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How Clinical Decision Support Can Help Alleviate Provider Burnout

HIT Consultant

New research from Mayo Clinic Proceedings found that 63% of physicians report at least one symptom of burnout, a drastic increase from 46% in 2011. In other cases, hospitals turn to travel nurses to alleviate understaffing, improve workflows, and reduce time spent on inefficient tasks.

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Ensuring Safety and Quality in America’s Nursing Homes

CMS.gov

Ensuring Safety and Quality in America’s Nursing Homes. Nursing facilities. This duty is especially important when it comes to the care provided for some of the most vulnerable in our society, Americans residing in nursing homes. CMS’ approach to oversight of nursing homes is constantly evolving. Jeremy.Booth@c….

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Podimetrics Secures $45M for SmartMat to Prevent Diabetic Amputations in High-Risk Patients

HIT Consultant

. – With this latest round of funding, Podimetrics plans to focus on hiring to build out their product development and research teams, while also expanding the breadth of services delivered by their nurse support team. The FDA-cleared and HIPAA-compliant SmartMat are remotely monitored by Podimetrics’ in-house nurse support team.

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SQA Regulatory Surveillance Summary for January and February 2024

SQA

United States Food and Drug Administration (FDA) Regulations and Guidances FDA Reports on Good Guidance Practices, 03 January 2024 In 2011, FDA issued a report entitled “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency.”

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. 552 (2011); Thompson v. FDA , 119 F. E.g. , Sorrell v.

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PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

Drug & Device Law

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. E.g. , Kindred Nursing Centers Ltd. 604, 624-25 (2011) (FDCA preemption case). Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , Partnership v.

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