Compromise reached between the European Parliament and the Council.

CC – 03/2024

During the night of 15 March, the Council of the European Union (EU) and the European Parliament reached a provisional agreement on the European Health Data Space (EHDS). This represents a decisive step forward for the European Commission's flagship health policy initiative in this legislative period.

After a total of five trialogue meetings - the first was on 14 December last year - a special meeting, 27 technical meetings and intense negotiations at various levels, not everyone believed that an agreement could be reached. Finally, three areas in particular were discussed controversially: the opt-out regulations, the electronic health record system (EHR system) and the implementation deadlines.

Opt-out provisions

In view of the different sensitivities in the Member States with regard to the degree of control patients have over their health data, Member States should have the option of providing for a right to object to access of all persons except the data controller (opt-out for primary data use). A slightly weakened opt-out option is to be provided for the use of secondary data. Patients should be able to refuse the provision of their personal electronic health data for secondary use (opt-out for secondary use). The aim is to strike a balance between the data users' need for comprehensive and representative data sets and the autonomy of natural persons with regard to their personal health data. For certain purposes that are closely related to the public interest, Member States should be able to provide for exemptions from the opt-out mechanism. For example, measures to protect against serious cross-border threats to health or scientific research for important reasons.

EHR systems

Through self-certification, electronic EHR systems should be able to demonstrate that they fulfil the requirements for interoperability, security and logging for the transmission of personal electronic health data. These requirements are defined in the EHR exchange format in two mandatory components - the "European EHR systems exchanged interoperability component" and the "European logging component for EHR systems". These are to be specified in more detail in implementing acts. In addition, a digital test environment is to be introduced in which EHR systems must be tested before being placed on the market or commissioned.

Implementation deadlines

Some deadlines were adjusted in the political agreement. The Regulation establishing the European Health Data Space is to apply two years after its entry into force. However, there are numerous exceptions, depending on the use case and type of data. For example, Chapter IV on the secondary use of health data will not apply until at least four years after it comes into force.

What happens next

Following a linguistic and legal review, the European Parliament and the Council still have to approve the provisional outcome of the negotiations. On 9 April, the Committees on "Environment, Public Health and Food Safety" (ENVI) and on "Civil Liberties, Justice and Home Affairs" (LIBE) will vote on the outcome of the negotiations in what is expected to be their last joint meeting. The plenary of the European Parliament will finally vote on the outcome of the negotiations on 22 April.

On 22 March, the Committee of Permanent Representatives (COREPER) technically approved the outcome of the negotiations before the Council votes on it in the final stage. Implementation of the EHDS is scheduled to begin in 2025. It appears that the EHDS will actually gradually come into force from 2026 onwards. This would be a major political success for the EU.

In Germany, the Act on the Improved Utilisation of Health Data (GDNG) and the Act to Accelerate the Digitalisation of the Healthcare System (DigiG) are now leading to the national parallel implementation of the EHDS.