Agenda: download .docx here

• 10’ CLIA Waiver: review draft and contact state surveyors

• 10’ FDA Transition Plan to move away from EUAs for permanent COVID support

  • submit comments by 3/23 (link)

  • Transition Plan for Medical Devices Issues Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (link)

  • Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (link)

• 5’ Featured papers

  • Bauer et al. Making a science out of preanalytics: an analytical method to determine optimal tissue fixation in real-time (link)

  • Morjaria et al. Strategic thinking in test selection for mass SARS-CoV-2 testing (link)

  • Lee et al. Disruptive and sustaining innovation in telemedicine: a strategic roadmap (link)

  • Bulten et al. Artificial intelligence for diagnosis and Gleason grading of prostate cancer; the PANDA challenge (link)

• 10’ Expanding patient advocacy presence:

  • Initial meeting with Sepsis Alliance; aims to become a collaborative community (link)

  • Initial meeting with APPIA (patient interest group) (link); interested in our pre-analytics; TOPS program (link)

• 10’ ISPOR abstract notifications due this week

  • Advancing Exchange of Digital Health Information by Embracing a National Tokenization Model for Unique Patient Identification

  • Unique Patient Identifier draft overview

• 10’ General Updates:

  • TIGER Grand Challenge (link)

    • TILS Grand Challenges (link)

  • Standards: HIT (ONC) Technical specifications (link)

  • RWE Program – Clinical Investigator Training Course Update (link)

  • 2022 Summer OSEL Regulatory Research Experience (SORRE) (link)

  • Truthing & Validation Update (link)

  • TILs RS Project – working on a survey

  • Website domain

  • MDIC Emerging Healthtech (link)

• 5’ Upcoming Events

  • 2/1/22 12-1PM ET MDICx: AI/ML Framework Public Comment Q&A (link)

  • 2/22/22 10AM-1PM ET PMLS Virtual Series 2022 – Precision Pathology (link)

  • 2/22/22 12-1PM ET FOCR Virtual Meeting: Supporting Development of Diagnostic Tests for Unmet Needs (link)

Meeting Credentials: