AI in Public Health: Privacy and Regulatory Challenges

The use of Artificial Intelligence (AI) in healthcare, primarily to access vast data sets of potentially life-saving information, is increasingly becoming mainstream with the growing use of technology in tackling health crises. With immense application potential that is responsive and cost-effective come significant concerns around patient privacy, lack of explainability, and legal culpability, raising pertinent questions about our preparedness in terms of regulations to take on challenges that come with both AI and public health in the Indian healthcare sector.

What is the biggest challenge for the regulation of AI in healthcare with regard to successful application in public health? What is the regulator view on balancing patient safety and promoting innovation for high stake AI-based clinical solutions? What clinical perspectives need to be integrated when we address AI regulation? What role does innovation have in the public health ecosystem, and can industry innovators share focus between tertiary and primary healthcare? What is the innovation sentiment around the government and regulator capabilities with respect to current infrastructure gaps? How is a regulator impacted by potential systemic changes in its structure and functioning, and what is the CDSCO’s plan of action? What is explainable AI and how can research guide a regulator’s perspective on striking the right balance? Is the Indian ecosystem ready for setting up AI sandboxes in research hospitals to explore the importance of context in explainable AI? Is there an enabling regulatory framework for data and AI, and if not when can one be expected to come into effect? What would be the quickest and most comprehensive way of establishing a benchmark for AI-based clinical efficacy? Have we developed any safeguards for AI-based tools? How has AI helped India in its fight against the coronavirus pandemic?

IIC Representative and Project Associate at MoHFW Krisstina Rao moderates a panel of Sheetal Ranganathan, Vice President and Global Head of Life Sciences and Healthcare Operations, Evalueserve, R Chandrashekhar, DDC CDSCO and Dr. Anurag Agarwal, IGIB, and AI Task Force for MoCI, that discusses existing regulatory challenges for AI in public health including the need to balance concerns for patient safety and clinical efficacy with the need to let innovation thrive. Bringing together perspectives from policy, industry, and innovation, it looks into the role of regulators in emerging technology for healthcare, a pressing imperative in the current context of the need for rapid certification and pre-market testing for technological solutions.

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