Regulations/Legal

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May 2024
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Session: What are the legal implications of AI in healthcare?

Editor's Note How will healthcare regulators deal with artificial intelligence? How will malpractice law change, and who will be liable for harm derived from AI diagnosis and treatment recommendations? What can be done about bias in AI? Even amid a surge in algorithms cleared by the FDA, all of these…

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By: Matt Danford
February 7, 2024
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Congressional hearing focuses on bill to protect healthcare workers from violence

Editor's Note Nearly 100 house and senate staff attended a January 30 briefing on the Safety from Violence for Healthcare Employees (SAVE) Act, a bill under congressional consideration that aims to protect healthcare workers from assault or intimidation while on the job. In addition to criminalizing these acts, the bill…

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By: Brita Belli
February 2, 2024
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New Joint Commission requirements for total hip, knee replacements focus on opioids, diabetes

Editor's Note The Joint Commission has released revised requirements for the advanced disease-specific care certification for total hip and total knee replacement (THKR). The requirements, which are designed to align with the updated AAOS clinical practice guidelines, go into effect July 1, 2024 and focus largely on addressing opioids and…

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By: Brita Belli
February 1, 2024
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FDA updates safety recall of certain saline, sterile water medical products

Editor's Note The US Food and Drug Administration (FDA) on January 24 updated its safety recall communication from November 6 to add to the voluntary recalls of saline and sterile water medical products associated with Nurse Assist, LLC. The FDA recall notice lists various water-based medical products manufactured by Nurse…

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By: Tarsilla Moura
January 31, 2024
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Impending sale of federal helium reserve raising concerns over supply chain disruptions

Editor's Note The US government's sale of the Federal Helium Reserve, a large underground helium stockpile in Amarillo, Texas, has raised concerns about the supply of helium for critical healthcare applications, especially MRI machines, NBC News reported January 25. The Federal Helium Reserve reportedly provides up to 30% of the…

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By: Tarsilla Moura
January 31, 2024
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DOJ cracking down on AI tools for clinical decision-making

Editor's Note:  The U.S. Justice Department is investigating how the healthcare industry is using artificial intelligence (AI) tools to analyze and make decisions using patients’ electronic health records (EHRs), Bloomberg Law reported January 29. So far, DOJ has served subpoenas related to EHRs to at least three major pharma companies:…

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By: Brita Belli
January 29, 2024
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Hackers use stolen identities, IT help desk to redirect hospital funds

Editor's Note:  In a sophisticated new scheme, hackers are stealing the identity of hospital employees in financial roles—such as revenue cycle employees—and then reaching out to the hospitals’ IT help desk in order to reset passwords, receive access codes, and redirect funds.  The American Hospital Association (AHA) sent out an…

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By: Brita Belli
January 26, 2024
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CMS announces new actions to support hospitals under EMTALA

Editor's Note The Department of Health and Human Services (HHS), in collaboration with the Centers for Medicare & Medicaid Services (CMS), announced a new initiative to ensure public access to emergency healthcare and assist hospitals in fulfilling obligations under the Emergency Medical Treatment and Labor Act (EMTALA), a CMS January…

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By: Tarsilla Moura
January 24, 2024
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Surgeons design implant coating to combat infections

Editor's Note: A point-of-care, antimicrobial coating for orthopedic implants could soon make implant-associated infections a problem of the past, UCLA Health reported on January 3. Developed by two UCLA surgeons, the coating is designed to kill or slow the spread of micro-organisms in order to prevent post-surgical infections. According to…

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By: Matt Danford
January 24, 2024
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CMS reforms prior authorization to improve care, streamline physician process

Editor's Note The Centers for Medicare & Medicaid Services (CMS) has implemented a final rule reforming the prior authorization process, with the aim to reduce delays in patient care and boost electronic efficiency for physicians, the American Medical Association (AMA) News Wire reported January 23. The Department of Health and…

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By: Tarsilla Moura
January 23, 2024
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