There is a need of clear-cut Guidelines on Veterinary Telemedication in India

There is a need of clear-cut Guidelines on Veterinary Telemedication in India

The Ministry of Health and Family Welfare (“MoHFW”), on March 25, 2020, issued the Telemedicine Practice Guidelines (“Guidelines”) providing Registered Medical Practitioners (“RMPs”) with guidelines to treat patients remotely by using the telemedicine tools at their disposal.

Concepts such as telemedicine have gained prominence pursuant to the rapid development of information technology and the need to service the requirements of patients who may not be able to visit healthcare facilities, or have little to no access to the same. Such services involve the transfer of medical information and expertise through telecommunication and computer technologies and aim to facilitate diagnosis, treatment and management of patients. Currently, in India, platforms such as ‘practo’ and ‘DocOnline’ exist which facilitate online medical consultations albeit in a restricted manner given stringent regulatory controls on the practice of medicine. Though such platforms would help to deliver widespread healthcare services, there exist several concerns that exist about the medicolegal implications of telemedicine relating to registration, licensing, insurance, quality, privacy and confidentiality issues, as well as other risks associated with electronic health care communication.

A primary concern in the Indian healthcare sector is the lack of quality healthcare services in the rural regions of the country and the large distances that need to be travelled by rural people to avail healthcare services. This is of particulate concern in the remote and rural regions of the country.

In addition, disasters and pandemics, such as the COVID-19, pose several unforeseen challenges to the healthcare framework of the country. A rising global concern is the lack of healthcare professionals to deal with these and risks to healthcare providers who are at the forefront dealing with the infected patients. Thus, in such situations, telemedicine services are in a unique position to help mitigate such a grave healthcare crisis, by not only ensuring quality services are available widely but also by reducing the chances of healthcare professionals being infected themselves.

Historically, in the absence of any guiding framework or regulations which govern the practice of telemedicine, there were several concerns regarding the registration, licensing, liability, quality, privacy and confidentiality issues, as well as other risks associated with such telemedicine services. There was significant hesitation on part of the courts in allowing medical consultation vide telecommunication mediums owing to grave concerns such as medical negligence and in larger public interest. Interestingly, the Bombay High Court in its judgement in Deep Sanjeev Pawaskar and Anr. v. State of Maharashtra has held the applicants in this case (the two doctors) liable for medical negligence in lieu of the medical consultation/ advice provided though telephonic medium. This judgement has acted as a strong deterrent to the practice of telemedicine in India, with doctors being gravely concerned about the medicolegal/ liability implications of such service. Consequently the Indian Medical Association (“IMA”) while acknowledging the role of telemedicine has clearly held that the practice of telemedicine has grave ethical dilemmas. Thus, the IMA has requested the Medical Council of India to lay down clear cut guidelines for the doctors for the practice of telemedicine in India.

 

India: Telemedicine & Law – An Indian Perspective

 

Telemedicine basically means “healing at a distance“. It is great for both patients and medical assistance provider. That there is no one definitive definition of telemedicine – a 2007 study found 104 peer-reviewed definitions of the word – the World Health Organization has adopted the following broad description:

INTRODUCTION:

OVERVIEW OF TELEMEDICINE “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 ¹“. In common parlance, telemedicine refers to the practice of caring for patients remotely when the provider and patient are not physically present with each other and in such cases, telecommunications technology is used to evaluate, diagnose and treat the patient.

HISTORY

Telemedicine was discovered in the early 20^th Century. In the early 20^th century one of the first published accounts occurring was when electrocardiograph data were transmitted over telephone wires from the physiology laboratory to the clinic about a mile away. ².

In 1950’s, a Canadian doctor built upon this technology and developed a Teleradiology System that was used in and around Montreal. Then, in 1959, Doctors at the University of Nebraska used a two-way interactive television to transmit neurological examinations to medical students across its campus. By 1964, they had built a telemedicine link that allowed them to provide health services at Norfolk State Hospital, 112 miles away from campus. ³

Telemedicine also was woven into various projects funded and initiated by the U.S. Government for a far wider reach. One such project, called the STARPAHC (Space Technology Applied to Rural Papago Advanced Health Care) which basically enabled the U.S. Government to render medical services to Native Americans on the remote Tohono O’odham Reservation in Arizona, U.S.A by linking the patients in mobile support units in such remote areas with physicians in hospitals in Sells and Phoenix, Arizona, U.S.A. Telemedicine found its role in disaster management as well when NASA first used telemedicine services during the 1985 Mexico City earthquake, and then again in the year 1988, during the Soviet Armenia earthquake, where the estimated casualties were more than 50,000 people with approximately 5,00,000 people who were left homeless. ⁴ Thus began the era of international co-operation in use of telemedicine for a far wider humanitarian purpose.

Over many decades, the technology has advanced with the use of smart devices, which are capable of transmitting high quality videos and with everyone using mobile and internet to access information, it is now becoming a convenient tool for delivering prompt medical care. It is now easy to educate people with videos and images transferring information specially images like X-ray, scan, etc to patient and/or specialist doctors.

DIFFERENCE BETWEEN TELEHEALTH & TELEMEDICINE

Both the terms telehealth and telemedicine are used by healthcare industry interchangeably.  [-> is a, interface for connecting storage devices with a computer!!! ATA in the context of telemedicine means “American Telemedicine Association”]   But if we get into technicality, the word telehealth is a much broader term which includes all kind of health information services, medical education, health care education in addition to health care services provided using telecommunications technology, whereas telemedicine refers specifically to providing clinical services using telecommunication technology.

BENEFITS AND DISADVANTAGES OF TELEMEDICINE  Use of technology brings with it not only advantages in the field of providing health care services, but certain disadvantages also follow. Telemedicine practice is safe and effective but as any other technology it can be misused there are certain risk, drawback, limitation and these drawback and limitation can be managed by training, protocols and issuing guidelines.  Some of the advantages and disadvantages are listed below for better understanding:

Advantages:

• Expands access to quality patient care even to remote areas;
• Convenient access to medical care for patients – especially in the present day and time where are on the go and on the move from the word go;
• Also makes it convenient for a patient/ physician to seek consultation and/or expert advice from specialists, from anywhere in the world;
• Saves time for the patient;
• Less expense incurred on travel to and fro the clinic – extremely beneficial for patients living in rural areas;
• Maintains privacy;
• No exposure to other contagious infections/ diseases;
• Increased revenue for the RMP – fewer missed appointments and cancellations and better utilisation of its time;
• Better quality Patient Care – as it enables RMP’s to follow-up with their patients in a more effective and prompt manner and ensure that everything is going well – thus leading to better care outcome;
• Hospitals can also expand their access to medical specialists, and thus increase their revenue.

Disadvantages:

• Requires RMP’s to be technology savvy and undergo tech training alongwith investment on equipments (such as a webcam)/ mobile apps (secure video chat app);
• Electronic glitches may affect the service – caused by harsh weather leading to power cuts and/or disruption in internet connection, thus affecting transmission of data;
• There is a line of thought in the medical profession which believes that use of such technology will reduce the in-person interactions with doctors (may result in missing of non-verbal cues which a doctor in a in-person consultation can see) and also make consultation a very impersonal affair – it is thus believed that telemedicine can supplement in-person consultation but not replace it.
• There is also a risk of the information exchanged via telecommunication being accessed by hackers and possibility of it being misused.

TELEMEDICINE AND INDIA

India being a very vast country which is densely populated, telemedicine plays a very important role in enabling medical services being made accessible and deliverable to the remote areas as well, more so since the concentration of medical health care facilities is found more in the cities than in rural India, which constitutes majority of the national population.

ISRO (Indian Space Research Organization) made a modest beginning in telemedicine in India with a Telemedicine Pilot Project in 2001, linking Chennai’s Apollo Hospital with the Apollo Rural Hospital at Aragonda village in the Chittoor district of Andhra Pradesh . The development of telemedicine facilities in India has largely been due to a combined effort of ISRO, Department of Information Technology, Ministry of External Affairs, Ministry of Health and Family Welfare coupled with the State Governments. This network of telemedicine has covered and connected 45 remote and rural hospitals (such as islands of Andaman And Nicobar and Lakshwadeep, hilly regions of Jammu & Kashmir, Medical College Hospitals in Orissa amongst other rural hospitals) and 15 super specialty hospitals.

Infact, telemedicine is one of the successful fields in India in which private sector has taken initiatives and has acted actively in for the public health management. Narayana Hrudayalaya, Apollo Telemedicine Enterprises, Asia Heart Foundation, Escorts Heart Institute, Amrita Institute of Medical Sciences and Aravind Eye Care  are some of the Indian private sector players in telemedicine.

In India, the telemedicine service comes under the jurisdiction of the Ministry of Health and Family Welfare and the Department of Information Technology.

Telemedicine has also been extended to traditional medicines in India, such as the National Rural AYUSH Telemedicine Network which aims to promote the benefit of traditional methods of healing to the public at large using the medium of telecommunications ⁷.

Prior to 2020, were few concerns regarding the practice of telemedicine which were largely due to lack of guidelines and ambiguity that accordingly existed. . Infact, in the matter of Deepa Sanjeev Pawaskar & Anr. Vs the State of Maharashtra ,  Bombay High Court refused to grant anticipatory bail to 2 doctors involved in the treatment of a patient who ultimately died and the husband filed criminal complaints against the doctors accusing them of criminal negligence. The case also involved use of telecommunication as a medium of consultation. As there existed no legislation in India which governed the practice of telemedicine consultation, said judgement led to medical bodies repeatedly petitioning Medical Council of India and the government to issue clear guidelines to govern Telemedicine.

Due to the prevalent Pandemic caused by widespread COVID-19, which has affected countries world over, there appeared challenges to provide health care services to people in need – especially in the wake of social distancing ordered to be maintained by people all over the world coupled with the high risk of catching the COVID-19 infection. It was the need of the hour to regulate Telemedicine and promote it as a tool available for patients suffering from other ailments to consult and seek timely medical advice, at the same time, also help the RMP’s to effectively manage patients and deliver timely consultation as and when desired and required – without requiring the patient to visit the hospital and/or clinic.

Thus with the lockdown in force all over the country, use of Telemedicine consultation can help both the patient as well as doctors from preventing the spread of highly contagious COVID-19 disease and reduce the risk of exposing vulnerable patients aa well as health workers to the COVID-19 virus.

TELEMEDICINE PRACTICE GUIDELINES, 2020

In order to meet with the crisis faced by the country and the need to enforce social distancing and do away with unnecessary movement of patients to the clinics/ hospitals, on 25^th March 2020 Ministry of Health and Family Welfare, Government of India issued Telemedicine Practice Guidelines, 2020 which were prepared in partnership with NITI Aayog (Also called “The National Institution for Transforming India” – which is the premier policy ‘Think Tank’ of the Government of India, providing both directional and policy inputs).

As stated in the “Background” of the above said guidelines, the purpose of these guidelines is to give practical advice to doctors to enable them to start using telemedicine as part of its normal practice as well as to provide them with a sound course of action to provide effective and safe medical care founded on current information, available resources, and patient needs to ensure patient and provider safety (to be used in conjunction with national clinical standards, protocols, policies and procedures).

Relevant Provisions of the guidelines, in brief, are as under:

DEFINITIONS

Guideline No.1.1.1 Telemedicine ‘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.’

Guideline No.1.1.2 Telehealth ‘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.’

Guideline No.1.1.3 Registered Medical Practitioner (RMP): ‘A Registered Medical Practitioner [RMP] is a person who is enrolled in the State Medical Register or the Indian Medical Register under the Indian Medical Council Act 1956′ [IMC Act, 1956].

Guideline No.1.2 – Exclusions: It specifically excludes following from its purview:

• 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;
• Does not provide for consultations outside the jurisdiction of India.

Guideline No.1.3.1 –  A Registered Medical Practitioner is entitled to provide telemedicine consultation to patients from any part of India.

Guideline No.1.3.3 – Lays down certain pre-requisites on the part of the Board of Governors as well as RMP’s, which are as follows:

• An online program tp be developed and made available by the Board of Governors in supersession of Medical Council of India.
• All registered medical practitioners intending to provide online consultation need to complete a mandatory online course within 3 years of its notification.
• In the interim period, the principles mentioned in these guidelines need to be followed.
• Thereafter, undergoing and qualifying such a course, as prescribed, will be essential prior to practice of telemedicine.

Thus completing the course as prescribed is essential to the practice of telemedicine consultation in India.

Guideline No.1.4.1 Specifies Tools to be used for Telemedicine: RMP may use any telemedicine tool suitable for carrying out technology-based patient consultation e.g. telephone, video, devices connected over LAN, WAN, Internet, mobile or landline phones, Chat Platforms like WhatsApp, Facebook Messenger etc., or Mobile App or internet based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc. Irrespective of the tool of communication used, the core principles of telemedicine practice remain the same

Guideline No.1.4.2 –  classifies Telemedicine applications into four categories, based on:-(i)the mode of communication, (ii)the timing of the information transmitted, (iii)the purpose of the consultation and (iv)the interaction between the individuals involved—be it RMP-to-patient / caregiver, or RMP to RMP.

Guideline No.2 and 3.3 –  states that to enable RMP’s to practice telemedicine, 3 different modes of technology can be used –

(i)Video (Telemedicine facility, Apps, Video on chat platforms, Skype/Face time etc.);
(ii)Audio (Phone, VOIP, Apps etc.);
(iii)Text Based:

• Telemedicine chat based applications (specialized telemedicine smartphone Apps, Websites, other internet-based systems etc.); or
• General messaging/ text/ chat platforms (WhatsApp, Google Hangouts, Facebook Messenger etc.); or
• Asynchronous (email/ Fax etc.).

with strengths and weaknesses laid down for each mode to enable the RMP to take an informed decision with regard to the mode of communication to be used for telemedicine consultation.

Guideline No. 3.1, 3.2 –  provides that an RMP is required to use its professional judgement to decide whether to go for telemedicine consultation or go for in-person consultation – interest of the patient being paramount.

Also the identity of both the patient and the RMP need to be disclosed to each other; Patient details to be given and taken by the RMP is as follows:

• Name;
•  Age;
•  Address;
•  email ID;
• phone number;
• registered ID or any other identification as may be deemed to be appropriate.

RMP details to be given to the patient are as follows:

• RMP should inform the patient about his/her qualifications;
• RMP should display the registration number accorded to him/her by the State Medical Council/MCI, on prescriptions, website, electronic communication (WhatsApp/ email etc.) and receipts etc. given to his/her patients.

Guideline No.3.4 –  Patient’s consent for telemedicine consultation is a must, in the form of an email, text or audio/video message. Consent could be of 2 types:

• Implied – If the patient initiates the telemedicine services then the consent is implied.
• Explicit – An explicit consent is given when the RMP, Healthcare worker and caregiver initiates telemedicine services.

Guideline No.3.5 –  Before making any professional judgement, its mandatory for the RMP to gather and record sufficient medical information about the patient’s condition;all records, such as case history, investigation reports, images etc. has to be maintained with regard to each patient.

Guideline No.3.7 –  specifies the kind of consultation to be provided and care to be taken while providing such consultation – such as health education, counseling and issuing prescriptions (as per prescription format – Annexure 2 to the guidelines) and transmit of prescriptions to the patient.It also lays down specific restrictions on prescribing medicines during telemedicine consultation –

• List O – those medicines which are safe to be prescribed through any mode of tele-consultation;
• List A – , those medicines which can be prescribed during the first consult which is a video consultation and are being re-prescribed for re-fill;
• List B – medicines which can be prescribed undergoing follow-up consultation in addition to those which have been prescribed during in-person consult for the same medical condition;
• Prohibited List – medicines which cannot be prescribed via telemedicine consultation (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)

Guideline No.3.7.1 and 3.7.3  – lays down the duties and responsibilities of an RMP, including what constitutes misconduct and penalties for such misconduct, fee to be charged for telemedicine consultation and issuance of receipt for such consultation.

Guideline No.4 –  specifies the framework (essential principles) or the step-by step process required to be followed by an RMP while practicing telemedicine consultation in various scenarios, including

(v)First Consult;
(vi)Follow-up consult;
(vii)consultation between RMP and patient through a caregiver and/or health worker;
(viii)Consultation(s) with a fellow RMP and/or specialist;
(ix)Emergency situations;

Guidelines No.5 – Castscertain obligations on the Technology Platforms such as mobile apps, websites etc., enabling Telemedicine consultations, such as:

• Due Diligence should be done before listing of any RPM on the portal;
• Technology Platforms to ensure that consumers are consulting only Registered Medical Practitioners, duly registered with National Medical Councils or respective State Medical Council and comply with relevant provisions;
• In case of non-compliance by any party, Technology Platforms shall be required to report the same to BoG, who may take appropriate action;
• Technology platforms based on Artificial Intelligence/Machine learning are not allowed to consult patient or prescribe medicines to any patient;
• Technology Platforms to ensure proper platform for patient(s) to place any queries and/or grievances;
• In case any specific Technology Platform is found in violation, BoG, MCI (Medical Council of India) may designate the Technology Platform as blacklisted, and no RMP may then use that platform to provide telemedicine.

Guidelines No.6  – Gives special powers to Board of Governors, in supersession to the Medical Council of India, to amend the drug lists as contained in the guidelines, to issue necessary directions or advisories or clarifications, and to amend the guidelines in consultation with the prior approval of Central Government [Ministry of Health and Family Welfare, Government of India]..

THIS GUIDELINES PDF  CAN BE DOWNLOADED FROM HERE:

Telemedicine Practice Guidelines

 LAWS IN INDIA RELATED TO PRACTISE OF TELEMEDICINE IN INDIA

Hon’ble Supreme Court in the matter of Mr. ‘X’ Vs Hospital ‘Z’ held that in a doctor–patient relationship, the most important aspect in doctor’s duty is to maintain secrecy – a doctor cannot disclose to any other person any information regarding his patient which he has gathered in the course of treatment nor can the doctor disclose to anyone else the mode of treatment or the advice given by him to the patient – doctors were held morally and ethically bound to maintain confidentiality – the only exception to the said rule being when the disclosure is necessary under public interest which would then override the duty of confidentiality, particularly where there is an immediate of future health risk to others.

A perusal of various provisions of the Guidelines makes it clear that the RMP’s and Telemedicine are required to comply with various laws applicable to medical practitioners in India such as –  Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002; Drugs and Cosmetics Act and Rules, IT Act, Indian Medical Council Act and other prevailing laws, including provisions related to Data Protection and Privacy Laws. Thus, laws applicable to telemedicine are the laws applicable to practice of medicine in India coupled with laws governing Information Technology. Various laws related to practice of medicine in India are:

• Drug And Cosmetics Act, 1940,  – governs the permissible and/or prohibited drugs which can     be prescribed in telemedicine consultation – such as Anti-Cancer drugs which have been    prohibited from being prescribed in telemedicine consultation; A “Drug” has been defined under Section 3 (b) of the Drugs and Cosmetics Act, 1940.
  Prescriptions made against medical consultation and diagnosis services under telemedicine formats should satisfy legal requirements. The term “prescribed” as per Section 3 [(i)] of the Drugs and Cosmetics Act, 1940 means prescribed by rules made under the Act.
  Section 8 of Drugs Act, “Standards of quality”— ―standard quality means— (a) in relation to a drug, that the drug complies with the standard set out in the Second Schedule, and (b) in relation to a cosmetic, that the cosmetic compiles with such standard as may be prescribed.
• Drugs and Cosmetics Rules,1945 – governs the permissible drugs which can be prescribed in telemedicine consultation; Prescription only drugs” are defined under Section 65(9) of the Drugs and Cosmetics Rules, 1945
  • Substances specified in Schedule H or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner only.
  • Further, in the case of substances specified in schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years.
  • The supply of drugs specified in Schedule H or Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a   period of two years;

A “prescription” has been defined under Section 65(10) of the Drugs and Cosmetics Rules,   

• The Narcotic Drugs and Psychotropic Substances, Act, 1985  – Schedule X of the Narcotics Act has been made applicable to telemedicine consultations. Thus all the drugs included in Schedule X cannot be prescribed in telemedicine consultation. For instance, Narcotics such as Morphine, Codeine etc;
• The Indian Medical Council Act, 1956 – governs the conduct/ misconduct of the RMP;
• The Indian Medical Council Regulations, 2002 – – governs the conduct/ misconduct of the RMP; and
• Indian Medical Council (Professional Conduct, Etiquette And Ethics) Regulations, 2002 [Code of Ethics Regulations, 2002] – govern various issues relating to patient-doctor confidentiality, collection of personal data from patients, issues of consent,
• The Clinical Establishment (Registration and Regulation) Act, 2010 – . Establishments falling under the definition of a ‘clinical establishment’ under the Clinical Establishments Act would be required to register with the relevant authority and conform to the minimum standards as prescribed under the act.
• Laws related to information technology includes:
• Information Technology Act, 2000, amended by the Information Technology (Amendment) Act, 2008 – provisions related to protection of electronic data such as:
• Section  43(a) to (h) – penalizes cyber contraventions attracting civil prosecution – includes unauthorised access to and downloading or extracting data from computer system or networks;
• Sections 63 to 74 – Cyber offences attract criminal action – eg. hacking with intent to cause
•  damage, and breach of confidentiality and privacy.
• Section 72 of the said Act which recognizes the breach of confidentiality and privacy as an offence is very limited in its scope and it reads as under:

“72. Breach of confidentiality and privacy– Save as otherwise provided in this Act or any other law for the time being in force, any person who, in pursuant of any of the powers conferred under this Act, rules or regulations made thereunder, has secured access to any electronic record, book, register, correspondence, information, document or other material without the consent of the person concerned discloses such electronic record, book, register, correspondence, information, document or other material to any other person shall be punished with imprisonment for a term which may extend to two years, or with fine which may extend to one lakh rupees, or with both.

The Information Technology  Reasonable Security Practices And Procedures And Sensitive Personal Data Or Information Rules, 2011 –

Sets out procedures for corporate entities which collect, process or store personal data (including sensitive personal information) – requires prior consent of the provider of the information while disclosing sensitive personal data to a third party; it holds a body corporate liable for compensation for any negligence in implementing and maintaining reasonable security practices and procedures while dealing with sensitive personal data or information; At the same time, the body corporate would be deemed to have complied with reasonable security practices if it has complied with security standards and has comprehensive data security policies in place;

Although there are laws which exist with regard to technology and or technology driven issues, however, one of the greatest concerns of use of technology has been the need to protect electronic data – in the case of telemedicine “personal sensitive information” related to the patient. Pursuant to the majority judgement (a 5 Judge Constitution Bench) passed in the matter of Justice K.S. Puttaswamy (Retd.) Vs Union of India , which recognized the right of privacy as a fundamental right for Indian citizens under Article 21 of the Constitution of India, the Government of India constituted a 10-member committee of experts under the Chairmanship of a retired Supreme Court Judge “to identify key data protection issues in India and recommend methods of addressing them”.

The Committee submitted its detailed report  which formed the basis of a proposed Personal Data Protection Bill, 2019 which was introduced in the Parliament in December 2019 and is pending approval, likely to be passed in 2020. The bill sets out rules as to how personal data should be processed and stored coupled with listing out people’s rights with respect to their personal information, while imposing strict compliance requirements for data protection on most businesses in India. Till the bill is passed into an Act of the Parliament, telemedicine consultation and data privacy will have to be governed by above mentioned Acts/ Rules and/or Regulations.

INSTANCES Liability In Civil Negligence

When there is a breach of contractual obligations between the telemedicine provider and the patient then civil suit arise. That if there is a breach of duty caused by the omission to do something then it is negligence.

Doctor Patient Relationship

That there must be a contract which must be expressed or implied between the doctor and the patient which means that the patient should with  consent and knowingly take the assistances of a doctor and the doctor accepts such consent. Nevertheless, the lines become unclear in telemedicine when determining whether a doctor-patient relationship can exist online or through email. The doctor-patient relationship has not been judicially or legislatively examined extensively in India, except to the extent of privacy and confidentiality requirement.

Liability In Criminal Negligence

The provisions for the criminal offences are the Indian Penal Code, 1860 (IPC) where the negligence is ‘gross’ in nature and proven beyond doubt. The common charges faced by doctors and other providers of such services are causing death by negligence (Section 304-A of the Indian Penal Code [IPC]), endangering life or personal safety of others (Section 336 of the IPC), causing hurt by an act endangering life or personal safety of others (Section 337 of the IPC) and causing grievous hurt by an act endangering the life or personal safety of others (Section 338 of the IPC). Punishment includes imprisonment as well as fine under the relevant sections.

Vicarious Liability

In the provision of eHealth services such as telemedicine where there is an employer-employee relationship, the employer could be proceeded against due to the principle of vicarious liability if deemed liable for acts and omissions of the employee arising in course of his/her employment. The principle of vicarious liability does not apply to criminal prosecutions.

In vicarious relationship between the doctor or any other healthcare provider and the hospital, or equivalent institution should be inferred for e.g. in case of errors which occur due to a breakdown in communication or organisation during the telemedical application, the primary principles of organizational responsibility will apply

Liability Under The Consumer Protection Act, 1986.

The Consumer Protection Act (CPA) allows consumers to claim compensation from service providers in case there is a deficiency in the service provided. Consumers can file claims for defective products and unfair trade practices. Consumer forums have been set up at the district, state and national levels to hear such matters. The Supreme Court in the case of Indian Medical Association versus V.P. Shantha and others held that medical services would fall within the ambit of the CPA, provided the patient is being charged for the service. One of the essential elements of a claim is the payment for the services, as the CPA excludes services that are rendered free of charge. Disciplinary control by the Medical Council of India .

A patient is entitled to raise a complaint with the relevant state medical council against a doctor for professional misconduct. If a complaint against a doctor has not been decided by the state medical council within 6 months from the date of receipt of the complaint, the Medical Council of India (MCI) may, on its own or on the request of the patient, ask the state medical council to decide on the complaint or refer the same to the Ethical Committee of the MCI. Consumers who are aggrieved by the decision of the state medical council also have the right to appeal to the MCI within a period of 60 days from the date of the order that was passed by the state medical council.

The Supreme Court in Indian Medical Association v. V.P. Shantha ¹⁴ has settled the dispute regarding the applicability of Consumer Protection Act, 1986 to persons engaged in the medical profession either as private practitioners or as government doctors working in hospitals or government dispensaries. It is also settled law that a patient who is a ‘consumer’ within in the meaning of the Act has to be awarded compensation for loss or injury suffered by him due to the negligence of the doctor by applying the same tests as are applied in an action for damages for negligence.

Telephonic medical consultation cannot be criminalised

 

Most of you reading this would have at some point consulted your doctor on the phone – through a call or text or whatsapp message and were prescribed medicines or advised tests, perhaps even hospitalisation. A 2018 judgment of the Mumbai High Court in Deepa Sanjeev Pawaskar Vs State of Maharashtra has been doing the rounds with messages suggesting that telephone consultation would make the doctor liable for prosecution under Section 304 of the Indian Penal Code (IPC) for culpable homicide not amounting to murder! However, the context in this case was entirely different. It was a finding in an anticipatory bail plea of a doctor couple who had allegedly advised a patient with post delivery complications not to go to another hospital although they were away and prescribed medicines on the phone to the chemist. The patient died and the police booked the doctors under Section 304 IPC.

The Mumbai High Court had noted that as the deceased was unwell 24 hours after her caesarean operation, she should have been referred to another doctor, when the original treating doctors were unavailable. ‘Not doing the same simply shows the commercial interest the applicants had in re-admitting the deceased to their hospital.’

The court had ruled that ‘an error in diagnosis could be negligence and covered under section 304A of the Indian Penal Code. But this is a case of prescription without diagnosis and therefore, culpable negligence. The element of criminality is introduced not only by a guilty mind but by the practitioner having run a risk of doing something with recklessness and indifference to the consequences’. The doctors clearly had no mens rea or criminal intention but the Court viewed the case as an act done with the knowledge that it is likely to cause death. The doctors ultimately obtained anticipatory bail from the Supreme Court.

There is a clear distinction between Section 304 and 304A of the IPC, usually the bone of contention in fatal motor accident cases. While 304 is culpable homicide not amounting to murder and is punishable with life imprisonment or for 10 years, 304A is causing death by a rash and negligent act, carrying a 2 year jail term.

The word ‘gross’ has not been used in Section 304A IPC, yet it is settled that in criminal law, ‘negligence’ or ‘recklessness’ must be of such a high degree as to be ‘gross.’ The Supreme Court in P.B. Desai Vs State of Maharashtra was categorical. ‘The solution to the issue of punishing what is described loosely, and possibly inaccurately, as negligence is to make a clear distinction between negligence and recklessness and to reserve criminal punishment for the latter. If the conduct in question involves elements of recklessness, then it is punishable and should not be described as merely negligent.’

The Apex Court in what is considered a landmark decision on medical negligence in Jacob Mathew Vs State of Punjab had cautioned prosecuting agencies that ‘Indiscriminate prosecution of medical professionals for criminal negligence is counter-productive and does no service or good to the society’ adding that ‘a medical practitioner faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act.’ The real test of criminal negligence is whether the hazard taken by the accused doctor is of ‘such a nature that the injury which resulted was most likely imminent.’

The re-surfacing of this old news has triggered panic in medical circles. Clinical examination before prescribing drugs is the correct practice in an ideal situation.

But life is full of surprises and emergencies and doctors cannot be omnipresent. Telephonic consultation may save lives, especially in cases where the patient cannot travel or when there is a delay in getting direct medical treatment. Even in the emergency wards of hospitals, specialists are not available round the clock, billboards claiming 24×7 emergency care notwithstanding. The duty doctor would invariably whatsapp or call the expert, say a cardiologist, with the ECG report,pulse and blood pressure readings, and based on the telephonic advice, administer first aid or shift the patient to the Intensive Care Unit.

Unlike certain places in the West, the concept of 24 or 36 hour shifts of specialist doctors does not exist. Neither is the practice of house calls in vogue today.

Although Section 97 of the Drugs and Cosmetics Act contains a warning that Schedule H drugs are to be sold only on the prescription of a Registered Medical Practitioner and only the required amount of medication specified in the prescription can be dispensed, it is common knowledge that chemists follow it in the breach. If a patient is able to convey symptoms accurately and truthfully and voluntarily seeks help on the telephone, it is up to the doctor whether or not to oblige or insist on clinical consultation.

For that matter, whatsapp is also being accepted for the service of summons and notices. The same Bombay High Court in Kross Television India Pvt. Ltd. Vs Vikhyat Chitra Production held that the ‘Indian Judiciary system is flexible enough to consider a notice issued through ‘WhatsApp’ or through email admissible in the court of law.’ Show up at your doctor’s clinic in person as far as possible. It is also professional and in your interest. But in an emergency, or for some valid reason, if clinical consultation is not viable, telephonic advice need not be feared by doctors or patients as it cannot be criminalised.

 

We the Veterinary Fraternity of India seeks clear-cut guidelines from the Veterinary Council of India (VCI) on the issue of Veterinary telemedication, while observing that the practice is illegal and unethical.Online Vet  consultations, onlineVet. prescriptions and Vet.telemedicine are all topics which have posed ethical dilemmas. . But at the same time, advancing technology can be harnessed for augmenting Livestock healthcare in remote areas, especially Vet. telemedicine and mobile health. The VCI must come out with clear-cut guidelines on these important issues, which many developed countries have.

Following a high court verdict to proceed with criminal prosecution in an incident which involved telephonic consultation, the issue came to the attention of the public and was widely discussed. Although the particular stand by the high court was not to find negligence in the telephonic consultation but for other reasons. Subsequently the arrest of the doctors in the case was stayed by the Supreme Court. As we know that the common practice involved in treating a  Veterinary patient is  eliciting history, physical examination, going through investigations and arriving at a diagnosis. Treatment is instituted after the diagnosis, In telephonic consultations, all or part of the above may not be undertaken. Hence there is always a possibility of alleging and finding negligence on the part of the Vet doctor by the legal fora, Although in 2021  AYUSH of Govt. of India has notified a guidelines for Medical Telemedicine . On the same pattern our veterinary profession also need such guideline so that we there should not be any litigation issue pertaining to vet. Telemedicine.We request all our veterinary fraternity to  Plz share your opinions on this matter so that we may prepare a  draft  to be sent to VCI for their perusal.

Regards

DR RAJESH KUMAR SINGH,Editor In Chief www.pashudhanpraharee.com

pashudhanpraharee@gmail.com

9431309542.

 

Reference- https://www.mondaq.com/india/healthcare/944860/telemedicine-law-an-indian-perspective