Lisa Suennen
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- Milken Institute1h 0m
Regulating Medical Innovation in the Digital Age
Lisa Suennen, William Carson, Aneesh Chopra, Sohini Chowdhury, Lucia Savage, Jeffrey Shuren, Lisa Sunin, Jeff Sheeran, Bill Carson
A panel of industry leaders and FDA officials analyzed the surge in digital healthcare investment, which has exceeded $40 billion, while addressing regulatory hurdles that slow the development of Software as a Medical Device. Key discussions highlighted the FDA's "Pre-Cert" pilot program and the critical need for interoperability standards like FHIR to reduce data costs and overcome fragmentation in telemedicine and direct-to-consumer markets. Despite breakthroughs such as the first digital medicine approval, experts emphasized that legacy frameworks struggle to accommodate rapid software iteration, opaque deep learning algorithms, and complex data privacy requirements across 57 state and federal jurisdictions.