Digitalization of Health Data: Interoperability of the Proposed European Health Data Space

On May 3rd, 2022, the European Commission published its legislative proposal to create a European Health Data Space (EHDS) enabling citizens of the European Union to gain secure access to their electronic health data by establishing a market for digital health. This market will feature the primary and secondary use of electronic health records by digital products and services. The articles of the proposal address many aspects of ensuring health data interoperability. That includes the creation of a European Electronic Health Record Exchange Format for defined data categories including patient summaries and electronic prescriptions, the development of a central platform to provide a cross-border digital infrastructure and that each Member State institutes a digital health authority and a national point of contact. In addition, the Commission will define common specifications that electronic health record systems and medical devices will have to meet as interoperability requirements. In its current form, the proposal does not stipulate specific standards that need to be universally adopted to ensure semantic and syntactical interoperability. Considering that many datasets are not internationally harmonized and lack standardization, these specifications will need to be provided for example by existing standards like the International Patient Summary.