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).
The HDDT requirements are based on § 374a SGB V and related regulations (e.g., § 139e SGB V for the DiGA VZ). However, the wording used in legal texts is not always suitable for technical specifications, particularly when concepts are described abstractly. A prominent example is the term “medical aids and implants” (Hilfsmittel und Implantate), which the law uses from a reimbursement eligibility perspective. For a technical specification, this term must be differentiated to distinguish between sensor devices and backend systems.
Therefore, this specification uses “medical aids and implants” only when directly referencing legal texts and their derived requirements. In all other contexts, more precise technical terms are used, such as “Personal Health Device” and “Device Data Recorder” (see section Building Blocks for an overview of key technical terms).
The following German proper nouns are not translated in this specification: