From Wellness to Clinical Care: Regulating at the Intersection of Medical and Non-Medical Devices in Hybrid Digital Health/AI Suites

Description: As digital health technologies evolve from standalone tools to interconnected suites—including AI-powered wearables and home-based monitoring systems—traditional regulatory and reimbursement models struggle to keep pace. This session examines how emerging digital health solutions are challenging existing frameworks and how regulatory approaches must adapt to ensure both safety and innovation.

Part One: Integrating Suites of Digital Health Tools
The second segment will explore how wearable devices, remote monitoring tools, and wellness platforms are increasingly integrated into flexible, clinically meaningful care suites. Speakers will discuss—from a regulatory science perspective—how to design patient-centered digital products by engaging stakeholders early on, using approaches such as Living Labs and Regulatory Sandboxes, how to strengthen post-market feedback mechanisms to enhance safety, and how regulation and reimbursement frameworks must evolve to support bundled technologies and new care environments like the FDA’s “Home as a Health Care Hub” initiative.
Part Two: French National Governance for Hybrid Digital Health Ecosystems
The second segment examines how national digital health governance frameworks implemented in France enable the secure, interoperable, and ethical integration of hybrid digital health solutions within a national reimbursement model. This model began with telemonitoring and now extends to a broad range of reimbursed software-enabled devices. The session will explore how national authorities are managing the diversity of devices, including those not traditionally regulated as medical devices but that handle sensitive patient data. It will also draw on policy experience from national implementation efforts and navigation of EU-level regulations, including the AI Act, GDPR, MDR, IVDR, and the Cybersecurity Act.
Together, these sessions provide a forward-looking perspective on modernizing governance to support integrated, patient-centered digital health innovations—whether at a health system level, in the clinic, at home, or on the body.