News & Analysis as of

Department of Health and Human Services (HHS) Patient Safety

Holland & Hart LLP

CMS Updates EMTALA Signage for Hospitals

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On August 13, 2024, the Centers for Medicare and Medicaid Services (CMS) and its Center for Clinical Standards and Quality / Quality, Safety & Oversight Group issued its memorandum QSO-24-17-EMTALA (the “Memorandum”),...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 31, Number 18. News Briefs: May 2022

Report on Medicare Compliance 31 no. 18 (May 16, 2022) - In a new report, the HHS Office of Inspector General (OIG) said 25% of Medicare beneficiaries experienced patient harm (adverse events and temporary harm events)...more

Epstein Becker & Green

CMS Releases Draft Guidance on Shared Space Arrangements

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The Centers for Medicare & Medicaid Services (“CMS”) recently released draft guidance for state survey agencies regarding shared space and co-location arrangements between hospitals and other hospitals or health care...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

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• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

Baker Donelson

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

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A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

Holland & Knight LLP

Healthcare Law Update: September 2017

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OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

King & Spalding

OIG Makes Monthly Update to Its Work Plan

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Last month, the HHS Office of Inspector General (OIG) announced that it would start updating its Work Plan website on a monthly basis instead of only once or twice per year. Consistent with this new initiative, the OIG...more

Robinson+Cole Data Privacy + Security Insider

HHS guidance seeks to clarify scope of PSQIA

On May 24, 2016, the Department of Health & Human Services (HHS) issued guidance (Guidance) to health care providers and patient safety organizations (PSOs) in an attempt to clarify the definition of patient safety work...more

Mintz - Health Care Viewpoints

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

Baker Donelson

WEBINAR: Protecting Your Patients, Workforce and Visitors from Workplace Violence and Active Shooters

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The Ober|Kaler Health Care General Counsel Institute presented this webinar on key considerations for health care facilities in protecting patients, workers and visitors from workplace violence and active shooter situations....more

Katten Muchin Rosenman LLP

The Changing PSO Landscape: National & Legal Perspectives – A Deeper Dive

Katten partner Michael Callahan recently presented a webinar, “The Changing PSO Landscape: National & Legal Perspectives.” The session covered in-depth the legal aspects, interpretations and status of court cases that have...more

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