Lucia Savage
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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.
- Milken Institute1h 4m
Digital Health Technology and Solutions
Steven Krein, Katie Agarwal, Matthew Stoudt, Sara Wajnberg, Joel White, Sarah Weinberg, John Birch, George Masregas, Lucia Savage, Hoyt Morgan, Paul Anthony, Lisa Fitzpatrick, Mike Goodman
The event convened leaders from Oscar Insurance, Maven Clinic, Applied VR, and Horizon Government Affairs to analyze how converging macro trends and $10 trillion in capital are reshaping global digital health. Despite rapid venture investment, the panel highlighted critical barriers including fragmented state licensing, stagnant Medicare reimbursement, and misaligned regulatory frameworks that force startups to pivot from consumer to employer models. Looking ahead, the industry aims to drive individualization and equity through unified data standards, risk-based FDA pre-certification, and cross-sector collaboration to eliminate friction in chronic pain management and women's health care.