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FDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners
In June 2024, the U.S. Food and Drug Administration (“FDA”) clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution requirements beyond November 27, 2024….By: Epstein Becker & Green
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AI Watch: Global regulatory tracker – United Kingdom
The UK prioritizes a flexible framework over comprehensive regulation and emphasizes sector-specific laws. Laws/Regulations directly regulating AI (the “AI Regulations”) The UK government’s AI Regulation White Paper of August 3, 2023 (the “White Paper”) and its written response of February 6, 2024 to the feedback it received as part of its consultation on the White…
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SEC Cyber Enforcement Update: Which Way Are the SolarWinds Blowing? (Update)
This Holland & Knight blog post is the second installment in a two-part series that examines the challenges to the U.S. Securities and Exchange Commission’s (SEC) charges in its landmark case against SolarWinds Corp. (SolarWinds) and the company’s Chief Information Security Officer (CISO) Timothy Brown. Part 1 examined the SEC’s material misrepresentation claims and provided……By:…
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M+ Check-Up: July 26, 2024
House Oversight and Accountability Committee Holds Hearing on PBMs. Republicans and Democrats shared concerns about the role and practices of PBMs. While generally supportive of free market principles, Republicans criticized PBMs for alleged lack of transparency and anticompetitive behaviors, such as vertical integration and the use of arrangements that allow PBMs to fall outside certain…
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Qualtrics Notifies Blue Cross Blue Shield of North Carolina Customers of Recent Data Breach
On July 19, 2024, Qualtrics, LLC filed a notice of data breach with the Attorney General of Montana after discovering that confidential information belonging to certain Blue Cross Blue Shield of North Carolina (“BCBS NC”) members was leaked following a cyberattack against Qualtrics. In this notice, Qualtrics explains that the incident resulted in an unauthorized…
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United of Omaha Life Insurance Company Announces Data Breach Following Phishing Attack
On July 26, 2024, United of Omaha Life Insurance Company (“Mutual of Omaha”) filed a notice of data breach with the Attorney General of California after discovering that an employee email account was compromised. In this notice, Mutual of Omaha explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive…
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HairClub for Men Notifies Consumers of October 2023 Data Breach
On July 24, 2024, HairClub for Men, Ltd., Inc. filed a notice of data breach with the Attorney General of California after discovering that an unauthorized party was able to access portions of the company’s computer network. In this notice, HairClub explains that the incident resulted in an unauthorized party being able to access consumers’…
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Northeast Rehabilitation Hospital Network Notifies Patients of Data Breach
On July 19, 2024, Northeast Rehabilitation Hospital Network (“NRHN”) filed a notice of data breach with the U.S. Department of Health and Human Services Office for Civil Rights after discovering that certain information stored on the company’s computer network were taken without authorization….By: Console and Associates, P.C.
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HealthEquity Notifies 4.3 Million Consumers of March 2024 Data Breach
On July 26, 2024, HealthEquity Inc. filed a notice of data breach with the Attorney General of Maine after discovering that an unauthorized party was able to access portions of its computer network. In this notice, HealthEquity explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive information, which includes…
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Olympic Gymnast Suni Lee Overcame Stalkers, Kidney Disease and Doubt
Sunisa Lee, the all-around women’s champion at the Tokyo Olympics, overcame personal strife, family expectations and serious illness to get to Paris.
