Specification of health data transfer from devices to DiGA (§ 374a SGB V)
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The standardisation of data to be transmitted from medical aids and implants will be carried out using an incremental approach by domains representing an area of use or a care environment. In an initial specification version 1 (MVP), a first set of data that MUST be made available — referencing the selected domains — will be defined, specified, and published. The selection of domains and use cases, from which the data to be provided and the affected devices are derived, is guided by various criteria, such as the frequency of prescriptions and the added value for patient care through DiGAs (see Methodology).
Mandatory Interoperable Values (MIVs) will be declared for each domain to be provided by medical aids and implants processing this data. Systems that comply with certification relevant systems and process data which is part of the Mandatory Interoperable Values (MIVs) MUST therefore implement according to the MVP.
The first specification version 1 (MVP) will specify selected Mandatory Interoperable Values (MIVs) from the domains
Underlying statutory deadlines can be found in § 374a SGB V.
Further domains will be defined as a result of ongoing use cases analysis to derive the potential for use in care processes.
In order to certify the conformity of the implementation with the specification, it is foreseen to provide an assessment procedure which will enable the manufacturers to easily prove the conformity of their implementation. The assessment procedure leads - if passed successfully - to a gematik certification of the medical aid’s implementation. As a support measure for manufacturers and as part of the conformity assessment, gematik will provide a locally executable testsuite that builds on the technical specification. Manufacturers of medical aids and implants MUST notify the BfArM about the implementation of the interface, which will result in the listing of the medical aid or implant in the new Verzeichnis der Hilfsmittel- und Implantat-Schnittstellen (HIIS-VZ) to be established by the BfArM. Further information about this process can be found here.
DiGA manufacturers report to the BfArM the data required for their use cases for intended use and, upon confirmation, receive authorisation to retrieve data from medical aids and implants that, according to the HIIS-VZ (BfARM Device Registry), make these data available. If the interface is implemented for a DiGA that is already listed in the DiGA directory, a change notification with a substantiated request for data use has to be submitted to the BfArM. Further information about this process can be found here.