The European Council has announced its adoption of a new law aimed at improving individual’s control over their data and making cross-border health data sharing easier, requiring all EHR systems to be “interoperable at EU level”. Member states will also be required to set up a digital health authority in order to “implement the new provisions”.
The regulation, which is introduced following the European Commission’s 2022 proposal for a regulation creating a European Health Data Space (EHDS), is set to be formally signed by the Council and the European Parliament, and will enter into force “20 days after publication in the EU’s Official Journal”.
Recognising that varying levels of digitalisation of health data in the EU make data sharing across borders “more difficult”, the new regulation requires all EHR systems to comply with the specifications outlined by the European Electronic Health Record Exchange Format, which focuses on interoperability, the sharing of health data “in a common format that is understood by everyone”, and the availability of patient health data across Europe.
Individuals will be afforded “faster and easier” access to their health data, “regardless of whether they are in their home country or another member state”, according to the Council’s press release, as well as “greater control over how that data is used”. The regulation will also reportedly offer researchers and policymakers access to “specific kinds of anonymised, secure health data”, helping boost research, develop treatments, and improve patient care.
To learn more about the new regulation, please click here.
Health data from across the NHS and beyond
The National Data Guardian for Health and Social Care shared an annual report for 2023-24 in December, highlighting the use of health data across the NHS, along with an update on the Federated Data Platform. The NDG also noted being “encouraged” by government efforts to improve information sharing across healthcare providers, pointing specifically to the Data (Use and Access) Bill, which “promises to drive interoperability by requiring technology suppliers to meet updated technical standards”, and lays the groundwork for seamless information sharing that “people expect from our healthcare providers”.
A research project reportedly involving more than 350 experts from 58 countries resulted in the development of a series of recommendations with the aim of ensuring inclusivity in datasets used to train medical AI systems, hoped to allow “everyone in society to benefit from technologies which are safe and effective”. The STANDING Together research project, published in The Lancet Digital Health, utilised a Delphi approach “supplemented by a public consultation and international interview study” to collect input from international experts on 29 consensus recommendations.
Earlier this month, the Scottish Government published a response to a report commissioned from an independent expert group on ‘Unlocking the Value of Data’, focusing on maximising the value of “Scotland’s public sector personal datasets in secure, ethical and transparent ways, to realise public benefit”. The response shared some of the actions in progress or planned, such as the development of an operational framework for public sector access to data for research purposes; the exploration of the feasibility of piloting a benefit-sharing model, “focusing initially on controlled access to NHS Scotland personal data by the private sector”; the Scottish AI Register, which encourages public sector organisations to be “open and transparent about their use of AI”; and the RDS Researcher Access Service, which enables academics and data users to access secure data for public good.
And the UK Government published its AI Opportunities Action Plan, accepting recommendations for expanding computing capacity, establishing AI growth zones, unlocking data assets, and sharing alongside a proposed delivery timeline. On data assets, accepted recommendations include rapidly identifying “at least 5” high impact public data sets to make available to AI researchers and innovators, with the DSIT reportedly planning to explore this as it develops the National Data Library, with further details to be published by summer of 2025.
