Wsgr.com

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

URL: https://www.wsgr.com/en/insights/ftc-final-rule-officially-broadens-health-breach-notification-rule-targets-health-and-wellness-apps.html

FDA Regulatory, Healthcare, and Consumer Products

WEBWilson Sonsini represents life sciences, healthcare, and consumer products companies in matters involving regulation by the F ood and D rug A dministration (FDA), the Federal …

Category:  Health Go Health

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

Category:  Health Go Health

Wilson Sonsini Advises Everlywell on Acquisition of …

WEBOn March 24, 2021, Everlywell, a leading digital health company, announced that it has acquired PWNHealth and Home Access Health Corporation and formed parent …

Category:  Health Go Health

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

Category:  Health Go Health

Wilson Sonsini’s 31st Annual Medical Device & Digital …

WEBWilson Sonsini Goodrich & Rosati’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health …

Category:  Medical Go Health

HHS OIG Announces Modernization of Compliance …

WEBThe U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is continuing its long-laid plans to update its existing …

Category:  Health Go Health

Digital Health Wilson Sonsini

WEBWilson Sonsini’s digital health clients encompass a wide array of technology-enabled, data, or AI-driven solutions that improve health and wellness through innovation. Wilson …

Category:  Health Go Health

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

U.S. Privacy Predictions: What to Watch for in 2024

WEB2023 was one of the busiest years for privacy yet—with more to come in 2024. Five new U.S. state privacy laws (in Texas, Florida, Oregon, Montana, and …

Category:  Health 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

Wilson Sonsini Advises Caption Health in Acquisition by GE …

WEBOn February 9, 2023, GE HealthCare, a leading global precision care innovator, announced that it has signed an agreement to acquire Caption Health, Inc., a privately owned …

Category:  Health Go Health

FTC, DOJ, and HHS Announce Joint Initiative to Intensify …

WEBOn March 5, 2024, the Department of Justice’s (DOJ’s) Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services (HHS) jointly …

Category:  Health Go Health

Firm Advises Redesign Health on $65 Million Series C …

WEBOn September 13, 2022, Redesign Health, a New York City-based company that builds other healthcare start-ups, closed a $65 million Series C funding round. The funding was …

Category:  Health 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 …

Category:  Health Go Health

Prescription Drug Provisions in the Build Back Better Act

WEBSome Worry Reduction in Pharmaceutical Revenues May Impact New Drug R&D and Innovation Lowering prescription drug pricing has been a hotly debated issue …

Category:  Health Go Health

EMPLOYEE COVID-19 SCREENING QUESTIONNAIRE Please …

WEB5 Have you have tested positive for COVID-19, or are you presumptively positive for COVID-19 based on your health care provider’s assessment or your symptoms?

Category:  Health Go Health

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 …

Category:  Health Go Health

Wilson Sonsini’s 30th Annual Medical Device Digital Health …

WEBThursday, June 15, 2023 - Friday, June 16, 2023. Dinner: Sharon Heights Golf and Country Club - Menlo Park, CA. Conference: Palace Hotel - San Francisco, CA. Register for …

Category:  Health Go Health