Article 48
Interoperability of wellness applications with EHR systems
In short: Manufacturers of wellness applications may claim interoperability with an EHR system in which case they themselves have to meet the requirements for EHR Systems.
- Manufacturers of wellness applications may claim interoperability with an EHR system, provided that the relevant common specifications and
essential requirements referred to in Article 36 and Annex II, respectively,
are met. In the event of such claim, those manufacturers shall duly inform users of the interoperability of such wellness applications
and the effects of such interoperability.
- The interoperability of wellness applications with EHR systems shall not entail the automatic sharing of all or part of the health
data from the wellness application with, or automatic transmission of all or part of such data to, the EHR system. The sharing or
transmission of such data shall only be possible if it is in accordance with Article 5 and after consent is given by the natural person
concerned and interoperability shall be limited exclusively to those purposes. The manufacturers of wellness applications claiming interoperability
with an EHR system shall ensure that the natural person concerned is able to choose which categories of health data from the wellness
application are to be inserted in the EHR system and the circumstances for the sharing or transmission of those categories of data.
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