Survey on the EU Legal Framework for Health Data and Data Driven Health Technologies

Why It Matters

Understanding real‑world compliance challenges helps the EU refine its regulatory framework, reducing market friction for data‑driven health innovators.

Key Takeaways

• Survey runs 13‑22 May 2026, 20‑minute questionnaire.
• Targets researchers, developers, regulators handling EU health data.
• Covers AI, virtual twins, genomics, synthetic data, biotech compliance.
• DG CNECT partners with PwC EU Services for data‑driven insights.
• Results will be aggregated, informing future EU health data policy.

Pulse Analysis

The European Union’s health‑data ecosystem sits at the intersection of stringent privacy rules and a fast‑moving digital health market. Regulations such as the GDPR, the Medical Device Regulation and the newly adopted Data Governance Act create a complex compliance landscape for organisations that wish to reuse patient information. While these rules protect citizens, they also generate uncertainty for innovators trying to scale AI‑driven diagnostics, virtual patient models, or genomics‑based therapies across member states. By gathering concrete experiences from the field, the Commission can identify practical bottlenecks and calibrate guidance that balances safety with innovation.

Digital health technologies are accelerating, with AI‑based imaging tools projected to exceed €10 billion in EU revenues by 2028, and synthetic data platforms gaining traction for privacy‑preserving research. Yet, each technology faces distinct regulatory hurdles—AI systems must meet the EU AI Act’s risk classifications, while virtual twins intersect with both medical device rules and data protection obligations. The survey’s focus on these emerging categories signals that policymakers recognize the need for nuanced, technology‑specific rules. Participants’ insights will help refine conformity assessment pathways and clarify the role of health‑data infrastructures, potentially shortening time‑to‑market for breakthrough solutions.

For industry, the survey offers a rare channel to influence policy before final rules are codified. Companies that contribute can anticipate upcoming compliance requirements, align product roadmaps, and mitigate investment risk. PwC’s involvement adds a strategic advisory layer, suggesting that the findings may translate into practical toolkits or best‑practice frameworks for European firms. Ultimately, the aggregated results will inform a more predictable regulatory environment, encouraging cross‑border collaboration and unlocking the full economic potential of data‑driven health technologies in the EU.