Tag: Rules and Regulations

Investigation reveals medical device safety testing concerns

Editor's Note Published December 21, a year-long investigation by KFF Health News into medical device malfunctions found that the FDA allows the sale of most medical devices, including many implants, without requiring tests for safety or effectiveness. Instead, manufacturers need to show only that they have “substantial equivalence” to an…

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By: Brita Belli
January 8, 2024
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Mastering surveys in 2024 by The Joint Commission and CMS

Takeaways • The Joint Commission eliminated 56 redundant or outdated Elements of Performance, revised four others, and is using more checklists. • The Joint Commission is emphasizing healthcare equity and identifies it as a priority to address healthcare quality and safety, calling organizations to integrate health equity into their QAPI…

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By: Uyen Vo, BSN, MBA
December 20, 2023
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First hospital joins FDA’s medical device information sharing and analysis initiative

Editor’s Note Charlotte, North Carolina-based Atrium Health is the first hospital to join the Medical Device Information Analysis and Sharing (MDIAS) public-private partnership (PPP) between the Food and Drug Administration (FDA) and private sector stakeholders. The news was announced December 12 by Mitre, a nonprofit research organization and the independent…

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By: Brita Belli
December 13, 2023
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Hospital associations file lawsuit against HHS over new website tracking rule

Editor's Note A number of prominent hospital associations have filed a lawsuit against the Department of Health and Human Services (HHS) over guidance that seeks to prohibit them from using tracking tools to monitor visitors on their websites, the American Hospital Association (AHA) November 2 reports. A few highlights of…

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By: Brita Belli
November 7, 2023
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