Introduction
As the global healthcare system combats with the myriad complexities associated with the coronavirus pandemic, digital health technologies and services are gradually emerging as potential solutions to a number of these challenges.[I]
Digital health is the amalgamation of genomic and digital interventions in the health care innovation ecosystem, to improvise the efficiency, healthcare delivery, and make medications more precise and tailored for every human.[ii] E-health or better known as “Digital Health”, is defined by the World Health Organization (“WHO”) as “use of information and communication technologies for health.”[iii] A robust and forward-looking digital healthcare system encapsulates scalable rapid crisis management capabilities such as mobile health, health and wellness applications, Big Data, telehealth, electronic medical records with interoperability of data, personal genomics, diagnostics, medical imaging, wearable technologies (fitness trackers, medical devices, etc.), and technologies to support integrated care. The analysis of the risks and opportunities involved in Digital Healthcare oscillate from the clinical domains (e.g. safety, clinical effectiveness) to the non-clinical domains (e.g. economic, legal, social, and ethical), that are often more sensitive to particular national/regional contexts.[iv][v]
As per the European Commission, Digital health and care refers to “tools and services that use information and communication technologies (ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle.”[vi] In India, a NITI Aayog report[vii], Health System for a New India (2019), also advocates that digital initiatives are crucial in effectively managing the health sector ubiquitously. As of now, Kerala is leading the way in successfully tracking and combating coronavirus cases by effective use of its digital health infrastructure to isolate and diagnose positive cases.[viii] As part of an intensive drive, the Pathanamthitta district administration has defined a GPS-supported system to track those quarantined in the district to contain stray movement.
“The healthcare sector is at the epicenter of this unprecedented global pandemic challenge”[ix] and despite the constant support of government and communities, the public and private healthcare systems are faltering due to inadequate health care personnel and resources.[x] At such a juncture when the medical infrastructure is in shambles due to the excessive burden[xi] because of the growing number of COVID-19 patients, it is the e-health technology that comes to the rescue of non-COVID-19 patients largely. China was quick to realize this and advised its patients to resort to online medical assistance rather than physical ones when the pandemic was at a nascent stage in Wuhan.[xii] The digital healthcare ecosystem facilitates not only the patients but also the medical practitioners, hospitals and mitigates many physical and economical barriers at the same time.
Growth Prospects of the Digital Health Market
The 2030 Agenda for sustainable development, sustainable development goals (SDGs) and National Health Policy (NHP 2017), recognize that health and development are intrinsically linked, and that multi-sectoral investments in health and other areas of development are mutually reinforcing considering the economic and social inequalities, rapid urbanization, threats to the climate and the environment, the continuing burden of communicable diseases and epidemics. By engaging in a forward-looking collaborative framework, digital health transformations and delivery channels will realize immediate and long term sustained progress of universal health coverage in ambitious SDG 3 outcomes.
A recent survey indicates that the telemedicine market in India was projected at 7.5 million USD and is expected to rise to 18.7 million USD by 2017.[xiii] The Indian health care market is valued at around 100 billion USD and is expected to grow at a CAGR of 22.9% to reach 280 billion USD by 2020.[xiv] The existing healthcare Information Technology (IT) market, valued at 1 Billion USD is expected to grow 1.5 times faster,[xv] as more hospitals are being recognized and certified, there is a greater understanding of the need to improve their quality in order to meet international standards. To herald the digital healthcare ecosystem, there is a need for effective coordination between different government agencies and the realization of the commercial prospects of digital healthcare innovation by prioritizing it at the national level and allocating funds that will facilitate the same.
The government needs to make a concerted effort in harmonizing the IT and medical laws that would materialize into digital health policies. The Danish Digital Health Strategy[xvi] has turned out to be the most promising government model which is tuning its medical arena to the 21st century.[xvii] The strategy emphasizes the coordination between each and every healthcare stakeholder by way of technology with the aim “to build an integrated network focusing on patients and looking at the person as a whole, not just at the individual diagnosis.”[xviii] Similarly, India’s National Digital Health Blueprint (NDHB) also recognizes the need “for a pan India health IT network that allows the seamless flow of clinical information across the country.”[xix]
Digital Health & Intellectual Property Rights (IPR) in India
How an IP strategy can be used to develop and protect digital health models within business ecosystems?
With the advent of global health delivery and progressive digital health sector landscape, the question of whether India’s intellectual property (IP) laws are aligned with the digital health transformation becomes imperative. Progressive IP management is the key factor to sustain and protect new business models in the age of digitization.
IPRs help digital health innovators to develop and safeguard processes, systems, and products for successful commercialization. This innovation cycle encourages inventors to prioritize socially responsible innovations. IPRs give them ‘techno-legal rights’ to get monetary rewards over their efforts. This has successively led to the recent boom in mHealth and eHealth innovations that encourage a variety of digital health applications and devices.[xx]
Various laws ranging from the Convention and Statute on Freedom and Transit of October 31, 1922, to National Intellectual Property Rights of 2016 with successive amendments in the Patent rules exist to facilitate the IP regime. The main mandate being to enhance the digital health R&D and affordable digital healthcare, the general focus of organizations’ R&D objectives, therefore, is to encourage innovative digital health inventors to secure IP and facilitate the industry for commercialization of socially relevant valuable inventions.
Do current IPR policies impact the growth of digital startups?
Recent developments in the nation’s IP policies like the National Intellectual Property Rights Policy 2016 (NIPR), the Patent (Amendment) Rule 2016 and Start-Up Intellectual Property Protection (SIPP) have brought several promising players into the digital healthcare market, which has, in turn, encouraged digital startups getting enough funding at varying innovation stages to improvise their business models. With extensive coverage of Internet and mobile technologies, support for digital healthcare initiatives is critical for health care access in the recent future.
The government has launched IPR focused initiatives such as Start-up India and Digital India[xxi] along with the support of the private sector, which has lead to the growth of many digital health start-ups.[xxii] “According to Inc42’s The State of Startup Ecosystem Report 2018, there are a total of 4,892 startups in the Indian health-tech space. 2018 saw an increase of 45.06% in the total investments in health-tech startups.”[xxiii] Through the Start-up India initiative, GoI facilitates start-ups’ growth through simplified IP procedures (like less compliance regime), relaxed norms [for public procurement, patent examination, scheme related to Supporting International Patent Protection in Electronics and IT (SIP-EIT), by SMEs and Technology Startup Units], legal and funding support (through credit guarantee funds), capacity building and awareness programs.[xxiv]
Through the NIPR policy, the duration of trademark registration and examination has gone down to 1 month from the earlier 13 months.[xxv] Furthermore, the Centre for IPR Promotion and Management (CIPAM) and Rajiv Gandhi National Institute of Intellectual Property Management (RGNIIP) have been established which conducts various IPR awareness programs and decimates pertinent information by way of conferences, seminars, etc in collaboration with international agencies.[xxvi]
The emergence of IP-based startups and social ventures in the health care ecosystem is noteworthy. Nasscom in its report titled “IoT: Driving the Patent Growth Story in India”[xxvii] stated that more than 5000 IoT patents were filled from 2014-2019, out of which “over 80 percent of these patents filed were related to applications pertaining to Industry 4.0 with the healthcare and automobile.”[xxviii] Digital Healthcare startups have the power to serve a large population, they have the potential to reach about 70% of the rural population[xxix] and carry out research initiatives leading to innovations and medical advancements.[xxx]
Apart from policy innovations to enhance the access and affordability of health care services, public policy needs to be flexible to nurture and encourage socially responsible inventions.[xxxi] A comprehensive public policy can include awareness initiatives that reach out to people of all strata, international collaborations, a more simplified licensing process, promotion of local IP, and enhanced investment in R&D.[xxxii] Such flexibility is critical as the success of such ventures is intricately linked to the ability of the startups to get integrated with the public health care delivery system.
Few Successful Startups
Most promising names in this space are Netmeds, Curefit, ImpactGuru, Doc Plexus, Mera Medicare, 3Hcare, eKincare, Practo, PharmEasy, Dr. Insta, Doctalk, Addresshealth, Docttocare, Onward Health, BeatO, and ten3T.
Digital Healthcare: The Legal Framework and Policy Road-map
To effectively address the growing need for digital health innovations, the healthcare innovation ecosystem needs a functional digital health governance structure to evaluate technologies, manage the digital business model in accordance with the regulatory framework and identify the pressing need with the implementation of short, medium, and long term planning.[xxxiii] .
E-Pharmacies
E-pharmacies in India seem to be on a roller-coaster ride, the sale of medicines is mandated only in accordance with the Drugs and Cosmetics Act, 1940 (“DCA”), and Drugs and Cosmetics, Rules 1945 (“DCR”). While the sector is witnessing an increase in the customer base, the lack of unequivocal regulations and policies by the government is causing mayhem amongst the stakeholders. On the business front, the e-pharmacy sector is expected to grow at an exponential CAGR of 63% and has nearly 30,000 skilled professionals employed in it.13
Instructed by Delhi High Court[xxxiv], the Centre compiled rules to regulate online pharmacies but the final version of the draft titled ‘The Drugs and Cosmetics Amendment Rules, 2018’ (‘the Rules’) is yet to come in effect.
Electronic Health Records
Data Privacy is the main concern in the use of sensitive personal data like health records. In September 2013, the MoHFW notified the Electronic Health Record Standards (EHR Standards) for India. Accordingly, the document of EHR Standards 2016 was notified and placed for adoption in IT systems by healthcare institutions and providers across the country. To facilitate the adoption, the MoHFW has made certain standards available such as the SNOMED CT[xxxv] and has also appointed the interim National Release Centre to handle the clinical terminology standard.[xxxvi]
In addition, the MoHFW has proposed a new bill, the Digital Information Security in Healthcare Act (DISHA) to govern data security in the healthcare sector. The purpose of this Act will be to provide for electronic health data privacy, confidentiality, security, and standardization.[xxxvii] The MoHFW, through the proposed DISHA,[xxxviii] plans to set up a statutory body in the form of a National Digital Health Authority for promoting and adopting: e-health standards; enforcing privacy and security measures for electronic health data; regulating the storage and exchange of electronic health records.
Also, the Personal Data Protection Bill, 2019 was introduced in Lok Sabha, on 11 December 2019 which intends to seek to provide for the protection of the personal data of individuals, and establishes a Data Protection Authority for the same.
In the present scenario, it is the Information Technology Act, along with the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data Or Information) Rules, which govern the law regarding the collection, storage and handling of data. Bodies that collect/manage data are mandated to obtain prior written consent from the provider of information for collection, storage, and handling of their data.[xxxix]
In addition, NITI Aayog is closely aligned with NHP 2017, on leveraging technologies such as big data analytics on data stored in universal registries through the creation of a supply-side digital infrastructure called National Health Stack (NHS) (NITI Aayog 2018).[xl] The NHS seeks to leverage the digitization push through IndiaStack, which seeks to digitalize “any large-scale health insurance program, in particular, any government-funded health care programs.”[xli]
AI and Robot-assisted Surgeries, etc.
Currently, India does not have any specific laws for the regulation of disruptive technologies like AI and machine learning. Accordingly, the activities for these must comply with the existing IT Acts and regulations. In addition, a confidentiality agreement between licensee and licensor can be in place for the record.
Challenges in Digital Health Services and System
While assessing medical and health-related innovations concerning the technology and system, forward-looking approaches need to be translated into a very general framework addressing social, ethical, and legal concerns such as:
Is the developed digitized technology and system harmful? What are the potential risks associated with it?
What are its possible advantages and is there any substantial confirmation available to them?
How shall this developed technology and system will impact on the self-sufficiency of affected parties?
How will the new system affect justice and equity in outer space? Will access to new technology be equally disseminated? Will it create new disparities?
What will be the effect on the relationship between patient and physician, therapist or counselor of the newly developed system?
What are the implications across the Healthcare Value Chain?
Further, the questions related to the role and importance of data and analytics, strategic digital initiatives, responsibility, diagnosis, and autonomy – which are among the most important ethical, and legal challenges while implementing eHealth innovations, must be integral for successful execution.[xlii]
Conclusion
Resilient and sustainable systems for health are an essential building block of universal health coverage and need to be complemented by capacity building that includes strengthening the use of digital health technologies, financial and risk management, sustainable health procurement, strengthening national health-related policies and affordable access to the quality healthcare system. “COVID-19 has firmly established the need for prompt action and the establishment of a robust, collaborative, scalable, and agile digital healthcare infrastructure.”[xliii] Digital healthcare overcomes the barriers of the physical clinic, like the lack of enough healthcare professionals, the territorial barriers, and the prevention of unnecessary contact. The COVID-19 pandemic has brought to light the need for consistent regulatory measures for the healthcare industry and associated patient health management services that focus on patients with Medicare and Medicaid. Digital healthcare takes off the burden from the administration personnel apart from the professional as there are fewer crowds and more self-automation. A comprehensive, forward-looking digital healthcare infrastructure established in compliance with the evolving regulations of government has plenty to offer and break the chains of the archaic healthcare system.
[i] https://www.mwe.com/events/webinar-digital-health-and-covid-19-roadmap-for-meaningful-implementation/.
[ii] Digital health market in India over the next ten years, DR. HEMPEL DIGITAL HEALTH NETWORK(Oct 18, 2018) https://www.dr-hempel-network.com/growth-of-digital-health-market/digital-health-market-in-india/.
[iii] Mohana Roy, Regulating E-Health Ecosystem: The dawn of healthcare delivery in India, Lexology (Apr. 29, 2020) https://www.lexology.com/library/detail.aspx?g=e9a1f9b2-50ee-4ccc-b926-2fd29459fb2e.
[iv] Arya Tripathy, Industrial Automation and Robot Law in India, MONDAQ (Jul. 19 2017) https://www.mondaq.com/india/new-technology/612028/industrial-automation-and-robot-law-in-india.
[v] Urvashi Prasad &Vedeika Shekhar, Prescriptions for a post-Covid health system, BUSINESS LINE (Apr. 17, 2020) https://www.thehindubusinessline.com/opinion/prescriptions-for-a-post-covid-health-system/article31366139.ece.
[vi] Rashmi Mabiyan, Coronavirus impact: Will life sciences industry turn to digital platforms for growth?, ET HEALTH WORLD (Mar 20, 2020) https://health.economictimes.indiatimes.com/news/pharma/coronavirus-impact-will-life-sciences-industry-turn-to-digital-platforms-for-growth/74724886.
[vii] Supra note 2.
[viii] Supra note 6.
[ix] Coronavirus impact on healthcare sector, ET Markets (Apr. 14, 2020) https://economictimes.indiatimes.com/markets/stocks/news/coronavirus-impact-on-healthcare-sector/articleshow/75136714.cms?from=mdr.
[x] Amitava Sengupta, Next Steps: Revisiting Global Healthcare in a Post-COVID World, ET HEALTH WORLD (May 5, 2020) https://health.economictimes.indiatimes.com/news/industry/next-steps-revisiting-global-healthcare-in-a-post-covid-world/75551176.
[xi] Harihar Sahoo, Chaitali Mandal, Suyash Mishra & Snigdha Banerjee, Burden of COVID-19 pandemic in India: Perspectives from Health Infrastructure, Intl. Inst. Population Sciences (May 22, 2020) https://iipsindia.ac.in/sites/default/files/iips_coivd19_bcpi.pdf.
[xii] Paul Webster, Virtual health care in the era of COVID-19, The Lancet, (Apr. 11, 2020) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30818-7/fulltext.
[xiii] Supra note 2.
[xiv] Ibid.
[xv] Supra note 4.
[xvi] DIGITAL HEALTH STRATEGY 2018–2022, Ministry of Health (Jan. 2018) https://sum.dk/Aktuelt/Publikationer/~/media/Filer%20-%20Publikationer_i_pdf/English/2018/A-coherent-and-trustworthy-health-network-for-all-jan-2108/A-coherent-and-trustworthy-health-network-jan-2018.pdf
[xvii] Where Is Digital Health Heading In Denmark? , The Medical Futurist (Feb. 7, 2019) https://medicalfuturist.com/danish-digital-health-strategy/.
[xviii] Ibid
[xix] Dileep V S, National Digital Health Blueprint(NDHB) – India’s blueprint to evolve a Digital Health Eco‐system, AyushEHR ( Jan. 4, 2020) https://ayushehr.com/national-digital-health-blueprintndhb-indias-blueprint-to-evolve-a-national-digital-health-eco%E2%80%90system/.
[xx] Tripta Dixit, Sadhana Srivastava, Smita Sahu & W. Selvamurthy, Intellectual property evolution and innovation ecosystem as effective tools in strengthening Indian healthcare sector, 114 CURRENT SCIENCE 8 (Apr. 25, 2018).
[xxi] IPR integral part of flagship Indian projects like Make in India, Digital India, The Economic Times(Feb. 26, 2016) https://economictimes.indiatimes.com/news/economy/policy/ipr-integral-part-of-flagship-indian-projects-like-make-in-india-digital-india/articleshow/51151587.cms?from=mdr.
[xxiii] Yatti Soni, Healthcare Landscape Of India: The State Of India’s Healthtech Startups, Inc 42 (May. 30,2019) https://inc42.com/features/healthtech-startups-landscape-india/.
[xxiv] Supra note 3.
[xxv] Amitabh Kant, Aishwarya Joshi & Kowthamraj VS, Building IPR policy to supercharge ‘Make in India’ in post-pandemic world, ETGovernment (May 12, 2020)https://government.economictimes.indiatimes.com/news/policy/building-ipr-policy-to-supercharge-make-in-india-in-post-pandemic-world/75697164.
[xxvii] IoT: Driving the Patent Growth Story in India, Community (Jun. 3, 2020) https://community.nasscom.in/communities/emerging-tech/iot-ai/iot-driving-the-patent-growth-story-in-india.html.
[xxviii] PTI, Over 5,000 IoT patents filed in India over last 5 years: Nasscom, Financial Express ( Jun. 5, 2020) https://www.financialexpress.com/industry/technology/over-5000-iot-patent-filed-in-india-over-last-5-years-nasscom/.
[xxix] The critical role of startups in the health care revolution, Dr. Hempel Digital Health Network (Jun. 21, 2017) https://www.dr-hempel-network.com/digital-health-startups/digital-health-startups-healthcare/.
[xxx] EH News Bureau, FICCI, KPMG releases paper on healthcare startups in India, Express Healthcare (Sep 1, 2016) https://www.expresshealthcare.in/news/ficci-kpmg-releases-paper-on-healthcare-start-ups-in-india/364555/.
[xxxi] Ashish Sinha & Shweta, E-Pharmacy: Caught In A Logjam, BUSINESS WORLD (Apr. 25, 2020) http://www.businessworld.in/article/E-pharmacy-Caught-In-A-Logjam/25-04-2020-190272/.
[xxxii] Supra note 25.
[xxxiii]Supra note 1.
[xxxiv] Zaheer Ahmed vs Union of India & Anr, Writ Petition (C) No:11711/2018.
[xxxv] Systematised Nomenclature of Medicine Clinical Terminology.
[xxxvi] Supra note 4.
[xxxvii] Placing draft of “Digital Information Security in Healthcare, act (DISHA)” in public domain, Ministry of Health & Family welfare (Mar. 21, 2018) https://www.nhp.gov.in/NHPfiles/R_4179_1521627488625_0.pdf Please complete the citation.
[xxxviii] Supra note 2.
[xxxix] Supra note 3.
[xl] Aayush Rathi, Is India’s Digital Health System Foolproof?, Vol. 54, Issue No. 47, 30 Nov, 2019 https://www.epw.in/engage/article/indias-digital-health-paradigm-foolproof
[xli] Ibid.
[xlii] Supra note 10.
[xliii] Ibid.
By Dr. Smita Sahu, Deputy Director (IPR), Associate Professor, Amity Institute of Biotechnology, Amity University Noida. Co-Authored by Harish Sharma, IPR Counsel, UFLEX Ltd., Noida and Anjuri Saxena, 3rd Year student of Rajiv Gandhi National University of Law, Punjab. This blog is part of the RSRR Blog Series on Digital Healthcare in India, in collaboration with Nishith Desai Associates.