Quality & Governance News

Biden Issues Executive Order to Ensure Safe, Secure AI Development

October 30, 2023 - Today, President Joe Biden signed an executive order on artificial intelligence (AI) that establishes guardrails for the technology to ensure that it is “safe, secure, and trustworthy,” according to a statement from the White House. The executive order’s standards for AI are focused on promoting safety and security; protecting...

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American Heart Association Releases Guidance for Patient Data Sharing

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The American Heart Association (AHA) released new policy guidance in Circulation this week outlining six principles for patient data sharing in medical research. The statement emphasizes that EHRs,...

Senator Calls on Google to Ensure Ethical Deployment of Health AI

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This week, United States Senator Mark R. Warner (D-VA), Chairman of the Senate Select Committee on Intelligence, sent a letter to Google CEO Sundar Pichai citing concerns about the company’s...

Discrepancies in Marketing, Clearance of AI-Enabled Medical Devices Found

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In a recent study published in JAMA Network Open, researchers found discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical...

Stanford Launches Responsible Health Artificial Intelligence Initiative

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Stanford Medicine and the Stanford Institute for Human-Centered Artificial Intelligence (HAI) launched the Responsible AI for Safe and Equitable Health (RAISE-Health) initiative this week, which aims...

AMA Seeks More Oversight of Prior Authorization Artificial Intelligence

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During its recent Annual Meeting, the American Medical Association (AMA) House of Delegates adopted a policy calling for increased regulatory oversight of health insurers’ use of artificial...

Artificial Intelligence May Be ‘Threat’ to Human Health, Experts Warn

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In a recent analysis published in BMJ Global Health, an international group of researchers and public health experts have argued that artificial intelligence (AI) and artificial general intelligence...

Coalition for Health AI Releases Blueprint for Trustworthy AI in Healthcare

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The Coalition for Health AI (CHAI) released its ‘Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare’ this week, which outlines recommendations to increase...

FDA Releases AI/ML-Enabled Medical Device Modification Guidance

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The Food and Drug Administration (FDA) released new draft guidance last week proposing an approach to ensure that artificial intelligence (AI) and machine learning (ML)-enabled devices can be safely...

ChatGPT Provides Accurate Information on Cancer Myths, Misconceptions

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In a study published last week in the Journal of The National Cancer Institute (JNCI) Cancer Spectrum, researchers from the University of Utah found that large language model (LLM)...

More Legal Clarification Needed For Clinical Algorithm Development, Use

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Researchers explored the intersection of clinical algorithms, anti-discrimination laws, and medical device regulation in a JAMA viewpoint published this month, arguing that recent directives from the...

More Guidance Needed to Curb Discrimination by Clinical Algorithm Use

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In a recent viewpoint published in JAMA, researchers explored the challenges of curbing discrimination by a clinical algorithm, arguing that the US Department of Health and Human Services’ (HHS)...

Coalition for Health AI Unveils Draft Blueprint for Ethical AI Implementation

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The Coalition for Health AI (CHAI) has published a draft of its ‘Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare,’ which outlines recommendations for...

Researchers Suggest Changes to FDA Oversight of AI Breast Cancer Screening

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In a special communication published this week in JAMA Internal Medicine, Yale researchers explore the current regulatory processes for artificial intelligence (AI)-based breast cancer screening tools,...

Coalition Shares Progress, Plans to Issue Responsible Health AI Guidelines

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The Coalition for Health AI (CHAI) has published papers related to the second round of workshops in its Bias, Equity, and Fairness series for public feedback and announced plans to share...

White House Unveils Artificial Intelligence Bill of Rights

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The White House unveiled its Blueprint for an AI Bill of Rights earlier this week, which identifies five guidelines for the design, use, and deployment of automated and artificial intelligence...

FDA Releases Guidance on AI-Driven Clinical Decision Support Tools

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The Food and Drug Administration (FDA) has released new guidance stating that some artificial intelligence (AI) tools should be regulated as medical devices as part of the agency’s oversight of...

ONC Expands Health Equity Data Initiative to Standardize Patient Addresses

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The Office of the National Coordinator for Health Information Technology (ONC) announced that it will incorporate recommendations from the HHS Equity Technical Assistance Center (ETAC) into the next...

HHS Awards $90M to Health Centers to Boost Health Equity Via Data Modernization

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The US Department of Health and Human Services (HHS) awarded approximately $90 million in American Rescue Plan funding to nearly 1,400 community health centers as part of an ongoing effort to advance...

Experts Propose Quality Measures for Veterans at High Risk for Adverse Outcomes

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In a consensus statement published this week in JAMA Network Open, a panel of 14 health experts and veterans identified what quality measure concepts are important to improve care for veterans at high...

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