Patient Safety

News & Analysis as of

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

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

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

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

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

What are experts saying about Stryker Accolade V40?

Stryker Accolade V40 LFIT Hip Implant Dissociation - Over the past few years, various orthopedic surgeons around the country and their patients have faced a catastrophic failure of Stryker’s Accolade and V40 LFIT hip...more

Are Stryker V40 Femoral Heads (CoCr) Defective?

Stryker V40 Femoral Heads (CoCr) Associated With Spontaneous and Catastrophic Head-Neck Dissociation - Stryker may face yet another crisis associated with their total hip replacement medical devices – and this time it...more

Australia Concerned About Stryker Made LFIT Femoral Heads

On September 27, 2016, the Department of Health Therapeutic Goods Administration (the Australian equivalent of the Food & Drug Administration) issued a hazard alert relating to LFIT Anatomic CoCr V40 femoral heads...more

Missed Opportunity by The Supreme Court to Address the Erosion of Hospital Self-Review Privileges

In Tibbs v. Bunnell, the U.S. Supreme Court recently denied a hospital’s petition for certiorari to review the scope of the patient safety work product privilege. The hospital appealed from a Kentucky Supreme Court decision...more

OIG Examines Adverse Events in Rehab Hospitals

According to a recent HHS Office of Inspector General (OIG) report, about 29% of Medicare beneficiaries experienced adverse or temporary harm events during their rehabilitation hospital stay, based on sample of 417...more

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

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

Illinois Supreme Court Upholds "Willful and Wanton" Immunity Protection in Peer Review Cases

Background - Dr. Steven Valfer is a licensed OB-GYN who was a member of the medical staff at Evanston Northwestern Hospital ("Hospital") until March 16, 2005 when the Hospital's board of directors approved the...more

Dental Malpractice May Be Painfully Underreported

Dental malpractice cases are often unreported because patients may not understand how to report dental mistakes. Insurance companies that represent dentists do not release details about cases. The statute of limitations also...more

CMS Releases Nursing Home Action Plan for 2016/2017

The CMS Survey and Certification Group has released its 2016/2017 Nursing Home Action Plan, which details the agency’s strategy for continuing to improve nursing home quality. The plan focuses on five strategies for quality...more

Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety,...more

Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound...more

NIH takes stronger steps to improve patient safety at Bethesda Clinical Center

Federal officials have decided to sweep out the executive ranks at the flagship hospital of the National Institutes of Health in Bethesda, this after a blue-chip investigating committee rebuked the institution and declared...more

FDA Outlines Future Medical Device Coordinating Center

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to...more

Health Law Insights Newsletter - Issue 9 - May 2016

NATIONAL - Medicare Proposes New Part B Payment System - The Center for Medicare and Medicaid Services (CMS) on April 27 proposed a new rule that would transform Medicare Part B reimbursement to practitioners into...more

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

52 Results
|
View per page
Page: of 3
Popular Topics

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×