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Medical device software needs a ‘Light Touch’

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υDigital tools are increasingly becoming as commonplace as drugs, vaccines and blood-pressure monitors in health management. Sidharrth Shankar, Partner  and Aman Bhatia, Associate, J Sagar Associates, further share their insights

Digital tools are increasingly becoming as commonplace as drugs, vaccines and blood-pressure monitors in health management. Given that software plays an important role in the running of these medical devices, it follows that medical device regulators across the world need to have control over such software, and affix responsibility in case any bugs are detected in the system.

India has already taken early cautionary measures in regulating its medical device sector. In its notification dated 11th February, 2020, the Ministry of Health and Family Welfare (MoHF&W) categorised all ‘software’ or ‘accessories’  intended for diagnosis, prevention, monitoring, and treatment of any disease, disorder, injury or disability as ‘drugs,’ under the Drugs and Cosmetics Act, 1940 (D&C Act) and the Medical Devices Rules, 2017 (MD Rules), with effect from 1st April, 2020. This means that the software offered by software companies to medical device companies and wearable device manufacturers would now be regulated under the MD Rules, with its licensing and registration requirements (which are on par with those of medical devices manufacturers) becoming applicable. As per the MD rules, the sale and distribution of medical devices can commence only after obtaining a licence from the regional Food and Drug Administration (FDA). In plain speak, software developers would now require a licence from the FDA to sell their products. How well the regional FDAs are equipped to handle licensing of such software and assessing software companies is yet to be ascertained.

It is noteworthy that the Ministry of Chemicals and Fertilizers has also expedited the regulation of prices of such newly-notified ‘drugs’ by its notification dated 31st March, 2020, which requires the prices of all such medical devices to be monitored under the Drugs (Prices Control) Order, 2013. If the implication is that software developers are henceforth expected to comply with the National Pharmaceutical Pricing Authority’s (NPPA’s) orders, they would no longer be in control of the price of the software developed by their team.

Given the increased level of regulation, a crucial question that needs to be ascertained is the point at which any software designed for medical and wearable devices qualifies as ‘software.’ Unfortunately, the notification provides little guidance on this score; it requires only that the software be intended by its developer for the specific purposes of diagnosis, prevention, monitoring, treatment, assistance or alleviation of any disease, disorder, injury or disability. Thus, any software that fulfills the intended purpose of being used for the aforementioned reasons would qualify as a medical device. Software used in medical devices as also mobile apps used for real-time tracking of vital parameters would fall squarely within the current regulatory framework. However, given the notification’s wide scope, software that may not pose any medical risks may also be covered under the MD rules. This includes software that enables clinical communication and workflow, such as patient registration, scheduling visits, voice calling and video calling.

While it may be too soon to decide whether the notification will stymie the growth of the ‘software as a medical device’ industry, opinion has always been divided on the benefits of any sectoral regulation. On one hand, stringent regulations result in a monopolistic, business environment by increasing entry barriers as well as the cost and complexity of doing business. On the other hand, it may be argued that such timely monitoring keeps a check on the overall systemic health. The ‘light touch’ approach in regulating technological innovations has always been the conventional choice.

The D&C Act is an archaic framework which has not kept pace with technological advancement. Going forward, the Government needs to recognise software as a class distinct from medical devices by notifying separate regulations for software. The policies, guidelines, and action plans formulated by developed countries such as the United States could act as a guidepost to improved legislation in India that fosters its growth in the health-tech space. An enabling framework would focus on India-specific issues and use-cases via the introduction of a regulatory sandbox for live-testing of software in a controlled environment under the supervision of the Central Drugs Standard Control Organization (CDSCO).

Healthcare regulators in other countries such as the USA have already recognised the benefits of new-age technology such as artificial intelligence and machine learning in lowering operational costs and clinical efficiencies. A few areas that would be impacted by technology include patient monitoring, workplace automation and preventive care.

Medical device companies have yet to penetrate the health-tech market in India. By contrast, approximately 28 per cent of China’s population uses connected health devices, as per a study conducted by Policy Advice. However, India’s growing concern with lifestyle diseases, and the increased focus on weight control and physical activity monitoring, are likely to give a fillip to the manufacture and distribution of new-age technology such as wearables and health apps.

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