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
The medical spa industry is rapidly growing, driven by technological advances and shifting consumer preferences for cosmetic and wellness services. While this growth offers many business opportunities for healthcare...more
News Briefs - Congress Extends Telehealth Flexibilities for Another Six Months - Pandemic-related telehealth flexibilities set to expire March 31 have recently been extended for another six months as federal lawmakers approve...more
The Ohio Board of Pharmacy (“Board”) published two new rules aimed at preventing and rooting out dispensing errors. The first new rule requires pharmacies to implement quality assurance programs for dispensing errors. The...more
A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more
Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more
Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs). Under the Biden...more
When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more
Medical visits can be overwhelming, especially when faced with complex diagnoses, unfamiliar medical jargon, or time constraints. However, being proactive during your appointment is critical to ensuring your health concerns...more
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
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