Wellness ApplicationWellness ApplicationIn short: a software application, intended to be used by a natural person, which provides information on the health of natural persons, or the delivery of care for purposes other than the provision of healthcare. Wellness applications only fall under the EHDS regulation if their manufacturer chooses to be compliant with the interoperability requirements for EHRs.
From article 2:
From Recital 49: given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A mandatory labelling scheme for wellness applications for which interoperability with EHR systems is claimed should therefore be established as an appropriate mechanism for providing transparency for the users of wellness applications regarding compliance with requirements under this Regulation, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. From the EHDS FAQ: this is a claim by the manufacturer of such apps or devices (that are not themselves EHR systems). It means that the manufacturer of such app claims that it can provide information to EHR systems in a way that it can be used. An example would be a sleep tracker that can feed information to an EHR system. Comments/Discussion
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