Digital health in need of disruptive regulation

 India recently announced the medical devices bill, which will likely have a lasting impact on making India a  global leader in the medical devices sector. Similarly, it is time for India to consider Digital Health. Digital Health will disrupt the healthcare and life sciences domain. Digital Health has come a long way; now,  ‘software is a drug’ and ‘Software is a medical device’, and India has the potential to emerge as the world’s leading provider of digital health solutions. Ayushman Bharat Digital Health Mission has already started India’s big push for digital health. This push needs to match the need of thousands of solutions that will be needed by patients, clinicians, hospitals, and the pharmaceutical industry. India’s digital health market has grown remarkably, projected to reach INR 2,528.69 Bn by 2027. With over 2000 digital health start-ups and four unicorns, the advent of artificial intelligence, and the fast-emerging field of digital therapeutics, the pharmaceutical industry is setting up the digital health division and has also increased its research and development to introduce innovative digital health products and services; this calls for looking at the other side, the users and ensuring that these innovative solutions meet their intended goals and not harm the users even inadvertently.

However, the digital health market may face challenges with too many products making tall claims and then, running into legal issues creating a ‘distrust’ in the minds of the users, and this can stifle the growth of the segment which can make healthcare accessible, affordable, and outcome driven. So we need to initiate a unique regulatory roadmap for a field that is evolving rapidly with far-reaching impact on populations’ health. The lack of any regulatory oversight has created grey areas that impede the potential growth of digital health products in international markets, cause unintended harm, and, in extreme cases, could be fatal. To ensure this sector’s sustainable development and avoid potential unintended harm, it is crucial to address these uncertainties promptly in the form of a unique and transformative regulatory pathway, which will encourage innovation, new products, and services and protect the users against untended harm. If we can do it, India will emerge as the world’s leader if it can do it.

As regulations mature, we will need a post-market surveillance mechanism for digital health products like pharmaceutical products. Currently, there is no reporting mechanism or registry where consumers can file complaints in case of adverse events related to digital health products & services. This lack of an effective surveillance mechanism hampers consumer confidence and poses potential risks to public health and safety.

I proposed to the CDSCO to establish a robust post-surveillance mechanism for digital health products and services. Such a mechanism would serve multiple purposes. Firstly, it would empower consumers to make informed choices by providing a platform to report adverse events and share their experiences. Also, this would let the world try out such products and services. Secondly, it would furnish real-time data to policymakers and regulators, enabling them to address emerging issues promptly and make data-driven decisions.

A unique regulation model is needed: the CDSCO, with its expertise and dedication to public health, is well-positioned to drive this crucial initiative. It can create a unique ‘Monitoring & Mentoring Model for Post-market surveillance’ of Digital Health Products & Services to ensure ‘Regulation & Innovation’ thrive in the digital Health Ecosystem, supporting the entrepreneurs in their journey. Under this model, the CDSCO and ICMR can join hands with patient bodies like the International Patient’s Union , create a registry of all digital health products and services, and monitor them for their intent versus impact. Also, the actions from the regulator’s perspective should not be punitive but handholding, mentorship from healthcare experts,  and sharing of the best practices till the industry matures. So, defining the regulation for the industry that has to still find its feet would be best, if the regulator lays a unique roadmap. This could mean starting a registry of all digital health products and services available in the country, classifying them into categories that are low, medium, and high risk for users, and then helping them with their scientific validation. Those with low risk can do self-regulation and those in the medium and high risk can be on the ‘Digital Health Monitoring and Mentoring cell of CDSCO’ .

Most start-ups are good at technology and poor at science and documentation, but their intentions are good, and they want to positively impact patients’ lives. Once the evidence starts gathering for digital health solutions, the regulations should evolve in a phased manner, walking the journey with the innovators, clinicians, and scientists. This is where the regulations will help innovation thrive and balance user safety and build trust. As the industry matures, the regulations will also mature and keep pace with the evolving needs of the time. The approach of the regulator has to change from distrust, policing, reprimanding, and punishment to co-creating the segment as a knowledgeable facilitator with best practices for the success and safety of products and services. I have said in the past that regulation kills innovation, but perhaps regulating digital health may transform how we regulate the products and services in health and other domains.