The approach of the European Commission to make the entire primary documentation of all service providers as well as the data of the health insurance funds available in the patient file is very extensive.
It is in contrast to the procedure in Germany, where only select information is to be included in the patient record. In addition, the patients decide themselves as to what they disclose. A specific opt-out option and thus, the possibility to object to the use of data is not provided for in the draft regulation.
Furthermore, it is problematic to transfer the data for claiming benefits – these are especially ePrescriptions – to the primary data use. This raises national regulations to the European level. However, since specific national features insurance cannot be taken into account at EU level, there is a risk that care in the Member States will be impaired by forcing adjustments in benefit law.
In addition, the proposals of the European Commission also raise questions regarding the usability of investments made so far, the adaptation of technology, processes, formats and standards – also in relation to national telematics infrastructure. In view of such areas needing improvement, it must be assumed that the path to a political agreement on the EHDS will be accompanied by protracted and difficult negotiations.