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

FDA Law Blog

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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Outcomes of Guidelines from Health Technology Assessment Organizations: A Systematic Mixed Studies Review [Systematic review, meta-analysis, or scoping review]

Annals of Family Medicine

HTA organizations are generally funded by governments, they guide health care professionals and decision/policy-makers, and they publish knowledge translation products such as guidelines. Population Studied: Family physicians, general practitioners, and patients. Setting: Community-based primary health care.

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Geriatric Medicine Board Meeting Summary | Spring 2025

ABIM

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Erica N.

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Rheumatology Board Meeting Summary | Spring 2025

ABIM

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information.

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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 Blog

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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

GeriPal

What hasn’t been shown, Eric, is that if you apply tools like this, clinical outcomes down the road are better for patients. I don’t have access to change the levers of government. They’re dedicated, committed, they’re there for their patients and they understand it’s really important.

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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Erica N.