Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Description: The European Health Data Space Act (EHDS Act) will change how health data is shared and reused in the European Union. In regulatory, the EHDS Act will ask for different data practices, and will allow for new data to become available. The act will require integration into MDR/ IVDR requirements, clinical practices and data protection processes.
This solution circle invites participants to unpack what the EHDS Act will mean in day-to-day regulatory work and what possibilities it brings. We will set the stage with a short overview of three pressure points:
• Primary use: proving interoperability for EHR systems and device data while safeguarding proprietary design. • Secondary use: handling data access requests, consent frameworks, and protection of confidential information. • Integration: impact of the EHDS Act in light of MDR, IVDR, AI Act and GDPR.
The discussion will then open to participants: Where are companies already preparing? Where are the biggest risks to their competitive position? How should regulatory teams document compliance strategies before the first requests land? By the end of the session, participants will have shared early approaches, identified expected pain points, and understand where to start with creating a strategy for addressing the EHDS Act within their companies.
Learning Objectives:
Upon completion, participants will understand the possibilities offered by the EHDS Act for obtaining access to additional data sets as well as understanding the limitations it places on such data use.
Upon completion, participants will understand why they should start preparing for the application of the EHDS Act.
