On Wednesday 13 December in Strasbourg, the European Parliament adopted its position with a view to negotiating with the Council of the EU on the creation of a European Health Data Space.
The report by Annalisa Tardino (ID, Italian) and Tomislav Sokol (EPP, Croatian), which substantially amends the European Commission’s initial proposal on the new European Health Data Space (EHDS), was adopted in plenary with 516 votes in favour, 95 against and 20 abstentions.
According to the rapporteur, Mr Sokol, this is a “good agreement”, even if it is not perfect, and a good starting point for negotiating a final compromise with the EU Council. “The first negotiating trilogue is scheduled for Thursday 14 December, and we hope to conclude an agreement as quickly as possible, with a view to a vote in Parliament during the last plenary session of the legislature”, Annalisa Tardino told the press.
One of the sticking points with the EU Council will be the role of the Member States and their freedom to define opt-out possibilities themselves, said Mr Sokol. He is aware of the need for flexibility on the part of the Member States, “but we need a harmonised approach”, defended Mr Sokol. In addition, the EU Council foresees the possibility for Member States to impose additional restrictions on the primary use of data in cross-border situations, which is deemed contrary to the Treaty, according to the MEP. The EU Council envisages nine years after the adoption of the text before the complete data system is available, while Parliament wants a shorter transition period.
At the plenary session, all the amendments from the two Parliament committees responsible (Civil Liberties and Environment) were ratified (see EUROPE 13302/16). A single amendment tabled by several MEPs was adopted, specifying that Member States may provide that individuals have a right to object to the recording of their personal health data in an electronic health record (EHR) system. Where a Member State provides for this right, it shall lay down the specific rules and guarantees concerning these opposition mechanisms, according to this amendment.
The proposal will allow patients to access their personal health data across different healthcare systems in the EU (primary use) and will allow healthcare professionals to access their patients’ data.
Each country will set up national health data access services on the MyHealth@EU platform.
MEPs want patients to have a greater say in how healthcare providers use their data. They propose an opt-out for the secondary use of most health data and require that explicit consent be obtained from a patient for the secondary use of certain sensitive data (e.g. genetic and genomic information).
Parliament wants to extend the ban on certain secondary uses, for example in the labour market or for financial services. Data shared for research purposes should be used to develop new medicines or other health products or services. MEPs want to ensure that all EU countries have sufficient funding to protect the secondary use of data and prevent it from falling under intellectual property rights or becoming a business secret.
The Member States adopted their negotiating position on 6 December (see EUROPE 13309/8). (Original version in French by Lionel Changeur)