| Regulatory Landscape of AI/ML in DHTs (Current Landscape, Knowledge Gaps, Best Practices for Regulatory Submissions, Challenges of Regulating AI) |
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Digital healthcare technologies (DHTs) show significant potential for enhancing data acquisition in clinical trials by enabling objective and accurate data collection. Examples of DHTs include wearable devices – sensors, smartwatches, fitness trackers – that continuously monitor vital signs, physical activity, sleep patterns, and medication adherence. Some DHTs, such as smartwatches, can be used both in clinics and at home for remote patient monitoring. Moreover, DHTs facilitate real-time data monitoring and safety analysis, enabling prompt identification of trends, outliers and adverse events. This timely information supports early intervention and decision-making, thereby improving participant safety and overall trial efficiency. However, the emergence of DHTs also raises regulatory-related questions. In this PHUSE quarterly forum, we will discuss the development of digitally derived measures (clinical outcome assessments and biomarkers) and germane regulatory policies from the perspectives of experts from the government and the industry. This Community Forum took place over Zoom on 25 September |
| Catch Up here! |
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This Community Forum took place on 11 July 2024. Catch up by viewing the recording |
| Presenter | Bio |
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| Anindita Saha, FDA Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She leads strategic initiatives in moving care into the home, artificial intelligence, and international collaborations for the DHCoE to advance health equity. This includes the use of patient-generated data and managing bias in DHTs and improving transparency. Annie helped incubate and continues to support advancing the science and adoption of patient input as evidence, including patient preference information (PPI) and clinical outcome assessments (COAs). Previously, she was the Director of the Partnerships team in the CDRH, where she oversaw a broad programme portfolio which supported several strategic partnership and regulatory science programmes. Annie started as a researcher in the Office of Science and Engineering Laboratories in imaging display technologies. Annie has a bachelor’s of science in bioengineering and a minor in history from the University of Pittsburgh. |
| Kausar Riaz Ahmed, Pfizer Dr Kausar Riaz Ahmed is Director, Generative AI Medical Engagement Lead at Pfizer. In this role, she leads the Generative AI strategy for Medical Affairs and engagement with external and internal stakeholders. She is founding member of the PHUSE project on use of artificial intelligence/machine learning in digital health technologies. She has extensive experience in AI, data analytics, oncology, strategic partnerships and regulatory affairs. Prior to joining Pfizer, Dr Riaz Ahmed spent over nine years at the FDA, where she led regulatory review of more than 150 new product submissions, developed computational tools to inform health risk assessments, steered strategic collaborations and medical device shortage assessments during the COVID-19 pandemic, and co-chaired the FDA-wide Modeling and Simulation Working Group. She has also worked with multiple digital health startups as a board member and advisor. |
| MiRa Jacobs, FDA Dr MiRa Jacobs is the Division Director for the Division of Digital Health Policy, which is part of the Digital Health Center of Excellence at the FDA. She has worked at the agency since 2018, first as Lead Reviewer in the Office of Product Evaluation and Quality, where she provided support for software and cybersecurity review in addition to her work as a lead reviewer on the neurointerventional devices team. Dr Jacobs joined the Digital Health Center of Excellence in 2020 and has since contributed to programmes and initiatives with a focus on developing and implementing policy for AI-enabled medical devices, the maturation of predetermined change control plans, and international harmonisation on approaches to software and AI-enabled devices. Prior to joining the FDA, Dr Jacobs earned her PhD in Biomedical Engineering from the University of Florida. |
