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In brief

The European Parliament voted in favor of a digital EU Health Data Space for electronic health records. Despite various policy concerns about data privacy, increasingly urgent health demands render efficient access to personal electronic health data necessary across all Member States.


Key takeaways

This expansion of health data is not all-encompassing, but rather subject to limitations in order to comply with ethical guidelines. Some information should be made readily accessible to natural persons, but Parliament emphasized the importance of being able to delay access to certain types of electronic health data, such as a diagnosis of a life-threatening illness that should be the subject of doctor consultation before publication. Consequently, Member States reserve the right to determine exceptions that are in line with Article 23 of Regulation (EU) 2016/679. Other general information such as laboratory results and patient summaries should be readily accessible.

Furthermore, the implementation of this law will facilitate interstate health data transfers, public interest research, and policy-making procedures. Patients’ ability to limit data sharing is of particular concern due to conflicting interests in withholding sensitive information and potential life-saving research facilitated by the data space.

This provisional agreement is still awaiting formal approval by the Council. Once formally approved, this law will only be enforceable two years after its publication in the EU Official Journal.

Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Author

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.