The European Parliament approves a regulation enabling the European Health Data Space (EHDS). This is an important step towards the introduction of the European healthcare sector- and domain-specific data space. What exactly is the EHDS?
The EHDS is a European Commission proposal for sharing medical data and making health data accessible to citizens. It aims to use data to improve the quality of care. Among other things, by providing citizens with greater visibility and access to their health data. On the other hand, the EHDS should facilitate access to healthcare data for research and innovation, among other things, with the aim of improving the quality of care.
Primary use
The proposal distinguishes between primary and secondary use of healthcare data. Primary use is aimed at supporting healthcare and all those involved in the healthcare process. On the one hand, the EHDS should expand people's rights currently regulated under the General Data Protection Regulation and make them more explicit for healthcare. Among other things, this translates into the right:
- on direct and free access to personal health data in readable and shareable form
- to add electronic health data to one's own patient record
- to allow health data to be corrected.
- to sharing personal health data with a (self-selected) healthcare provider.
The EHDS also obliges parties who have health data to offer it free of charge and unhindered to patients who request it.
Improved data sharing should give healthcare workers better access to up-to-date health data of a person they are treating. The EU country of treatment or where a person comes from should not play a role in this. Healthcare providers must also take into account self-measurement data that a person has shared with the healthcare provider. Moreover, patients can choose to restrict access to data for (certain) healthcare providers.
Data exchange across borders
Ten member states have now joined the MyHealth@EU infrastructure. This infrastructure currently supports patient summaries and electronic prescriptions for medication. Data comprising the patient record or data needed to retrieve a repeat prescription for medication are thus more easily available across borders. The EHDS is mandating MyHealth@EU services for cross-border exchange and is also expanding its services. The EHDS mandates the following data services through MyHealth@EU:
- Patient summaries
- Electronic prescriptions
- Electronic dispensing
- medical images and related reports
- laboratory results
- redundancy reports
The proposal requires member states to connect all national healthcare providers to a National Contact Point for e-Health (NCPeH). EU member states are additionally required to connect this NCPeH to the MyHealth@EU network. The Netherlands has had an NCPeH, managed by CIBG, since 2021.
Secondary use
Secondary use puts the focus on other societal goals. Think of scientific research, but also patient safety, personalised medicine, official statistics or regulation. By making better use of electronic health data, the European Commission wants to take steps in these areas and thus improve healthcare.
The EHDS should give knowledge institutes and innovative companies access to data collections. This will enable them to conduct better research and develop new medicines or treatments that improve quality of life.
Various sources
Data can be available from various sources; data holders in the healthcare sector are broadly defined in the EHDS. They include all healthcare systems that contain health data, such as healthcare systems of public or private healthcare providers, healthcare providers or other organisations. The proposal mandates opening up all systems in which data holders maintain data for secondary use.
It covers a wide range of types of electronic healthcare data. These include electronic health records, clinical trial data and data from public health and disease-specific registries, as well as data from biobanks and special databases and data related to insurance status.
Who will get access?
A yet-to-be-designated national health data access body (Health Data Access Bodies) will determine who gets access to these data. A national health data access body is a public entity and assesses applications from so-called data users.
If a party meets the requirements, the authority can grant a licence to access relevant healthcare data. This licence also determines the conditions for which the data can be used. The analysis of the data can take place in one Member State, but also in several or the entire EU. Provided data are always anonymous and only data relevant to the purpose of the data user are provided.
Banned
The proposal also imposes a number of prohibitions on secondary use. For example, the national access authority will not grant access for:
- making decisions that disadvantage individuals based on their health data
- denying an insurance contract or changing reimbursement for insurance
- advertising or marketing activities
- making the data available to third parties not included in the authorisation
- developing products or services that could harm individuals or societies.
Single market for digital health products
A third part of the legislative proposal revolves around the development of a single market for digital health products and services. Think of electronic health record systems. The European Commission wants to harmonise the rules for (product) safety, security and interoperability within the EU. This should improve the effectiveness and efficiency of healthcare.
More information on the EHDS is available here.
Author: Wouter Hoeffnagel
Image: Darko Stojanovic via Pixabay
