Personal health data: better portability and safe sharing

This article is brought to you in association with the European Parliament.

• A European Health Data Space to give citizens the right to access prescriptions, imagery and lab tests across border  
• Aggregated health data to be shared for research purposes e.g. into cancer and rare diseases 
• Strong privacy safeguards governing how and why sensitive data is shared  

The Environment and Civil Liberties committees adopted their position on creating a European Health Data Space to boost personal health data portability and more secure sharing.

The creation of a European Health Data Space (EHDS), empowering citizens to control their personal healthcare data and facilitate secure sharing for research and altruistic (i.e. not-for-profit) purposes, took a step forward with the adoption of a draft Parliament position by the committees on Environment, Public Health and Food Safety, and on Civil Liberties, Justice and Home Affairs. MEPs adopted the report on Tuesday with 95 votes in favour, 18 against, and 10 abstentions.

Better healthcare with portability rights

The law would give patients the right to access their personal health data across the EU’s different healthcare systems (so-called primary use), and allow health professionals to access data on their patients. Access would include patient summaries, electronic prescriptions, medical imagery and laboratory results.

Each country would establish national health data access services based on the MyHealth@EU platform. The law would also set out rules on the quality and security of data for providers of Electronic Health Records (EHR) systems in the EU, to be monitored by national market surveillance authorities.

Data-sharing for the common good with safeguards

The EHDS would make possible the sharing of aggregated health data, including on pathogens, health claims and reimbursements, genetic data and public health registry information, for reasons of health-related public interest, including research, innovation, policy-making, education, patient safety or regulatory purposes (so-called secondary use).

At the same time, the rules would ban certain uses, for example advertising, decisions to exclude people from benefits or types of insurance, or sharing to third parties without permission. Requests to access secondary data would under these rules be handled by national bodies, which would ensure data is only provided in an anonymised or, if necessary, pseudonymised format.

In their draft position, MEPs want to make explicit permission by patients mandatory for the secondary use of certain sensitive health data, and provide for an opt-out mechanism for other data. They also want to give citizens the right to challenge a decision of a health data access body, and allow non-profit organisations to lodge complaints on their behalf. The adopted position would also expand the list of cases where a secondary use would be banned, for example in the labour market or for financial services. It would ensure that all EU countries receive sufficient funding to provide protections for the secondary use of data, and protect data falling under intellectual property rights or constituting trade secrets.

Quotes

Annalisa Tardino (ID, Italy), Civil Liberties Committee co-rapporteur, said: “This is a very important and technical proposal, with huge impact on, and potential for, our citizens and patients. Our text managed to find the right balance between a patient’s right to privacy and the enormous potential of digital health data, which is meant to improve healthcare quality and produce healthcare innovation.”

Tomislav Sokol (EPP, Croatia), Environment Committee co-rapporteur, said: “The European Health Data Space represents one of the central building blocks of the European Health Union and a milestone in the EU’s digital transformation. It is one of the few pieces of EU legislation where we create something completely new at the European level. The EHDS will empower citizens by enhancing healthcare at a national and cross-border level, and will facilitate the responsible sharing of health data – boosting research and innovation in the EU.”

Next steps

The draft position will now be voted on by the full house of the European Parliament in December.

Background

The European Data Strategy foresees the creation of ten data spaces in strategic fields including health, energy, manufacturing, mobility and agriculture. It is also a part of the European Health Union plan. Parliament has long requested the creation of a European Health Data Space, for example in resolutions on digital healthcare and the fight against cancer.

Currently, 25 member states are using ePrescription and Patient Summary services based on MyHealth@EU.