Panel
Regulating Medical Innovation in the Digital Age
Milken InstituteLisa Suennen, William Carson, Aneesh Chopra, Sohini Chowdhury, Lucia Savage, Jeffrey Shuren, Lisa Sunin, Jeff Sheeran, Bill Carson
- Cumulative digital healthcare investment over the last eight years is projected to exceed $40 billion, with current year investment expected to reach approximately $11 billion.
- The digital marketplace is characterized by rapid growth, while Anish Chopra forecasts that 130 million lives will have accessible, longitudinal claims-based health records for commercial use starting next year.
- Regulatory frameworks, particularly payment reform and EHR standards, are identified as primary catalysts for new care delivery models, with Anish Chopra predicting that linking data liquidity and standards to Medicare participation will accelerate technical adoption.
- The FDA is developing a new regulatory model for software as a medical device (SaMD) aligned with software development cycles and international harmonization, with a white paper on machine learning considerations expected next year.
- The field of Parkinson's sensors and digital applications is currently in an earlier stage, with industry participants anticipating that fundamental questions regarding measurement standards and validation will eventually be resolved.
- The "sightless model" for clinical trials is expected to face challenges regarding patient care and adverse event monitoring, necessitating an industry-wide adaptation analogous to the shift from Blockbuster to Netflix.
- Future clinical trial efficiency and cross-state telemedicine licensure rules are viewed as areas requiring reform, with suggestions to tie reimbursement to data collection and address cross-state licensing barriers.
- Anish Chopra anticipates that nonprofit groups and technology will expedite drug development, while financial incentives from payment reform will drive physician engagement with data insights.
- The industry is expected to self-organize to establish ethical and safety "guardrails" for AI, potentially through a voluntary but enforceable code of conduct for the unregulated consumer app economy.
- Blockchain technology is proposed as a mechanism to enable patient data trading, enhance safety reporting, and improve FDA data quality, though privacy concerns regarding user understanding of keys persist.
- Concerns exist regarding continuous catch-up on privacy and security guidelines, with warnings that future regulatory changes may require rebuilding existing processes.
- The FDA's pre-cert program is slated to pilot hypotheses regarding product quality, patient safety, and cybersecurity, while the National Evaluation System for Health Technology (NEST) remains a community-driven approach rather than an FDA-operated entity.
- Upcoming regulatory challenges include handling algorithms that surpass human intelligence, increased draft guidance on clinical decision support, and a potential push to shift ongoing data collection sharing from proprietary to public domains.
- Omada Health is expected to expand its scope to include type two diabetes and hypertension services alongside its existing digital prevention program.