Within a week of Prime Minister Narendra Modi declaring the Janta Curfew against the COVID-19 pandemic, where he said that people should simply consult doctors over the phone instead of visiting them, the Health Ministry notified the Telemedicine Guidelines 2020, laying down norms for an industry that has so far operated in a regulatory grey area. Doctors can now consult patients via phone, video, and chat applications including telemedicine platforms and WhatsApp. The guidelines, formulated by NITI Aayog, were notified under the Indian Medical Council (Professional Conduct, Etiquette, and Ethics Regulation, 2002).
The guidelines place the onus on the doctor to decide whether a teleconsultation will suffice, or if an in-person review is needed, based upon factors such as complexity of the patient’s situation, whether he/she can identify the patient, among other things. Apart from direct doctor-patient consultation, telemedicine consultations can be held between a caregiver and doctor; doctor to doctor; and health worker to doctor (more on this below). Some of the basic guidelines and restrictions are:
- Both parties should be able to identify and verify each other. Doctors have to collect patient’s personal details, including address, phone number; there needs to be a mechanism for patients to verify the doctor’s credentials, the doctor’s registration registration number has to be prominently.
- Age verification: Doctors need to explicitly ask the age of the patient to issue a prescription, and can also ask for proof. Teleconsultation for minors will be allowed only with an identified adult family member.
- Patient Consent: The patient’s consent is implied if they initiate a consultation. The patient’s explicit consent is needed via email, text, audio/video message, if a health worker or doctor initiates the consultation. The doctor has to maintain the record of consent and the patient’s case history in his records.
- Prescribing medicines: Doctors can issue prescriptions after confirming the patient’s age, and will have to provide the patient a copy of the prescription. If the doctor is sending the prescription directly to a pharmacy, he/ she must take the patient’s explicit consent that entitles him/her to get the medicines dispensed from any pharmacy of their choice. Doctors can prescribe over-the-counter medicines (List O) such as paracetamol and medicines required during a public health emergency.
- List A medicines, such as for hypetension and skin problems, can be precribed during the first consultation can be prescribed for re-fill.
- List B medicines, can be prescribed after follow-up consultation, after an initial in-person consultation took place.
- The same fees will be charged for a telemedicine consultation as for an in-person consultation.
- Right to stop consultation: Both the patient and the doctor have the right to discontinue the teleconsultation at any stage.
AI, machine learning cannot counsel patients or prescribe meds
Technology platforms based on AI and machine learning are not allowed to counsel the patients or prescribe any medicines; only a doctor can counsel and prescribe medicines. AI, IoT, data science-based decision support systems etc. can assist and support a doctor on patient evaluation, diagnosis or management, but the final prescription or counseling has to be directly delivered by the doctor.
- Technology platforms providing telemedicine services have to ensure that doctors on their platform are duly registered with the relevant medical council and have to carry out due diligence before listing any doctor.
- The platform must ensure a proper mechanism to address any customer queries or grievances.
- Any non-compliance has to be reported to the Medical Council of India’s board of governors who have the power to blacklist the platform, and prevent all doctors from using it for telemedicine.
The doctor’s responsibilities: ensuring data privacy, ethics, and maintaining records
1. Ethics, data privacy, and confidentiality: Doctors have to follow existing regulations around ethics, confidentiality, in the Indian Medical Council Regulations, the Information Technology Act, and any future data protection and privacy laws. The Personal Data Protection Bill treats health data as sensitive personal data, and places restrictions on its movement and use.
- The doctor “needs to be cognizant” of existing data privacy laws. For instance, doctors cannot add patients to virtual support groups without the patient’s consent. Doctors have to be wary of the patient’s willingness.
- The doctor will not be held responsible for any privacy or confidentiality breach, if it was a technology breach or if somebody else was responsible for it.
- Doctors consulting via telemedicine cannot misuse patient images and data, especially private and sensitive in nature, insist on a teleconsultation when the patient is willing to travel to a facility, and cannot solicit patients via any advertisements.
2. Maintain documentation of consultation: It is the doctor’s responsibility to maintain the records of the telemedicine interaction and other documents “for the period as prescribed from time to time”. This includes patient records, diagnostics, data used in the consultation, and prescriptions.
Rules for consultation with caregivers, health workers, and between doctors
Apart from a patient directly seeing a doctor via teleconsultation, the interaction can also take place between:
1. Patient and doctor via a caregiver: If the patient is a minor or is incapacitated (such as in dementia or physical disability). the doctor will proceed with consultation to the caregiver. The caregiver needs to have a formal authorisation establishing their relation with the patient, and this has to be verified by the patient in an earlier in-person consultation.
2. Health workers to doctor: A health worker — a nurse, allied health professional, mid-level health provider, auxiliary nurse midwife — can facilitate a consultation for a patient. This can take place only after the health worker has already seen the patient and is of the judgment that a teleconsultation with a doctor is required. The worker should explain the potential use and limitations of a telemedicine consultation to the patient.
- The health worker can help take history, examine the patient, and convey the findings. They can also explain/reinforce the advice given by the doctor to the patient.
- The health worker must ensure that the patient gets immediate relief and first aid from the doctor, and that the patient is advised for an in-person consultation at the earliest.
3. Doctor to Doctor: The doctor may use telemedicine to consult another doctor or specialist for a person under his care. The original doctor will be responsible for treatment and other recommendations given to the patient. This will include:
- Tele-radiology: sending x-rays, PET scans, MRI scans, ultrasound reports from one location to another.
- Tele-pathology: sending pathology data between distant locations for diagnosis, education, and research.
- Tele-ophthalmology: gives access to eye specialists for patients in remote areas, including ophthalmic disease screening, diagnosis and monitoring.
Download the Telemedicine Guidelines 2020 here.