Advancement in the field of healthcare has always been a challenge in all developing countries, especially like India due to its vast geographical, demographical and landscape factor. These advancements have given rise to one such platform known as Telemedicine. Telemedicine is a practice of caring and engages in treatment of patients remotely when the provider and patient are not physically present at the same place.
World Health Organization (WHO) has defined telemedicine as:
"the delivery of healthcare services, where distance is a critical factor, by all healthcare 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 healthcare providers, all in the interests of advancing the health of individuals and their communities."
The word "telemedicine" literally translates to 'healing at a distance'. It is often used as an umbrella term to embrace health care delivery in addition to activities namely; education, research, health surveillance, etc.
TECHNOLOGICAL ADVANCEMENT AFFECTING TELEMEDICINE
Laptops and handheld computers are increasingly powerful, portable and wireless, allowing consultant expertise to be brought straight away to the patient's bedside. The capability of networks and the internet to transfer huge amount of information reliably and securely is also ever-increasing, although the downloading of images, animated material and videos can still be frustratingly slow, even on "high-speed" connections.
With the technological advancements, the growth of smartphone ownership and spread of broadband internet connectivity are creating a large untapped market for telemedicine consultations.
The government has also pitched in by drafting supportive legislation, such as the Digital Information Security in Healthcare Act ("DISHA"). It is intended to ensure the confidentiality and reliability of digital health data.
The purpose of this Act is to provide electronic health data privacy, confidentiality, security and standardization and provide for establishment of National Digital Health Authority and Health Information Exchanges and such other matters related and incidental thereto.
With the recent introduction of Ayushman Bharat Scheme, the biggest health financing scheme, Indian Government has come up with Information and Communication Technology (ICT), focusing on the development of health sector in the country. The said scheme includes tele-health development ideology for long distance medical care to make a safe, effective, efficient, patient-centred and timely health management environment.
In the past three years, ISRO's telemedicine network has expanded to connect 45 remote and rural hospitals and 15 super specialty hospitals. The remote / rural nodes include the offshore islands of Andaman and Nicobar and Lakshadweep, the mountainous and hilly regions of Jammu and Kashmir including Kargil and Leh, Medical College hospitals in Orissa and some of the rural / district hospitals in the mainland states.
The telemedicine software system has also been developed by the Centre for Development of Advanced Computing(C-DAC) which supports Tele-Cardiology, Tele-Radiology and Tele-Pathology etc. It uses various mediums of satellite communications to connect to the three premier medical institutes of the country namely All India Institute of Medical Sciences (AIIMS), New Delhi, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS), Lucknow and Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.
The telemedicine system has been installed in the School of Tropical Medicine (STM), Kolkata and two District Hospitals have been implemented by Webel ECS at two Referral Centres.
Several competitors have already entered the market, with different methods for reaching out to the patients. Practo has gained significant scale, by offering a package of services that combine remote medical consultations with insurance claims filing, electronic health records and linkages with traditional networks of doctors and hospitals.
Meanwhile, Apollo Health, a large incumbent provider, has begun to set up "tele clinic centres" in rural locations. Video chat technologies available in clinics allow patients to speak directly to doctors, while health extension workers at the clinics are able to perform tasks like checking blood pressure, which must be done physically. Apollo's tele clinics have achieved significant scale, offering 10 million specialty tele-consultations to date.
NEED FOR ADVANCEMENT OF TELEMEDICINE
India is a large nation with a population of more than 121 crores of sundry people. Due to this fact, the equitable distribution of healthcare services has proven to be a major goal in public health management time and again. As per Census of 2011:
"The concentration of healthcare facilities to the cities and towns amounts to 75% of the population of doctors situated away from rural India, where 68.84% of the national population live."
WHO recommends a doctor-population ratio of 1:1000 while the current doctor population ratio in India is only 0.62:1000. Training of new physicians is time consuming and expensive and therefore, the doctor to patient ratio may be expected to remain low for a long time. This deficit is partly being made up by the active telemedicine services in various parts of the country which further allows Medicinal practitioners to use tele-medicine systems, keeping in mind their insecurity of getting infected with the virus.
Digital technology has the potential to deliver value in many areas of the healthcare system. As per the Mckinsey Report 2019- It is estimated that it may save $4 billion to $5 billion in 2025. Telemedicine models have the technical capability to handle up to 50% of in-person regular consultations. It is believed that a program of implementation may enable India to tap 60% to 80% of this potential by 2025. Telemedicine initiatives taken globally have reflected that virtual doctor visits cost about 30% less than in-person visits.
With the country in the midst of an almost complete 21-day lockdown and a further partial lockdown for a period of 51 days in certain areas, telemedicine consultations seem to have gained popularity and use. The recent modification of guidelines related to telemedicine by the Government has meant that this is an area that could help patients seek immediate help in case of a health emergency. The telemedicine guidelines mentions:
"Disasters and pandemics pose unique challenges in providing healthcare. Though telemedicine will not solve them all, it is well suited for scenarios in which medical practitioners can evaluate and manage patients. A telemedicine visit can be conducted without exposing staff to viruses/infections in the times of such outbreaks".
Amid the Coronavirus outbreak, these guidelines were issued to give relaxation to the healthcare facilities as doctors can consult the patient remotely which would protect the patients and the doctors from virus transmission and thereby abiding the lockdown measures.
BOOST IN THE TELEMEDICINE INDUSTRY POST COVID – 19
With COVID-19 being declared a pandemic and spreading far and wide, patients are not comfortable and refraining from going to the hospitals, scared that they may contract some infection there. This is really a boon as someone could be concerned even about a slight pain thinking that it may be something more serious.
Dr Gurushankar, Chairman, (MMHRC Consult) has stated that –
"Telemedicine is a fast-emerging sector in India. As of Financial Year 2016, it was valued at $15 million and is expected to rise at a compound annual growth rate (CAGR) of 20 per cent during Financial Year 2016-20, reaching up to $32 million by 2020. So, the graph is definitely on an upward swing. Hospitals in rural India now have good primary healthcare centres. Telemedicine services are being offered for more than a decade now, through nine of our outreach centres in rural Tamil Nadu."
In the current scenario where the world is dealing with COVID-19 epidemic, telemedicine will help reduce the panic, multiplication of fake news, and bring satisfaction as people can consult a physician from their home and get educated on symptoms and anything they need to take care of in specific, because of their other 'ongoing' conditions like diabetes, asthma, etc. It will help patients to continue regular OPDs for issues other than Coronavirus Disease. An important point to note is that India has a million times more cases of diabetes, hypertension and chronic headache, etc. as compared to Coronavirus as of now.
TYPES OF TELEMEDICINE
Telemedicine can be classified into 5 types on the basis of the following:
- On the basis of timing of the information transmitted; and
- Real time or synchronous telemedicine
- Store-and-forward or asynchronous telemedicine
- Remote Monitoring type of telemedicine, also known as self-monitoring or self-testing
- On the basis of interaction between the individuals involved
- Health professional to health professional, which gives easier access to specialty care, referral.
- Health professional to patient which provides healthcare to the unreached population by giving them direct access to a medical professional.
APPLICATIONS OF TELEMEDICINE
Tele-Medicine has various educational applications such as 'Tele-education', which is a flexible and interactive long distance learning programme providing easier training and updates of the recent advances for more accurate and effective treatment methods. 'Tele-Conferencing' which entails discussion and interaction between doctors during workshop, conferences, seminar or continual medical education programs in a virtual room environment. It also includes mentoring and evaluation of surgical trainees from distance with the involvement of sophisticated video-conferencing equipment termed as 'Tele-Proctoring'.
- Healthcare Delivery
Telemedicine allows a school nurse, remote access to specialist medical opinion and helps manage chronic conditions like bronchial asthma, diabetes and obesity. It provides quick access to a remote physician or medical specialist and also helps avoid evacuations and unscheduled diversions during a medical emergency. Tele-Medicine also caters to the healthcare needs of the inmates without the expense and danger of inmate transportation or the need for a specialist doctor to enter.
- Healthcare Management
Some of the Healthcare Applications of Tele-medicine include 'Tele-health care' which includes the use of Information and Communication Technologies for preventive and primitive healthcare; it is further divided into tele-consultation and tele-follow up. Monitoring patients from a central station (Remote patient monitoring) with the help of a Computer Telephone Integrated (CTI) system for 24 hour vitals monitoring known as Tele-home healthcare and some specialties like tele-ophthalmology, tele-psychiatry, tele-cardiology, and tele-surgery, tele-radiology and tele-endoscopy.
- Screening of Diseases
Diabetic screening project by MDRF: The Chunampet Rural Diabetes Prevention Project and Ophthalmology screening by Aravind Hospitals at Andipatti village are some examples of Tele-Medicine application in screening of diseases.
- Disaster Management
Tele-Medicine has also worked as a tool to safeguard against disasters including NASA tele-medicine services provided during 1985 Mexico City earthquake and 1988 Soviet Armenia earthquake and Amrita hospital tele-medicine services provided during 2004 Tsunami disaster.
The tools used are a mobile and portable telemedicine system with satellite connectivity and customized telemedicine software is ideal for a disaster-stricken region where all other modes of connectivity are disrupted.
TELEMEDICINE – PRE & POST COVID – 19
With the emergence of telemedicine, start-ups investors and consumers have been looking forward to Regulations and Guidelines pertaining to the procedure, reimbursement, quality of service and privacy issues.
Looking at the gravity of the situation during the Covid-19 pandemic, the Government of India had launched guidelines for telemedicine solutions on March 25, 2020. Previously, telemedicine operations were governed by several statutory guidelines in India.
As per Section 27 of the Medical Council of India Act, 1956, any person who is enrolled in Indian Medical Register, can practice in any state of India. Hence inter-state telemedicine service was legal, though it was not formalised.
Previously, telemedicine services were governed by the Information Technology Act, 2000 however, there were no clear guidelines regarding privacy, security, confidentiality of the patient data and misappropriation of electronic data records related to the healthcare industry.
In May 2003, the Ministry of Information Technology recommended a few guidelines and standards of practice for telemedicine in India. The current telemedicine guidelines in India provides a comprehensive framework for applications, mode of communication, medical ethics, data privacy and confidentiality, document requirements, fees, process, drug list, technological platforms and more. The regulatory framework will also attract more investors to the telemedicine segment as businesses will have clarity for business models.
The present crisis should be used as an opportunity to identify deficiencies in our health system and plan a strategy to overcome them. The fact that from producing hardly any PPE kit in India till February, India is now capable of producing 50,000 to 1 lakh kits in a day, should be encouraging enough to become a net exporter in the near future.
The use of telemedicine could be of great value in India's smaller cities, towns and rural areas where there is a severe shortage of doctors. According to an estimate, around 70% of the country's population lives in the backwoods and with the OPDs of major hospitals shut or partly functional, patients are unable to seek specialised treatment. It is the need of the hour to expand the use of telemedicine and its implementation at grass root level.
It can overcome the issues of accessibility, inconvenience, affordability while maintain social distancing and can further reduce the burden on tertiary care hospitals. Apart from direct patient-doctor consultation, it could be used between tehsil/district hospitals at the one end and medical colleges/multispecialty hospitals at the other for doctor-specialist consultation.
TELEMEDICINE PRACTICE GUIDELINES 2020
The Board of Governors under the sanction of Ministry of Health and Family Welfare in partnership with NITI Ayog recently amended the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 and thus released the Telemedicine Practice Guidelines in Appendix 5. This amendment came into force right at the moment when the spread of Covid-19 and the imposition of lockdown throughout the Country has resulted in shortage of medical services and resistance of patients suffering from other diseases to visit hospitals.
The background which led to the drafting of these guidelines is the need to provide a practical advice to the doctors and other Registered Medical Professionals on the standard procedure of practice as well as to ensure sound course of action for providing safe medical care and ensure patient-safety.
This has also clarified the position of law on the legality of telemedicine sector. The case of Deepa Sanjeev Pawaskar v. The State of Maharashtra (Criminal Anticipatory Bail Application No. 513 of 2018) led to some medical professionals in interpreting the very practice of telemedicine as deemed to be illegal. In this case, two medical professionals had prescribed medicine to a patient through instructions to the nurse over telephone, which finally led to the death of the patient. However, this interpretation is incorrect as the Court was only concerned with the failure on the part of the doctors to arrive at a proper diagnosis.
SALIENT FEATURES OF THE GUIDELINES
- MEDIUM OF TELE-COMMUNICATION
The Registered Medical Professional (RMP) may use any medium of telecommunication as per their choice. However, such choice is to be made by an exercise of professional judgment in the interest of the patient. For instance, on the basis of complaints, to conclude whether a physical examination is required or not.
The medium may include chat platforms like WhatsApp, Facebook, telephone, video-calls and/or any other internet based digital platforms. In cases of emergency, while the doctor must not deny tele-consultation but attempt to restrict to immediate assistance or first aid only and recommend an in-person consultation.
- STANDARD OF CARE
The Guidelines mandates the professionals to exercise same standard of care as is required in case of in-person consultation. In other words, the consultation took place through telecommunication shall not be a valid defence in case of any negligence. This position also resonates the reasoning adopted by the High Court of Bombay in the Deepa Sanjeev Pawaskar case.
- CORRECT INFORMATION
The Guidelines have placed the burden to provide correct information on the patient i.e. in an action of medical negligence against the doctor, if the information provided by the patient was in itself incorrect, no liability would be entailed upon the doctor.
- IDENTITY OF THE DOCTOR AND THE PATIENT
The Guidelines mandate the Doctor to provide their identification, registration number and qualification before beginning every telecommunication, even if the patient is known. On the other hand, the confirmation of identity of the patient is not mandatory for every subsequent session.
In case where the patient is a minor or incapacitated due to physical or mental disability, the caregiver shall be deemed to be authorized to consult on behalf of the patient. Therefore, the consultation can take place with the caregiver even in the absence of the patient. Before offering such consultation, the doctor is required to confirm the identity and authorization of the care-giver.
- FORMAT OF PRESCRIPTION
The guidelines provide a suggestive format of prescription. While following that format is not mandatory, it is essential for the doctor to provide a signed scanned or digital copy of the prescription. An appropriate fee may be charged by providing an invoice of the same.
- RECORDS OF PATIENTS
The Doctors are required to maintain proper records of the patients. It is noteworthy that while there is no such mandate for in-person or OPD consultations, the Guidelines mandate a record of patient-history, observations, findings and prescription.
The Guidelines also have left the question of duration of preservation of such record unanswered. However, the general practice suggests to be of minimum three years.
- LIMITATION ON PRESCRIPTION OF MEDICINE
This is one of the most significant mandates of the Guidelines. It states that the prescription of medicine is to be made ONLY when the Doctor is satisfied that sufficient and adequate information is gathered.
The reason for such a mandate is to prevent the abuse of telecommunication and it may amount to professional misconduct. Before issuing a prescription, the doctor is required to:
- Inquire about the age of the patient and seek age-proof in case of any doubt.
- If the tele-consultation has not taken place over video, the doctor can prescribe on over-the-counter (O.T.C) drugs such as paracetamol, ORS solution, cough lozenges etc. The list of O.T.C. medicines is prescribed in the List O of the Appendix 5, Code of Conduct.
- In case the patient is examined through video consultation, the list of medicines is prescribed in the List A of the Appendix 5.
- No doctor can prescribe medicines enumerated in List X through any mode of telecommunication.
- GUIDELINES FOR TECHNOLOGY PLATFORMS
In the recent times, several technology platforms in the forms of Apps and Website have emerged providing telemedicine services such as mFine, Practo etc. The guidelines mandate such platforms to ensure that the services are being provided only by Registered Medical Professionals (RMP). The identification details of every such professional should be provided on the platform.
Further, the platforms cannot adopt such machine-learning AI's to provide consultations. That is, only the RMPs are entitled to counsel the patients.
Additionally, a proper mechanism to consult the grievances must be ensured. Failure to ensure any of the mandates of the Guidelines by the technology platform shall result in the blacklisting by the Board of Governors and MCI.
The relationship between a doctor and the patient is fiduciary in nature, i.e. based on trust. Parallely, there must also be an express or implied contract where the patient (or the caregiver) voluntary consents to the assistance by the doctor. The advancement of technology and the development of telemedicine sector leads to blurring of lines and creates a grey area between the rights, duties and liabilities of a medical professional.
Additionally, the impact of the Covid-19 has led to an urgent need of availability of alternative platforms of consultation in health-sector for non-chronic and less serious medical problems, keeping in view the risk posed to both the patients as well as the doctors by physical consultations in hospitals.
The Guidelines mention that 'in the interim period, the principles mentioned in the guidelines need to be followed'. While the term interim has not been defined, this suggests the encouragement to the doctors to use the sector during the lockdown phase. In such situations, the Telemedicine Guidelines is a much-needed initiative. It gives a sense of clarity to the stakeholders involved such as – technology platforms (start-ups), RMP, hospitals, clinics etc. However, given the current exigencies, the requirement of compulsory training seems to have been temporarily waived.
Consequently, the Guidelines are sufficiently subjective to allow the doctors to exercise their professional judgment. However, this does not dilute their duty of care standards. Therefore, the liability of the professionals in cases of medical negligence, consumer protection etc. are to be essentially complied with.
It may also be noted that the guidelines are silent on the aspects of data privacy of the patients and the cases where the patients are not based in India. A clarity on these aspects may be looked into, given the professional ethical conduct of the doctors.
Considering the overall impact, these guidelines will ensure a boost to the telemedicine sector in the post-COVID scenario and promote the interests of stakeholders namely; start-ups, doctors and patients in a fair manner.
Originally published 16 June, 2020.
This content is purely an academic analysis under "Legal intelligence series".
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