India’s new Telemedicine Practice Guidelines – the dawn of a new era in Healthcare

The Medical Council of India (“MCI”) has legitimized the practice of telemedicine by registered medical practitioners, giving a significant relief to doctors and patients amid the current scenario of COVID-19 pandemic where face-to-face consultations are difficult.

The Government of India has prepared a new set of “telemedicine practice guidelines” in collaboration with NITI Ayog and has notified the same under the Indian Medical Council (Professional Conduct, Etiquette, and Ethics Regulation, 2002), on March 25th 2020 (“guidelines”). With the advent and practice of telemedicine, doctors can now provide remote consultations, remote diagnosis, treat patients through different modes of telecommunications such as video, audio (phone), emails or texts and Mobile apps (Whatapp, Hangout, Skype, Facebook messenger etc.).

Telemedicine provides an optimal solution for not just providing timely and faster access, it also reduces financial costs associated with travel. It also reduces the inconvenience/impact to family and caregivers and other social factors and particularly in cases where there is no need for the patient to physically see the RMP e.g. for regular, routine check-ups or continuous monitoring. Telemedicine can greatly reduce the burden on the secondary hospitals. It can also provide rapid access to medical practitioners who may not be immediately available in person.

These guidelines 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 counseling.

 

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An Overview of the Telemedicine Practice Guidelines

As per the guidelines framed, “telemedicine” is 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 the continuing education of health-care workers, with the aim of advancing the health of individuals and communities and only a Registered Medical Practitioner (“RMP”) who is enrolled with the State Medical Register or the Indian Medical Register under the Indian Medical Council Act,1956 can offer telehealth services.

Types of Consultations

These guidelines provide for the different types of patient consultations, namely, first consult and the follow-up consult.

First Consult is where 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.

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. However, it will not be considered a follow up if:

i. There are new symptoms that are not in the spectrum of the same health condition; and/or

ii. RMP does not recall the context of previous treatment and advice.

It has also been stated that for Non – Emergency consult, the first consultation between doctor (RMP) and patient need not be an in-person consultation, and doctors in India can provide the first consultation to patients located in any State remotely through teleconsultation.

Emergency consult for immediate assistance or first aid etc., where 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 professional judgment. 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, counseling 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.

 

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Issue of Prescription and Transmit

For issuing a prescription, the RMP needs to explicitly ask for the age of the patient, and if there is any doubt, the RMP can ask for the patient’s age proof. Where the patient is a minor, after confirming the age, tele consultation would be allowed only if the minor is consulting along-with an adult whose identity needs to be ascertained.

An RMP should begin the consultation by informing the patient about his/her name and qualifications. If the RMP has prescribed medicines, 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 Rule. The 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. A sample prescription format is suggested in Annexure – 2.

These guidelines specifically state that in a Telemedicine consultation both the patient and the RMP need to know each other’s identity. Going forward, all doctors who provide teleconsultation will have to display their registration number accorded to him/her by the State Medical Council/MCI, in all communications exchanged with the patient – for example, in emails or WhatsApp messages, on prescriptions, website and on fee receipts. The RMPs have to verify the patient’s identity by name, age, address, email ID, phone number, registered ID or any other identification as may be deemed appropriate.

Patient Consent:

The guidelines state that the patient consent is necessary for any telemedicine consultation. The consent can be Implied or explicit depending on the situation.If the patient initiates the telemedicine consultation, then their consent is implied. However, if a Health worker, RMP or a Caregiver initiates a Telemedicine consultation then an Explicit patient consent is required. The RMP must record the patient consent in his patient records.

Modes of Telemedicine:

In situations where in order to reach a diagnosis and to understand the context better; a real- time consultation may be preferable over an asynchronous exchange of information. Similarly, there would be conditions where an RMP could require hearing the patient speak, therefore, a voice interaction may be preferred than an email or text for a diagnosis. There are also situations where the RMP needs to visually examine the patient and make a diagnosis. In such a

  

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case, the RMP could recommend a video consultation. A decision on whether a remote consultation or in – person consultation is appropriate is left to the doctor’s discretion by exercising his/her‘s professional judgment without compromising the quality of care in the best interest of the patient.

Apart from direct RMP and patient consultation, the telemedicine consultations can be held between a caregiver and a RMP, RMP to RMP, health worker and RMP.

Mandatory Online Training for all RMPs:

All RPMs will have to complete a mandatory online course in telemedicine administered by the MCI’s board within 3 years of its notification to provide remote consultations. Since an online course may take a while to develop, doctors can examine patients remotely in the interim but must abide by the guidelines. Thereafter, undergoing and qualifying such a course, as prescribed, will be essential prerequisite to practice telemedicine consultation.

Permissible Drug list and Specific Restrictions:

The Government of India has also imposed certain specific restrictions on the type of medications that can be prescribed based on the type and mode of consultations.

‘List O’ comprises of those medicines which are safe to be prescribed through any mode of tele- consultation. It encompasses medicines which are used for common conditions and available over-the counter drugs and that may be deemed necessary during public health emergencies.

‘List A’ comprises of relatively safe medicine with low potential for abuse. These medications can be prescribed during the first consultation over video consultations and are being re- prescribed in a follow-up consultation for a re-fill.

‘List B’ is a list of medication which RMP can prescribe to 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.

Meanwhile, The Government of India has also listed out certain drugs that cannot be prescribed through telemedicine. This includes drugs listed under ‘Schedule X’ of the Drugs and Cosmetics Act of 1940 and its Rules, and any narcotics and psychotropic substance listed in the Narcotics Drugs and Psychotropic Substances Act of 1985.

The drugs in the above mentioned list is summarized in Annexure – 1

 

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The guidelines states that it is incumbent on part of the RMP to maintain the digital trail/records/ documentations and prescriptions of the patient consultation for the period as prescribed from time to time.

Fee for Telemedicine Consultation

The RMP may charge an appropriate fee for the Telemedicine consultation provided and he/she should also give a receipt/invoice for the fee charged for providing telemedicine based consultation.

Guidelines for Technology Platforms enabling Telemedicine

These telemedicine guidelines also address technology platforms that enable telemedicine services. It specifically states that such platforms can list a doctor only after conducting their due diligence verifying the doctor’s credentials before listing any RMP on its platform. Importantly, the guidelines allow the use of artificial intelligence and machine learning tools to assist and support RMP in patient evaluation, diagnosis or management, the final prescription or counseling has to be directly delivered by the RMP.

Exclusions:

The guidelines explicitly exclude the following:

  Does not provide for consultations outside the jurisdiction of India.

  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.

  

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Annexure – 1

Medicine Lists 1. List O

 Common over-the counter medications such as:

o Antipyretics: Paracetamol
o Cough Supplements: Lozenges,
o Cough/ Common-cold medications (such as combinations of Acetylcysteine, Ammonium

Chloride, Guaifensen, Ambroxol, Bromhexene, Dextromethorphan)

o ORS Packets

o Syrup Zinc

o Supplements: Iron & Folic Acid tablets, Vitamin D, Calcium supplements o Etc.

 Medications notified by Government of India in case from time to time on an Emergency basis:

o Such as Chloroquine for Malaria control for a specific endemic region, when notified by Government.

2. List A

  First Consult Medications (Diagnosis done on video mode of consultation) such as:
o Ointments/Lotion for skin ailments: Ointments Clotrimazole, Mupirocin, Calamine Lotion, Benzyl Benzoate Lotion etc.
o Local Ophthalmological drops such as: Ciprofloxacillin for Conjunctivitis, etc. o Local Ear Drops such as: Clotrimazole ear drops, drops for ear wax etc.
o Follow-up consult for above medications.

  Follow-up medications for chronic illnesses for ‘re-fill’ (on any mode of consultation) such as medications for:
o Hypertension: Enalapril, Atenolol etc.
o Diabetes: Metformin, Glibenclamide etc. o Asthma: Salmetrol inhaler etc.
o Etc.
3. List B
On follow-up, medications prescribed as ‘Add-on’ to ongoing chronic medications to optimize
management such as:
o For hypertension: Eg, add-on of Thiazide diuretic with Atenolol. o Diabetes: Addition of Sitagliptin to Metformin.
o Etc.

    

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Annexure – 2
Sample Prescription Format

 

REGISTERED MEDICAL PRACTITIONER’S NAME: Qualification:
Registered number:
Address:

Contact details (Email and phone number):

Date of consultation: Name of Patient: Address:
Age:

Gender:
Height (Whenever applicable): Weight (Whenever applicable): LMP (Whenever applicable):

Chief complaints:
Relevant points from history: Examination/Lab findings: Suggested investigations:

Diagnosis or Provisional Diagnosis: Rx:

1.NAME OF THE MEDICINE (in capital letters only with generic name) drug form, strength, frequency of administration and duration.

2.NAME OF THE MEDICINE (in capital letters only with generic name) drug form, strength, frequency of administration and duration.

3.NAME OF THE MEDICINE (in capital letters only with generic name) drug form, strength, frequency of administration and duration.

Special Instructions:

RMP’s Signature & Stamp

Note: This Prescription is generated on a teleconsultation.

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BOARD OF GOVERNORS
In supersession of the Medical Council of India

Frequently Asked Questions [FAQs] on

 

 

Note:

Telemedicine Practice Guidelines

April, 2020

The Telemedicine Practice Guidelines is an integral part of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, popularly known as the Code of Medical Ethics. Hence, the principles enunciated therein are ipso facto applicable to the practice of Telemedicine. FAQs are indicative only , not exhaustive.

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FAQs on Telemedicine Practice Guidelines

FromPatients/ Care-seekers’ point of view

1. How can I know whom to contact or how to get in touch with the doctor (Registered Medical Practitioner, RMP) on telemedicine? Patient can contact any RMP of modern medicine duly registered with MCI/State Medical Councils; and if he/she agrees to provide a telemedicine consult, then it means mutual consent has been given.

2. I am old and unable to physically visit a hospital and I have a nurse taking care of my clinical condition. Can I ask my nurse to consult on my behalf and how can she enable me for a better consultation? Definitely. Your nurse ( duly trained and registered in Nursing Council ) can consult on your behalf if you record your consent with the RMP for the same during tele-consultation. The RMP can request your Nurse to do routine clinical examination (for which nurse is duly trained) and provide requisite information, and then RMP can provide health care advice, counselling and prescribe appropriate medications.

3. In case of an emergency, can I call any RMP for an immediate advice?
Yes, you may call any RMP for an advice for a medical emergency, but you cannot insist for an advice if the RMP chooses not to reply or give any specific advice.

4. How would teleconsultation be useful in an emergency?

In case alternative care is not immediately feasible, tele-consultation might be the only way to provide timely care. In such situations, RMPs may provide consultation to their best judgement. Such services might be limited to first aid, life-saving measure, counselling and advice on referral. However, telemedicine should be avoided for emergency care to the possible extent specially when alternative in-person care is available.

 

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5. Would a RMP be entitled for fee for his/her consultation through telemedicine also?
As per the guidelines, an RMP is authorized to charge a fee for a consultation and provide a receipt for the same.

6. Can a RMP refuse or discontinue tele-consultation at any point of time?
The guidelines allow a RMP to refuse or discontinue a teleconsultation, with due notice to the patient , during any time of the consultation process. Similar liberty has also been provided to the patients.

7. Are the prescriptions provided via teleconsultation legally valid and how do I ensure that the RMP is qualified for the prescription?
It is mandated in the guidelines that for all teleconsultations, the RMP should identify him/herself and also mention/ display his/her MCI/State Medical Council registration number. It is also mandatory that the RMP issues prescription as per the specified format, which should have his/her digital signature and the Registration number. The Registration of the RMP can always be counter checked, if desired on the websites of relevant Medical Councils.

8. How do we know that our privacy is not breached by tele- consultation?
The Guidelines have laid down strict norms for the RMPs not to breach the privacy of the patients in any form. However, the RMP cannot be held responsible 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.

9. If I am on a follow-up care for a Chronic condition (say Diabetes), for how long can I continue to request for refill for my medications to my RMP?
The Guidelines define follow-up consultation for a maximum period of 6 months. After this period, an in-person consultation is mandatory.

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10.We are a group of Technology Platform providers for enabling teleconsultations on behalf of patients with RMPs. How does the guideline enable us?
Section 5 of the Tele medicine Guidelines have laid down specific guidelines for the same and may please be referred to.

From RMP/ Care-givers’ point of view

1. Who are entitled to provide telemedicine consultation?

As on date all Registered Medical Practitioners (RMP) under IMC Act, 1956 can provide telemedicine consultations but only after they qualify the prerequisites.

2. What are the prerequisites to be for doing a telemedicine consultation?
The MCI is in process of developing an online telemedicine course for ensuring uniformity. Once the course is developed, it will be mandatory for all RMPs to undertake this course within three years of its notification. Thereafter, it will be compulsory for all RMPs who wish to tele-consult to have undergone such a course.
As on date, all RMPs can tele-consult, provided they follow the Telemedicine Practice Guidelines notified under IMC Act, 1956.

3. Can a Health Worker and Care givers do teleconsultation for a patient?
Yes a health worker such as Auxiliary Nurse Mid-wife (ANM)/Nurse etc. can do tele-consultation for a given patient. The guidelines mention the framework for such a scenario.

4. In case I feel the patient requires a physical examination, how do I ensure that?
The RMP has the right to pause his/her tele-consultation and recommend an in-patient consultation. Besides, if during the teleconsultation it appears that a physical examination is mandatory but not feasible on the mode being used for the consultation, the tele-consultation should be aborted and the patient referred for an in-person review.

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5. Do I need to keep screenshots and records to safeguard myself?

Yes. It is specified in guidelines. It is incumbent on the RMP to maintain the following records/ documents for the period, as prescribed from time to time. These include Log or record of Telemedicine interaction (e.g. Phone logs, email records, chat/ text record, video interaction logs etc.). The RMP should retain patient records, reports, documents, images, diagnostics, data (Digital or non-Digital) etc. utilized in the telemedicine consultation. 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.

6. Recently, I have heard in legal disputes that judgement has been given that doctors are not supposed to communicate on WhatsApp. What is the status after these guidelines?
With the notification of Telemedicine Practice Guidelines under the IMC Act, 1956 RMPs under IMC Act, 1956 are now empowered and legally protected to provide teleconsultation by any mode, for various settings, as specified in the document.

7. What are the legal effects of inadequate management as perceived by a patient?
The Telemedicine Guidelines comprehensively provides various settings under which different modes of teleconsultation can be undertaken and also enunciates steps to be undertaken to prevent any miscommunication between the patient and RMP. Besides, it also mentions steps to be taken to ensure documentation and thereby avoid legal issues. If despite these measures, the patient still perceives inadequate management, which can also happen in an in-person consultation, the legal issues need to be dealt in a similar way.

8. What happens if a doctor does not want or wishes not to attend to a request made by phone or WhatsApp?
The Telemedicine Guidelines mention that a RMP has the liberty not to attend a teleconsultation request made by a patient.

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9. What if a patient calls at an odd time like midnight when the RMP is not on duty?
The RMP can choose either to attend the call or not. The RMP can also choose not to provide consultation to the patient (if it does not suit the RMP) during on duty hours also.

10.In trauma and in acute emergency, if the RMP asks for immediate referral to a hospital and a patient insists for tele-management, what to do?
The doctor should record his/her statement about the advice given regarding referral for in-person consult (as specified in the guide lines) and referral. In case the patient insists, the best possible care that can be given on tele-consult in the form of advice, counselling, first-aid measures to enable immediate relief should be provided. In case the consultation is through a Health Worker of another RMP, advice on medications, as specified in the guidelines can be given.

11.In case of problems with internet connectivity, the resultant telephonic consult may be of poor quality. What should be done in this context?
If the issue of connectivity is in the beginning of the consult, the RMP may choose not to proceed with the consultation, citing the reasons. If the issue of poor connectivity happens during the course of the communication, the same can be recorded and kept as a proof.

12.Will the prescription sent online as an image or scan be honoured by the local chemist?
Yes, the following are specified in the guidelines:
If the RMP has prescribed medicines, 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 is suggested in Annexure 2 of the document. 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

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that entitles him/her to get the medicines dispensed from any pharmacy of his/ her choice

13.Do I need a print out of the prescription?

No, an e-prescription as specified in the guidelines will be sufficient. However, it should comply with the guidelines as mentioned.

14.For that matter if some investigations are needed and doctor asks for them through tele communication, will the Pathology Lab/Imaging Centre etc. honour it?
Yes, the labs or centres etc. will honour it. The Telemedicine guidelines clearly mention that counselling a patient may also involve ordering new investigations, if deemed necessary by the RMP.

15.How to tackle issue of payment of fees to an RMP, as a patient may be reluctant to pay as physical examination is not possible?
For the purpose of fees in telemedicine consultation, the guidelines specify that Telemedicine consultations should be treated the same way as in-person consultations from a fee perspective and an RMP may charge an appropriate fee for the Telemedicine consultation provided. The very fact that the tele-consultation has been initiated, it means that both patient and doctor have mutually consented for the same. These are specified in the flowcharts accompanying the Guidelines.

16.The RMP may advise beyond his jurisdiction, for which he may not have specialization. How to take care of this issue?
Once a tele-consultation has been initiated on a mutual consent between a patient and a consulting RMP, then the RMP can advise on the health issues to the best of his knowledge. All RMPs can practice modern medicine and are also aware of the jurisdiction of their specialization.

17.Can schedule H class of Drugs be prescribed by tele-consultation? Which classes of drugs have been enabled by the guidelines for tele- prescription?
The drug prescription in Telemedicine guidelines is based on the clinical scenario, judgement of the RMP and the mode of consultation, as specified in the framework. Hence, specific nomenclatures such as Schedule H etc. classes of drugs have been avoided.

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The classification of list of drugs provided in the document is based on practical clinical pathways.
A prohibited list of drugs is also given and this is specified as to include Schedule X of Drug and Cosmetic Act and Narcotic, Psychotropic substances. As such these lists of drugs mentioned in guidelines can be amended from time to time based on directions of the MCI and MoHFW.

18.Can I prescribe antibiotics on tele-consultation?

Antibiotics can be prescribed by the RMP, if he/she is strongly convinced about the same based on the type and mode of tele-consultation. As such, all tele-consultations mandate a clear documentation of provisional diagnosis and reasons for prescription of particular drug. This is as well applicable for antibiotics. As in all scenarios, the RMP will be responsible for his/her prescriptions.

19.Can I prescribe injectable medications on tele-consultation?

Prescriptions for injectable medicines can only be given if the consultation is between an RMP with another RMP. In certain circumstances, it may be prescribed to a Health Worker for administration to a given patient. In such a scenario, the RMP must be confident of the setting of the facility and the technical expertise of the Health Worker. The exceptions to these would be prescribing some follow-up medications which are available only as injections such as Insulin, Low Molecular Weight Heparin, Vaccines etc.

20.I run a busy OPD and cannot attend to many patients at the same time. Can I record a tele-consultation through my allied healthcare professional on video and then, prescribe medications off-line to the patient ?

No, this is absolutely not allowed in the guidelines. The very premise of tele-consultation through a Health worker (as per the guidelines) dictates that the RMP, Health worker and the patient introduce themselves to each other and give mutual consent for the tele-consultation. The role of Health worker is just to facilitate the process of tele-consultation to enable RMP to take informed decisions during this process. These are possible only on a live consultation. It would be highly unethical for an offline consultation through a health worker.

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21.We are a group of RMPs who would like to start a ‘Telemedicine Clinic’ to care for the needy patients who would approach us. How do the guidelines help us do that?
Foremost, you have to decide the appropriateness of tele-medicine consult and its mode for a given scenario, as specified in the guidelines. You will have to record all tele-consultations and would be responsible for all consultations provided by telemedicine.

Broadly, the following are the services your group could provide:

  Health education

  Guide patients for an appropriate in-patient consult

  If it’s a follow-up consult for a patient whom you have seen, can
prescribe for medications for optimizing that particular medical
condition to the patient or care-giver

  If it’s a new clinical condition which can be reasonably diagnosed
on a video-call (such as Dermatological lesions etc), then you can
prescribe medications to the patient or care-giver

  If you are a group of specialists, then, can advise other RMPs
appropriately

  If you have a Health Worker on the field with the patient, then you
can prescribe medications based on the Health Workers’ inputs-
provided these are as per norms of the guidelines.

  In case of emergency clinical conditions, provide advice for
immediate relief, first-aid and guide/ facilitate appropriately for an immediate in-patient consult.
22.Could you try to expand on the list of conditions by examples, which you can advise on Video-call consultation?
Video consultation give an added advantage of visual perception (provided it is of reasonable good quality) which is crucial for many clinical conditions. For instance, a RMP can take suitable tele- consultation pathways for conditions such as:

  Pallor and Koilonychia: Prescribe Iron tablets on first-consultation and advice further investigations

  Jaundice/ Cyanosis: Advice for urgent referral for in-patient consultation

  Trauma: Can assist in Tele-triaging through a Health Worker
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  Respiratory distress: Assess work of breathing and advice another RMP/ Health Worker for appropriate intervention

  Rheumatic conditions: Can assess range of motion of joints through a health worker and can modify medications during a follow-up consultation

  Tele-radiology, Tele-ophthalmology, Tele-pathology can be leveraged for discussion between two RMPs.

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