Healthcare policy and regulation
Healthcare policy and regulation encompass laws, guidelines and practices that govern healthcare systems and providers. These protocols ensure the quality, accessibility and affordability of healthcare services. Healthcare policy and regulation address public health concerns, patient rights, ethical standards and resource allocation to improve care quality and safety.
Top Stories
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Feature
21 Mar 2025
Health AI industry left to self-regulate as feds change course
Even as Trump rescinded AI executive orders, health AI stakeholders continue to self-regulate, creating guidelines and frameworks for safe and responsible health AI development. Continue Reading
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News
21 Jan 2025
Trump rescinds Biden's trustworthy AI development order
President Trump has rescinded a 2023 executive order that laid out guiding principles for fair and safe AI development, which has implications for healthcare AI tools. Continue Reading
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News
08 Jan 2025
FDA issues AI-enabled device lifecycle management guidance
New FDA draft guidance provides recommendations for the design, development and maintenance of AI-enabled medical devices to ensure their safety and effectiveness. Continue Reading
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Definition
21 Oct 2024
What is an electronic health record (EHR)?
An electronic health record (EHR) is an individual's official health document that's shared among multiple facilities and agencies. Continue Reading
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News
06 May 2024
Federation of State Medical Boards publishes AI governance best practices
New FSMB guidelines outline how providers can meet their professional and ethical duties when utilizing artificial intelligence in clinical settings. Continue Reading
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News
07 Feb 2024
Researchers Call for Outcome-Centric Approach to Health AI Regulation
University of California San Diego researchers argue that healthcare AI regulations should require developers to demonstrate how these tools impact patient outcomes. Continue Reading
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Answer
20 Dec 2023
How Will Biden's Executive Order on Trustworthy AI Impact Healthcare?
Legal experts detail how Biden’s executive order on safe, secure, and trustworthy artificial intelligence will impact AI regulation in healthcare. Continue Reading
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News
05 Apr 2023
FDA Releases AI/ML-Enabled Medical Device Modification Guidance
The FDA released new guidance proposing a science-based approach for AI/ML-enabled medical devices to be modified and improved more quickly. Continue Reading
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News
29 Sep 2022
FDA Releases Guidance on AI-Driven Clinical Decision Support Tools
The FDA has released new guidance recommending that some artificial intelligence-powered clinical decision support tools, like sepsis prediction devices, should be regulated as medical devices. Continue Reading