EHDS implementing acts consultation: Commission releases draft HDAB specifications

The European Commission has released draft implementing act specifications for Health Data Access Bodies (HDABs) under the European Health Data Space (EHDS) regulation, opening a formal consultation period for stakeholder input. These specifications define how HDABs will operate across Member States, covering data access procedures, interoperability requirements, and governance structures that will shape secondary use of health data for research, policy, and regulatory purposes. The draft reflects the Commission’s attempt to harmonise what remains a fragmented landscape of national health data infrastructures, though significant variation in Member State capacity and legal interpretation persists. For pharmaceutical and MedTech organisations developing real-world evidence strategies, understanding these specifications now is not optional. The HDAB framework will directly determine which datasets are accessible, under what conditions, and through which national entry points across the EU.