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European Health Data Space (EHDS) Regulation Enforcement Date
The European Health Data Space (EHDS) Regulation went into force on 26 March 2025. The Regulation, FAQs, recorded videos, and press release are available: HERE
Background
Currently, health data is stored in different formats and systems across the EU, making cross-border healthcare difficult. Patients often face difficulties in accessing their own medical data, and healthcare professionals may not have complete information when treating patients from other EU countries.
Purpose
The EHDS Regulation establishes a common framework for accessing, using, and exchanging electronic health data, while simultaneously ensuring data protection and patient rights.
The aim is to improve the use and sharing of health data across the EU. For example:
- It gives patients full control over their electronic health records across the EU.
- Researchers, regulators, and policymakers can access anonymized health data for innovation, research, and public health improvements.
- It is built on GDPR principles but with specific rules tailored for health data, and ensures strong cybersecurity and patient consent mechanisms.
Impact on Manufacturers
The EHDS Regulation primarily targets healthcare providers, patients, researchers, and public health authorities. However, medical device manufacturers, particularly those involved in digital health, AI-driven diagnostics, and software as a medical device (SaMD), will also be affected:
- Manufacturers of devices that generate, store, or process Electronic Health Data (e.g., wearables, remote monitoring tools, digital therapeutics) will need to ensure their devices comply with EHDS interoperability and security standards.
- Manufacturers of software that collects or processes patient health data must align with EHDS interoperability requirements and data access rules, and AI-based medical devices that rely on large datasets for training or decision support will need to comply with EHDS secondary data use provisions.
- Companies that leverage real-world data (RWD) or real-world evidence (RWE) for clinical evaluations, AI training, or regulatory submissions may benefit from structured access to EU-wide health data but must also comply with EHDS governance rules.
While the EHDS Regulation went into force on March 26, 2025, its immediate impact on medical device manufacturers is limited. This is due to the phased implementation timeline:
- March 2027: Implementing acts are expected to be adopted.
- March 2029: Primary use (e.g., patient summaries) and secondary use (most data categories) rules begin to apply.
- March 2031: Expanded data categories (e.g., medical imaging, lab results) come under EHDS rules.
In the meantime, manufacturers could start internal assessments on the applicability of the EHDS Regulation, e.g., whether their devices claim interoperability with Electronic Health Record systems, and if so, begin familiarizing themselves with the new legislation.