EP approves provisional EHDS agreement

1 May 2024
Data
News

The European Parliament's approval of the political agreement on the European Health Data Space Regulation (EHDS) is an important step towards its final signing. The Dutch Ministry of Health, Welfare and Sport (VWS) said this in response to an EP vote on April 24. 70 percent of parliamentarians voted in favor of the provisional political agreement on the EHDS that the European Council and the EP reached on March 14, 2024. On May 15, VWS will organize a meet-up about the impact of the EHDS during the ICT&health World Conference.

The EHDS is the first of the European sector- and domain-specific data spaces that the Commission wants to realize in its European data strategy. The purpose of the regulation is to arrange better care through data availability. This manifests itself in various ways:

  • Citizens should have better insight and access to certain health data recorded about them.
  • Electronic health data may be viewed for primary use (care provision) and used for secondary purposes (research, policy and innovation) under strict conditions, provided there is no objection to making it available and under guarantees of privacy and security.

In addition, electronic health records in Europe must meet the same requirements so that healthcare providers can better exchange health data about and for patients they treat.

The new rules should give citizens faster and easier access to certain digitally recorded health data, regardless of where they are within the European Union. This is now very difficult, partly because the rules surrounding access to health data vary in the EU.

The next step after approval of the provisional agreement is the so-called legal linguistic reading in May. Then, after the European elections (from June 6 to 9), the signature in the European Parliament and the Council is planned: expectedly in the second half of 2024. The regulation will then enter into force 20 days after it has been published in the Official Journal of the European Union has been published. This must be fully implemented in the Member States within six years of its entry into force.

Easier access

When the EHDS has been implemented into legislation across the EU, no later than 2030, it will in theory be easier for Dutch citizens to receive the right care in a timely manner in other EU countries. This offers advantages for Dutch tourists abroad, Dutch people who work abroad and Dutch people who live and work in border regions. For example, a Dutch person can use his medicine prescription at a German pharmacy. For example, a Dutch doctor can gain access to health information about a Belgian patient who is being treated by that Dutch doctor.

Citizens will have a say over who can view that data and have the right to opt-out. Member States may opt out of availability for the primary use of health data. For the secondary use of health data recorded about citizens (such as for scientific research), they have the right not to make it available.

In addition, citizens will have the right to more transparency in the use of (anonymous) electronic health data for scientific research, innovation and policy, and more privacy and security guarantees that this is done responsibly.

Research

The electronic health data of EU citizens can only be made available for research under strict privacy and security safeguards. This secondary use of health data is important to promote good, accessible and affordable care and to support prevention.

The use of this health data only concerns anonymous or pseudonymous data with additional guarantees, VWS emphasizes, and is always done on the basis of a granted permit and under strict supervision of an authority yet to be set up for access to health data within a secure processing environment. All EU Member States must set up such a Health Data Access Body (HDAB) as a prerequisite for secondary use of health data under the EHDS. The Netherlands has been working on the Health Data Access Body since December 1, 2023.

Uniform legal framework

A third goal of the EHDS is to standardize a legal framework for the development, marketing and use of electronic patient records (EPDs). Currently, the level of digitalization in healthcare varies considerably between EU member states. This makes it difficult to share health data across borders.

The EHDS requires that all EPDs contain components that meet the specifications of a European format for electronic patient records. This concerns components such as interoperability and logging and security. The EU thus wants to guarantee interoperability between and control of access to the files.

National vision and strategy

The starting point of the EHDS for better availability of health data (data availability) is in line with and in some aspects implements national policy as expressed in the National vision and strategy on the health information system and the vision and Dutch strategy on secondary data use. In addition, the EHDS supports the interoperability of data for exchange. This means it can also support the already adopted Electronic Data Exchange in Healthcare Act (Wegiz).

In November 2020, the idea of a European Health Data Space was announced, which was eventually published as a proposal in May 2022. Since then, European Member States have negotiated among themselves and then with the European Parliament and the European Commission. VWS has largely managed to capitalize on its main positions during the negotiations. The EHDS community has played an important role in the realization of the Netherlands' contribution.

Meet-up during ICT&health World Conference

Now that a political agreement has been reached on the European proposal for better data exchange in healthcare, the European Health Data Space (EHDS), the question arises: what now? What does this mean for patients, healthcare providers, IT suppliers and researchers? These questions will be central to a meetup on May 15 in Maastricht.

The EHDS Meetup will be held during the ICT&health World Conference at the MECC in Maastricht on May 15 from 1:00 PM to approximately 5:30 PM. VWS is the main partner of this event and, in addition to the EHDS meetup, also has other sessions on data availability scheduled during these three days.

The topic of EHDS is frequently discussed during this conference. On May 14, Johanna Seppänen, Director FINDATA (Chair of the Community of Practice) will speak about the data access body Finndata and the Community of Practice; the meetup is on May 15th; on May 16, Maxime Moren Attaché Permanent Representation, Belgium will speak about how the bill came to a political agreement.