The World Health Organisation defines the term Digital Health as “a broad umbrella term encompassing eHealth, as well as emerging areas, such as the use of advanced computing sciences in ‘big data’, genomics and artificial intelligence”.
However, in 21st century people tend to group every technological advancement in healthcare under an umbrella of “Digital Health”. Therefore, the expression Digital Health may be said to include the apparatuses and services that use information and communication technologies (ICT) for the purposes related to health.
These purposes widely include improving accuracy in diagnosis, monitoring chronic diseases meticulously and improving treatment processes for the patients.
NOTABLE EXAMPLES OF DIGITAL HEALTH
Use of telecommunications technology to provide for healthcare services is termed as telemedicine. Per se telemedicine is not recognized as distinguished innovation in itself however, its usage in terms of providing healthcare services to the patients makes it useful in the present times.
Telemedicine broadly includes tele-radiology, tele-consultation, tele-nursing, tele-surgery, etc. which works as mechanism to connect the doctors and the patients and reduces a gap between them.
2. Self – Monitoring Healthcare Devices
Development of smart devices integrated with technological advancement are able to monitor the changes in the functioning of a human body.
Raw data used as an input in these devices result into self-monitoring of various changing health symptoms and highlighting the potential issues that may arise in near feature.
Further, such devices being used as wearable’s in today’s time also caution about the impending threats and alerts the human body by consistent monitoring and sensoring of the body.
3. M – Health
It refers to Mobile-health services under an umbrella of Digital Health provided on a mobile platform. It is a lucrative option at the end of the service providers considering India as the 2nd largest smartphone hub across the globe.
The accessibility of Digital Health paired with the flexibility of m-Health widens the scope for online health service providers to revolutionize the trend of Digital Health in India.
4. E – Pharmacies
In the recent past, India has seen a rising trend in e-pharmacies or online pharmacies that operates over a platform via an internet network and receives & sends the orders to customers through mail, courier or delivery persons.
Such online pharmacies allows a chemist or the pharmacist to cater to the needs of the larger group of people barring the territorial restrictions in an online business model.
E-pharmacy models can be two-fold wherein:
1.online-only pharmacies, and
2.physical pharmacies with online presence.
PROTECTION OF IPR IN DIGITAL HEALTH
Since the concept of Digital Health in India is in a nascent stage and has seen a lot of innovative products being developed, protection of these ideas and inventions becomes need of the hour in this extremely competitive scenario.
Therefore, the Indian Intellectual Property Rights (“IPR”) laws allows for protection of such inventions and creations in numerous forms namely; patents, copyright, trademarks and designs.
The Patents Act, 1970 (“Patent Act”) provides for patent protection in India. The Patent Act is largely compliant with the Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) and India, being a signatory, has been committed to fully adopting and implementing the provisions of the agreement.
For an innovation to be regarded as an “invention” and seek protection under Indian Patent, it ought to fulfil three basic criterion as stipulated in the Patent Act, namely; novelty, non-obviousness and industrial applicability.
In addition to the above, an invention must also not be excluded from being considered an ‘invention’ under Sections 3 and 4 of the Patent Act. These exclusions provide for ‘a process for the medicinal or other treatment of human beings and animals’ and a ‘computer program per se’.
On a Digital Health application platform, there is a software that runs it, which is prima facie a computer program. A computer program per se is excluded from patentability under Section 3(k) of the Patent Act.
However, as per the ‘Guidelines for Examination of Computer Related Inventions (“CRI”)’ issued by the Indian Patent Office in 2017, it is permissible wherein CRI in itself is not patentable, it is likely for a CRI claimed in conjunction with a novel hardware to be patented, provided it satisfies the requirements as stipulated in the guidelines.
The Copyright Act, 1957 (“Copyright Act”) provides for protection of copyright in India. Copyright can subsist in the form of original literary, dramatic, musical or artistic work, cinematograph films and sound recordings. It is imperative to note that copyright does not protect an idea per se but protects the extension of idea in a concrete and substance form.
Copyright protection is practised on the doctrine of ‘Sweat of the Brow’. Therefore, copyright protection of clinical guidelines and data in Digital Health may be granted though the originality of the content may not exist provided that the creator or the author of such database has undertaken such an activity independently. In such a situation, the author of the work is entitled to protect his efforts and benefit out of it commercially.
The Trade Marks Act, 1999 (“TM Act”) governs and protects trade marks in India. A mark that is capable of being ‘graphically represented’ and indicative of a connection in trade with the owner of the mark can be registered as a trademark. The rules formulated under the Trademark Mark Act provides for further classification of trademarks. India follows the NICE Classification of Goods and Services, which has been incorporated in the schedule to the rules.
The ‘mark’ of a Digital Health application or a device may be registered as a trademark under the Trademark Act, subject to certain exclusions as provided under Section 9 and 11 of the Trademark Act forming the grounds for refusal of the trademark.
In India, there are no specific legislations that deal with protection of confidential information and trade secrets. However, the third pillar of Indian democracy has helped the nation to secure its proprietary information and business secrets by virtue of entering into various kinds of agreements.
Confidential information that a company share with its employees during the course of business can be protected by means of contractual obligations tailored in order to safeguard the business formulae, products, processes and plans.
One of the smartest strategies would be to enter into a Non-Disclosure Agreement with the employees which provides for available remedies in case of disclosure or breach of confidential information and trade secrets by the employee. Another way to protect disclosure of unwarranted business information is Non-compete clause.
Further, a combination of Non-disclosure Agreement with a Non-Compete Clause shall add an additional stratum for protection of proprietary knowledge and confidential information of the business, in absence of exclusive legislation on trade secrets in India.
Digital Health Industry is presently in a developing stage wherein it provides for numerous opportunities in the domestic arcade. Innovation and invention being the backbone of this industry provides for constant development and opportunities for growth. The legislative framework to protect and regulate such developments are also in the evolving phase and will grow as the industry advances.
In a country like India where access to affordable healthcare is still a matter of concern, creators and inventors of the Digital Health industry in the public shall stand and gain immensely from the development of this industry.
Keeping in view the larger public interest and that of the innovators, revelation of upcoming legal and regulatory framework in the country will decide and revolutionize the Digital Health industry.
Disclaimer: The information contained in this document is intended for informational purposes only and does not constitute legal opinion, advice or any advertisement. This document is not intended to address the circumstances of any particular individual or corporate body. Readers should not act on the information provided herein without appropriate professional advice after a thorough examination of the facts and circumstances of a particular situation. There can be no assurance that the judicial/quasi-judicial authorities may not take a position contrary to the views mentioned herein.