Keyless Ignitions and the Dangers of Carbon Monoxide Poisoning
Straight Talks: Autonomous regulations around the world
Straight Talks: Innovations in product liability for autonomous and connected vehicles
In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a global supply chain, rapid...more
While we wait for long-anticipated federal regulations from the Occupational Safety and Health Administration (OSHA) addressing the issue of workplace violence in health care, activity continues at the state level....more
CMS published its FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule on August 1, 2024. Under this final rule, CMS is implementing several changes to its Hospital Inpatient Quality Reporting...more
A first-of-its-kind executive order issued October 2023 already has the voluntary commitment of several major technology companies — here’s why. Just last week, President Joe Biden signed a new, first-of-its-kind AI...more
On October 30, 2023, President Biden issued an “Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence” designed to spur new AI safety and security standards, encourage the development of privacy-preserving...more
On September 29, 2022, the United States Government Accountability Office (“GAO”) and the National Academy of Medicine (“NAM”) jointly published a detailed Report to Congressional Requesters titled Artificial Intelligence in...more
Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and their...more
The Department of Labor’s Occupational Safety and Health Administration (OSHA) recently issued a COVID-19 Emergency Temporary Standard (ETS) for the healthcare industry. The new standard focuses on protecting healthcare...more
Nevada recently enacted a pair of COVID-19 related laws that reward businesses for adhering to safety standards and carry the threat of serious business interruption for any that don’t. The first law grants legal immunity...more
A few months back, I posted some thoughts about recent efforts to legalize medical and recreational marijuana, with an emphasis on the potential issues such laws would have on manufacturers – particularly manufacturers in a...more
On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals...more
On November 3, 2016, the National Labor Relations Board issued a Decision and Order in Trump Ruffin Commercial, LLC, finding that the Trump International Hotel, Las Vegas unlawfully refused to bargain with UNITE HERE...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
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