EC sets out plans for sharing health data across borders

The European Commission (EC) has launched plans to enable citizens to access their patient records, and share their data across the European Union (EU).

The EC set out the proposals in a document on enabling digital transformation of health and care across Europe.    

The commission said that across Europe, citizens have “limited electronic access to data about their own health”, and that the data is often untraceable and “scattered in different places”, which could affect both diagnosis and treatment, especially if the person is abroad and does not have access to their medical information.  

The EC said that as with the EU General Data Protection Regulation (GDPR), which comes into force on 25 May 2018, citizens have a right to access and share their health data.  

“In essence, citizens should have secure access, anywhere in the EU, to a comprehensive electronic record of their health data,” the document said. “Citizens should remain in control of, and be able to share, their health data securely with authorised parties (for medical treatment, preventive services, research or for any other purpose they deem appropriate).

“This should be irrespective of where the data is located and in line with data protection legislation.”

The document added that the EU already has a cross-border patient data exchange programme on a voluntary basis, where health authorities can connect to the e-health digital service infrastructure. This only covers patient summaries and online prescriptions, and will launch this year with eight or nine member states. The EC expects about 22 member states to have joined the scheme by 2020.

However, as this project moves on, the EC wants to “gradually extend these two use cases to also cover the interoperability of member states’ electronic health record systems by supporting the development and adoption of a European electronic health record exchange format”.

It said that often, “incompatible formats and standards in electronic health record systems continue to be used across the EU”, which means cross-EU standards must be put in place.

“Developing specifications for a European electronic health record exchange format should be based on open standards and build on appropriate technical expertise, taking into account the potential use of data for research and other purposes,” the document said.

“Additionally, the commission intends to monitor the cross-border interoperability of electronic health record systems and, once in place, the adoption of the European electronic health record exchange format across the EU.”

The EC also wants to test cross-border data exchange of health information for research, diagnosis and prevention of diseases.

This includes sharing genomic data to advance personalised medicine. There are already national and regional initiatives in place for genomic data across the EU.

In the UK, the government plans to embed genomic technologies in the NHS through a new genomic medicine service, which is due to launch this year. This includes a number of genomic centres, or “hubs” across the country. 

While the EC commended the national and regional projects, it said these initiatives need to be better coordinated to “reach the necessary critical mass at EU level and match similar initiatives in other world regions”.

“Significant breakthroughs can be achieved by linking Europe's fragmented resources through secure cross-border digital infrastructures, while ensuring full compliance with data protection legislation and ethical principles,” the document said.

“Ensuring interoperable standards for genomic and other data is also critical for an effective sharing of datasets.” 

European commissioner for health and food safety Vytenis Andriukaitis said the EC’s proposals “make use of the full potential of digital technologies to improve healthcare and medical research”.

“This will lead to easier access to health data, which will lead to better disease prevention and patient-centred care, rapid responses to pandemic threats, and improved treatments,” he said.