The recently tabled Parliamentary standing committee report on health has shed light on the critical urgency of regulating digital devices and wearables, including smart watches, to ensure the security of individuals’ health data. This report, presented during the monsoon session, delves into discussions surrounding medical devices, regulations, and control.
The committee’s report has raised significant concerns about the vast amount of data generated through digital devices and wearables, and it has pointedly highlighted the absence of data security provisions in the Medical Device Policy. As the market has become saturated with an array of affordable smart watches offering multifunctional features like health record tracking, heart rate monitoring, and weight measurement, the potential risks to individuals’ personal health data have become increasingly apparent.
The government’s push for health records digitization, especially under initiatives like the Ayushman Bharat Digital Mission (ABDM), has intensified the need for stringent regulations to protect personal health data. Despite the strides made with the launch of the medical device policy in May, concerns remain regarding the absence of provisions specifically addressing data security for patients.
The Parliamentary panel, cognizant of the escalating importance of data security in healthcare, has advocated for immediate action to address these vulnerabilities. Given the substantial volume of data being generated, the committee strongly recommends incorporating stringent data protection norms into the existing medical device policy.
The medical devices sector in India is burgeoning rapidly, positioned as a sunrise sector with significant growth potential. The sector’s market size was estimated to be approximately $11 billion (₹90,000 crore) in 2020, with projections that it could reach $50 billion by 2050. Presently, India’s share in the global medical device market stands at around 1.5%, reflecting both its growth potential and the importance of robust regulatory frameworks to maintain data security and patient privacy.
As of now, queries sent to the health ministry spokesperson have not yet been addressed. The Parliamentary report underscores the criticality of addressing the pressing concerns related to health data security in the context of the proliferation of digital devices and wearables. The recommendations and concerns voiced in the report serve as a call to action for immediate attention to safeguard individuals’ health data while simultaneously fostering the growth of the medical devices sector in India.
