German experts: EU wants to set health data standards

EU Commission to define data formats, writes Pharmazeutische Zeitung (link in German). It will be the task of the member states to process e-prescriptions, e-patient summaries, image data, laboratory results and discharge reports into a common European format. Digital health authorities designated in advance in each individual country are to take over this task. These in turn are connected at the same time via the common digital infrastructure called “MyHealth@ EU”, managed by the EU Commission . The responsibility of the Commission should include defining the formats for data exchange.

In the future, cross-border projects for secondary data are to be run via the second infrastructure called “HealthData@ EU”. This is planned to be decentralized, so the member states will continue to manage their own health data . However, there is currently no obligation to recognize each other’s data approvals.

The EU distinguishes between primary use of data, for example for e-patient files, medical devices or high-risk systems, and secondary use, by which the EU means a trustworthy and networked environment for research, innovation and policy-making. Among other things, the General Data Protection Regulation (GDPR) should serve as a basis. However, since it is about sensitive health data, further regulations will soon have to come into force, concludes Pharmazeutische Zeitung

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