Patient Safety

News & Analysis as of

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

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

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