February 21st Newsletter

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Department of Health & Human Services (HHS) Office for Civil Rights Imposes a $1,500,000 Civil Money Penalty Against Warby Parker in HIPAA Cybersecurity Hacking Investigation - Warby Parker was fined $1.5 million by HHS for failing to protect nearly 200,000 individuals’ health information in a credential-stuffing cyberattack. The investigation found multiple HIPAA Security Rule violations, including inadequate risk analysis and failure to implement sufficient security measures to protect sensitive customer data. Link

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CAR T-cells enable record-breaking 18-year nerve cancer remission - A woman remains in remission 18 years after receiving CAR-T therapy for advanced pediatric neuroblastoma, marking the longest success observed for this immunotherapy in solid tumors. Her case highlights both the potential and challenges of CAR-T beyond blood cancers. Link

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AI can now model and design the genetic code for all domains of life with Evo 2 - Nvidia and the Arc Institute release largest-ever AI model for biology, trained on the genomes of more than 100,000 animals; platform may identify disease-causing mutations, design new genomes, and more. Link

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Engineers turn the body’s goo into new glue - Engineers develop "bio-glue" by combining proteins extracted from the human body with polymers inspired by mussels; biomedical adhesive is water- and bacteria-proof. Link

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Pancreatic cancer: blocked nerves as a possible new treatment strategy - Pancreatic cancer tumors reprogram adjacent nerve cells in ways that fuel tumor growth; study may lead to new ways to slow or halt the disease, which has a five-year survival rate of around 10%. Link

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Hims & Hers Acquires At-Home Lab Testing Facility, Expanding Capabilities to Ultimately Include Affordable Whole Body Testing for Subscribers - Hims & Hers will integrate at-home lab testing into its platform, allowing customers to track key health markers like hormone levels, cardiac risk, and thyroid function without traditional needles or blood spot cards. The acquisition of Trybe Labs will also enhance AI-powered care, helping providers create more personalized treatment plans based on real-time biomarker data. Link

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Promising results from first prenatal therapy for spinal muscular atrophy - Rare genetic disorder known as spinal muscular atrophy treated in the womb for the first time; patient, now 2 years old, shows no signs of the progressive neurodegenerative disorder. Link

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Ohio Becomes First State to Require Hospitals to Publish Prices - Ohio hospitals must now fully comply with federal price transparency rules under a new state law that blocks noncompliant hospitals from collecting medical debt or reporting it to credit agencies. With only 13% of Ohio hospitals previously following the federal rule, the law aims to protect patients from hidden fees and unexpected charges by requiring clear, machine-readable pricing for at least 500 services. Link

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Lumeris Introduces Tom?, an AI-Powered Breakthrough to Transform Primary Care - Lumeris has launched Tom?, an AI-powered Primary Care as a Service? solution designed to ease physician workloads and improve patient access by autonomously handling key care tasks like scheduling, medication monitoring, and outreach. Built on over 20 years of research and AI innovation, Tom integrates real-time data and social determinants of health to close the primary care gap, with backing from leading healthcare and technology partners like MIT, ōURA, and Wolters Kluwer. Link

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RECALLS:

1.??? JE Bakery 2019 LLC DBA Broadway Bakery Issues Allergy Alert for Mislabeled Raisin Bran Muffin 6 Count Due to Undeclared Walnuts.

2.??? ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling.

3.??? Mauna Loa Macadamia Nut Company, LLC Issues a Product Recall on Undeclared Almonds in Mauna Loa Milk Chocolate Covered Macadamias (1oz) Pouches.

4.??? BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep? Clear 1 mL Applicators Due to Fungal Contamination.

5.??? Naturipe Value Added Fresh LLC Issues Allergy Alert On Undeclared Wheat & Eggs In "Berry Buddies, Berries & Pancakes” Lot # 1097901.

6.??? One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadala?l.

7.??? Kedake Inc. Issues Allergy Alert on Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6 in Botana Mix Snacks.

8.??? ZB Importing Issue Voluntary Recall and Allergy Alert on Undeclared Egg, Wheat and Milk in Certain Ulker Brand Products.