Author: Reet Kaur Co-Author: Saumya Vanvari
“I think the biggest innovations of the twenty-first century will be the intersection of biology and technology”
-Walter Isaacson, Steve Jobs
In the last few years paving its way towards achieving the digital-India vision, the country has shown tremendous growth and proliferation in the E-health and Telemedicine sector. Telemedicine in general refers to treatment from a distance through the usage of information and communication technology. As per the Fortune Business Insights Report, the telemedicine market in India would be projecting a remarkable growth reason being its large rural population. Further, the current COVID-19 global pandemic and the subsequent lockdown have also significantly contributed to this sector growth with the launch of nationwide telemedicine platform “SWASTH”. This technical service overcomes the traditional healthcare problems caused due to crisis by virtually connecting 100 healthcare specialists and providing free health care to 1.3 billion people despite their income or geographical positioning within the country. As per the Grand View Research Inc., it has also been estimated that the global telemedicine market would attain USD 155.1 billion by 2027.
There are essentially three main types of Telemedicine services, which include- (1) Real-time interactive services, which allow the usage of communication technology for interactions with the patients, (2) Remote Monitoring, wherein the provider monitors the health and clinical signs of the patient remotely and (3) Data storage services, also known as store-and-forward, under which the patients’ medical data such as biosignals and medical images are provided to the specialist. All these services are software-oriented and thereby much of the innovation within the field of telemedicine is dependent on the fact as to how the software operates.
Further, as the development of Telemedicine in India, currently is at a very nascent stage, therefore being a highly expensive process, the protection of these innovations becomes the need of the hour within this extremely competitive scenario. Intellectual Property Laws facilitate the protection of these innovations and creations in various forms like patents, copyrights, trademarks, etc. Through this paper, the authors aim to highlight the significance of emerging Telemedicine in India and discuss its IPR perspective.
telemedicine in India:
India being a vast country and densely populated, telemedicine plays an important role in enabling medical services to be made available, accessible, and deliverable in remote areas of the country. The concept of telemedicine and online clinical administrations are derived from the exchange or transmission of clinical information or data through electronic arrangements and mediums, to cut across existence over the world to benefit from clinical headway. Digital Health care can also be considered as “Healthcare of future”. One can witness the existence of the Private sector in the field of Tele Medicine in which these sectors took initiative and actively participating in Public Health Management.
Telemedicine has also extended the scope and importance of the traditional outlook of treatment such as AYUSH, an initiative by the Ministry, concerned to promote the benefit of the traditional method of healing utilizing Tele Communication. Indian Space Research Organisation prepared meek beginning in Tele Medicine linking Chennai Apollo Hospital with Apollo Rural Hospital in Chittoor district of Andhra Pradesh. The development in the field of Tele Medicine is the combined effort of Indian Space Research Organisation, Ministry of External Affairs, Ministry of Health and family welfare coupled with various State Governments. As biology and technology go hand in hand, the initiative and network of telemedicine have covered around 45 remote areas including Andaman and Nicobar Island.
Though Tele Medicine is reaching ample of people, there is some sort of danger attached to it. Preceding 2020, there was the least concern for the practice of telemedicine which was generally because of the absence of guidelines and ambiguity that in like manner existed. As discussed in Deepa Sanjeev Pawaskar & Anr. Vs the State of Maharashtra (2018 SSC Online Bom. 1841), Bombay high court refused to grant anticipatory bail to both the doctors who were facing criminal charges as they practiced telecommunication and granted prescription without diagnosis. The importance to regulate telemedicine practises arises from this arbitrariness. Medical Council of India controls and passes guidelines that set a uniform standard to regulate these sectors. Because of the predominant Pandemic brought about by far-reaching COVID-19, which has influenced the nation’s world over, there showed up difficulties to give human services especially in the wake of social distancing norms. It was the caution and guideline required to control the misuse of telemedicine in India and at the same time consultation can be hunt from professionals by the use of Artificial Intelligence.
significance of intellectual property in telemedicine:
With the origin of TRIPS, the intellectual property regime has changed in most of the world trade organisation member countries. The Intellectual property system operates by providing limited access to the third party. Their protection is majorly done to strengthen the market-based incentive for the private sector and stakeholders to invest. As many medical technologies are expensive to develop at first but maybe relatively cheap to reproduce. In such an instance, it is difficult for companies to invest in a risky affair. The agreement with TRIPS has considerable implications for the application of IP, and as per the new standard, all the arena of the invention in telemedicine is focused. Therefore, the Indian IPR provides and allows protection for invention and creation in numerous forms which is elucidated below.
patent: Under the Patent Act, 1970, for an innovation to be recognised as “invention” and attain protection, it must get three basic requirements fulfilled- (1) novelty, (2) non-obviousness, and (3) industrial applicability. It should also not fall under Section 3 and 4 of the Patent Act that excludes the medicinal treatment of human beings and animals and computer programs from patentability.
Consequently, as these “advanced health applications” are operated through the software, which is a type of computer program and thus should be excluded from obtaining patent under Section 3(k) of the Act. However, following the Guidelines for Examination of Computer Related Inventions, 2017, CRI could be patentable in cases wherein the software is applied for in conjunction with novel hardware and meet the three-stage long patentability test mentioned under the guidelines.
copyright: Copyright Act, 1957 defines certain criteria to be recognized as copyright “as the idea is not copyrightable instead it is the expression that is taken into account”. Under Section 13 copyright can persist in the form of original literary, dramatic, musical and artistic works, cinematograph films, and sound recording. It is obvious to note that copyright does not protect the idea per se, but the “extension of the idea”.
Broadly categorizing there are two classes of literary work that are recognized by this act first, primary work second, derivative work. This act does not define the meaning of the term “original” hence, interpretation is based on facts of the cases and copyright protection works on the doctrine “Sweat of the brow”. In Feist Publications Inc. v. Rural Telephone Service Co. Inc., the Supreme Court held that the sine qua non of copyright is originality, and that needs to be taken into consideration for the protection of telemedicine especially in the COVID 19 situation.
non- disclosure agreement: Non-Disclosure Agreements permit the concerned parties to share the secret information while also restricting on how that particular information is employed or disclosed. As there are no specific legislations present in India for the protection of trade secrets or confidential information, thereby the business plans, products, or secrets of the entity are protected under certain contractual agreements. NDAs provide the business entities or companies with the remedies when the employees or parties involved breach their confidential information or secrets. NDAs are not only used when there are no other IP protections available but also when it is important to divulge confidential information to any other person.
Moreover, in the country with no exclusive legislation on trade secrets, the usage of NDAs in conjunction with the Non-Compete Clause would further supplement the shield of the valuable and confidential details of the businesses.
The telemedicine industry currently is at the emergent stage wherein it provides numerous opportunities in domestic colonnades. As invention and innovation go hand in hand, being the backbone of this industry provides for constant development and growth along with the risk involved. India still has a long way to go toward the intellectual property framework. These guidelines and advancement is just a beginning in life science and biomedical. As our country focuses on the “Make in India” initiative then it’s the dire need to form a regulatory body that can control India’s Intellectual Property Right Policy if we want our country to move forward and add value chain in the economy then telemedicine is a new way forward.