This article attempts to shed light on India’s opportunity at the 2023 the Group of Twenty (G20) summit in the Software as a Medical Device (SaMD) market. In doing so, the author highlights its relevance in the global market and discusses the lapses in the existing global SaMD framework. Further, the author points out how the 2019 and 2014 G20 led to a reform in India’s Medical Devices Law, and the scale of opportunity cost if effective engagement on this matter is forgone in the present one. The author argues that through thoughtful dialogue and diplomacy at global events such as G20, transparent, trustworthy, and thorough best practices can be adopted for future global governance.
Understanding software as a medical device and its impact
Software is altering how medical professionals perform their profession, how patients and doctors communicate, and how users control their health across the world. A variety of services that complement the product are already being offered by an increasing number of medical device manufacturers. Software as a Medical Device (SaMD), as defined by International Medical Device Regulators Forum (IMDRF) is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”.1
SaMD can make diagnoses, provide therapies, and guide clinical care.2 Some examples of SaMDs include electronic versions of books and dictionaries used in medicine; patient education, empowerment, and awareness portals; arranging doctor shifts; generic aids or all-purpose apps, such as magnifying glasses, web-based video chat platforms that let patients speak with doctors.3
For instance, to ensure data sharing across all healthcare institutions and encourage the adoption of electronic health records, Kaiser Permanente has installed a new computer system called HealthConnect;4 by creating an interconnected technology system that will enable physicians, hospitals, and healthcare plans to provide personalised evidence-based care; Blue Shield, California is enhancing the quality of healthcare delivery and patient outcomes using artificial intelligence (AI) and machine learning (ML);5 and AstraZeneca formed four-year cooperation with WellPoint’s data and analytics division.6 HealthCore, to carry out studies in the real world to identify the most efficient and affordable therapies for several prevalent ailments and chronic conditions.
The combined strength of the USA, Japan, and the UK’s pharmaceutical manufacturing sector account for almost 80% of the global healthcare economy.7 These countries are also India’s biggest medical device exporters (75-80% in FY 2018-2019).8 Although the healthcare industry in India has undergone revolutionary improvements due to technological innovations, the concept of SaMDs remains new.
Why should SaMD be a talking point in G20?
(a) Past G20s and shift in India’s Medical Devices Policy
Globally, by 2023, there will be more than 50 million patients being monitored remotely, up 44% from the previous year9 and the patient monitoring system in India would register a CAGR of 9.39% between 2022-2027,10 accounting for around US $800 billion by 2030 globally.11
Furthermore, the increase in technological devices at home or in the form of wearables over the years has changed how end-users interact with their devices. Clinicians obtain information to aid in disease diagnosis, monitoring, and prevention, while patients avoid needless (and expensive) hospital visits and can access helpful dietary and lifestyle guidance.
The G20 summit can play a key role in India to tap into a fairly new and emerging field. For instance, the Global Health Security Agenda (GHSA) in 2014 was endorsed by the G20 leaders at their summit in Brisbane, Australia.12 India’s adoption of the GHSA marked a significant shift in the country’s approach to global health security.
Before the GHSA, India’s public health policies focused primarily on the management of individual diseases, such as tuberculosis and malaria. However, the GHSA encouraged countries to take a more comprehensive approach to global health security, including strengthening disease surveillance systems, improving laboratory capacity, and enhancing emergency preparedness and response. Top of Form
Furthermore, the IMDRF member countries in 2018 recognised the importance of a globally harmonised unique device identification (UDI) system for medical devices to ensure patient safety and support public health13 which would require manufacturers to assign a unique identification code to each medical device, allowing for better tracking and monitoring of devices throughout their lifecycle.
Following this commitment, India’s Central Drugs Standard Control Organisation (CDSCO) issued a draft notification in November 2020, proposing to implement the UDI system for medical devices in the country which was incorporated under Rule 46 of the Medical Devices Rules, 201714.
The adoption of the UDI system was a significant policy shift for India’s medical device sector, as it aligned the country’s regulations with global standards and improved patient safety. The G20’s recognition of the importance of the UDI system and India’s commitment to implementing it demonstrates the potential influence of the G20 on individual countries’ healthcare policies.
Another recent example of how global summits impact policies at a domestic level is the recent discussions during the India-US Trade Policy Forum which has led to an agreement between countries on a new “draft Drugs, Medical Devices, and Cosmetics Act”15 to make medical treatments more accessible and affordable for patients.
(b) India’s outlook and opportunity in the medical devices market via G20
India has already showcased the benefits of its data-driven insights in the healthcare industry through the usage of the COVID-19 India platform, Co-WIN, and the encouragement of telemedicine16 during times of distress. For instance, to manage the lack of beds during Covid-19, more than 30 hospitals teamed up with Dozee in April 2021 to provide remote medical monitoring in COVID-19 wards;17 and Royal Philips unveiled the nation’s first mobile intensive care units (ICUs) in July 2020.18
In 2017 and 2020, India launched the National Health Policy19 and Ayushman Bharat Digital Mission20 with the aim of achieving universal health coverage and digitising healthcare in India. This year, India aims for the growth of the medical devices industry to funnel through the promotion of the “One Health”21 policy as a future emergency, prevention mechanism.
The safety of patient data, access and affordability of healthcare exacerbating existing disparities, and regulatory hurdles leading to an unfair marketplace to hinder new health technologies are some concerns that India shares with the world today. For instance, in 2016, Alibaba debuted in the healthcare market by investing $35 million in a medical imaging company22 which led to Big Tech being in a dominant position to put pressure on reputable medical supply wholesalers and manufacturers by cutting margins by up to 20%.23 With time, these new competitors are anticipated to get past regulatory hurdles and migrate upscale to offer more expensive goods. This trend is already apparent in the pharmaceutical market and clients.
With the world’s third largest startup ecosystem,24 India has an opportunity to not just attract investments but also contribute equally to advancing healthcare domains. Through One Health, it aims to make healthcare infrastructure robust by digitising the entire industry, providing affordable healthcare for all and equipping professionals with digital skilling. The G20 is a forum that brings together the world’s largest economies to discuss global issues, including healthcare. As such, it is a relevant platform to discuss the regulatory challenges and opportunities facing the SaMD sector in India and beyond.
Some of the key issues that could be discussed include:
Regulatory harmonisation. — Different countries have different regulatory frameworks for SaMDs, which can create barriers to trade and innovation. The G20 could discuss ways to harmonise these frameworks to facilitate the global development and distribution of SaMDs.
Patient safety. — SaMDs have the potential to significantly improve patient outcomes, but they also pose unique risks that need to be managed. The G20 could discuss ways to ensure that SaMDs are safe and effective and that patients have access to the information they need to make informed decisions about their use.
Data privacy. — SaMDs generate large amounts of sensitive patient data, which must be protected. The G20 could discuss ways to ensure that SaMD developers and users are complying with data protection regulations and that patients have control over their data.
Software as a Medical Device (SaMDs), or software that can carry out sophisticated medical duties, is a breakthrough advancement in digitised healthcare technology. As more and more patients adopt smarter ways to connect with their physicians, there is an emerging need for clarity in healthcare policies which affect citizens’ everyday lives, it is evident that the rise of the SaMD market is to sustain longer and bring forth new challenges. Although India has initiated regulating SaMDs, there is a need to catch up with the novel questions posed by market players. Collaboration between players in many disciplines is undoubtedly required in the era of sustainable development goals if global health impacts are to be improved. The policies impacted by the G20 can vary depending on the issue and the level of consensus among member countries. Overall, given the potential of SaMDs to transform healthcare, it is important for the G20 to discuss ways to ensure that they are developed and used safely, effectively, and ethically.
† Student, BBA LLB (Hons.) from CMR School of Legal Studies, Bangalore and Postgraduate Diploma in IPR Law from NLSIU, Bangalore. Author can be reached at: firstname.lastname@example.orgemail@example.com.
1. International Medical Device Registration Forum, “Software as a Medical Device”: Possible Framework for Risk Categorisation and Corresponding Considerations, IMDRF/SaMD WG/N12FINAL:2014, p. 5, available at <https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf> accessed on 7-11-2022.
2. Dr Asif Dhar, Mike Delone and Dan Ressler, Reimagining Digital Health Regulation: An Agile Model for Regulating Software in Health Care, Deloitte Center for Government Insights <https://www2.deloitte.com/content/dam/Deloitte/us/Documents/public-sector/reimagining-digital-health-regulation.pdf> accessed on 18-11-2022.
3. Wade Schroeder, Software as a Medical Device: Definitions, Examples & Regulatory Framework, dated 14-10-2021 <https://www.greenlight.guru/blog/software-as-a-medical-device> accessed on 13-11-2022.
4. Kaiser Permanente International, Kaiser Permanente: The Electronic Health Record Journey, July 2019 <https://international.kaiserpermanente.org/wp-content/uploads/2019/07/EHR_Journey_final.pdf> accessed on 10-1-2023.
5. Blue Shield, California, Californians Say Health Care is Improving, New Poll Finds, News Center, 8-6-2022 <https://news.blueshieldca.com/2022/06/08/californians-say-health-care-is-improving-new-poll-finds> accessed on 10-1-2023.
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7. Aya Ishizuka, “The Role of the G20 Economies in Global Health”, ResearchGate, October 2019 <https://www.researchgate.net/publication/337360436_The_role_of_the_G20_economies_in_global_health> accessed on 10-1-2023. (link not accessible)
8. Engineering Export Promotion Council of India (EEPC India), Indian Medical Devices — An Overview, p. 3 <https://indianembassy-moscow.gov.in/pdf/eco-com/Indian%20Medical%20Device%20Sector%E2%80%93220720.pdf> accessed on 22-1-2022.
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15. Joint Statement on the United States-India Trade Policy Forum, Washington, DC, 11-1-2023 <https://www.advamed.org/wp-content/uploads/2023/01/Joint-Statement-on-the-United-States-India-Trade-Policy-Forum.pdf> accessed on 19-1-2023.
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17. Press Trust of India (PTI), “Hospitals in India Turn to Remote Patient Monitoring Solutions to Manage Shortage of Beds in COVID-19 Second Wave”, The Week, 14-4-2021 <https://www.theweek.in/wire-updates/business/2021/04/14/pwr10-dozee.html> accessed on 10-1-2023.
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