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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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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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Gastroenterology Board Meeting Summary | Spring 2025

ABIM

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The Specialty Board discussed the LKA in greater detail, as well as the use of artificial intelligence (AI) in assessment development and the integration of public members in ABIM Governance.

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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. Community Practice in ABIM Governance* Erica N.

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Q&A: Prioritizing Early Intervention in Pediatric Obesity

Physician's Weekly

I have found explaining the pathophysiology of obesity (eg, the role of biology, genes , and systemic risk factors), addressing the lived experience related to weight bias, individualizing the intervention to match the child’s family needs, and focusing on building the patient/family agency for change helps with engagement.

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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. Dave noted the Diplomate Professional Profile’s potential outside of Specialty Board discussions with data that could be valuable to patients with specific needs and conditions.

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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

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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