Digital Health, AI, and the FDA
Q&A with Dr. Sanjeev Bhavnani
Dr. Sanjeev Bhavnani is a Senior Cardiologist in the Division of Cardiology at Scripps Clinic Medical Group. He was previously at the FDA Digital Health Center of Excellence. He recently spoke in our MBA Course on the role of Government in advancing digital health. In this Q&A, he shares his thoughts on digital health, artificial intelligence and the role of the FDA.
Tell us a little bit about your background and how you got interested in digital health?
My initial interest in digital health began early in my career as a medical student when we were trying to develop an implantable sensor to detect cardiac injury. While the idea did not go forward as planned, it did instill in me how a technology is developed from engineering, sensor fabrication, clinical and animal studies, and how to position and idea for fundraising. In many ways, it helped me to understand medicine from a different angle as training continued. I later became a clinical cardiologist involved in implantable technologies at the University of Connecticut, and then as a digital health clinical trialist at Scripps. I’ve learned over this time how to design digital health and machine learning products, trials for regulatory submissions, and what we need to think about for post-market, clinical use of such technologies. Much of my interests focus on how we deliver care with new digital and decentralized platforms, and how we need to shift our approach for real world data generation with new technologies. Bringing together clinical, research, and policy towards understanding how new technologies impact healthcare quality, with a priority in rural and geographically displaced communities, are some of my current interests as these fields evolve.
Can you talk about your role at the FDA and the purpose of the Digital Health Center of Excellence?
I am privileged to have served in US healthcare at the FDA as a physician and medical officer in digital health policy. The purpose of the Digital Health Center is to empower stakeholders to advance healthcare by fostering responsible and high-quality healthcare innovations. The Digital Health Center is tasked with a lot of interesting and impactful work, to connect and build partnerships, share knowledge and best practices, and to innovate regulatory approaches for safe and effective products. It is tasked with being cross cutting, to collaborate across the FDA and government agencies, and to be an interface for the public when questions come up about digital health policy. As the public – this can be people, patients, students, developers, clinicians, and anyone else - become interested in digital health, the role of the government becomes increasingly important to ensure that trusted and accurate information is available to all.
Can you describe a few of the key projects you were involved with while at the FDA?
I served in roles tasked with applying medical and scientific considerations into digital health and real-world evidence guidances - that is recommendations to industry and product developers building digital health and AI/ML products. These guidances outline FDA’s requirements for the safe and effective development of new products. I was involved in equity strategic priorities to advance the diversity, equity, and inclusion approaches with how new products can be designed through the lens of equitable patient participation. Other projects I was involved in were in new patient preference designs for remotely capturing patient reported- and clinician reported-outcomes in patients with rare diseases such as ALS, and the International Medical Device Regulators Forum software-as-a-medical device workgroup to harmonize regulatory frameworks as new software and those with device function are developed and used in clinical settings.
With the rapid interest in using artificial intelligence within healthcare, what do you think are some of the approaches we should know about?
Artificial intelligence is uniquely positioned to change much of what we understand about healthcare from how diseases are diagnosed, how patients and people interact with their healthcare, and how we can deliver care more effectively and efficiently through digital approaches. As we look to transformation, we must develop robust evaluation and validation frameworks for AI to ensure what is developed will function well when used in real world settings. Some of these frameworks will define benefit and risks, while others will identify and measure how transparent and explainable an AI/ML algorithm is. Among the many approaches, I think clinical implementation and AI/ML assurance and governance are important areas that bring together product development, policy, and clinical requirements to gauge benefits and risks in patient care. A shared ecosystem such as this and one that monitors post-market performance, the preparedness of an organization for the implementation of AI/ML algorithms, and one that adapts clinical infrastructures can lead to AI/ML devices that are used based on an assurance of quality, and to monitor and mitigate bias when observed. While it is quite a task to ensure the robustness of AI/ML, in doing so - and hopefully in real-time - will position our collective approach as the field continues to develop, and to keep us well aligned with what patients expect in their care as AI/ML is implemented into broader healthcare delivery.
What are the key challenges ahead for digital health and how do you see the Government’s role in addressing them?
The Government has an important role ahead to continue to ensure safety and effectiveness of digital health technologies and AI/ML devices. It also has a role to develop the necessary frameworks that identify and address key challenges. These can include frameworks for transparency and explainabilty of AI/ML devices, use of datasets in training and validation that are equitable and representative of the population in which a new device will be used, and how digital health and AI/ML are covered and reimbursed. While the evidentiary requirements can be different between product development, coverage, and clinical use, the Government’s role is important in each and it has a vital role with bringing together multiple stakeholders, identifying important use cases, and promoting responsible innovation for the US population.
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