Policy and Regulation

WHO Releases Governance Guidelines for Generative Artificial Intelligence

January 22, 2024 - The World Health Organization (WHO) has released new guidance on the governance of large multi-modal models (LMMs) – a type of generative artificial intelligence (AI) – in healthcare. The publication contains over 40 recommendations for governments, technology companies, and providers to ensure that healthcare LMMs are used...


More Articles

Exploring the National Academy of Medicine’s AI Code of Conduct

by Shania Kennedy

The question of how the healthcare industry can leverage artificial intelligence (AI) ethically and responsibly has become a hot topic in recent years. Throughout 2022 and 2023, industry professionals, policymakers, and regulatory...

How Will Biden’s Executive Order on Trustworthy AI Impact Healthcare?

by Shania Kennedy

In October, President Joe Biden signed the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI). The order establishes guardrails focused on promoting safety and security, protecting...

AMA Establishes New Principles for AI Development, Deployment and Use

by Shania Kennedy

The American Medical Association (AMA) issued new principles to guide the development, deployment and use of augmented intelligence (AI) in healthcare, according to a press release shared with...

Biden Issues Executive Order to Ensure Safe, Secure AI Development

by Shania Kennedy

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,”...

American Heart Association Releases Guidance for Patient Data Sharing

by Shania Kennedy

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,...

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

by Shania Kennedy

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...

Researchers Identify Barriers to AI Integration into Clinical Practice

by Shania Kennedy

Researchers from the University of Miami Miller School of Medicine, Weill Cornell Medicine, and technology innovation firm Covered By Group have identified barriers that early-stage digital health...

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

by Shania Kennedy

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...

FDA Releases AI/ML-Enabled Medical Device Modification Guidance

by Shania Kennedy

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...

More Legal Clarification Needed For Clinical Algorithm Development, Use

by Shania Kennedy

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

by Shania Kennedy

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)...

How Does the White House AI Bill of Rights Apply to Healthcare?

by Shania Kennedy

In October, the White House unveiled its Blueprint for an AI Bill of Rights, providing guidelines for the design, use, and deployment of AI-based tools to protect Americans from harm as the use of these technologies continues to grow in...

Researchers Suggest Changes to FDA Oversight of AI Breast Cancer Screening

by Shania Kennedy

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,...

FDA Releases Guidance on AI-Driven Clinical Decision Support Tools

by Shania Kennedy

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...

Researchers Call for ‘Reimbursement Framework’ for Healthcare AI

by Shania Kennedy

A paper published in npj Digital Medicine earlier this month outlines a potential “reimbursement framework” for the adoption of healthcare artificial intelligence (AI), which researchers...

New Data Reveals Massive Spike in Self-Harm, Suicide Calls Among Adolescents

by Mark Melchionna

While reviewing data from the peak of the COVID-19 pandemic, researchers from the Washington Poison Center (WAPC) found that there was a substantial increase in reports of self-harm and suicide among...

Researchers Call for ‘Distributed Approach’ to Clinical AI Regulation

by Shania Kennedy

Researchers argue that the national, centralized regulation of clinical artificial intelligence (AI) is not sufficient and instead propose a hybrid model of centralized and decentralized...

Stakeholders Urge White House’s AI Office to Include Healthcare

by Shania Kennedy

In a letter to the chair and vice-chair of the National Artificial Intelligence Initiative Office (NAIIO), healthcare and technology stakeholders asked that healthcare be included in the scope of its...

Mayo, CDC Leaders: Policy, Coalitions Key Barriers to Data Modernization

by Shania Kennedy

To prepare for the next pandemic, healthcare leaders believe that data modernization is key, but several challenges stand in the way, including conflicting policies, lack of interoperability, and the...