Physician Burnout: The Next Pandemic?
Second-Wave Contingency Planning and Risk Mitigation Strategies - Diagnosing Health Care Podcast
Long-Term Care Investigations: Critical Steps To Mitigate Risk and Protect Your Residents, Staff and Reputation
Compliance Perspectives: Health Care Compliance and the COVID-19 Virus
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
On August 13, 2024, the Centers for Medicare and Medicaid Services (CMS) and its Center for Clinical Standards and Quality / Quality, Safety & Oversight Group issued its memorandum QSO-24-17-EMTALA (the “Memorandum”),...more
Two New Jersey healthcare facilities that violated the New Jersey Patient Safety Act, N.J.S.A. §§ 26:2H-12.23 to -12.25, (PSA), must provide plaintiff patients with internal reports and documents relating to adverse events,...more
Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more
Pennsylvania Superior Court holds that trial court correctly entered nonsuit on plaintiff’s corporate negligence claim for failing to show actual or constructive knowledge....more
Lahr v. Lehigh Valley Hosp., Inc., 2023 WL 8665017 (Pa. Super. Dec. 15, 2023) - The trial court had ordered production of patient safety reports which were (i) prepared in accordance with MCARE, (ii) intended to be...more
True to their word in several recent public statements, the Chief and Deputy Chief of the Medicaid Fraud Division of the Massachusetts Attorney General's Office have brought several recent criminal cases against dentists for...more
At long last, the "sole purpose" argument used by trial courts and plaintiffs' attorneys was soundly rejected in a recent decision issued by the 11th Circuit Court of Appeals, In Re: BayCare Medical Group, No. 23-12571, May...more
Does your compliance program incorporate quality and patient safety issues? Or, are you treating the two areas as separate and distinct departments? The OIG’s General Compliance Program Guidance recommends all healthcare...more
In April, we shared with you our thoughts on what to consider before opening in or investing in a medical spa, thinking about corporate structure, scope of practice, licenses and registrations, referral restrictions, HIPAA...more
On May 9, 2024, Connecticut Governor Ned Lamont signed into law Public Act No. 24-4, “An Act Concerning Emergency Department Crowding,” (The Act). The Act requires all Connecticut hospitals with an emergency department to, no...more
At the Health Care Compliance Association’s recent Annual Compliance Institute in Nashville, artificial intelligence (AI) dominated the conversation. A common theme: how does the compliance officer keep pace with this...more
Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety. However, companies seeking to advance...more
The World Health Organization (WHO) recently released guidelines for the ethics and governance of large multi-modal models (LMMs). In the past year, LMMs like Chat GPT have come to the forefront of the news, and people have...more
Last Friday, in Lahr v. Lehigh Valley Hosp., the Superior Court of Pennsylvania issued an unpublished opinion once again narrowly interpreting the scope of the statutory privilege applicable to patient safety reports prepared...more
On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and...more
Depression during pregnancy, or prepartum depression, is a common condition that an estimated ten percent of women in the United States experience. The development of selective serotonin reuptake inhibitors (“SSRI”) offered...more
Are you a diabetes patient who took Ozempic? Did you take Wegovy in hopes of losing weight? Have you suffered life-changing gastrointestinal issues since you’ve been taking Ozempic or Wegovy? If so, you are not alone....more
On Tuesday September 12, 2023, the Superior Court of Pennsylvania issued a published opinion interpreting, for the first time, the scope of the statutory privilege applicable to patient safety reports prepared under the...more
Cybersecurity attacks on health care systems continue to pose a threat to national security and to patient safety. In the webinar Cybersecurity Best Practices in Health Care presented by Clark Hill attorneys John Howard and...more
The Pennsylvania House of Representatives recently passed House Bill 106, entitled the “Patient Safety Act” (the “Bill”), which proposes specific patient-to-nurse staffing ratios, staffing plans and reporting requirements for...more
Effective July 1, 2023, The Joint Commission (TJC) is accepting applications from eligible hospitals and hospital systems for its Health Care Equity (HCE) Certification program. By way of background, TJC generally accredits...more
On June 13, 2023, Texas Governor Greg Abbott signed a major new patient safety bill into law that is intended both to reform the disciplinary authority of the Texas Medical Board (TMB) and to better protect patients from...more
Under the Patient Safety Act (PSA), a health care facility’s incident and investigative reports are “absolutely privileged”, says the New Jersey Appellate Division. Earlier this month, the court held in Keyworth v. Careone at...more
In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more
Ohio lawmakers are considering a bill – House Bill 89 – that would bar medical, nursing, and other medical-professional students from performing pelvic, prostate, or rectal exams on anesthetized or otherwise unconscious...more