Telemedicine And Medico-Legal Issues In India: A Critical Analysis

Sr. No.	Area	Purpose
I	Tele Consultation Tele diagnosis Tele treatment	The patient with the local doctor consults the specialist, obtains the line of treatment
II	Tele-education  Tele-training	For Continuing Medical Education, Training for doctors & paramedics from a higher level Hospital/Institution
III	Tele-monitoring Tele-support	Regular monitoring for intensive care & emergency care Support during disaster management

Types of Technology

Two different kinds of technology make up most of the telemedicine applications in use today. The first, called store and forward, is used to transfer digital images from one location to another. A digital image is taken using a digital camera, ‘stored’ and then sent (‘forwarded’) by a computer to another location. This is typically used for nonemergent situations, when a diagnosis or consultation may be made in the next 24-48 hours and sent back. Teleradiology, telepathology and teledermatology are a few examples.[7]

The other widely used technology, the two-way interactive television (IATV), is used when a ‘face-to-face’ consultation is necessary. The patient and sometimes their provider or more commonly a nurse practitioner or telemedicine coordinator (or any combination of the three), are at the originating site. The specialist is at the referral site, most often at an urban medical center. Videoconferencing equipment at both locations allow a ‘real-time’ consultation to take place.[8]

Beside the aforesaid, the telemedicine facility is also being put to use through remote monitoring by monitoring the patients at Specialised Units such as ICU, CCU, etc. of Hospital and for guidance and instructions to the medical team.

 

Telemedicine in India

In contrast to the bleak scenario in healthcare, computer literacy is developing quickly in India. Healthcare providers are now looking at Telemedicine as their newly found Avatar. Theoretically, it is far easier to set up an excellent telecommunication infrastructure in suburban and rural India than to place hundreds of medical specialists in these places. We have realized that the future of telecommunications lies in satellite-based technology and fiber optic cables.[9]

The concept of Telemedicine is being adopted and recognized also by the leading government medical institutes of India such as All India Institute of Medical Sciences, New Delhi, Post Graduate Institute of Medical Education and Research, Chandigarh, etc.

The Apollo Hospitals system has become one of Asia’s largest private health-care groups and the seventh largest in the world which is also involved in providing telemedicine services.  The Apollo Project has opened remote telemedicine centers that link villagers via satellite to specialist services.[10] The Apollo Hospitals also facilitate Army Hospitals in South India via a network hub to its telemedicine facilities.[11]

In nut shell, Telemedicine is an emerging field in healthcare arising out of the synergistic convergence of Information Technology with Medical Science having enormous potential in meeting the challenges of healthcare delivery to rural and remote areas besides several other applications in education, training and management in health sector. It may be as simple as two health professionals discussing medical problems of a patient and seeking advice over a simple telephone to as complex as transmission ofelectronic medical records of clinical information, diagnostic tests such as E.C.G., radiological images etc. and carrying out real time interactive medical video conference with the help of IT based hardware and software, video-conference using broadband telecommunication media provided by satellite and terrestrial network[12]

 

Legal position of Telemedicine in India:

Despite the concept being recognized and defined by WHO and its spreading influence over the past decade, there is no legislation which singularly deals with the practice of Telemedicine in India. In the absence of a specific law, as the practice of Telemedicine is fundamentally an intricate combination of ‘the practice of medicine’ with ‘information technology’, undoubtedly all the existing laws relating to both ‘medicine’ and  ‘information technology’ in India would apply to Telemedicine.[13]

Laws governing Medical and para medical professionals:

There are various Legislation governing the qualifications/ Practice and Conduct of Professionals vis-à-vis Indian Medical Council Act 1956, Indian Medical Council (professional conduct, etiquette and ethics) Regulations 2002, Indian Medical Degree Act 1916, Indian Nursing Council Act 1947, The Dentists Act 1948, The Dentists (code of ethics regulation) 1976, AICTE Rules of physiotherapy, Rehablitation Council of India Act 1992,  etc.                                                                                                                         

Laws governing Drugs:

 Beside the aforesaid legislations, the laws governing storage, sale, prescription of Drugs and its safe mechanism consists of Drugs and Cosmetics Act 1940, The Drugs and Cosmetic Rules 1945, The Drug Control Act 1950, Pharmacy Act 1948, Narcotics and Psychotropic Substances Act 1985, Central Excise Act (for permit to use and store spirit) 1944, Blood Bank Regulations under Drug and Cosmetic (2^nd Amendment) Rules 1999, Homeopathy Central Council Act 1973, etc.                                    

Laws conferring rights and duties upon patients:

In addition to above, there are also laws governing Management of Patients vis-à-vis Drug and Magic Remedies (objectionable advertisements) Act 1954, Pre Conception and Pre Natal Diagnostic Techniques Act 1994, Medical Termination of Pregnancy Act 1997, Transplantation of Human Organ Act, 1994, Birth and Death and Marriage Registration Act 1886, Indian Lunacy Act 1912, The Epidemic Disease Act 1897, Lepers Act 1975, Guardians and Wards Act 1890, The Mental Health Act 1987, Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes Act 1982, Eyes (Authority for Use for Therapeutic Purposes) Act 1982, etc.                                                                                                           

Laws governing the safety of Patients, Public and Staff within the Hospital Premises and Environmental Protection:

Various laws have been passed by the legislature governing the safe of patients, public and staff within the Hospital Premises and Enviornmental Protection such as, Biomedical Waste Management Handling Rules 1998, Water (prevention and Control of Pollution) Act 1974, The Noise Pollution Rules 2010, Air (prevention and Control of Pollution) Act 1982, Environment Protection Act 1996, Indian Boilers Act 1923, Explosive (for Diesel Storage) Act 1884, Petroleum Act and storage Rules 2002, Gas Cylinders Rules 2004, Prevention of Food Adulteration Act 1954, The Radiation surveillance procedures for the medical application of radiation rules 1989, Radiation Protection Rules 1971, Insecticides Act 1968, The Indian Fatal Accidents Act 1955, Vaccination Act 1880, Maternity Benefit (Amendment) Act 2008, Persons with Disability (Equal Opportunities, Protection of Rights and Full Participation) Act 1995, The Public Liability Insurance Act 1991, etc.             

Thus, from the bunch of foregoing legislations passed it is evident that the law makers have been taking note and making efforts from time to time for ensuring better medical facilities by giving the rights a force of law. However the concept of Telemedicine despite of its worth and acceptance across the world has remained untouched by the law makers. No specific legislation covering the concept, admissibility, regulation, authorities, minimum standards, protection of interest of medical practitioners and patients, through the medium of telemedicine has been passed by the legislature. Not only this, even the legislations protecting the rights of patients in the cases of medical negligency in cases of otherwise than telemedicine are also very limited. At present, the medical negligence issues are being dealt with the victims with the help of Penal provisions contained under Indian Penal Code and compensatory provisions under Consumer Protection Act 1986.                             

Need of laws on telemedicine:

The need of having a detailed legislation on telemedicine is growing day by day. Beside the private health service providers promoting and adopting the techniques of telemedicine, the government is also actively participating and promoting the said concept in its various leading medical institutions. Days are not far when the concept of telemedicine would reach and would be accessed at every corner of the Country. With the rapid growth of information technology, challenging issues are ahead. Undoubtedly, the development of information technology has one or other way served the humanity. However, roses comes with thorns. In order to deal with thorns one need to have strong tools. The law being silent upon the issue of telemedicine would not only apprehend the enhanced cases of medical negligence but would also incite incompetent and unqualified persons to present themselves in white coats on the screen pretending themselves to be medical service providers.

Connecting existing legislations with telemedicine:

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.

1. 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
2. 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
3. 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
4. registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or
5. who is engaged in the practice of veterinary medicine and who possesses qualification approved by the State Government.

1. 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;
2. 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;
3. all substances intended for use as components of a drug including empty gelatin capsules; and
4. 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.

1. 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.
2. 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;

1. be in writing** and be signed*** by the person giving it with his usual signature and be dated by him;
2. 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;
3. indicate the total amount of the medicine to be supplied and the dose to be taken.

1. Rendered or made available in electronic form, and
2. Accessible so as to be usable for subsequent reference."

1. Subject to the provisions of the section any subscriber may authenticate an electronic record by affixing his digital signature.
2. 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.

1. if it was sent by the originator himself;
2. by a person who had the authority to act on behalf of the originator in respect of that electronic record; or
3. by an information system programmed by or on behalf of the originator to operate automatically.

1. unique to the subscriber affixing it;
2. capable of identifying such subscriber;
3. 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.

Comprehensive legislation on  Telemedicine

Although the provisions prescribed under various medical laws can be inferred for conduct and regulation of telemedicine. However, by and large, the existing medical laws are not able to satisfy the requirements and demands of telemedicine. Thus, there is a need for enforcing a comprehensive legislation covering various aspects such as:

                                i.            Redefining Medical Practitioner and Para Medical Service provider;

                              ii.            Redefining minimum qualifications and inclusion of working knowledge of IT equipments mandatory;

                            iii.            Special licensing of the health service providers;

                            iv.            Orientation programmes of telemedicine for practitioners;

                              v.            Prescribed health issues which can fall under the category of telemedicine;

                            vi.            Regulating Authority;

                          vii.            Detailed written consent;

                        viii.            Complaint redressal portals;

                            ix.            Time bound resolution of complaints;

                              x.            Appellate Authorities;

                            xi.            Confidential back ups of sessions took place between service providers and patients;

                          xii.            Protection of interests of service providers;

                        xiii.            Safe payment of fees;

                        xiv.            Online confirmation for accessing hospital facilities;

                          xv.            Regulating telepharmacy by relaxing provisions of Drugs and Cosmetics Act;

                        xvi.            Random inspection of backups for ensuring proper facility by competent authorities;

                      xvii.            Ensuring confidentiality of patients;

                    xviii.            Payment of compensation;

                        xix.            Provisions as to Health Insurance;

                          xx.            Control of Advertisements;

                        xxi.            Disposal of death claims by Insurance Company;

                      xxii.            Evidentary value of records of telemedicine;

                    xxiii.            Special provisions for patients in remote areas;

                    xxiv.            Special provisions for providing service to Armed Forces;

                      xxv.            Making mandatory for a medical institute with requisite infrastructure;

                    xxvi.            Periodical inspections of private as well as government hospitals and their IT records;

                  xxvii.            Setting up of special Tribunal;

                xxviii.            Overriding provision declaring conflicting provisions of existing medical laws invalid, etc.

After incorporation of the aforesaid provisions in the bill of telemedicine the same needs to be deliberated with the experts in the field of Medicine, Information Technology and Law. Only then, there can be a hope of safe and assured telemedicine. Although Ministry of Communications and Information Technology, Government of India had constituted Technical Working Group for Telemedicine Standardization on 04.12.2002. The said Technical Working Group had also submitted its Report on Telemedicine Standardization namely “Recommended Guidelines & Standards for Practice of Telemedicine in India” in May 2003. As the name suggests, the report has been submitted by the committee in the shape of Guidelines having no binding force of law. These guidelines can be treated as merely advisories.[15]

Conclusion