Patient Safety

News & Analysis as of

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more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

Medicare/Medicaid Requirements for Long-Term Care Facilities

On July 13, 2015, CMS issued a much-anticipated proposed rule seeking to consolidate the long-term care (LTC) facility participation requirements for the Medicare and Medicaid programs. This major proposal marks the first...more

Update on Opposition to ABA Hijinks

Last month, we described the proposal by the American Bar Association’s Standing Committee on Medical Professional Liability concerning legislation on “defective medical products” and punitive damages for “patient harm...more

Health Alert (Australia) - June 22, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria. Inquest Into the Death of Baby Chloe Lee Kellett - The Victorian Coroner investigated an infant's death from...more

The Top 10 Patient Safety Concerns for Healthcare Organizations in 2015

The Emergency Care Research Institute, (ECRI) Patient Safety Organization (PSO) has issued its 2015 “top 10 list” of safety concerns for multiple healthcare settings, such as hospitals, ambulatory care centers, doctor’s...more

Hospital Engagement Network Contract Solicitation

CMS is requesting proposals for Hospital Engagement Network (HEN) contracts from qualified entities to work on reducing preventable hospital acquired conditions and readmissions through the Partnership for Patients...more

Recent Developments in PA and NJ Regarding Scope of Privilege for Health Care Facilities Engaged in Peer Reviews and Self-Critical...

Three recent cases offer guidance to health care entities in Pennsylvania and New Jersey regarding the discovery of documents created in connection with peer reviews, quality of care reviews and adverse event investigations...more

Are Hospitals Safer Today? Why Patient Safety Levels Remain Static

We have entered a new era in medical technologies. From electronic patient charts to robotic surgeries, hospitals have become more advanced in the types of care they provide. Despite a multitude of technological and...more

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