8/30/2023 Updates Meeting

Written By PIcc Alliance

Steering Committee Series

Watch the recording of the meeting:

Download the slides from the meeting here

FDA

Download the presentation here

  • Guidance: Off-The-Shelf Software Use in Medical Devices (download .pdf)

  • Presentation at MPS World Summit 2023: Advancing New Alternative Methods at FDA (download .pdf)

  • CDRH Experiential Learning Program (ELP) (link)

  • Tips for submitting comments on CDRH guidance documents (link)

  • MDUFA IV and Beyond - Video Reports (link)

  • List of Cleared of Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (link)

  • Total Product Life Cycle Advisory Program (TAP) (link)


Legislative & Federal Updates

Download the presentation here

  • CMS and HHS Proposed Rule August 7, 2023: Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program (link)

  • Presentation in progress (input and comments requested): QSO–22–13–CLIA outlines enforcement discretion in certain clinical laboratory practices (download .pptx)

MDIC

  • Join us at MXR2023 (link)

  • 2023 MDIC Annual Public Forum (link)

  • MDIC’s Advanced Manufacturing Clearing House (AMCH) has funding for you to apply for (link)


Professional Societies & Patient Advocates

  • Tuesday, September 12 DPA Webinar: Building Bridges Between Bytes and Biopsies: Resident Pathologists Discuss the Potential of Digital Pathology and AI (link)

  • Tuesday, September 26 FOCR: Future in Focus: Digital Pathology in Oncology Drug Development (link)

  • Friday, October 6 CAP: The Future of Cancer Data: Unlocking Insights With Pathology Reporting (link)

  • CAP Today: Lab leaders on moving markets and tipping points (link)

HTT Update (Brandon Gallas, FDA)

DEI

  • Avraham Cooper and Adam Rodman. AI and Medical Education — A 21st-Century Pandora’s Box (download .pdf)

  • Cagala et al. Commitment Requests Do Not Affect Truth-Telling in Laboratory and Online Experiments (download .pdf)

Europe

  • European Parliament: Artificial Intelligence in Healthcare - Applications, risks, and ethical and societal impacts (download .pdf)

  • European Medicines Agency: Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle (link)

Resources & Publications

  • PatientGPT Reduces Months of Pharma Research To Seconds (link)

  • Michael Anne Kyle and Zirui Song. The Consequences and Future of Prior-Authorization Reform (download .pdf)

  • Henderson et al. Delivering the precision oncology paradigm: reduced R&D costs and greater return on investment through a companion diagnostic informed precision oncology medicines approach (download .pdf)

  • Marie-Caroline Schulte. Evidence-Based Medicine – A Paradigm Ready To Be Challenged? How Scientific Evidence Shapes Our Understanding And Use Of Medicine (download .pdf)

  • Agarwal et al. Combining Human Expertise with Artificial Intelligence: Experimental Evidence from Radiology (download .pdf)

  • Are synthetic health data ‘personal data’? A PHG Foundation report independently commissioned by the MHRA to assess the status of synthetic health data in UK data protection law (download .pdf)

  • DeciBio: Pharma Investment Trends in Precision Oncology R&D (download .pdf)

  • Nicholson Price II et al. Enabling collaborative governance of medical AI (download .pdf)

  • Desai et al. Retrospective Cohort Study on the Limitations of Direct-to-Consumer Genetic Screening in Hereditary Breast and Ovarian Cancer (download .pdf)

  • Moon et al. Machine learning for genetics-based classification and treatment response prediction in cancer of unknown primary (download .pdf)

  • Jassim et al. Cancers make their own luck: theories of cancer origins (download .pdf)

  • CMS Innovation Center, HHS release new dementia care model (link)

  • C. Joseph Ross Daval and Aaron S. Kesselheim. Authority of Medicare to Limit Coverage of FDA-Approved Products Legal and Policy Considerations (download .pdf)

  • Kyle. Utilization Management Trends in Medicare Part D Oncology Drugs, 2010-2020. JAMA. (download .pdf)

  • Heba W. Z. Khella and George M. Yousef. Translational Research: Empowering the Role of Pathologists and Cytopathologists (download .pdf)

  • Huang et al. A visual–language foundation model for pathology image analysis using medical Twitter (download .pdf)

  • Richardson et al. Noninterpretive Uses of Artificial Intelligence in Radiology (download .pdf)

  • Cui et al. scGPT: Towards Building a Foundation Model for Single-Cell Multi-omics Using Generative AI (download .pdf)

  • Hu et al. Flexible and Highly-Efficient Feature Perception for Molecular Traits Prediction via Self-interactive Deep Learning (download .pdf)

  • Hasanzadeh et al. Hypertension Detection From High-Dimensional Representation of Photoplethysmogram Signals (download .pdf)

  • Zarella et al. Artificial intelligence and digital pathology: clinical promise and deployment considerations (download .pdf)

  • Barbarajean Magnani and Clive R. Taylor. Immunohistochemistry Should Be Regulated As an Assay (download .pdf)

  • Frewing et al. Don’t Fear the Artificial Intelligence: A Systematic Review of Machine Learning for Prostate Cancer Detection in Pathology (download .pdf)

  • Glaviano et al. PI3K/AKT/mTOR signaling transduction pathway and targeted therapies in cancer (download .pdf)

  • Lilley et al. Virtual Pathology Elective, Real Education: The PathElective.com Experience as a Model for Novel Pathology Pedagogy and a Primer for Curricular Evolution (download .pdf)

  • Nick F. Ramsey & Nathan E. Crone. Speech-enabling brain implants pass milestones (download .pdf)

  • NIH OCCPR: Novel 64-Protein Signature Predicts Treatment Response in High-Grade Serous Ovarian Cancer (link)

  • Kramer et al. RAD51 as a biomarker for homologous recombination deficiency in high-grade serous ovarian carcinoma: robustness and interobserver variability of the RAD51 test (download .pdf)

  • Thagaard et al. Pitfalls in machine learning-based assessment of tumor-infiltrating lymphocytes in breast cancer: a report of the international immuno-oncology biomarker working group (download .pdf)

  • Page et al. Spatial analyses of immune cell infiltration in cancer: current methods and future directions. A report of the International Immuno-Oncology Biomarker Working Group on Breast Cancer (download .pdf)

  • Yang et al. scBERT as a large-scale pretrained deep language model for cell type annotation of single-cell RNA-seq data (download .pdf)

  • Wornow et al. The shaky foundations of large language models and foundation models for electronic health records (download .pdf)

  • Barata et al. A reinforcement learning model for AI-based decision support in skin cancer (download .pdf)

  • Wilcox et al. Exome sequencing identifies breast cancer susceptibility genes and defines the contribution of coding variants to breast cancer risk (download .pdf)

  • Hallast et al. Assembly of 43 human Y chromosomes reveals extensive complexity and variation (download .pdf)

  • Kumar et al. A spatially resolved single-cell genomic atlas of the adult human breast (link)

  • Ana Luísa Correia. Locally sourced: site-specific immune barriers to metastasis (download .pdf)

  • Scott et al. Trends in the approval of cancer therapies by the FDA in the twenty-first century (download .pdf)

  • de Wit et al. EGFR-targeted fluorescence molecular imaging for intraoperative margin assessment in oral cancer patients: a phase II trial (download .pdf)

  • Shortell et al. The Better Care Plan: a blueprint for improving America’s healthcare system (download .pdf)

  • Waissengrin et al. Artificial intelligence (AI) molecular analysis tool assists in rapid treatment decision in lung cancer: a case report (download .pdf)

  • Irajizad et al. Mortality Benefit of a Blood-Based Biomarker Panel for Lung Cancer on the Basis of the Prostate, Lung, Colorectal, and Ovarian Cohort (download .pdf)

  • Powles et al. Molecular residual disease detection in resected, muscle- invasive urothelial cancer with a tissue-based comprehensive genomic profiling–informed personalized monitoring assay (download .pdf)

  • Nick F. Ramsey and Nathan E. Crone. Speech-enabling brain implants pass milestones (download .pdf)

  • Ying et al. Theranostic gastrointestinal residence systems (download .pdf)

  • Otlu et al. Topography of mutational signatures in human cancer (download .pdf)

  • Chowdhury et al. Proteogenomic analysis of chemo-refractory high-grade serous ovarian cancer (download .pdf)

PIcc Alliance
Previous

9/27/2023 Updates Meeting

Next

7/26/2023 Updates Meeting