Food & Drug Law Institute’s Digital Health Technology and Regulation Conference
Event summary
Digital health tools and services enable industry to enhance care quality, provider efficiency and patient access. Continued exponential growth in this sector challenges regulators to craft timely, relevant and adequate measures at the state and federal level to safeguard public interest. This conference explores current and prospective regulatory policy and legislation on prescription drug use-related software, laboratory-developed tests, quality management systems, predetermined change control plans, and generative artificial intelligence (AI) safety, efficacy and bias. Sessions will address pivotal concerns to the digital health community – including US Food and Drug Administration (FDA) enforcement discretion policies and compliance with federal and state privacy laws.
Featured agenda items
Wednesday, February 26, 2025 | 11:00 am – 12:00 pm EST
The Next-Gen Regulatory Arena
Cooley associate Sunny Levine is a speaker for this session, which anticipates what digital health stakeholders should expect from the new administration in a Loper Bright world. As more states enact laws over emerging technology, agencies produce guidance on use, and appointees are announced, questions about telemedicine licensing, data privacy, Medicaid reimbursement and health equity emerge. Panelists will explore these topics through the lens of regulatory authority, interpretation and preemption.
Wednesday, February 26, 2025 | 12:10 – 1:10 pm EST
Clinical Decision Support in Diagnostics: Managing Regulatory Uncertainty and Facing Practical Challenges
Cooley special counsel Son Nguyen is co-chair of the planning committee for FDLI’s Digital Health Technology and Regulation Conference and is moderating this panel.
Clinical decision support software (CDSS) plays an important role in healthcare by providing clinically relevant information and recommendations. Increasingly, CDSS is used in conjunction with diagnostics, including laboratory-developed tests (LDTs), to make medical recommendations by leveraging bioinformatic data. This session will outline the regulatory uncertainty and practical challenges that exist, discuss the limitations of innovative decision-support technologies, highlight the importance of transparency for the end user, and demonstrate how the expense of these tools may affect healthcare facilities in underserved areas.
For more information, please email Rebecca Lanz.
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