Specification of health data transfer from devices to DiGA (§ 374a SGB V)
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Requirements, as an expression of normative specifications, are indicated by the keywords “MUST”, “SHOULD”, “MAY”, “SHOULD NOT”, “MUST NOT”, “REQUIRED”, “RECOMMENDED” and “OPTIONAL” as defined in RFC 2119. “SHALL” is used synonymous to “MUST”.
| Subject | Emphasis | Example |
|---|---|---|
| FHIR ResourceDefinition | Hyperlink | Observation |
| FHIR resource element | Code | valueSampledData |
| HDDT building block (class) | Uppercase | Device Data Recorder |
| HDDT class attribute | Code | calibrationStatus |
| HDDT object properties | Code | Store-Capacity-Count |
| Example value (element, attribute) | Italics | calibrated |
| Proper Nouns | Italics | BfArM |
Whenever a HDDT building block or HDDT class is introduced and defined for the first time, the name of the building block or class is emphasized in bold letters (example: Device Data Recorder).
Baseline for the HDDT requirements is § 374a SGB V together with related regulations (e.g. § 139e SGB V for the DiGA VZ). However, the wording in the legal texts is not always suitable for technical specifications, escecially in cases where things are described in a very abstract way in the law. The most prominent example is the term “medical aids and implants” (Hilfsmittel und Implantate) which is used in the law from the viewpoint of reimbursement eligibility. For the technical specification this term needs to be differentiated to distinguish between the sensor device and the backend devices. Therefore, in this specification the term “medical aids and implants” is only used when referring to the legal text and its derived requirements for the HDDT specification. In all other cases, more precise technical terms are used, e.g. “Personal Health Device” and “Device Data Recorder” (see section Building Blocks for an overview of the most relevant technical terms).
The following German proper nouns are not translated in this specification: