News & Analysis as of

Patient Safety

Requirements for Participation Guidance for LTC Surveyors Published

by Baker Ober Health Law on

The State Operations Manual Guidance for Long Term Care Surveyors (Appendix PP), effective November 28, 2017, has undergone substantial revision. As a result of regulatory changes, the F-tags for surveys have been renumbered....more

Peer Review Not Protected: U.S. Supreme Court Will Not Disturb Florida Decision Limiting the Patient Safety and Quality...

by Baker Ober Health Law on

A multi-year discovery dispute regarding the adverse medical incident reports of a Jacksonville, Florida hospital concluded on October 2, 2017 when the United States Supreme Court denied a petition for a writ of certiorari in...more

Is Your Hospital Compliant With the Revised Joint Commission Standards for Pain Assessment and Management?

by Nossaman LLP on

On January, 1, 2018, The Joint Commission’s (“TJC”) new and revised pain assessment and management standards go into effect for TJC accredited hospitals. The changes to the standards stem from a review commenced by The Joint...more

Sixth Circuit Court Agrees with Home Healthcare Employer’s Termination of Nurse

by Seyfarth Shaw LLP on

Seyfarth Synopsis: In this case a home-care nurse complained about the quality of care her patient received from the patient’s family members. Subsequent review and inspections by the company found some “serious problems”...more

FDA Launches New Tool For Accessing Drug Adverse Event Information

by Hogan Lovells on

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D....more

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

by Baker Ober Health Law on

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

Hollywood Hills Nursing Home — Grim News

Victims of Profit? The death toll mounted again in the Broward County nursing-home disaster following Hurricane Irma. A ninth patient expired after being evacuated from The Rehabilitation Center at Hollywood Hills in the...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

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

Top 10 Health Technology Hazards for 2017

Clinicians, engineers, safety analysts and scientists at the ECRI Institute have released a looming list of things that could go wrong with modern medical devices and technology in the marketplace....more

To the Spoiler Go the Spoils: OIG Approves Limited Product Replacement Program

by Hogan Lovells on

A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes...more

OIG Makes Monthly Update to Its Work Plan

by King & Spalding on

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

Better Healthcare Newsletter from Patrick Malone - August 2017

Medicine's dirty secret: tens of thousands suffer injury and death from preventable error - Each year tens of thousands of Americans are killed by medical mistakes and errors. These avoidable deaths and the many more...more

Ministers Provide Insight on the UK's Position on the Regulation of Medicines post-Brexit

by Hogan Lovells on

With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...more

Economists’ Rx for MDs’ legal wellbeing? Practice better medicine

In the battles between lawyers and doctors over malpractice lawsuits filed by patients harmed while seeking medical services, it may be worth heeding economists’ prescription for caregivers: Physicians, heal thy selves....more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Health Care Perspectives

With deep experience in the health care industry and a comprehensive understanding of its diverse participants, Katten attorneys serve as conference moderators and panelists, host accredited events, and produce webinars to...more

Florida Supreme Court Rejects PSQIA Preemption of Florida Constitution

On January 31, 2017, the Florida Supreme Court held that adverse medical incident reports produced in accordance with Florida law cannot constitute confidential and privileged patient safety work product (PSWP) under the...more

And Now – From the Same Court That Gave Us Engle….

by Reed Smith on

That’s Engle v. Liggett Group, Inc., 945 So. 2d 1246 (Fla. 2006), the most bizarre use of res judicata that we’ve ever seen – giving preclusive effect to a class action verdict despite also finding that the class was not...more

Advocating for Patient Safety: Coalition for Patient Vision Care Safety submits comments in response to FTC Proposed Rule...

The Coalition for Patient Vision Care Safety (“Coalition”) is a group of health care providers, medical device manufacturers and academic institutions dedicated to ensuring the safe and appropriate use of contact lens so that...more

Amendment 7 Stands Its Ground Against the Federal Patient Safety and Quality Improvement Act

by BakerHostetler on

It is well known in Florida that Article X, Section 25 of the Florida Constitution (Amendment 7) provides patients with access to any adverse medical incident report (even involving other patients) created by healthcare...more

Client Alert: Florida Supreme Court Broadens Patient Access to Adverse Incident Reports

A recent decision by the Florida Supreme Court has significant implications regarding certain adverse incident reports previously viewed as outside the scope of permitted discovery. Florida health care providers currently...more

Amendment 7 Prevails Over Patient Safety Work Product Protections

by Carlton Fields on

On January 31, the Florida Supreme Court ruled that the “Patient Safety Work Product” privilege cannot shield Florida health care providers from Amendment 7 requests. The court’s decision in Charles v. Southern Baptist...more

Florida Supreme Court: Federal PSQIA Does Not Pre-empt State's Constitution

by Holland & Knight LLP on

In Charles v. Southern Baptist Hospital of Florida, Inc., published on Jan. 31, 2017, the Florida Supreme Court held that the federal Patient Safety and Quality Improvement Act (PSQIA) is not and was never intended to be a...more

FDA bans powdered gloves in human, animal medicine

by Thompson Coburn LLP on

Effective Jan. 18, 2017, the federal Food and Drug Administration has, by implementation of a final rule, banned the use of powdered gloves by a physician when treating humans or animals. Powdered gloves are now added to the...more

The AHA’s Letter to Santa Claus

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

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