From Narratives to Requirements to Plug-and-Trust - Tooling for a New Level of Testability & Rigor

The intent of the Gemini SDPi+FHIR program is to establish a new level of requirements detail and traceability from user narratives to use cases to requirements that are expressed in a clear, concise and TESTABLE ASSERTION form that can be mapped and traced through all the way to the interoperable "plug-n-trust" interface that is tested.  Establishing a set of specification formats and supporting tool chain is the challenge.  

This  discussion slide deck details the approach being developed for this program:

Note:  Updated 2020-07-06A

See Narratives to Plug-n-Trust: Capture & Traceability & V&V & CA for a more detailed discussion.

RI+MC+RR for MedTech Specifications Initiative

During the January 2021 review of areas that should be advanced in this Gemini SES MDI program, three linked areas were identified as key opportunities for the work, as initially indicated in the 2021 Year 3 Update presentation:

RI – Requirements Interoperability –  Ability to integrate & automate requirements and capabilities from component specifications & standards to enable traceability & coverage at CA of the component product interface

MC – Model Centric – Transition from a document-centric to a computable model-based "single source of truth" specification from which the Technical Framework becomes a view of the model

RR– Regulatory Ready – Enable CA test reports that are genuinely "regulatory submission ready" (e.g., inclusion in a U.S. FDA 510(k) submission package)

A set of confluence sandbox discussion pages have been created to support discussions and short-fuse pilot projects for these interlinked areas, including

• ReqIF for Requirements Interoperability Pilot – Does integration of computable / toolable ReqIF specifications support RI+TF+CA?
• MBSE / SysML for MedTech Solutions Pilot  – Does moving from a document-centric to a model-centric specification "source of truth" provide next gen computability support for RI+TF+CA?
• FDA ASCA & IHE CA Pilot – Can alignment of IHE CA and FDA ASCA processes facilitate the "regulatory submission ready" CA test reports objective of RI+TF+CA?

Conclusions from these short term pilots - anticipated for end of "Summer" 2021 (Northern Hemisphere!) will directly impact the SDPi Supplement (1.0) specification as well as the processes and tooling utilized within the Gemini SES MDI program in general.

SDPi+FHIR Specification Tooling

<add tooling stuff from above "inspiring narratives" discussion slide deck>

Reference Implementation / Open Source Resources

<add from white paper and subsequent discussions>

Test Tooling Resources

<add from white paper & subsequent discussions>

Roadmap & Team Collaboration

CA & Tooling Support Roadmap

1. Develop an SDC / SDPi Conformity Assessment & Tool Chain Strategy
2. Roadmap pathway to IHE EU CAT '20 & IHE NA CAT '21 
3. Roadmap pathway to IHE CA of SDC/SDPi products 

Development Status

1. <include general updates per roadmap above>

Team Participants

The following individuals have requested to be included in the CA & Tooling Team:

NOTE:  Team participants who are also registered HL7 Confluence users  be able to comment and add content.

Team Discussion Notes

Older CA & Tooling meeting notes are available at Gemini CA Meeting Notes Archive

Other related web meeting discussion notes are captured on the SDPi+FHIR Meeting Logs & Notes page.