CA Strategy Workshop at NIST 27-09-2022

Workshop Information

Workshop:  Gemini SES+MDI Conformity Assessment Strategy  

Background:

The joint IHE-HL7 Gemini SES+MDI* program is focused on establishing a robust ecosystem of plug-and-trust interoperable component products based on the ISO/IEEE 11073 Service-oriented Device Connectivity (SDC) standards family, HL7 V2 and HL7 FHIR, ISO/IEC JWG7 and other open standards development and profiling organizations.  IHE SDPi ** profiles are being developed that combine these foundational standards into specifications that may be consistently adopted and implemented across the ecosystem.  Organizations - both commercial and academic - are actively developing and testing prototype systems and are advancing medical device products that integrate these specifications.  Testing includes general events such as plugathons (PAT) / hackathons, connectathons (CAT,  independent 3rd party monitors), and ultimately formal product conformity assessment (CA).  Many unique challenges face the SDPi product implementation community, where products developed and deployed around the world must adhere to the same specifications, established by rigorous CA programs, and must be able to dynamically establish "trust" at network connection time.  Products that individually provide a system component role to an overall clinical system function (SFC & SFC Contribution).  

Considerable work has been done, especially in establishing SDC conformity assessment principles and supporting standards (e.g., ISO/IEEE 11073-1070x Participant Key Purposes standards, in development); however, a clear pathway for product testing, from PAT to CAT to CA has yet to be clearly established, including how this SES+MDI CA (incl. DoC) can be productively integrated with the other product non-SES+MDI testing and CA attestations so as to facilitate regulatory requirements and processes.  

Bringing clarity to both these challenges and an initial CA strategy and roadmap will inform the current IHE-HL7 Gemini program activities, and ultimately facilitate adoption, implementation and use of these SES+MDI products - impacting the healthcare of patients around the world.

* SES+MDI = Safe, Effective & Secure + Medical Device Interoperability 

** SDPi = Service-oriented Device Point-of-care Interoperability, IHE profiles against which SES+MDI will be assessed for conformity

Objectives:

Understand the general and unique challenges around CA of  Gemini SES+MDI system component products 
Craft a basic conformity assessment strategy and roadmap to help guide Gemini SES+MDI program activities  (2023-2025)

Note:  Though regulatory agency involvement is welcomed, the CA strategy & roadmap is purely invormational and for planning purposes, with no implicit nor explicit intent to represent any positions or policies of regulatory authorities, both in the U.S. and EU.  

Participants:

• • Open to all subject matter experts from the NIST, IHE-HL7 Gemini communities (esp. Ecosystem Pathway + CA & Tooling groups), FDA, EU NBs, and OR.NET (Germany-based non-profit industry consortium)
  • Web conferencing will be provided to support international and local-remote participants 

Note:  Sessions #1 & #2 will be of general interest;  Session 3 (workshop) will be more focused on discussion and participants who are ready to actively contribute to the Objectives above.

Schedule / Agenda:

Morning Session #1 - Presentations (1.5 hours) - Start at 8:30 A.M. (U.S. Eastern)

• • • Introductions & Agenda Review (Garguilo & Cooper)
    • Gemini SES+MDI - Concepts & CA Challenges (Cooper)  - Note this will include a short overview of the IHE CA program that we are considering
    • NIST CA Overview - General concepts and principles  (Phelps)
    • EU MDR MDI CA - Overview & Challenges (Bothe)

Break (30 minutes)

Morning Session #2 - Workshop Discussion:  (1.5 hours) 

• • • US FDA MDI CA - What makes a digital health standard "regulatory ready"? (FDA staff)

Lunch (60 minutes)

Afternoon Session #3 - Workshop Discussion (2 hours) 

• • • Confirm core set of SES+MDI CA challenges and objectives
    • Craft a proposal Gemini SES+MDI CA Strategy / Pathway / Roadmap (international scope)
    • Identify follow-on needs and activities

Workshop Materials: 

Background materials & presentations will be provided in advance to facilitate focused discussion;  All materials related to the workshop will be made publicly available by 7 October 2022.

Workshop Materials

These presentations and documents were provided before and during the workshop:

1. Pre-Workshop Materials
   1. ISO/IEEE 11073 SDC References
   2. IHE-HL7 Gemini SES+MDI Program References
      1. Program "Library" Confluence Page - 
         1. General Updates - Briefings (over last 2+ years)
         2. CA & Tooling '22 Strategy (PDF) 
      2. General Gemini Community Co-Working Wiki Article (especially the 3 core groups working within the project)
      3. Program Github sdpi-fhir Repository Wiki Articles, especially 
         1. SDPi Supplement Articles ...
         2. SDPi Version Plan / History - Maps out the versioning / planned for near term work 
      4. Conformity Assessment & Tooling for Gemini SES+MDI Article (in development, but a useful graphic is included)
      5. Bi-Monthly "Plugathon" Testing Confluence Pages - for example, see this recent "interoperability matrix" for PAT #10
   3. Other Presentations / Papers 
      1. IHE & IHE Catalyst: Advancing Interoperable MedTec Solutions with "Regulatory Submission Ready" Conformity Assessment (PDF) ... and (Recording)
      2. SDC Conformance Principles (PDF)
      3. Technical Report:  Approval Based on PKP (PDF) 
   4. IHE Conformity Assessment Program
      1. Simple graphic high-level overview:  IHE Testing Continuum 2021-07-02A.png  
      2. IHE CA Scheme – Part 1  (Processes, lab accreditation, etc.)
      3. IHE CA Scheme – Part 2  (Test methods to each of the IHE profiles)
   5. FDA ASCA Program 
      1. FDA Standards & Conformity Assessment Program (S-CAP) 
      2. FDA Accredited Standards Conformity Assessment (ASCA) Pilot Program 
      3. FDA Webinar (April 2021) on both the above
   6. NIST CA Program References
      1. NIST ABC's of Conformity Assessment
      2. NIST Conformity Assessment Considerations for Federal Agencies 
2. Workshop Presentations
   1. "IHE-HL7 Gemini SES+MDI –  CA Strategy Workshop –  Plug-n-Trust Concepts & Challenges" (Todd Cooper) – Gemini SES+MDI CA Workshop - NIST - 2022.09.27B.pdf
   2. "Conformity Assessment Toolbox Overview" (Amy Phelps) – CA-Overview_Phelps_27SEP22.pdf 
   3. "EU MDR MDI CA - Overview & Challenges" (Michael Bothe) – NIST_MDR_MDI_CA_WS_DQS-MED_Bothe_20220927_2.pdf 
   4. "Standards and Medical Device Regulatory Oversight" (Scott Colburn) – 2022-09-27 ISO-IEC Gemini WG - Colburn.pdf
3. Discussion Materials
   1. <...>

See also the "Bibliography / References" section below for additional materials.

Discussion Notes

The following notes (not "minutes"!) capture the discussion and follow-on activities identified during the workshop.

1. Questions & Challenges Parking Log
   1. Optimal - or "good start"! - pathway to product CA → DoC → Submissions → patient use:  Target late 2H 2023?
   2. Maximize synergies between product CA & regulatory submissions for SES+MDI and other functionality & Standards Conformity
   3. Broad test lab (17025) support ... especially those already active in the medical device CA space
   4. Multi-Standards / Multi-Schemes and one interface testing 
   5. SDOs:  HL7 & IHE ... recognition process?
   6. Standards from HL7 & IHE ... recognition process?!
   7. ...
2. Session #1 - Presentations Q&A
   1. <Q&A discussion notes>
3. Session #2 - Presentation Q&A
   1. <Q&A discussion notes>
4. Session #3 - Workshop Discussion
   1. NOTE:  Given the late hour in Europe and other meeting conflicts, the Q3 session was ... short
   2. (Garguilo)  Dug deeper into the question of establishing "competent" accredited labs + accreditors 
      • Discussion continued around the comment from earlier that from the ASCA Pilot, one of the issues identified (or asked by labs) was how do you know that the accreditors are themselves competent to accredit a lab for a given scheme?
      • Generally, how do you build competency on the part of regulatory reviewers + test labs (17025) and accreditation organizations etc.?  
      • As mentioned in recent months by Michael Bothe & Matthias Marzenko, this is a major issue within Europe, for example, and not only competency but also reviewer/tester capacity
      • ISSUE:  Establishing ecosystem competency & capacity should be a core consideration of the Ecosystem Pathway effort for CA & RR
   3. (Fitzgerald) MDI Market Driver Challenges
      • By analogy, looking at medical security and the market drivers that took 10+ years to bring it to where it was a "market" priority
        • NOTE:  CA programs explicitly address MARKET needs to establish and maintain confidence on the part of all stakeholders; thus the crucial relevance of this question 
      • Interoperability & Security are necessarily (ontologically) intertwined ... each needs the other / supports the other
      • Whereas MD Security has had market forces secure its importance as a driver (e.g., ransomware), the same is still ... evolving
      • MDI remains a nice to have vs. a need to have 
      • Including Gemini SES+MDI SDPi in PURCHASING REQUREIMENTS (private & public) remains a key element
      • For regulators, vendors submitting products with 

Participants

The following individuals participated in the workshop:

Bibliography / References

The following items were referenced during the workshop discussions or identified as helpful for follow-on activities: