5/29/2024 Updates Meeting
Steering Committee Series
Watch the recording from the meeting.
FDA
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff (download .pdf)
Medical Devices; Laboratory Developed Tests (download .pdf)
Drug Trials Snapshots Summary Report 2023 (download .pdf)
Guidance Document: Informed Consent Guidance for IRBS, Clinical Investigators, and Sponsors (download .pdf)
FDA’s Final Rule Including a Phaseout Policy Regarding Laboratory Developed Tests (download .pdf)
Visit the FDA LDT Website
MDIC
Learn more about HEPV’s Commercial Payer Council here
MDIC Releases Second Annual Medical Device Cybersecurity Maturity Benchmark Report
To read the report, click here.
Cybersecurity
Security Categorization and Control Selection for National Security Systems (download .pdf)
Federal Updates
Reps. Finstad and Crenshaw, Sen. Paul Introduce Resolution to Repeal Harmful FDA Rule Limiting Access to Laboratory Developed Tests (download .pdf)
Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile (download .pdf)
Driving U.S. Innovation in Artificial Intelligence (download .pdf)
Lack of Reimbursement Hindering AI Adoption, American College of Radiology Warns Congress (download .pdf)
Europe and Beyond
Regulatory Requirements for In-House IVDs (download .pdf)
Resources & Publications
Navigating the HER2-Low Paradigm in Breast Oncology: New Standards, Future Horizons (download .pdf)
New Regulatory Thinking is Needed for AI-based Personalised Drug and Cell Therapies in Precision Oncology (download .pdf)
Development and Validation of a Deep Learning-Based Microsatellite Instability Predictor from Prostate Cancer Whole- Slide Images (download .pdf)
Machine Learning-Driven Histotype Diagnosis of Ovarian Carcinoma: Insights from the OCEAN AI Challenge (download .pdf)
Understanding the Financial Aspects of Digital Pathology: A Dynamic Customizable Return on Investment Calculator for Informed Decision-Making (download .pdf)
Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages (download .pdf)
A national evaluation analysis and expert interview study of real‐world data sources for research and healthcare decision‐making (download .pdf)
Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus (download .pdf)
A guide to artificial intelligence for cancer researchers (download .pdf)
Guardrails for the use of generalist AI in cancer care (download .pdf)
Health Care Measurements that Improve Patient Outcomes (download .pdf)
Integrated Practice Units: A Playbook for Health Care Leaders (download .pdf)
Comprehensive peripheral blood immunoprofiling reveals five immunotypes with immunotherapy response characteristics in patients with cancer (download .pdf)
Artificial intelligence in digital pathology: a systematic review and meta-analysis of diagnostic test accuracy (download .pdf)
Digital pathology structure and deployment in Veneto: a proof‐of‐concept study (download .pdf)
Selection of Germline Genetic Testing Panels in Patients With Cancer: ASCO Guideline (download.pdf)
Advancing Translation of Clinical Research Into Practice and Population Health Impact Through Implementation Science (download .pdf)
Large Language Models Are Poor Medical Coders — Benchmarking of Medical Code Querying (download .pdf)
A framework enabling LLMs into regulatory environment for transparency and trustworthiness and its application to drug labeling document (download .pdf)
Protecting scientific integrity in an age of generative AI (download .pdf)
Single-cell and spatial transcriptomics analysis of non-small cell lung cancer (download .pdf)
A whole-slide foundation model for digital pathology from real-world data (download .pdf)
Image-based consensus molecular subtyping in rectal cancer biopsies and response to neoadjuvant chemoradiotherapy (download .pdf)
Use of Artificial Intelligence Chatbots in Interpretation of Pathology Reports (download .pdf)
Laboratory Considerations for Releasing Next-Generation Sequencing Data to Patients (download .pdf)
Does context matter in digital pathology? (download .pdf)
AI in Health: Huge Potential, Huge Risks (download .pdf)
Principles for Augmented Intelligence Development, Deployment, and Use (download .pdf)
Actionable Tips Imaging Departments can Implement to Reduce Energy Consumption (download .pdf)
Greening the Laboratory: A framework for sustainability (download .pdf)
Incorporating Integrated Diagnostics into Precision Oncology Care: Proceedings of a Workshop (2024) (download .pdf)
DEI
Career trajectories of MD-PhD physician scientists: The loss of women investigators (download .pdf)
PNPL
Digital Pathology and AI (download .pdf)