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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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Rheumatology Board Meeting Summary | Spring 2025

ABIM

He suggested that ABIM work with ACR in the future to publish information about practicing rheumatologists to make it easier for patients to seek rheumatology care from certified physicians in their region. Dr. Mansoor stressed that fellows train with specialist support that does not truly reflect community practice.

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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

But the thing that really motivates me is seeing, you know, and trying to manage later stage, you know, we can call them complications of people who haven’t had a diagnosis are now really in, you know, a world of complexity around other conditions, around managing life and managing practical things.

Screening 119
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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

FDA interprets “other medical information” to include items such as “peer-reviewed clinical studies, clinical practice guidelines, and information that is similarly independently verified and validated as accurate, reliable, not omitting material information, and supported by evidence.”

Clinic 52
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FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. The DCP should follow applicable regulations governing human subject protections, where applicable.

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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

Highlights from the data so far show that 91% of respondents are clinically active, with a large majority practicing in hospital- or system-owned offices, private practice or academic faculty practice, and more than half in multi-specialty group practice. Community Practice in ABIM Governance* Erica N.

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Infectious Disease Board Meeting Summary | Spring 2025

ABIM

They discussed an interest in its ability to collect data specific to practice areas like HIV and geographic areas—like practice ZIP codes—to better understand workforce needs and patterns. Community Practice in ABIM Governance* Erica N.