Tuesday, Oct 24, 2023 | 9:30 AM ET
Charting the Digital Health Regulatory Frontier
The digital health landscape has changed dramatically in recent years, including in three major developing areas—real world evidence (RWE), the monetization and secondary use of health data, and artificial intelligence/machine learning (AI/ML)—across key jurisdictions in the U.S., Europe and China. Regulatory authorities recognize RWE and health data as complementary data sources to traditional clinical trials; however, their quality, reliability, regulatory permissions and cybersecurity risk remain in question. Advances in AI/ML devices continue to evolve in silos, leaving regulators with the challenge of unifying a global approach to AI/ML devices, specifically medical devices, as these technologies rapidly learn and develop.
Join our panel of regulatory experts as they discuss recent developments and emerging trends impacting the development and deployment of digital health technologies in the U.S., Europe and China.
Key topics will include:
- How various jurisdictions are approaching the regulation of digital health technologies
- The potential for a more unified approach to global digital health regulation
- What’s on the horizon for digital health technologies
Katherine WangPartner, Asia Life Sciences Regulatory, Ropes & Gray LLP
Lincoln TsangPartner, European Life Sciences Chair, Ropes & Gray LLP
Kellie CombsPartner, FDA Regulatory & Digital Health Co-Chair, Ropes & Gray LLP