1/29/2025 Updates Meeting

Steering Committee Series


Watch the recording from the meeting.

Download the slides from the meeting here


Legislative Updates

  • Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (download .pdf)

  • ACLA vs FDA (download .pdf)

  • ACLA vs FDA: Defendants’ Cross-Motion for Summary Judgment, Opposition to Plaintiffs’ Motions for Summary Judgment, and Combined Memorandum of Points and Authorities (download .pdf)

  • Bipartisan House Task Force on AI (download .pdf)

  • HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information (download .pdf)

  • Discussion Paper on Laboratory Developed Tests (LDTs) (download .pdf)

  • U.S. Department of Health and Human Services: Strategic Plan for the Use of Artificial Intelligence in Health, Human Services, and Public Health (download .pdf)

FDA Updates

  • Artificial Intelligence-Enabled Device 1 Software Functions: Lifecycle 2 Management and Marketing 3 Submission Recommendations (download .pdf)

  • IT Operating Plan (download .pdf)

  • Outsourcing Tissue Histopathology Investigations in Support of Clinical Trials for Novel Therapeutics: Considerations and Perspectives (download .pdf)

  • Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (download .pdf)

  • Safety and Performance Based Pathway: Guidance for Industry and  Food and Drug Administration (download .pdf)

Europe and Beyond Updates

  • The role of the pathologist in the design and conducting of biomarker‑driven clinical trials in cancer: position paper of the European Society of Pathology (download .pdf)

  •  Call for expression of interest for Academia to participate in the European Platform for Regulatory Science Research (download .pdf)

  • 17th European Public Health Conference 2024 (download .pdf)

  • Die Pathologie im Rahmen des europäischen und nationalen Medizinprodukterechts: Betrieb, Anwendung und Eigenherstellung von In-vitro-Diagnostika (download .pdf)

  • Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (download .pdf)

  • Unpacking Performance Factors of Innovation Systems and Studying Germany’s Attempt to Foster the Role of the Patient Through a Market Access Pathway for Digital Health Applications (DiGAs): Exploratory Mixed Methods Study (download .pdf)

  • Epidemic effects in the diffusion of emerging digital technologies: evidence from artificial intelligence adoption (download .pdf)

DEI Updates

  •  The State of Women in Academic Medicine 2023-2024 (download .pdf)


Publications and Resources

  • A review of the clinical efficacy of FDA-approved antibody‒drug conjugates in human cancers (download .pdf)

  • Regulating radiology AI medical devices that evolve in their lifecycle (download .pdf)

  • Large language models and multimodal foundation models for precision oncology (download .pdf)

  • Quantum classical hybrid convolutional neural networks for breast cancer diagnosis (download .pdf)

  • Tumor cell-based liquid biopsy using high-throughput microfluidic enrichment of entire leukapheresis product (download .pdf)

  • Multimodal Whole Slide Foundation Model for Pathology (download .pdf)

  • Why implementing machine learning algorithms in the clinic is not a plug-and-play solution: a simulation study of a machine

    learning algorithm for acute leukemia subtype diagnosis (download .pdf)

  • Artificial Intelligence and Radiologist Burnout (download .pdf)

  • International multicenter validation of AI-driven ultrasound detection of ovarian cancer (download .pdf)

  • A new understanding of tissue biology from MS-based proteomics at single-cell resolution (download .pdf)

  • A Large-Scale Foundation Model for RNA Function and Structure Prediction (download .pdf)

  • Metrics Reloaded toolkit report (download .pdf)

  • Finding FDA-authorized devices with Predetermined Change Control Plans (Access Here)

  • ARPA-H ImagiNg Data EXchange (INDEX) (Access Here)

  • INDEX: Imaging Data Exchange (Access Here)

  • MIC-MET Tree: Decision Tree for Medical Imaging AI/ML Classification Metrics - Catalog of Regulatory Science Tools to Help Assess New Medical Devices  (Access Here)

  • An interactive Decision Support Tool for Evaluating Machine Learning Algorithm Performance in Medical Image Analysis (Access Here)

  • MIC-MET Tree: Decision Tree for Medical Imaging AI/ML Classification Metrics (Access Here)

  • Metrics Reloaded (Access Here)


Society Updates

  • Value-Based Reimbursement Model for Integrative Diagnostic Centers (download .pdf)

  • US Digital Pathology 2024 Supplemental Questionnaire (download .pdf)

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12/18/2024 Updates Meeting