Partner, Vaish Associates Advocates, New Delhi, India, email@example.com
The concept of telemedicine and web based medical services are derived from the exchange or transmission of medical knowledge or information through electronic formats and mediums, so as to cut across time and space across the world for the benefit of medical advancement. Medical information is communicated through electronic media in interactive formats such as audiovisual media, telephonic conferences, satellite communication, internet etc. for medical consultation, examination or remote monitoring / medical procedure purposes. The model has popularized since it links isolated communities to advanced medical services and provides speedy delivery of medical expertise. Certified medical practitioners world over have started taking advantage of the telemedicine concept, expanding their services. The United States licensure laws promote the model while requiring a practitioner following the format to obtain a full license across states to deliver telemedicine healthcare services across state lines. In India practitioners and medical societies have been tele-transmitting medical information and remote monitoring health services since as early as 1975. The medium of tele applications and web-interface based systems linking patients and medical practitioners through telemedicine services may use wireless diagnostics tools like stethoscopes; blood pressure, temperature and insulin monitors, and ultrasounds enabling remote diagnosis, treatment, advanced healthcare and medical services.
The Medical Council of India regulates uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. Official registration of doctors with recognized medical qualifications is controlled by the council, and procedures have been laid out under the Indian Medical Council Act 1956 and Indian Medical Degree Act 1916. Although there are no legal constraints specifically dealing with methodology of executing or dispensing medical services in India, various laws including the Drugs and Cosmetics Act, 1940 define negligence; criminal intent; sale, manufacture and distribution of drugs etc., while judicial precedent and case laws determine medical negligence on a case by case basis. The healthcare service provider adopting telemedicine methods of medical practice must ensure that medical consultation, prescriptions, treatment and drugs are dispensed only in accordance with legal provisions and guidelines regulating the medical and healthcare sector in India.
Under the present laws relating to the above in India, a fully automated process solely based on an artificial intelligence program may not be legally feasible, as it is a basic requirement that only medical practitioners registered before the Medical Council of India and other relevant lawsare allowed to provide medical consultation,prescriptions and treatment. For understanding the legal proposition in regard to the telemedicine in India, one has to understand the implications of some important legal provisions relating to medical healthcare and drugs in India, as under:
A *"Registered medical practitioner" has been defined under Section 2 (ee) of the Drugs and Cosmetics Rules, 1945 of India as a person-
- holding a qualification granted by an authority specified or notified under Section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified In the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or
- registered or eligible for registration in a medical register of a State meant for the registration of persons practicing the modern scientific system of medicine excluding the Homoeopathic system of medicine; or
- registered in a medical register, other than a register for the registration of Homoeopathic practitioner, of a State, who although not falling within subclause (i) or sub-clause (ii) declared by a general or special order made by the State Government in this behalf as a person practicing the modern scientific system of medicine for the purposes of this Act; or
- registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or
- who is engaged in the practice of veterinary medicine and who possesses qualification approved by the State Government.
A "Drug" has been defined under Section 3 (b) of the Drugs and Cosmetics Act, 1940 and includes-
- all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
- such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
- all substances intended for use as components of a drug including empty gelatin capsules; and
- such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.
The term "prescribed" as per Section 3 [(i)] of the Drugs and Cosmetics Act, 1940 means prescribed by rules made under the Act.
Prescriptions made against medical consultation and diagnosis services under telemedicine formats should satisfy legal requirements given below so as to be a valid legal prescriptionunder the laws of India. The Drugs and Cosmetics Rules, 1945 specify the type of drugs that require valid medical prescriptions for retail purchase, classifying them under Schedules appended to the Rules.
"Prescription only drugs" are defined under Section 65(9) of the Drugs and Cosmetics Rules, 1945, which states that –
- 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
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;
The above provision deals only with the dispensing of medicine and supply of a certain category of medicine. However, irrespective of the schedule in which a medicine may fall, prescription of a medicine can be made only by a registered medical professional as per the Rules. Since there are no legal provisions describing the manner of treating a patient, prescriptions instructing a patient to consume any drugs are very important documentary evidence of negligence or lack of it on the part of a medical practitioner while treating a patient. The Rules have defined the important components that constitute a valid legal prescription, for all medical practice purposes.
A "prescription" has been defined under Section 65(10) of the Drugs and Cosmetics Rules, 1945 so as to have the following components-
- be in writing** and be signed*** by the person giving it with his usual signature and be dated by him;
- specify the name and address of the person for whose treatment it is given, or the name and address of the owner of the animal if the drug is meant for veterinary use;
- indicate the total amount of the medicine to be supplied and the dose to be taken.
For all medical treatments through telemedicine or web-interface format, it is important to ensure that the prescriptions must satisfy the above requirements of being in writing and signed by a registered medical practitioner, without which the prescription will be invalid in the eyes of the law.
Due to the recognition of electronic documents under the Information Technology Act, 2000, a prescription in an electronic format may be validated as a legal prescription if it is a secure electronic record affixed with a secure digital signature as prescribed under the Information Technology Act, 2000 of India. The Information Technology Act, 2000 provides for authentication of secure electronic records and affixing of digital signatures so as to ensure the legal validity of the same. Section 4, mentioned herein below, of the Information Technology Act, 2000 which recognizes electronic records is important for understanding above:-
"where any law provides that information or any other matter shall be in writing or in the typewritten or printed form, then, notwithstanding anything contained in such law, such requirement shall be deemed to have been satisfied if such information or matter is –
- Rendered or made available in electronic form, and
- Accessible so as to be usable for subsequent reference."
Section 3 of the Information Technology Act, 2000 deals with authentication of electronic records as under:-
- Subject to the provisions of the section any subscriber may authenticate an electronic record by affixing his digital signature.
- The authentication of the electronic record shall be effected by the use of asymmetric crypto system and hash function which envelop and transform the initial electronic record into another electronic record.
Digital signatures are legally recognized under Section 5 of the Information Technology Act, 2000, which states as under:-
"where any law provides that information or any other matter shall be authenticated by affixing the signature or any document shall be signed or bear the signature of any person then; notwithstanding anything contained in such law, such requirement shall be deemed to have been satisfied, if such information or matter is authenticated by means of digital signature affixed in such manner as may be prescribed by the Central Government."
Automated artificial intelligence based telemedicine formats controlled by a registered medical practitioner can formulate legal prescriptions in the form of an electronic record, provided the same can be attributed, under Section 11 of the Information Technology Act, 2000, to the originator-
- if it was sent by the originator himself;
- by a person who had the authority to act on behalf of the originator in respect of that electronic record; or
- by an information system programmed by or on behalf of the originator to operate automatically.
Section 14 of the Information Technology Act, 2000, defines a secure electronic record, wherein any security procedure has been applied to it at a specific point of time, after which such record shall be deemed to be a secure electronic record from such point of time to the time of verification.
Under Section 15 of the Information Technology Act, 2000, a secure digital signature by application of a security procedure agreed to by the parties concerned, can be verified to be a digital signature, at the time it was affixed, if it was—
- unique to the subscriber affixing it;
- capable of identifying such subscriber;
- created in a manner or using a means under the exclusive control of the subscriber and is linked to the electronic record to which it relates in such a manner that if the electronic record was altered the digital signature would be invalidated.
Since telemedicine formats of medical practice are essentially based on mediums of technology, the medical practice model may use the above legal provisions to their advantage with respect to preparation of valid legal electronic prescriptions.
'OTC Drugs' (Over The Counter drugs) are drugs legally allowed to be sold 'Over The Counter', i.e. without the prescription of a Registered Medical Practitioner. In India, though the phrase has no legal recognition, all drugs not included in the list of 'prescription only drugs' under the Drugs and Cosmetics Act, 1940 may be considered as non-prescription drugs (or OTC drugs). A proposal for a list of over the counter (OTC) drugs has been under the government's consideration and a committee appointed for the purpose has been working on it. The Drug Controller General of India is expected to lay down a separate set of rules or guidelines for OTC marketing once the list is official.
In a scenario where advice is provided electronically through a telemedicine interface, which is manned by certified medical practitioners and/ or an artificial intelligence system validated by medical practitioners entitled to practice medicine in India, the guidelines issued by the Medical Council of India under the Code of Ethics Regulations, 2002 also apply. Some guidelines, which may apply to a telemedicine system are listed below:-
Section 1.4 of the Code of Ethics Regulations, 2002 states that registration numbers of medical practitioners/ doctors accorded by the State Medical Council / Medical Council of India must be displayed in the clinic and in all prescriptions, certificates, money receipts given to patients.
Under Section 6.1.1 of the Code of Ethics Regulations, 2002 the act of soliciting patients directly or indirectly is unethical, by a physician or a group of physicians, institutions or organizations. Although no legal provision deals with the manner of communication between a medical practitioner and patient with respect to diagnosis and treatment, there are numerous legal provisions dealing with ethical conduct to be followed by medical practitioners while dispensing specialized medical services.
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