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Steering Committee Meeting

Agenda: Download .doc HERE

5’ Communications

  • FDA logo request

10’ Support request from TILs and Breast Cancer group (proposal HERE)

10’ Federal notice withdrawal (HERE)

  • “Upon review, HHS and FDA have determined that the proposed exemptions in the January 15, 2021, Notice were published without adequate scientific support, that the Notice contained errors and ambiguities, and that the Notice is otherwise flawed, as described below.”

5’ FOCR updates

10’ AMA information blocking

  • Information blocking exceptions (HERE)

  • CAP CURES Act Fact Sheet (HERE)

  • CAP Comment on information blocking (HERE)

5’ Work Group updates

5’ MDIC updates

5’ General updates:

  • Relevant articles from FDA Voices

    • Accelerating medical device innovation with regulatory science tools (HERE)

    • Leveraging real world evidence in regulatory submissions of medical devices (HERE)

  • Publication: Do not sell regulatory sciences short (HERE)

  • Privacy law changes (HERE)

  • NFDI4Patho (Peter Boor, Germany). National Research Data Infrastructure for (Digital) Pathology proposal; LOI

  • Nominate a 2021 STAT Wunderkind (HERE)

5’ Important dates (link to calendar HERE):

  • April 19-20 BWH cPath Symposium (HERE)

  • April 22 DPA Webinar Series: Enabling Interoperability for Digital and Computational Pathology in the Age of Artificial Intelligence – Current Status and Future Directions (HERE)

  • April 23 PIcc Trainees Group Speaker Event with Lakshman Ramamurthy (HERE)

  • May 1 - June 18 DICOM WG-26 Hackathon (HERE)

  • May 5 - 7 Pathology Informatic Summit 2021 (HERE)

  • May 24 - 27 SIIM 2021 Annual Meeting (HERE)

  • May 26 – 27 FDA Science Forum (HERE)

Conclusion

Meeting Login Credentials:

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BWH Computational Pathology Symposium
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April 22

DPA Webinar Series Session 2