EHDS, Artikkel 1, SE

1. This Regulation establishes the European Health Data Space (EHDS) by providing for common rules, standards and infrastructures and a governance framework, with a view to facilitating access to electronic health data for the purposes of primary use of electronic health data and secondary use of those data.

2. This Regulation:

(a)

specifies and complements the rights laid down in Regulation (EU) 2016/679 of natural persons in relation to the primary use and secondary use of their personal electronic health data;

(b)

lays down common rules for electronic health record systems (‘EHR systems’) in relation to two mandatory harmonised software components, namely the European interoperability software component for EHR systems and the European logging software component for EHR systems, as defined in Article 2(2), points (n) and (o), respectively, and for wellness applications which are claimed to be interoperable with EHR systems in relation to those two harmonised software components, as regards primary use of electronic health data;

(c)

lays down common rules and mechanisms for primary use of electronic health data and secondary use of electronic health data;

(d)

establishes a cross-border infrastructure enabling the primary use of personal electronic health data across the Union;

(e)

establishes a cross-border infrastructure for secondary use of electronic health data;

(f)

establishes governance and coordination mechanisms at Union and national level for both primary use of electronic health data and secondary use of electronic health data.

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