House Passes Budget Bill With Expanded Funding
The bill includes a provision to add $9 billion in new spending to the MPFS via an inflation-based update to the conversion factor.
Read moreThe American College of Radiology® (ACR®) provided comments to the U.S. Food and Drug Administration (FDA) regarding the agency’s draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices, including radiology AI. The document discusses information that manufacturers should share with FDA reviewers and other relevant stakeholders, including physicians and practices, to help them evaluate and monitor AI tools’ safety and effectiveness.
ACR’s comment letter supported the advancement of safe, effective, and clinically useful AI innovation. The College recommended further specificity in product information provided by manufacturers and regulators regarding clinical end-user qualifications. For example, radiologist end-users of imaging AI tools help mitigate risk because they are qualified to interpret imaging examinations without AI assistance. ACR also recommended various enhancements to the guidance’s content on site-level validation, performance monitoring and AI types with novel oversight considerations.
For more information about ACR’s AI-related initiatives, visit the ACR DSI website. For questions about AI oversight and digital health policy, contact Michael Peters, ACR Senior Director, Government Affairs.
House Passes Budget Bill With Expanded Funding
The bill includes a provision to add $9 billion in new spending to the MPFS via an inflation-based update to the conversion factor.
Read moreState Legislation Update
ACR tracks hundreds of healthcare-related bills each state legislative cycle.
Read moreCDC Alert: Use Only Sterile Ultrasound Gel for Percutaneous Procedures
The Centers for Disease Control and Prevention (CDC) alerted healthcare facilities about non-sterile ultrasound gel products.
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