This article is written by Khyati Basant, from Symbiosis Law School, NOIDA. This article analyses telemedicine regulation in India released with the partnership with NITI Aayog.
Communication technology growth is having a drastic effect on culture. The internet, mobile phones and e-mail are different domains and if health care providers want to join this space, they will be cautious to do so. Telemedicine has medico-legal ramifications relating to aspects of identification, licenses, insurance, safety, privacy and confidentiality, as well as other risks related to online health care contact. The International Consulting Group of the World Health Organization (WHO), which met in Geneva in 1997, described telemedicine as the delivery of healthcare services, where distance is a critical factor, by healthcare professionals, using information and communication technology to share relevant information for the diagnosis, treatment and prevention of diseases and injuries, and for continuing healthcare education.
Amidst the COVID-19 pandemic lockdown, the Government of India has granted telemedicine, legal status in India. The Board of Governors, constituted by the Government in the session of the Medical Council of India under the approval of the Ministry of Health and Family Welfare, published a notification dated 25 March 2020 (“Amendment”) amending the Indian Medical Council Regulations, 2002 to regulate telemedicine in India. The amendment inserted ‘Telemedicine consultation’ into the Legislation.
The telemedicine market is rising rapidly. With advancements in technology, telemedicine devices are more available and affordable. Telemedicine was introduced to treat people with restricted access to healthcare facilities in rural areas. Yet it is now a comfort device in the healthcare field. The growing use of cell phones is a significant factor responsible for development in this area. The availability of smartphone apps helps patients to monitor their health status. This constructive approach allows them to use innovative ways to get facilities such as telemedicine for healthcare.
Tele-medicine and tele-health
The World Health Organization (“WHO”) describes telemedicine as “the delivery of healthcare facilities, where distance is a vital factor, by all healthcare practitioners using information and communication technology, the sharing of relevant knowledge for the diagnosis, treatment and prevention of diseases and accidents, study and assessment, and continuing healthcare education.” Telemedicine is the transmission of medical knowledge and skills through telecommunications and electronic technology, to promote patient diagnosis, care and management. Telehealth encompasses distance learning, patient care programs, scientific peer review, etc. Telemedicine is an upcoming healthcare sector field that makes use of telecommunications technology to provide healthcare. In India telemedicine is also in its infancy. Given that a large percentage of our population tends to live in rural areas and health care services are largely located in urban areas, telemedicine has a tremendous capacity for development and fills the divide between demand and access.
A virtual consultation is a process of obtaining a medical opinion without in-person visiting the specialist, which is the only difference from a traditional medical consultation. Virtual consultations also allow a physician to initiate a chat with another physician to consult different electronic medical records. The primary aim of telemedicine and remote consulting is to provide reliable healthcare services in India. It involves promoting access to services for both affluent and underprivileged communities, providing quicker, affordable, and reliable patient contact, specialist follow-up, and record-keeping.
Telemedicine is helpful in most cases. This offers access to healthcare facilities in rural areas for those with mobility problems and disabled people. This can also resolve regional obstacles to the delivery of healthcare facilities. It may provide an opportunity for the patient and caregiver to cut spending on healthcare and save time. With the advent of telemedicine, a medical practitioner or hospital may consult with various specialists, regardless of where they are located. Telemedicine allows patients to interact more often with their health care providers, in a comfortable way, which can lead to a stronger interaction between doctor and patient. Patient follow-up is expected to be higher and may boost results. Telemedicine, in general, has the power to provide people with quality health care.
Regulations in India
Registration of medical practitioner
A Registered Medical Practitioner (RMP) is a person registered in the State Medical Registry or Indian Registry of Medicine Rule of the Scientific Council, 1956. Health practitioners must enrol with the state medical councils (SMCs). Upon receipt by the Medical Council of India (MCI) of state medical records and verification (if required), names are included in the Indian medical registry and these medical practitioners are then approved to practice in India. Nevertheless, some jurisdictions allow medical practitioners to have a license to practice in their respective states through their state relevant medical councils. In the telemedicine sense, it is uncertain if a medical practitioner licensed in one state would be allowed to offer care in another state without any additional authorization. While the MCI’s Ethics Committee has stated that a medical practitioner is not required to obtain registration from more than one SMC, there has been no amendment under the IMCA to this effect.
It is known that certain medical specialities such as radiology, anatomy, ophthalmology, cardiology, dermatology, etc. may be at advanced stages of the implementation of information communication technologies, or others may be early in the process. Guidelines endorse and promote cooperation with RMPs/specialists using IT to treat, control and prevent disease. Teleradiology is the ability to transfer radiographic images from one site to another (x-rays, CT, MRI, PET/CT, SPECT/CT, MG, Ultrasound). For treatment, education, and study, telepathology uses technology to transfer image-rich pathology data between distant locations. Tele-ophthalmology access for patients in rural areas to the eye doctors, ophthalmic condition screening, diagnosis and supervision.
Steps involved in telemedicine
The following steps are followed for telecommunication –
- Consultation for the first consult – The patient initiates the telemedicine consultation, for example, a patient may make an audio or video call with an RMP, or send an email or text with a health query RMP decides to conduct the consultation. The initial visit indicates for the first time, the patient consults with the RMP; but more than 6 months have passed after the last consultation or the patient consulted the RMP earlier but with a different health problem.
- Identification and consultation of the patient- RMP should confirm the patient’s identity to the patient’s satisfaction by requesting the patient’s name, age, address, email ID, telephone number or any other identification that might be reasonable.
- Assessment of the patient- The patient’s situation has to be determined immediately by the RMP based on appropriate information, and whether emergency treatment is needed, RMP uses its medical expertise to determine if emergency care is necessary. If the patient’s situation needs emergency action, then first aid/immediate relief advice is given and referral information is provided if needed.
- Patient evaluation- The RMP can require that the patient submit appropriate information (complaints, information about any other appointments about the same issue, possible specifics of the investigation and treatment, if any). The patient is responsible for the quality of the details which he/she exchanges with the RMP. If the RMP thinks the information given at this point is insufficient, otherwise he/she will ask the patient for more details. As per the essence of such information, this information can be exchanged in real-time or exchanged later via email/text. The appointment can resume at a rescheduled period after the additional information has been obtained (this may include any laboratory or radiological tests).
- Management of the patient- If the condition can be adequately managed by telemedicine, the RMP may take a professional judgment either to provide health education as appropriate in the case or to provide advice on specific clinical conditions, including advice on new investigations to be conducted before next consultation or to provide specific treatment by prescribing medicinal products as outlined in List O If the ongoing teleconsultation is on video, additional medicines (as per List A) may be prescribed as well.
Tools for telecommunication
RMP may use any telemedicine tool suitable for carrying out technology-based patient consultation, such as telephone, video, LAN, WAN, Internet, mobile or landline phones, chat platforms such as WhatsApp, Facebook Messenger, etc., or mobile apps or internet-based digital telemedicine platforms or data transmission systems such as Skype/e-mail/fax, etc. Different tools can be used to provide telemedicine consultation. There are 3 primary modes: video, audio, or text (chat, messaging, email, fax, etc.) Each of these systems has its respective strengths, weaknesses, and contexts in which they may be appropriate or inadequate to provide a proper diagnosis.
RMPs using telemedicine, within the intrinsic limitations of telemedicine, must uphold the same professional and ethical norms and standards as applicable to traditional in-person care. To enable all those, RMPs who wish to practice telemedicine to familiarize themselves with these guidelines as well as with the process and limitations of telemedicine practice: an online program will be developed and made available by the Board of Governors in the Medical Council of India’s supersession. Both licensed medical practitioners wishing to give online consultation must complete a mandatory training course within 3 years of notice. The guidelines outlined in these Guidelines must be observed in the interim period. Then it will be essential to undergo and qualify such a course as prescribed before telemedicine is practised.
Principles of telemedicine
- Consultation- The RMP must decide which communication method to use, viz. text, voice or video. In providing telemedicine consultation, the RMP should use professional judgment and should advise in-person consultation, if the same seems necessary. Typically it should be performed in person for emergency care or diagnosis, but the RMP can continue with telemedicine diagnosis if it is urgent and necessary in its professional judgement. RMP can opt not to prescribe at any time and return to in-person consultation, and the patient is entitled to discontinue the consultation as well.
- Prescription- From time to time, the Central Government may alert medicinal products (other than those already specified in Annex 1 to the Guidelines) that may be recommended by teleconsultation, along with the restrictions that may apply, in the following categories: List O: medicinal products that are safe with by any teleconsultation process, such as those used for specific conditions (paracetamol, ORS) List A: Medicines that may be given during the initial visit which is a video visit which is re-prescribed for re-filling in the case of follow-up. List B: Medicines that can be prescribed in addition to those prescribed during the in-person consultation for the same medical condition to a patient undergoing a follow-up consultation.
- Confidentiality- Any information exchanged by the patient shall be private and the RMP shall be expected to carry out fair caution through the use of channels to protect the secrecy of this nature. RMP is expected to report all specifics and maintain the patient’s full record of all documents or material used during the diagnosis and medications.
- Fee- RMP can charge the correct fee, and the consultations in telemedicine shall be handled in the same way as the consultations in person. RMP will send a receipt/invoice of the fee so paid for consultation for telemedicine.
As telemedicine is being developed, it will carry with it, like any other medical field, numerous medico-legal problems. Problems regarding medical confidentiality, quality of care, doctor’s credentials and informed consent, fraud, licenses, compensation, clinical incompetence, responsibilities, fines and civil responsibility will need to be discussed. Due to their virtual nature, telemedicine has certain downsides. It requires infrastructure and technical training. It can minimize the direct contact between patients and doctors as internet communications are impersonal and physical evaluation has to be performed to make a proper diagnosis. The interface requires a structured framework, and the absence of a form of agreement to either ask for or refuse the service. Telemedicine is not currently a part of medical education. In addition to uncertainty about liability in the event of neglect, there are questions about safety, confidentiality, medical information protection and care. Concerning medico-legal problems resulting from telemedicine, there is little clarification. No health care scheme has considerations in telemedicine in India.
The enormous payoff has been commonly promoted in consolidating and preserving electronic health records (EHRs). Aside from enhancing the quality of treatment and providing easy access to patients’ medical records, EHRs can also be harnessed for scientific study. However, the growing issues around preserving a patient’s sensitive data need to be resolved as quickly as possible to effectively incorporate technical solutions that can enable the storing, analysis, and retrieval of medical data.
Telemedicine practice routinely involves medical practitioners who prescribe medicines merely based on telephone conversations (or discussions with the patient about any other audiovisual means). Accordingly, the confusion surrounding the legality of e-pharmacies and tele-pharmacies in India continues to be the most significant problem for telemedicine service delivery in India.
Future of telemedicine
Telemedicine presently only accounts for three-thousandths of one percent of all patient appointments. But it expects rapid development in the days ahead. This would boost connectivity and coordination, and give patients satisfaction. Telemedicine is used in several cases, e.g. telehealth, telecare, teleradiology, telepathology, tele-consulting, telediagnosis, telemonitoring, telepsychiatry, teledermatology, tele-emergency, telemonitoring, tele-pharmacy, telecardiology, tele-endoscopy, teledentistry, tele-dialysis, telemedicine, telesurgery, robotic surgery and robotic follow-up.
There is a lot of hope for the telemedicine future. Telemedicine would become simpler and more commonly embraced over the coming years, with increasing technological advancements. We need to develop strategies and recommendations for the effective incorporation of telemedicine with the current healthcare system. There is an immediate need for regulations to address medicolegal problems about the use of telemedicine so that patients can access such facilities without reservation. There is also a need for an open network to use telemedicine for communication, which ensures that telemedicine services would be freely accessible in a safe manner to protect security and secrecy in the interaction between doctor and patient. The use of smartphone-based apps will be introduced to make healthcare facilities accessible so that a patient can reach a specialist without needing to personally travel for an appointment.
If we look at figures, India’s telemedicine sector scale looks very promising, and with an upward development trend, one with incredible promise. The McKinsey Global Institute recently released a study estimated that introducing telemedicine technologies could save $4-5 billion a year and replace half of India’s in-person emergency consultations. A report by Global Market Insights, the global telemedicine industry is estimated to hit a $130.5 billion valuation by 2025, with India’s market forecast to expand at 2.4 per cent CAGR. Telemedicine programs will prove to be an important method for bridging the gap between urban and access to reliable care facilities in rural areas. The heavy emphasis of the present government on digitisation has acted as a stimulus to accelerate business growth.
However, the fate and future of this sector remain unclear, in the absence of clear rules and regulations on telemedicine services in India. To prevent any potential risk, manufacturing companies will ensure that they conform with all current relevant legislation and are contractually protected.
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