The creation of a European Health Data Space (EHDS), empowering residents to manage their private healthcare information and facilitate safe sharing for analysis and altruistic (i.e. not-for-profit) functions, took a step ahead with the adoption of a draft Parliament place 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 in opposition to, and 10 abstentions.

Better healthcare with portability rights

The regulation would give sufferers the proper to entry their private well being information throughout the EU’s completely different healthcare programs (so-called major use), and permit well being professionals to entry information on their sufferers. Access would come with affected person summaries, digital prescriptions, medical imagery and laboratory outcomes.

Each nation would set up nationwide well being information entry providers based mostly on the MyHealth@EU platform. The regulation would additionally set out guidelines on the standard and safety of information for suppliers of Electronic Health Records (EHR) programs within the EU, to be monitored by nationwide market surveillance authorities.

Data-sharing for the widespread good with safeguards

The EHDS would make potential the sharing of aggregated well being information, together with on pathogens, well being claims and reimbursements, genetic information and public well being registry data, for causes of health-related public curiosity, together with analysis, innovation, policy-making, schooling, affected person security or regulatory functions (so-called secondary use).

At the identical time, the principles would ban sure makes use of, for instance promoting, selections to exclude folks from advantages or forms of insurance coverage, or sharing to 3rd events with out permission. Requests to entry secondary information would below these guidelines be dealt with by nationwide our bodies, which might guarantee information is barely supplied in an anonymised or, if vital, pseudonymised format.

In their draft place, MEPs wish to make specific permission by sufferers obligatory for the secondary use of their well being information. They additionally wish to give residents the proper to problem a call of a well being information entry physique, and permit non-profit organisations to lodge complaints on their behalf. The adopted place would additionally broaden the listing of instances the place a secondary use could be banned, for instance within the labour market or for monetary providers. It would be sure that all EU nations obtain enough funding to offer protections for the secondary use of information, and defend information falling below mental property rights or constituting commerce secrets and techniques.

Quotes

Annalisa Tardino (ID, Italy), Civil Liberties Committee co-rapporteur, mentioned: “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, mentioned: “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 place will now be voted on by the total home of the European Parliament in December.

Background

The European Data Strategy foresees the creation of ten data spaces in strategic fields together with well being, vitality, manufacturing, mobility and agriculture. It can also be part of the European Health Union plan. Parliament has lengthy requested the creation of a European Health Data Space, for instance in resolutions on digital healthcare and the fight against cancer.

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