Regulatory Landscape of AI/ML in DHTs (Current Landscape, Knowledge Gaps, Best Practices for Regulatory Submissions, Challenges of Regulating AI)

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 Forum will be taking place over Zoom on 25 September at 14:00-15:30 (BST) / 9:00-10:30 (EDT).

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