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ACR seeks enhancements to FDA AI risk management guidance

AuntMinnie

Food and Drug Administration (FDA) should ideally review manufacturers' plans for enabling clinical site-level validation of AI-enabled device software functions (AI-DSF), the American College of Radiology (ACR) recommended in comments on FDA's AI lifecycle management draft guidance. The FDA published its draft guidance January 7.

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Insights from ACC 2025: How Aidoc Is Shaping the Future of AI in Cardiovascular Care

Aidoc

This AI-powered solution helps overcome operator variability and workflow resource constraints, to improve clinical efficiency. AI can help make this a scalable reality, all while streamlining both frontend workflows and backend processes, to reduce clinical burden and increase efficiency.

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Northeast Radiology to pay $350K to resolve data breach

AuntMinnie

The settlement marks OCR's sixth enforcement action in its "Risk Analysis Initiative," the HHS said in an April 10 update specific to the Northeast Radiology breach of unsecured electronic protected health information (ePHI) that the company reported in March 2020. The company will also be monitored for compliance for two years.

Radiology 100
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The Value of Standardized Quality and Performance Metrics in Clinical Trials

Median

The Value of Standardized Quality and Performance Metrics in Clinical Trials It’s not just tumor measurements that matter! Quality and performance metrics are just as important and necessary for running a successful clinical trial with image analysis metrics as the endpoints. Quality and Performance Measurements are critical too.

Clinic 52
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The Responsible Path: How Risk Frameworks and AI Governance Work Together

Aidoc

Clinical AI represents a paradox. While its potential to revolutionize patient care is undeniable (and increasingly being proven ), healthcare leaders remain acutely aware of the risks involved with implementation. 2,3,4 Each framework offers unique guidance tailored to specific aspects of AI risk management. Clearwater.

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The International Council for Harmonization (ICH) Q10: A Model for a Robust Pharmaceutical Quality Management System

Open Medscience

ICH Q10 is a global model for managing pharmaceutical quality, ensuring compliance, continuous improvement, and risk manage The post The International Council for Harmonization (ICH) Q10: A Model for a Robust Pharmaceutical Quality Management System appeared first on Open MedScience.

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The Risks of Not Being Proactive with Healthcare Cybersecurity When It Comes to AI

Aidoc

Navigating the Cybersecurity Challenges of Clinical AI Integration As healthcare embraces new technologies like clinical AI, cybersecurity must evolve to address the unique challenges that come with it. Clinical AI depends on patient data, requiring health systems to share this information with AI developers for accurate performance.