Page Comparison

Reviewing minutes from the last call - Action Item Follow up

• Pull out the definitions from LIVD for test kit and equipment and put here: SHIELD Glossary

• UDI presentation:

  • Planned for Oct 2

• Outreach to Dr. DeBaca

  • Hung will check for more info and maybe see, if she could participate in SHIELD

• Hung is still working on the examples

• Waiting for response from Ed

Review the use case page

Please add any content for the different use cases

Reviewing the in-scope / out-of-scope elements

• Standards WG was also talking about reagents - how to we keep in sync between WG?

  • have a liasion / do that at the Steering Committee

• UDI is in-scope - at the device level, not instance level

  • we need to define the process of how to add/update existing elements, then nothing is out of scope

  • identify the high volume, least complex tests

• Lot numbers being withdrawn by manufacturers - this is important at the result level, because those are notno longer valid to be used for diagnostics

• Standards WG can looks at the information modeling issue - what has to be send along with the results

• What is stored in the data repository vs what is needed for result data exchange

• initial scope on result values - why do we need orders?

  • orders provide some clinical context around the results

  • part of the medical record may also be important, but if we model this content consistently we could make those elements accessible via APIs when needed

Adjourned

9:31 AM ET