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
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)