The EU set to benefit from a common health data space

The set-up of the EU health data space is at its final legislative stages. The European Parliament gave its final green light with 445 in favour, 142 against and 39 abstentions to the regulation proposed by the European Commission in May 2022. The text approved was previously agreed during the interinstitutional negotiations with the EU Council, which now is being given the last word before the new rules enter into force. 

The new regulation will empower patients to access their data in an electronic format to reduce hurdles for medical consultations also when travelling in another EU Member State. Access to the electronic health records (Ehc) will be granted to practitioners through the MyHealth@EU infrastructure and based on the patient’s consent. The download of the health record will be charge-free. 

Data will be presented in a common European format with standard vocabularies for translation. Also, softwares that store, intermediate, export, import, convert, edit or view personal electronic health data will be subject to self-certification for compliance with specific requirements to be placed on the market.

The new rules aim to provide patients with full control over their data and decide if sharing them with health professionals or restrict access to them. 

The use of data for research and statistics purposes or other public interest needs (the so-called “secondary use”) is expected to unleash its full potential. This has been one of the major sticking points during the interinstitutional negotiations between co-legislators. European deputies position was strongly focused on the citizens’ right to refuse access to their data for secondary use. However, this right is designed to ensure its reversibility, and Member States are authorised to adopt laws to over-ride the opt-out decisions, to allow secondary use by entities in charge of public tasks in the field of public health, in specific situations of public interest.

However, more widespread data sharing across Europe can tackle the problem of small datasets and fragmentation in the treatment of cases such as terminal illnesses and rare diseases. Secondary use will not be allowed for commercial purposes including advertising, assessing insurance requests or lending conditions or making job market decisions. Health data access bodies would be responsible for making sure that data is anonymized and is not used against people. 

The use of patients’ data without consent can be accepted only for certain public interest purposes. The request of access to patients’ data has to be always notified, with the possibility for them to correct the conditions of data treatment in case of incorrect data.

The proposal is expected to increase health protection for citizens and a financial benefit of 4.5 billion euro over ten years resulting in efficiency gains, better information for policy makers and better value for consumers. 

Once the EU Council gives its green light the regulation will be published in the EU’s Official Journal and enter into force twenty days later. It will be applied two years after, with certain exceptions, including primary and secondary use of data categories, which will apply four to six years later, depending on the category.