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FTC Final Rule Officially Broadens Health Breach Notification Rule
WEBOn April 26, 2024, the Federal Trade Commission (FTC) announced a Final Rule that amends the Health Breach Notification Rule (HBNR or Rule) to significantly broaden the FTC’s enforcement power in the area of digital health. Under the Final Rule, many developers of everyday health and wellness apps (Developers) will now constitute …
Actived: 7 days ago
FTC Releases Health Products Compliance Guidance
WEBBusinesses making health claims about their products (e.g., foods and dietary supplements) or services (e.g., apps) should take note of new guidance that the Federal …
Category: Supplements, Food Go Health
New Reimbursement Rules Will Likely Impact Digital Health and
WEBThe Final Rule includes several rules relating to coverage and payment for in three areas of particular interest to our clients: telehealth services, digital remote therapeutic monitoring (RTM), and behavioral health services. The Final Rule also addresses changes to expect after the COVID-19 public health emergency (PHE) expires, which was
Home Wilson Sonsini
WEBWilson Sonsini Advises Soleno Therapeutics on $138 Million Public Offering. On May 2, 2024, Soleno Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced the pricing of the underwritten public offering of 3,000,000 shares of its common stock at a public offering
FDA Issues Framework for Digital Health Technologies in Drug …
WEBThis month, the U.S. Food and Drug Administration (FDA) released its Framework for the use of digital health technologies (DHTs) in drug and biological product development. This Framework is part of the FDA’s ongoing effort to support the increased use of DHTs for new drug applications, biologics license applications, supplements to …
Category: Supplements, Food Go Health
FDA Outlines Efforts to Modernize Regulation of Dietary …
WEBIntroduction Dietary supplements are big business. Three out of four Americans take a dietary supplement, and the rate rises to four out of five among older …
Category: Supplements Go Health
Washington State Governor Signs Sweeping Health Privacy Act (My Health …
WEBOn April 27, 2023, Washington State Governor Jay Inslee signed a far-reaching health privacy law entitled the “My Health My Data Act” (the Act), which extends protections to consumer health data collected by entities not currently covered under the Health Information Portability and Accountability Act of 1996 (HIPAA). The Act may transform …
Firm Advises Verana Health in Acquisition and $100 Million …
WEBOn February 5, 2020, San Francisco-based Verana Health, a tech start-up curating and analyzing real-world clinical data to advance patient care, announced it has acquired the technology assets and team behind PYA Analytics (PYAA), which specializes in large-scale data architecture solutions. Additionally, Verana announced the close of a …
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