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
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
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
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
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
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
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
In the aftermath of the COVID-19 pandemic, we now know that well over 1,000 nursing homes “experienced an average overall mortality rate approaching 20%”, according to a recent report from the Office of Inspector General...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
The federal Patient Safety and Quality Improvement Act of 2005 (PSQIA) established a voluntary reporting system for licensed health care facilities and professionals designed to "enhance the data available to assess and...more
The case has rocked the medical profession. On March 25, 2022, a Tennessee jury found a former Vanderbilt University Medical Center nurse guilty of criminally negligent homicide and negligent abuse of an impaired adult....more
Editor’s Note: In January 2021, Manatt Health described the ten health care imperatives essential for improving our health care system and advancing health equity....more
Florida is continuing its efforts to improve patient safety in hospitals and ambulatory surgical centers (ASCs). The Florida Legislature previously approved a requirement that hospitals and ambulatory surgical centers (ASCs)...more
Wealthy investors want to enrich themselves yet more, partly by pushing doctors to oust patients from their practices unless they sign away invaluable constitutional rights. These rights can protect them if they are harmed...more
Katten has prepared the following advisory on the new appellate court decision in Pennsylvania interpreting the scope of privilege protections under the Patient Safety Act and Pennsylvania’s Peer Review Protection Act (PRPA)....more
The application of EMTALA to psychiatric hospitals has long presented compliance concerns for psychiatric hospital providers. To provide clarity, the CMS recently released two memos that offer incremental additional guidance....more
On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more
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
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
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
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