Add Device Specialization Detail & Referenced Artifacts (XML/JSON) Volume 3

Section Number

3:8.7 Device specialization content modules

Priority

• Medium: Significant issue or clarification. Requires discussion, but should not lead to long debate.

Issue

Since the first version of the IHE Technical Framework in 2006, Volume 3 (Semantic) Content Modules were defined for key modalities (pumps, monitors, ventilators) with a basic containment tree and nomenclature based on the ISO/IEEE 11073 "Classic DIM" MDC standards. All drafts of the SDPi standard have included some (not all!) of this content with BICEPS updates (based on the 11073-10207 standard), and from the beginning a "referenced-artifacts" folder was created to contain an executable (XML/JSON) version of what is summarized in the Volume 3 section.

Some of these sections were never updated from the published IHE TF-3 content with BICEPS examples (e.g., 3:8.7.1 Device: Infusion Pump), and no referenced artifacts were ever included. Note that the intent was for the TF-3 content to be an overview and description of the device specialization, but the executables were never integrated.

the intent was to more clearly support: (a) Content Modules for association with Volume 1 SDPi-P content actors, (b) simulation and facilitating implementation; (c) conformity assessment for specific device specializations.

Note: For the IEEE standards, there are XML files made available for the BICEPS standard. This should be similar.

Finally, it should be stated that this is an evolutionary path. For decades, there has been interest in creating IEEE 11073-10xyz Device Specialization standards; however, it has always proved elusive. The approach here will build on the 20 years of specialization work done by the IEEE-IHE-HL7 experts since the 90's, and at some point may include Gemini device specialization profiles that leverage the SDPi standards. These profiles could be the precursor for IEEE 11073 specializations, if there is a market need for these.

Proposed Change

Update SDPi TF-3 to include:

1. BICEPS Device Specialization Content from the current IHE TF-3 publication
2. Add XML/JSON referenced-artifacts to the associated specialization
3. Add / update / expand a general section on HOW to add device specializations and how to create and define the associated referenced artifacts.
4. Add linkages as appropriate to the TF-1 Content actors to support specialization-level verification testing.
5. Consider how device specialization requirements could be integrated, including at which point a SOMDS_INFUSION_PUMP actor needs to be defined! How could a pump ICS be created out of the SDPi specifications, short of a new profile?