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Attendees

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nameparticipants_85881872295.csv

Slides:

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nameAnnotated_Application of STPA to the U.S. Diagnostic Laboratory Data Ecosystem_All SHIELD_ 1.9.24.pdf

From Chat:

SZARFMAN 12:19 PM
Wanted to share that I reviewed the HHS ONC 2024 Interoperability Standards Advisory (ISA) Reference Edition.Regarding the 38 mentions in the ISA:“Secure Message Router – Securely route and enforce policy on inbound and outbound messages without interruption of delivery.” Advocated adding after “without interruption of delivery” the following specific recommendation for assuring a successful comprehension and delivery of the messages: “need to have multi-directional feedback loops for prompt access to ancillary data, for clarifications, and for quickly reporting and addressing system and data transmission errors.” See https://www.nature.com/articles/s43856-022-00148-x.

Steve Powell to Everyone 12:20 PM
Overview of our findings and recommendations https://synensysglobal.com/wp-content/uploads/2024/01/FDA-System-Safety-Final-Report_One-Page-Summary_Revised-3-1.pdf

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Pam Banning - 3M Health Info Systems 1:00 PM
Great conversation; thank you all

Recording:

Action items

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https://drive.google.com/file/d/1CbsegIBwrJN1sMwPboj6EjJRu7C9SrSG/view?usp=sharing

Reports

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    View file
    nameExecutive-Summary_System-Safety-within-Laboratory-Data-Exchanges-Report.pdf
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    View file
    nameFDA-System-Safety-Final-Report_One-Page-Summary_Revised-3-1.pdf
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    View file
    nameSystem-Safety-within-Laboratory-Data-Exchanges-Report.pdf

Quick decisions not requiring context or tracking

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