No separate ethical assessment
EHDS allows a separate ethical assessment
The European Health Data Space (EHDS) forms a fundamental pillar of the European data strategy and has the explicit goal of significantly increasing the availability of health data for useful reuse. It promises to put an end to the legal fragmentation and reluctance to share data that have hampered cross-border research for years. The EHDS introduces a harmonised system with Health Data Access Bodies (HDABs). However, the regulation contains a political compromise: Member States retain the power to require an additional ethical assessment for an EHDS permit. They would do well not to make use of this option. Here is why a separate assessment by an ethics committee would solely do harm.
The HDAB as a comprehensive gatekeeper
An analysis of the rules shows that an additional ethical layer is superfluous. The new HDABs are required under the EHDS and the GDPR to conduct an extensive assessment:
- EHDS assessment : The HDAB checks whether the goal of the applicant is one of the recognized purposes, such as scientific research aimed at public health, whether this is not prohibited use, and whether there is a broader public interest. It checks whether the applicant possesses the appropriate qualifications and whether the proposed research is scientifically sound.
- Privacy and GDPR compliance: The HDAB acts as a gatekeeper for the GDPR and continuously verifies the lawful basis, proportionality, and subsidiarity of the data processing.
Strict security: Data is not transferred directly but may only be processed within a controlled Secure Processing Environment (SPE), which serves as the primary technical safeguard for patient rights.
Patient participation: The HDAB manages the complex assessment regarding opt-out and opt-in regimes, depending on national legislation.
An additional assessment has no purpose
The rules on how to write laws in many countries stipulate that if legislation is prescribed, an extensive analysis must be conducted to determine whether a problem actually exists and how it can best be resolved. An ethical review is therefore only permitted if the HDAB’s review leaves a gap that must be filled by national legislation. However, this does not appear to be the case. Because physical risks to the patient are absent in data research (unlike in clinical trials), and privacy aspects are fully covered by the HDAB, there is no remaining ‘ethical vacuum’ that a separate committee would need to fill.
Instead an extra assessment could be harmful
Sometimes, current ethics committees impose requirements that the EHDS is explicitly abolishing: such as the requirement that the data holder be listed as a co-author, or a payment that significantly exceeds the costs of making the data available. Moreover, an ethics committee has legal disadvantages: a decision on an EHDS permit application is an administrative decision. It must therefore comply with, among other things, the principle of legal certainty. And if it is not strictly defined what that ethics committee must still assess, then that requirement has not been met. Moreover, the ethics committees will make different decisions per country, thereby restricting the free movement of data; which therefore directly contradicts the intent of the EHDS Regulation.
Consequences for innovation and science
The development of precision medicine and the treatment of rare diseases requires enormous statistical power, which necessitates the aggregation of multinational cohorts. If Member States adopt their own, divergent ethical criteria, this directly undermines the fundamental objective of the EHDS: a seamless, pan-European ecosystem for health data. It reintroduces the administrative friction that often made important studies unfeasible under the old system. Member States must therefore refrain from adding extra national safeguards on top of this unified European framework. The most effective strategy is not to duplicate decision-making, but to integrate the expertise of members of existing ethics committees into the structure of the HDAB. This prevents conflicts of interest, guarantees legal certainty, and ensures that the cross-border potential of the EHDS can be fully utilized.
Would you like to know more about the HDAB assessment and the EHDS? Contact Antoinette Vlieger.
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