PatentNext Takeaway: This post highlights the FDA’s increasing regulatory efforts for artificial intelligence (AI) and machine learning (ML)-enabled medical devices (MLMDs), with a focus on managing device AI/ML updates through Predetermined Change Control Plans (PCCPs). The FDA emphasizes five guiding principles for PCCPs to ensure safety, risk management, and transparency for MLMDs throughout their lifecycle….
Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen to the Daily Compliance News. All from the Compliance Podcast Network. Each day, we consider four stories from the business world: compliance, ethics,…
In a pair of letters, 195 members of Congress recently urged leadership to extend the enhanced premium tax credits that will expire in 2025. The enhanced premium tax credits — which were introduced in 2021 — lowered health insurance premium costs for millions of people purchasing coverage on the marketplace. One of the letters was…
Main: Aurora Hartley discusses the shock of retrieving her stillborn child’s birthing blanket only to find the remains of a child still in the blanket. Inset: The birthing blanket and hospital bracelet for Hadley Hartley is show. (Screengrabs via KWTV) An Oklahoma woman is taking legal action against a local funeral home after she says…
The Georgia State Election Board approved a new on rule on Friday, which will require all paper ballots to be counted by hand for the election in November. The rule will require three poll officers to independently count each box of ballots. Any discrepancies found between the hand count and recorded totals are required to…
Argentina has approved a new national plan on the prevention and control of Trichinella. The National Service for Agri-Food Health and Quality (Senasa) said the move updates the regulations on the management of the disease throughout the country. The aim is to reduce cases in humans through the early detection of animals with parasites and directing…
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. As part of the House’s “China Week”—focusing on legislation to curb threats from Beijing—the House passed the BIOSECURE Act (H.R. 8333) on September 9 with strong bipartisan support (in a…
Sheriff Allegedly Shot Judge In His Chambers: The sheriff surrendered shortly after. Put This In Your Outline: Law Professor visually assaults students deploys legitimate pedagogical tactic of teaching via hardcore pornography. Democracy Matters: Amy Coney Barrett sings democracy’s praises. Wish her jurisprudence did the same. Feels And Judgement: Do judicial feelings determine legal outcomes? Honestly,…
Left to right: Heather Alice Lang Vass and Carlos Chacon in court (KGTV) Inset: Megan Espinoza (Glen Abbey Memorial Park & Mortuary). A California plastic surgeon and his nurse were sentenced for their roles in a botched plastic surgery that killed a patient and mother of two. Dr. Carlos Chacon was sentenced on Friday to…
Brazil’s Supreme Court ordered social media platform X (formerly Twitter) to pay a daily fine of R$5 million ($900,000 USD) on Thursday following the platform’s failure to comply with the court’s order to suspend its operation in Brazil. The decision comes after Brazil’s National Telecommunications Agency (ANATEL) reported an update to X’s application that provided…
