Agenda: please find an overview of the meeting topics below

• FDA

  • Spotlight Digital Health Reg Sci Research Opportunities

  • 2022 Collaborative Community Townhall (PIcc presented by Lennerz/Gallas)

  • Modeling & Simulation at FDA

  • Medical Device Development Tools (MDDT)

  • Cybersecurity
    Minimal performance criteria.
    Digital health center of excellence.
    Catalog of regulatory science tools
    Digital health policy navigator
    CDRH Learn
    Medical device regulatory science research program.
    Update HTT project (Brandon Gallas)

  • Installing WSI viewer (+digital transformation symposium) (Brandon Gallas)

  • Real world evidence program.
    Advancing the real-world evidence.

• WHO updates

  • Publication BMJ open.
    Barriers in access to oncology drugs essential medicines
    Essential diagnostics
    IARC oral cancer prevention.

• Legislative updates

  • Cyber security standards White House
    VALID act update.
    Device versus technology.
    Switzerland decision
    Voluntary alternative pathway.

• MDIC update

  • New approach to clinical trial design.
    Cyber security threat modeling, virtual Boot Camp
    Professional societies
    Empty proposal for modernization of clear regulation.
    CAP gnu counsel CPCPI
    DPA update.
    CtDNA

• Grant challenges update

  • Data

• CPIM update

  • Toxicologic pathology update

• Ethics, diversity and inclusion update

  • Hippocratic oath for artificial intelligence.
    Addressing racism and ethical bias in AI.

• Patient advocacy update

  • Friends of Cancer Research annual meeting

  • Friends of Cancer Research Update HRD essay harmonization project

  • Friends of Cancer Research Digital pathology and clinical oncology drug development

  • APPIH general tissue handling guidelines

  • Bio archive Fully annotated genome

• Resources

  • ML tool for pathology images

  • Free no code and a P platform

  • Call for authorship

  • Deloitte reports technology, driven personalized in preventive healthcare in Europe.
    Unifying force paper and regulatory signs and diverse set of research publications

• Payor update

  • A reimbursement framework for AI and healthcare.
    Paying for AI in medicine.

• Events

  • Reimbursement opportunities digital pathology (CAP)FDA digital transformation symposium (FDA)

  • FDA clinical investigator training course (FDA)