Agenda Item | Notes |
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Quorum evalution (two-thirds (2/3) of the Voting Representatives shall be necessary to constitute a quorum for the transaction of business) | Currently we have 18 named members, so 2/3 = 12 (excluding chair and government members) |
Open Meeting | |
Feedback from FDA , specifically Collaborative Community leadership in CDRH on our Charter | They recommended that the percentages of various groups be more “fungible”… In that what happens if you are not able get the exact percent representation from particular groups? So anticipate that somehow by saying that is a goal, and that leadership can approve deviations from those numbers, or have the documents say that they are guidelines, not absolute. Suggested change since current SC numbers are close, but not exact – so probably change: “according to” to “approximately”:
Discuss and vote For the SHIELD projects, they want to see some goals that are long-term sustaining projects. Not projects that look like they will wrap up in 1-2 years… The question being is this a temporary type group that we might support in the short term more as an focus group, or is this a longer term group that is worth FDA planning to be in partnership with for a long time. We will need to write a statement of intent with quotes from the roadmap, that make clear that SHIELD is a long-term community, with projects that will become permanent fixtures in the healthcare ecosystem - any volunteers to pull this together?
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Call schedule in the summer | June 13th - Andrea will lead - topics: June 20 - Andrea will lead June 27 - ALL SHIELD call July 4 - need to reschedule - move to July 11th or just cancel? |
Meetings | https://loinc.org/conference/atlanta-2023/ October 17-20 Plan to submit session - Andrea to do by due date June 7th |
HT1-NPRM Comment Collection | |
Feedback from ONC on Roadmap (FINAL VERSION) | Was discussed mentioned on May 30th call - any follow up30 call - here are the comments: The roadmap mission section describes a broad vision of lab interoperability. However, the roadmap proposed solution is limited to the FDA use cases around In-vitro diagnostics (IVD) data, specifically populating the IVD data hub. ONC suggests clearly describing the roadmap scope so the proposed solutions can be discussed within that context. The roadmap identifies training and education needs around using LOINC as a barrier to interoperability. ONC suggests clarifying how the roadmap addresses this barrier. ONC recognizes that terminologies require training and education, and replacing LOINC with another standard will not address the barrier. There are several solutions proposed, including repositories and tools, which need to be further evaluated before ONC could fully support the roadmap. ONC suggests the roadmap be updated to include details around feasibility, scalability and how the proposed changes can be integrated into the current laboratory ecosystem (e.g., regulation and industry).
- any volunteers to draft a response / suggested updates in the roadmap? |
Review Working Group Committee list and establish SC representation | Working Groups Created Confluence pages for the 4 priority groups Leads will find call time and invite interested people |
Next call | June 20. 2023 12 -1 PM EDT |
Adjourned | |