the Hon’ble High Court of Bombay had created uncertainty about the place and legitimacy of telemedicine because an appropriate framework does not exist. <Interpretation>: All the ambiguity is now removed.
In India, till now there was no legislation or guidelines on the practice of telemedicine, through video, phone, Internet based platforms (web/chat/apps etc). The existing provisions under the Indian Medical Council Act, 1956, the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 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 primarily govern the practice of medicine and information technology. Gaps in legislation and the uncertainty of rules pose a risk for both the doctors and their patients.
It also spells out how technology and transmission of voice, data, images and information should be used in conjunction with other clinical standards, protocols, policies and procedures for the provision of care.
1.3.3 - All registered medical practitioners intending to provide online consultation need to complete a mandatory online course within 3 years of its notification. <Interpretation>: RMP must be trained on Telemedicine course within 3 years of this notification
1.4 - Classification of Telemedicine:
Communication - Real time vs Asynchronous
Purpose - First, Follow-up, Emergency
Individuals - RMP, Health worker, Caregiver, Patient
2.0 - Limitations of Telemedicine: <Interpretation>: It is difficult to establish the ID of the Patient and the RMP over Video/Audio/Text. Hence proper and sufficient ID proof has to be presented from both sides. Patient identification needs to be clearer, greater chance of imposters representing the real patient over a Audio Call. It is difficult for the RMP to do a Physical Examination. Only possible when there is a Healthcare Worker on the other side also.
3.0 - The professional judgment of a Registered Medical Practitioner should be the guiding principle for all telemedicine consultations: An RMP is well positioned to decide whether a technology-based consultation is sufficient or an in-person review is needed. Practitioner shall exercise proper discretion and not compromise on the quality of care.
3.2.2 - 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 should ensure that there is a mechanism for a patient to verify the credentials and contact details of the RMP.
3.4.1 - If, the patient initiates the telemedicine consultation, then the consent is implied [Similar to Physical In Office Consultation]
3.4.2 - An Explicit patient consent is needed if: A Health worker, RMP or a Caregiver initiates a Telemedicine consultation.
3.5.1 - An RMP would 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 he/she can request for additional information from the patient.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. RMP shall maintain all patient records including case history, investigation reports, images, etc. as appropriate. <Interpretation>: Data of the Current Consult and sufficient data of the past is required for providing the Consult. Digital or Non-Digital Data has to be kept by the RMP. How much Information required is Left to the discretion of the RMP but it has to be sufficient to support the diagnosis and treatment plan.
3.6.2 - 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.
3.7.1 - 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 Counseling related to specific clinical condition; and/or
Prescribe Medicines
<Interpretation>: RMP can prescribe Medicines over a Telemedicine Consult.
3.7.4 - Prescribing medications, via telemedicine consultation is at the professional discretion of the RMP. It entails the same professional accountability as in the traditional in-person 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. Hence, Prescribing Medicines is Left to the clinical judgement of the RMP as per the guiding lists given below:
List O - OTC with Any kind of communication mode.
List A - Re-Fills and reasonably safe medication after Video Consult.
List B - Follow-Ups with Any kind of communication mode.
Prohibited - Potential for Abuse, Scedule X, Narcotics etc. can not be prescribed.
3.6.4.2 - Prescription Format is given in the Annexure. RMP shall provide photo, scan, digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform o 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. <Interpretation>: ePrescription is explicitly allowed. No need for physical signatures in ePrescriptions. RMP has to obtain explicit Consent of patient before sending ePrescription to the Pharmacy.
3.7.1.2 - Registered Medical Practitioner would be required to fully abide by Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 and with the relevant provisions of the IT Act, Data protection and privacy laws or any applicable rules notified from time to time. Interpretation: All Telemedicine controls to be built as per IT Act, Data Privacy and Data Security regulations etc.
3.7.1.3 - RMP Protected from breach if the breach is attributable to Technology or a person other than the RMP. The RMPs should ensure that reasonable degree of care undertaken during hiring such services.
3.7.2 - MAINTAIN DIGITAL TRAIL/ DOCUMENTATION OF CONSULTATION: It is incumbent on RMP to maintain the following records/ documents for the period as prescribed from time to time. Log or record of Telemedicine interaction (e.g. Phone logs, email records, chat/ text record, video interaction logs etc.). Patient records, reports, documents, images, diagnostics, data etc. (Digital or non-Digital) utilized in the telemedicine consultation should be retained by the RMP. Specifically, in case a prescription is shared with the patient, the RMP is required to maintain the prescription records as required for in-person consultations. <Interpretation>: RMP is responsible for Maintaining Digital Trail or Documentation including Logs, Digital or Non-Digital patient records.
3.7.3 - RMP can charge a reasonable Fee for Consultation and should provide a receipt for the Fees.
4. - Telemedicine envisaged in 5 scenarios:
Patient to Registered Medical Practitioner
Caregiver to Registered Medical Practitioner
Health Worker to Registered Medical Practitioner
Registered Medical Practitioner to Registered Medical Practitioner
Emergency Situations
<Interpretation>: In 3 and 4 physical examination is possible. Gives greater visibility into the disease condition of the patient. RMP can prescribe medicine with more confidence.
5.4 <Interpretation>: Artificial Intelligence not allowed to Consultation. Artificial Intelligence can at best be an assistant the RMP.
-------------------------
Points to Ponder:
Telemedicine Notes shared by Dr Pankaj Gupta for the Medical Fraternity
- Do not step out of your clinical comfort zone;
- Keep all the past and present records - Text, Audio, Video, Paper, Films etc. It is mandatory to keep records. Also the records provide a legal cover to the medical practitioner in case of any MLC.
- Any Consultation without Physical Examination was not allowed.
- Telemedicine needed Healthcare professionals on both sides of the Electronic Line.
- Only Triage was allowed over a Voice call.
- ePrescription was not allowed. MCI insisted on physically signed prescriptions.
- Online Pharmacy delivery without verification of physically signed prescriptions was not allowed.
- As per MCI, Patient walking into the Physical clinic is considered as Deemed consent. Law did not interpret the same for Telemedicine calls.
- Guidelines were silent on Consent, privacy and data security.
- Telemedicine service providers had to be registered with respective States under the Shops Act and Clinical establishment Act.
- MCI Contributory Negligence Clause included the Telemedicine software and service providers also i.e. they also had to share the legal Liability.
- Access and Availability.
Technology Requirement:
- Cloud First Design: Gone are the days when you needed a big technology infrastructure for Telemedicine setup. Just host your App on the cloud.
- Mobile First Design: Now in the FAANG Digital era, all you need is an EMR on your mobile with a Text/ Audio/ Video calling plugin like Skype, WhatsApp, Team, Meet...etc.
- EMR is Mandatory: Make sure the EMR output is in compliance with the NDHB/EHR/MDDS Digital Health Standards. EMR should have ability to push the medical records to a National PHR whenever it becomes available.
- Connectivity: Internet 4G is required for Video calling. Internet 3G is enough for Audio calling and Text Consultation.
- Patient demographics & encounter / visit clinical summary should use the government published libraries of data elements & code directories from MDDS_EHR standards. There are 1000 + data elements and 144 code directories defined and available in PDF format to be used by application developers. (XSDs, CSV, JSON, XML formats for the same are available with Access Health International in open source)
- Diagnosis & chief complaints- Diagnosis & chief complaints to be captured using WHO- ICD 10 code list.
- Clinical Notes- SNOMED CT codes to be used that are published and available with NRCeS on their website with tools for implementation.
- Lab & radiology Investigations- LOINC mapped with local investigation codes are to be used for all investigation orders to be paced through an EMR.
- Procedures (non-diagnostics & radiology procedures) - SNOMeD CT is recommended to be used for creating/prescribing any procedure order for the patient. A telemedicine provider can download and use free SNOMeD codes for India by registering on NRCeS website.
- Drug Prescription- An electronic prescription is required to be generated with a prescribing physician licence ID using NFI recommended Generics or Indian Drug Extension available on NRCeS website in SNOMed format.
- Referral Management- Solution shall support an electronic referral and an E-referral note with standardized digital visit/encounter summary to facilitate "continuum of care" with futuristic place holders for Facility & doctor registry lookup services.
- Health Information Exchange- NDHB recommends FHIR resource 4 to be used for clinical & health claim information exchange between providers and payers with indian specific semantic & terminology standards.
- Note- A FHIR compliant Digital clinical summary structure & design (electronic encounter note ,electronic referral note and electronic prescription note) as per telemedicine guidelines & MCI guidelines, are readily made available in JSON format on www.openbodhik.in
Relevant Clause by Clause Summary - Telemedicine Practice Guidelines - 25 March 2020
This constitutes Appendix 5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation, 2002Definition:‘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 for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.'
With telemedicine, there is higher likelihood of maintenance of records and documentation hence minimalizes the likelihood of missing out advice from the doctor and other health care staff. Conversely, the doctor has an exact document of the advice provided via tele-consultation. Written documentation increases the legal protection of both parties. <Interpretation>: Keeping Electronic Medical Records is now mandatory.
help patients adhere better to their medication regimens and manage their diseases better. Telemedicine can also enable the availability of vital parameters of the patient available to the physician with the help of medical devices such as blood pressure, blood glucose, etc management.
Unnecessary and avoidable exposure of the people involved in delivery of healthcare can be avoided by using telemedicine and patients can be screened remotely.
India’s digital health policy advocates use of digital tools for improving the efficiency and outcome of the healthcare system and lays significant focus on the use of telemedicine services, especially in the Health and Wellness Centers at the grassroots level wherein a midlevel provider/health worker can connect the patients to the doctors through technology platforms in providing timely and best possible care. <Interpretation>: Telemedicine Guidelines have to be read in conjunction with and will be governed under the ambit of India's Digital Health policy i.e. NDHM, NDHB Standards, EHR Standards and MDDS Standards for Health.
However, there has been concern on the practice of telemedicine. Lack of clear guidelines has created significant ambiguity for registered medical professionals, raising doubts on the practice of telemedicine. The 2018 judgement of the Hon’ble High Court of Bombay had created uncertainty about the place and legitimacy of telemedicine because an appropriate framework does not exist. <Interpretation>: All the ambiguity is now removed.
In India, till now there was no legislation or guidelines on the practice of telemedicine, through video, phone, Internet based platforms (web/chat/apps etc). The existing provisions under the Indian Medical Council Act, 1956, the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 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 primarily govern the practice of medicine and information technology. Gaps in legislation and the uncertainty of rules pose a risk for both the doctors and their patients.
It also spells out how technology and transmission of voice, data, images and information should be used in conjunction with other clinical standards, protocols, policies and procedures for the provision of care.
1.3.3 - All registered medical practitioners intending to provide online consultation need to complete a mandatory online course within 3 years of its notification. <Interpretation>: RMP must be trained on Telemedicine course within 3 years of this notification
1.4 - Classification of Telemedicine:
Communication - Real time vs Asynchronous
Purpose - First, Follow-up, Emergency
Individuals - RMP, Health worker, Caregiver, Patient
2.0 - Limitations of Telemedicine: <Interpretation>: It is difficult to establish the ID of the Patient and the RMP over Video/Audio/Text. Hence proper and sufficient ID proof has to be presented from both sides. Patient identification needs to be clearer, greater chance of imposters representing the real patient over a Audio Call. It is difficult for the RMP to do a Physical Examination. Only possible when there is a Healthcare Worker on the other side also.
3.0 - The professional judgment of a Registered Medical Practitioner should be the guiding principle for all telemedicine consultations: An RMP is well positioned to decide whether a technology-based consultation is sufficient or an in-person review is needed. Practitioner shall exercise proper discretion and not compromise on the quality of care.
3.2.2 - 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 should ensure that there is a mechanism for a patient to verify the credentials and contact details of the RMP.
3.4.1 - If, the patient initiates the telemedicine consultation, then the consent is implied [Similar to Physical In Office Consultation]
3.4.2 - An Explicit patient consent is needed if: A Health worker, RMP or a Caregiver initiates a Telemedicine consultation.
3.5.1 - An RMP would 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 he/she can request for additional information from the patient.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. RMP shall maintain all patient records including case history, investigation reports, images, etc. as appropriate. <Interpretation>: Data of the Current Consult and sufficient data of the past is required for providing the Consult. Digital or Non-Digital Data has to be kept by the RMP. How much Information required is Left to the discretion of the RMP but it has to be sufficient to support the diagnosis and treatment plan.
3.6.2 - 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.
3.7.1 - 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 Counseling related to specific clinical condition; and/or
Prescribe Medicines
<Interpretation>: RMP can prescribe Medicines over a Telemedicine Consult.
3.7.4 - Prescribing medications, via telemedicine consultation is at the professional discretion of the RMP. It entails the same professional accountability as in the traditional in-person 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. Hence, Prescribing Medicines is Left to the clinical judgement of the RMP as per the guiding lists given below:
List O - OTC with Any kind of communication mode.
List A - Re-Fills and reasonably safe medication after Video Consult.
List B - Follow-Ups with Any kind of communication mode.
Prohibited - Potential for Abuse, Scedule X, Narcotics etc. can not be prescribed.
3.6.4.2 - Prescription Format is given in the Annexure. RMP shall provide photo, scan, digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform o 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. <Interpretation>: ePrescription is explicitly allowed. No need for physical signatures in ePrescriptions. RMP has to obtain explicit Consent of patient before sending ePrescription to the Pharmacy.
3.7.1.2 - Registered Medical Practitioner would be required to fully abide by Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 and with the relevant provisions of the IT Act, Data protection and privacy laws or any applicable rules notified from time to time. Interpretation: All Telemedicine controls to be built as per IT Act, Data Privacy and Data Security regulations etc.
3.7.1.3 - RMP Protected from breach if the breach is attributable to Technology or a person other than the RMP. The RMPs should ensure that reasonable degree of care undertaken during hiring such services.
3.7.2 - MAINTAIN DIGITAL TRAIL/ DOCUMENTATION OF CONSULTATION: It is incumbent on RMP to maintain the following records/ documents for the period as prescribed from time to time. Log or record of Telemedicine interaction (e.g. Phone logs, email records, chat/ text record, video interaction logs etc.). Patient records, reports, documents, images, diagnostics, data etc. (Digital or non-Digital) utilized in the telemedicine consultation should be retained by the RMP. Specifically, in case a prescription is shared with the patient, the RMP is required to maintain the prescription records as required for in-person consultations. <Interpretation>: RMP is responsible for Maintaining Digital Trail or Documentation including Logs, Digital or Non-Digital patient records.
3.7.3 - RMP can charge a reasonable Fee for Consultation and should provide a receipt for the Fees.
4. - Telemedicine envisaged in 5 scenarios:
Patient to Registered Medical Practitioner
Caregiver to Registered Medical Practitioner
Health Worker to Registered Medical Practitioner
Registered Medical Practitioner to Registered Medical Practitioner
Emergency Situations
<Interpretation>: In 3 and 4 physical examination is possible. Gives greater visibility into the disease condition of the patient. RMP can prescribe medicine with more confidence.
5.4 <Interpretation>: Artificial Intelligence not allowed to Consultation. Artificial Intelligence can at best be an assistant the RMP.
-------------------------
Points to Ponder:
- Telemedicine guidelines have Equated Telemedicine Consult with Physical in office Consult. All laws and regulations that apply to physical in-office Consult will now apply to Telemedicine Consults also.
- All Liability is now on the Medical Practitioner. So commensurate Standard Treatment Guidelines [STG] should emerge. STG have to emerge for prescribing List A, B drugs.
- Mandatory for Medical Practitioner to keep sufficient Medical records, of current and enough records of the past. In other words the Telemedicine marketplace has to get together to build an interoperability framework across facilities and geographies to enable the longitudinal patient health record [PHR].
- RMP absolved of Liability if problem attributed to Technology - So Contributory negligence for Telemedicine software and service provider should also be spelt out.
Telemedicine Notes shared by Dr Pankaj Gupta for the Medical Fraternity
Labels: #Digital, #Healthcare, cloud applications, EHR, Healthcare Information Technology, Standards
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