On Wednesday, MEPs adopted their position on creating a European Health Data Space to ease access to personal health data and boost secure sharing.
The new European Health Data Space (EHDS) would empower citizens to control their personal healthcare data and facilitate secure sharing for research and altruistic (i.e. not-for-profit) purposes. Plenary adopted the report, which will serve as Parliament’s negotiating mandate in talks with Council on the final form of the legislation, with 516 votes in favour, 95 against, and 20 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, strictly based on what is necessary for a given treatment. 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 allow aggregated health data, including on pathogens, health claims and reimbursements, genetic data and public health registry information, to be shared for public interest reasons, including research, innovation, policy-making, education and patient safety purposes (so-called secondary use). Sharing data for advertising or for assessing insurance requests will be banned.
Stronger safeguards for sensitive data
MEPs want patients to have more say in how health care providers use their data. They propose an opt-out system for the secondary use of most health data, and demand that it be mandatory to have a patient’s explicit consent for the secondary use of certain sensitive data (e.g. genetic and genomic information).
Parliament also aims to expand the secondary uses to be banned, for example in the labour market or for financial services. Data shared for research purposes should lead to the development of new medicines or other health care products or services. MEPs want to ensure that all EU countries receive sufficient funding to protect the secondary use of data, and to avoid data falling under intellectual property rights or constituting trade secrets.
Annalisa Tardino (ID, Italy), Civil Liberties Committee co-rapporteur, said: “The European Health Data Space will contribute to providing state-of-the-art healthcare to patients everywhere in the EU. We have included in the text significant reinforcements regarding the protection of sensitive personal data, striking a balance between exchanging health data for treatment and life-saving research, and protecting the privacy of our citizens.”
Tomislav Sokol (EPP, Croatia), Environment Committee co-rapporteur, said: “The European Health Data Space represents a central building block 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. It 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.”
On Wednesday 13 December at 14:00 CET, co-rapporteurs Annalisa Tardino (ID, Italy) and Tomislav Sokol (EPP, Croatia) will discuss the Parliament position ahead of negotiations with the Council, and answer questions. You can follow the event here.
Parliament is now ready to start talks with the member states, who adopted their position on 6 December, on the final form of the law.