Summary- Telemedicine guidelines 2020

The guidelines have been prepared with NITI Aayog, the guidelines include definitions of Telemedicine, telehealth and registered medical practitioners, scope of telemedicine and its applications. It also explains the mode of communication and responsibilities of registered medical practitioner.

Definitions: 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, 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.’(WHO)

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.’ (NEJM Catalyst)

REGISTERED MEDICAL PRACTITIONER

‘A Registered Medical Practitioner [RMP] is a person who is enrolled in the State Medical Register or the Indian Medical Register under the Indian Medical Council Act 1956.’ [IMC Act, 1956]

-Dr Sachin N

Background:

Disasters and pandemics poses significant challenges in providing the health care. Considering the multitude of benefits such as timely and faster access to services, reducing the financial costs, improved documentation. In cases of pandemics medical practitioner can practice without getting himself/staff to the infections. Its beneficial for both patients and health care professionals.

There was lack of clear guidelines poses a risk for practitioners and patients by creating confusion. 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.

Purpose:

To give practical advice to doctors so that all services and models of care used by practitioners are encouraged to consider the use of telemedicine as a part of normal practice. These guidelines will assist the medical practitioner 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.

It 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

counselling. 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. Where clinically appropriate, telemedicine is a safe, effective and a valuable modality to support patient care.

Through appropriate training, enforcement of standards, protocols and guideline, the risks and drawbacks can be mitigated.

Scope:

These guidelines will be published under the IMC Act and are for privileged access only. These guidelines are designed to serve as an aid and tool to enable RMPs to effectively leverage Telemedicine to enhance healthcare service and access to all

• The guidelines are meant for RMPs under the IMC Act 1956
• The guidelines cover norms and standards of the RMP to consult patients via

telemedicine

• Telemedicine includes all channels of communication with the patient that leverage Information Technology platforms, including Voice, Audio, Text & Digital Data exchange

EXCLUSIONS:
The guidelines specifically explicitly exclude the following:

• Specifications for hardware or software, infrastructure building & maintenance

• 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
• Does not provide for consultations outside the jurisdiction of India

REGISTERED MEDICAL PRACTITIONERS ARE ENTITLED TO PRACTICE TELEMEDICIN: ALL OF THEM WILL TAKE AN ONLINE COURSE ON PRACTICE OF TELEMEDICINE OLINE COURSE ON

• A Registered Medical Practitioner is entitled to provide telemedicine consultation to patients from any part of India

• Shall uphold the same professional and ethical norms and standards as applicable to traditional in-person care

• RMPs must familiarize with the process and limitations through

. a) An online program developed by the Board of Governors in
supersession of Medical Council of India.

. b) RMPs intending to provide online consultation need to complete a
mandatory online course within 3 years of its notification.

. c) In the interim period, the principles mentioned in these guidelines need
to be followed.

. d) Thereafter, undergoing and qualifying such a course, as prescribed, will
be essential prior to practice of telemedicine.

Tools for Telemedicine RMP may use any telemedicine tool suitable for carrying out technology-based patient consultation e.g. telephone, video, devices connected over LAN, WAN, Internet, mobile or landline phones, Chat Platforms like WhatsApp, Facebook Messenger etc., or Mobile App or internet based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc

Telemedicine applications can be classified into four basic types,

• mode of communication, – Video/audio/text

• timing of the information transmitted, – Real time and asynchronous
exchange of information

• the purpose of the consultation-Nonemergency and emergency
Emergency consult for immediate assistance or first aid etc. 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 judgement. 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, counselling 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
• the interaction between the individuals involved—RMP-to-patient / caregiver, or RMP to RMP
The professional judgment of a Registered Medical Practitioner should be the guiding principle for all telemedicine consultations

Seven Elements to be considered before any telemedicine consultation

Context

Identification of RMP and Patient

Mode of Communication

Consent

Type of Consultation

Patient Evaluation

Patient Management

Patient consent is necessary for any telemedicine consultation. The consent can be Implied or explicit depending on the following situations: If, the patient initiates the telemedicine consultation, then the consent is implied.

An Explicit patient consent is needed if: A Health worker, RMP or a Caregiver initiates a Telemedicine consultation.

Prescribing Medicines, via telemedicine consultation is at the professional discretion of the RMP. It entails the same professional accountability as in the traditional in-person consult. If a medical condition requires a 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 Medicines without an appropriate diagnosis/provisional diagnosis will amount to a professional misconduct.

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

Matrix of the permissible drug lists based on the type and mode of consultation

Source: Telemedicine guidelines, March 2020

MEDICAL ETHICS, DATA PRIVACY & CONFIDENTIAILITY

. a) privacy and confidentiality as per IMC Act shall be binding and must be upheld and practiced

. b) RMPs 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 for protecting patient privacy and confidentiality and regarding the handling and transfer of such personal information regarding the patient

. c) Registered Medical Practitioners will not be held responsible for breach of confidentiality if there is a reasonable evidence to believe that patient’s privacy and confidentiality has been compromised by a technology breach or by a person other than RMP.

. d) Misconduct: while using telemedicine all actions that wilfully compromise patient care or privacy and confidentiality, or violate any prevailing law are explicitly not permissible.
Some examples of actions that are not permissible:
• RMPs insisting on Telemedicine, when the patient is willing to travel to a facility and/or requests an in-person consultation
• RMPs misusing patient images and data, especially private and sensitive in nature (e.g. RMP uploads an explicit picture of patient on social media etc)
• RMPs who use telemedicine to prescribe medicines from the specific restricted list
• RMPs are not permitted to solicit patients for telemedicine through any advertisements or inducements

. e) Penalties: As per IMC Act, ethics and other prevailing laws
a) Its is quintessential to maintain the records
RMP may charge an appropriate fee for the Telemedicine consultation provided

Framework for practicing telemedicine in 5 scenarios:

1. Patient to Registered Medical Practitioner
2. Caregiver to Registered Medical Practitioner
3. Health Worker to Registered Medical Practitioner
4. Registered Medical Practitioner to Registered Medical Practitioner 5. Emergency Situations

Essential Principles:

• The professional judgement of a Registered Medical Practitioner should be the guiding principle

• Same principles apply irrespective of the mode (video, audio, text) used for a telemedicine consultation.

• RMP should exercise his/her professional discretion for the mode of communication depending on the type of medical condition. If a case requires a video consultation for examination, RMP should explicitly ask for it.

• The RMP can choose not to proceed with the consultation at any time. At any step, the RMP may refer or request for an in-person consultation.

• At any stage, the patient has the right to choose to discontinue the teleconsultation

Source: Telemedicine guidelines, March 2020

Emergencies:

In all telemedicine consultations, as per the judgment of the RMP, if it is an emergency, the goal and objective should be to provide in-person care at the soonest. However critical steps could be lifesaving and guidance and counselling could be critical. For example, in cases involving trauma, right advice and guidance around maintaining the neck position might protect the spine in some cases. The guidelines are designed to provide a balanced approach in such conditions. The RMP, based on his/ her professional discretion may

• Advise first aid
• Counselling
• Facilitate referral

In all cases of emergency, the patient MUST be advised for an in-person interaction with a Registered Medical Practitioner at the earliest.

The guidelines conclude with describing the guidelines for technology platforms enabling telemedicine and Special responsibilities of Board of Governors in supersession to Medical Council of India (BoG-MCI)

Reference:

Telemedicine Practice Guidelines Enabling Registered Medical Practitioners to Provide Healthcare Using Telemedicine