Telemedicine Now Possible in India - Guidelines for Practice Released by Ministry of Health

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Highlights :

• Telemedicine and Tele-health practice now possible in India
• Registered Medical Practitioner empowered to decide which form of consultation appropriate for the patient
• Diagnosis and treatment can be administered using telemedicine in India

25th March was a historic day, a day to celebrate despite the grim reality of COVID-19 crisis. The Ministry of Health in India, released a much awaited 51 page document spelling out the guidelines for the practice of telemedicine in India.

Many in India including many stalwarts from Telemedicine Society of India & Medical Computer Society have been pushing for these guidelines for over two decades, however it required an invasion by an invisible enemy - the COVID-19 corona virus to wake up our policy makers to put together these guidelines on its website.

‘Telemedicine and Tele-health practices are now made possible by the Ministry of Health in India, where diagnosis and treatment can be administered using telemedicine in India.’

Interestingly a day previously, on the 24th of March, we silently celebrated the day as 'Telemedicine day' in India. Tele-consults particularly makes sense at a time when the COVID-19 virus is spreading exponentially. This important step will ensure the safety of both the patients and physicians safe.

These guidelines will be a giant leap in making access to healthcare possible for one and all.

India has 597,464 census villages as of 2018 census and each village has several hamlets. Many are in very remote locations with no road access. Our Prime Minister in 2018 said that all of nearly 600,000 villages had been given electricity connection. According to a report from market research firm TechARC over 77 per cent of Indians are now able to access wireless broadband through smartphones and the 3G/4G connectivity can be used by 502.2 million smartphone users. The online payment gateways also seem to be maturing and are becoming easier to use and can be seamlessly integrated into tele-health applications.

With having both the connectivity and cash transactions in place, it will certainly help telemedicine take off in India within no time. This telemedicine regulation will change the way we interact with our doctors, it will at last change healthcare in India just like travel, banking and so many other sectors.

What is Telemedicine & Tele-health?

The guidelines define telemedicine as follows-

�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.'

It defines Telehealth as - �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.'

What are the Telemedicine Practice Guidelines?

The guidelines were prepared in partnership with NITI Aayog and available on Ministry of Health website.

Who can practice telemedicine and telehealth- It can be practiced by a REGISTERED MEDICAL PRACTITIONER, who is defined as �A Registered Medical Practitioner [RMP] is a person who is enrolled in the State Register or the National Register under the IMC Act 1956.'

The guidelines recognise the gaps in legislation and the uncertainty of rules pose a risk for both the doctors and their patients and quote the 2018 judgement of the Hon'ble High Court of Bombay that had created uncertainty about the place and legitimacy of telemedicine because an appropriate framework or legislation did not exist.

Purpose of Guidelines -To provide practical advice to doctors so that all services and models of care used by doctors and health workers are encouraged to consider the use of telemedicine as a part of normal practice.

The purpose of these guidelines is to 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 both the patient and provider safety.

The guidelines do not provide for -

• consultations outside the jurisdiction of India.
• It does not cover hardware or software, infrastructure building & maintenance, data management systems; standards and inter operability
• use of digital technology to conduct surgical or invasive procedures remotely.

Requirements to practice Telemedicine

• RMPs should be familiar with the guidelines as well as with the process and limitations of telemedicine practice
• All RMPs to take a mandatory online course within 3 years of notification of the guidelines - this is to be developed by MCI
• All qualifying RMPs will need to undergo and qualify such a course before they are give license to practice

In all cases of emergency, the patient must be advised for an in-person interaction with an RMP at the earliest. However if this is not possible emergency consult for immediate assistance or first aid etc. maybe offered

Type of Telemedicine applications allowed: Four types will be allowed according to the Mode of Communication

• Video (Telemedicine facility, Apps, Video on chat platforms, Skype/Facetime )
• Audio (Phone, VOIP, Apps etc.)
• Text Based:
• chat based applications (specialized telemedicine smartphone Apps, Websites, other internet-based systems etc.)
• General messaging/ text/ chat platforms (WhatsApp, Google Hangouts, Facebook Messenger etc.)
• Asynchronous (email/ Fax etc.)

How to Do a Telemedicine Consult in India

The guidelines gives the liberty of deciding which type of consultation is best suited to the patient on the RMP. The practitioner should exercise proper discretion and not compromise on the quality of care. They should follow �Seven elements' before considering any telemedicine consultation -

1. Context
2. Identification of RMP and Patient
3. Mode of Communication
4. Consent
5. Type of Consultation
6. Patient Evaluation
7. Patient Management

1. Context - Depending on the complexity of diagnosis RMP should decide on the mode and suitability of such consults and decide if they need health education or counselling or medication. As every patient/case/medical condition maybe different, for example, a new patient may present with a simple complaint such as headache while a known patient of Diabetes may consult for a follow-up with emergencies such as Diabetic Ketoacidosis . The RMP shall uphold the same standard of care as in an in-person consultation but within the intrinsic limits of telemedicine.

2. Identification of RMP and Patient -Telemedicine consultation is should not be anonymous: both the patient and the RMP need to know each other's identity.

• Patient'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.
• RMP's Identity -The RMP should ensure that there is a mechanism for a patient to verify the credentials and contact details of the RMP. The RMP should introduce themselves and their qualification before starting the consultation. They should display the registration number accorded by the State Medical Council/National Medical Commission, on prescriptions, website, electronic communication (WhatsApp/ email etc.) and receipts etc. given to the patients.
• Check age when prescribing medication - through proof. If minor they should be accompanied by an adult and proof of both should be available including relationship.

3. Mode of Telemedicine - Multiple technologies can be used to deliver telemedicine consultations. All these technology systems have their respective strengths, weaknesses and contexts in which they may be appropriate or inadequate in order to deliver proper care. RMP should decide what is best suitable for the patient and if face to face consult would be better for diagnosis and treatment and advise the patient accordingly

4. Consent - Patient consent is necessary for any telemedicine consultation. The consent can be Implied or explicit depending on the following situations

• Implied Consent - If the patient initiates the telemedicine consultation, then the consent is implied. In an in-person consultation, it is assumed the patient has consented to the consult by their actions. When the patient walks in an OPD, the consent for the consultation is taken as implied. Like an in-person consultation, for most of the tele-consultations the consent can be assumed to be implied because the patient has initiated it.
• Explicit Consent - if a Health worker, RMP or a Caregiver initiates a Telemedicine consultation.An Explicit consent can be recorded in any form. Patient can send an email, text or audio/video message. Patient can state his/her intent on phone/video to the RMP (e.g. "Yes, I consent to avail consultation via telemedicine" or any such communication in simple words). The RMP must record this in his patient records.

5. Exchange of Information for Patient Evaluation - This is critical for coming to the diagnosis and initiating treatment. All possible information should be obtained including history, examination findings, investigation reports, past records, supplemented further through conversation with a healthcare worker/provider and by any information supported by technology-based tools.

If such information is inadequate the RMP can request for additional information from the patient and pause the consult and restart when such info is available or suggest a face to face consultation. If physical examination is critical judgement, he should suggest such an examination by another RMP or in-person consult. Safety for patient is of utmost importance in making a judgment to proceed with tele-consult or not.

6. Types of Consultation: First Consult/ Follow-Up Consult - There are two types of patient consultations, namely, first consult and the follow-up consult.

• First Consult means 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 or if new symptoms appear or the RMP cannot recall earlier consult. In such consults first consults video consults is better as RMP can make a much better judgment and hence can provide much better advice including additional medicines, if indicated.
• 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 the continuation of care of the same health condition. In this type consults other than video should be possible

7. Patient Management: Health Education, Counseling & Medication
If the condition can be appropriately managed via telemedicine, based on the type of consultation, then the RMP may proceed with professional judgment to:

• Provide Health Education as appropriate in the case; and/or
• Provide Counselling related to specific clinical condition; and/or

Prescribe Medicines

Prescribing medications, via telemedicine consultation is left to 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 particular protocol to diagnose and prescribe as in a case of in-person consult then the 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

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 notified in consultation with the Central Government from time to time. The categories of medicines that can be prescribed are listed below:

• List O: It will comprise those medicines which are safe to be prescribed through any mode of tele-consultation. In essence they would comprise of �over the counter' medications. For instance, these medicines would include, paracetamol, ORS solutions, cough lozenges etc
• List A: These medications are those which can be prescribed during the first consult which is a video consultation and is 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 Is a list of medication which RMP can prescribe in a patient who is undergoing follow-up consult, as a refill.
• List B: Is a list of medication which RMP can prescribe in 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: An RMP providing consultation via telemedicine cannot prescribe medicines in this list as these medicines have a high potential of abuse and could harm the patient or the society at large if used improperly. These include medicines listed in Schedule X of Drug and Cosmetic Act and Rules or any Narcotic and Psychotropic substance listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985

How to Issue a Prescription and Transmit

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 Rules.

A sample format has been suggested and can be referred on the ministry website. 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

Duties and Responsibilities of a RMP in GENERAL

Medical Ethics, Data Privacy & Confidentiality

• Principles of medical ethics, including professional norms for protecting patient privacy and confidentiality as per IMC Act shall be binding and must be upheld and practiced.
• 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 for protecting patient privacy and confidentiality and regarding the handling and transfer of such personal information regarding the patient. This shall be binding and must be upheld and practiced.
• Registered Medical Practitioners will not be held responsible for breach of confidentiality if there is reasonable evidence to believe that a patient's privacy and confidentiality has been compromised by a technology breach or by a person other than RMP. The RMPs should ensure that reasonable degree of care is undertaken during hiring such services.
• Misconduct It is specifically noted that in addition to all general requirements under the MCI Act for professional conduct, ethics etc, 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 3.7.1.5 Penalties: As per IMC Act, ethics and other prevailing laws.

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:

1. Log or record of Telemedicine interaction (e.g. Phone logs, email records, chat/ text record, video interaction logs etc.).
2. Patient records, reports, documents, images, diagnostics, data etc. (Digital or non-Digital) utilized in the telemedicine consultation should be retained by the RMP.
3. 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.

Fee for Telemedicine Consultation

• Telemedicine consultations should be treated the same way as in-person consultations from a fee perspective: RMP may charge an appropriate fee for the Telemedicine consultation provided.
• An RMP should also give a receipt/invoice for the fee charged for providing telemedicine based consultation.

Other areas covered by the Guidelines

Consultation Between Patient and RMP Through a Caregiver - in which case authorization by the patient is required. In medical conditions like dementia or physical disability etc. The care giver is deemed to be authorized to consult on behalf of the patient. A detailed requirement is spelled out.

Consultation Between Health Worker and RMP - For the purpose of these guidelines, "Health worker" could be a Nurse, Allied Health Professional, Mid-Level Health Practitioner, ANM or any other health worker designated by an appropriate authority Proposed Set up. This would help the upcoming health and wellness center to initiate and coordinate the telemedicine consultation for the patient with a RMP at a higher center at district or State or National level.
The guidelines do not permit technology platforms based on Artificial Intelligence/Machine Learning to counsel the patients or prescribe any medicines to a patient. New technologies such as Artificial Intelligence, Internet of Things, advanced data science-based decision support systems etc. can assist and support a RMP on patient evaluation, diagnosis or management, the final prescription or counselling has to be directly delivered by the RMP.
Overall the guidelines have covered all aspects of telemedicine and the grey areas such as prescription and reimbursement. These guidelines will be the start of a new chapter in healthcare in India. The tele-health inclusion will open up consultations for primary health centers and the health and wellness center. It will also help nurse practitioners to get empowered and be utilised better when they are in the field.
The immediate requirements now to follow are

• Health insurance reimbursement for telemedicine consults in India will strengthen this form of practise and it is hoped soon that some of the insurance companies will announce their requirement.
• Minimum standards requirement for maintaining EMR
• Minimum standards requirement for hardware and software
• Training and education of all healthcare professionals and healthcare workers
• Putting a robust ethical and legal document that will substantiate the already laid down guidelines

Telemedicine has long been in the offing in India and its arrival will surely see the dawn of a new era in the field of healthcare in India.

Reference :

1. BOARD OF GOVERNORS - In supersession of the Medical Council of India - (https:www.mohfw.gov.in/pdf/Telemedicine.pdf)

Source: Medindia

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