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Compliance Tip of the Day: Design Objectives for Compliance Training
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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
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The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.”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
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
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 In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
Virtual Forum on Obstetric Malpractice Claims is taking place on November 18th EST. During this one-of-a-kind event, our unparalleled faculty of claims specialists, risk managers, medical experts – as well as an outstanding...more
Obstetrics malpractice claims continue to be the most expensive within the medical malpractice arena. In 2019, there were several multi-million-dollar verdicts alone. During this one of a kind event, our unparalleled...more
It is no surprise that COVID-19 whistleblower lawsuits are being filed against healthcare employers – and a recent claim filed by a former assistant director at a nursing home facility reveals ways in which healthcare...more
Join us as they share their insights on risk management, compliance, and litigation and help you develop the necessary strategies to avoid mistakes that cost facilities millions in jury verdicts annually. This year’s...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...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
On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more
With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more
Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more
Incident reports involving patient care can be protected by Ohio’s peer review privilege. They can also be protected under the Patient Safety Quality Improvement Act (PSQIA), the federal statute creating patient safety...more
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