Patient Safety

News & Analysis as of

CMS Finalizes Updated Fire Safety Standards for Health Care Facilities

On May 4, 2016, CMS is publishing a final rule amending fire safety standards applicable to the following types of Medicare- and Medicaid-participating health care facilities: hospitals, critical access hospitals, long-term...more

NLRB Rejects General Employee Behavior Standards in Code of Conduct

The National Labor Relations Board continues its assault on employer handbooks and other policies it considers to impede employees’ rights to engage in protected concerted activity under Section 7 of the NLRA. Last month, the...more

AFFs, BPs, ONJ: Understanding Alphabet Soup of Osteoporosis Treatment

The American Society for Bone and Mineral Research recently reassessed the efficacy of bisphosphonate, long hailed as a wonder drug for patients with osteoporosis, and its risk factors. Through the course of two clinical...more

FDA Proposes Ban on Powdered Gloves

The U.S. Food and Drug Administration has announced a proposal to ban most powdered medical gloves in the United States due to a health risk posed to patients....more

GAO Examines Hospital Challenges in Implementing Patient Safety Practices

The Government Accountability Office (GAO) has issued a report focusing on the roadblocks hospitals face in implementing evidence-based patient safety practices, such as the use of antiseptics to reduce Central...more

The 2017 Exchange Regulations: Network Adequacy Challenges Remain

The Centers for Medicare and Medicaid Services (CMS) recently issued the final 2017 Benefit and Payment Parameters Rule (Final Rule) and concurrently released a final 2017 Letter to Issuers (Letter to Issuers) in the...more

Field Trips, Resident Safety and Liability: Considerations for Long Term Care Facilities

In virtually any skilled nursing or assisted living facility, activities for senior residents are an integral part of the facility's operations. Many facilities tout or advertise the activities that their facility offers to...more

GAO Report Identifies Three Major Obstacles to Implementing Patient Safety Practices in Hospitals

On February 25, 2016, the Government Accountability Office (GAO) issued a report detailing the findings of a review of information on the implementation of patient safety practices in hospitals, focusing on hand hygiene and...more

FTC Again Urges Consideration of Competitive Impact on State Regulation of APRNs

The Federal Trade Commission (FTC) submitted written comments last week on the likely competitive impact of a legislative proposal in West Virginia to modify the supervision requirements imposed on Advanced Practice...more

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

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

Laboratory Developed Tests Emerging in FDA Regulation

Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...more

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

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

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

Federal Preemption and Peer Review - A New Frontier

It’s not often that we get to blog about a new area of federal preemption, but we do so today. This isn’t a big area, otherwise we would have known about it before, but it is pertinent to drug and medical device product...more

Culture of Safety Wins: Federal Patient Safety Law Preempts Amendment 7

Florida’s First District Court of Appeal issued its opinion in the highly watched case of Southern Baptist Hospital of Florida, Inc. v. Charles et al. The First District Court ruled that the federal Patient Safety and Quality...more

Health Hackers: Problems in Applying Traditional Products Liability Theories to Latent Cyber-Vulnerabilities in Medical Devices

October is National Cyber Security Awareness Month (yes, that’s a thing), so it seems fitting to write about an unprecedented alert recently released by the FDA to health care providers that warned of a medical device’s...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Diagnostic Errors: Overlooked and Critically Important

People make mistakes in any line of work, and diagnosing a medical problem is no exception. But new research shows that diagnostic errors not only aren’t rare, they’re disturbingly common. Almost all U.S. residents will be...more

Medical Device Cybersecurity: Maybe Dick Cheney Was Not So Paranoid After All

Dick Cheney famously disclosed a few years ago that he had the wireless function of his pacemaker disconnected while he was Vice President because he was concerned that hackers might fiddle with the device remotely and do him...more

Cybersecurity for Medical Devices: A Risk Mitigation Checklist for In-House Counsel

Just this summer, a cybersecurity firm issued a report widely cited in the media detailing cases where unnamed hospitals were allegedly hit by data breaches after medical devices (identified only generically as a blood gas...more

The Patient Safety Act goes [back] to Washington

The scope of a little-known but nonetheless significant federal healthcare law, the Patient Safety and Quality Improvement Act ("Patient Safety Act), may soon be considered by the United States Supreme Court. In a petition...more

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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