Healthcare IT Today

JANUARY 3, 2024

The HIPAA Security Rule was drafted in 2003 and has not been substantively updated since that time. While this issue has gained the attention of the government, leading them to release the National Cybersecurity Workforce and Education Plan, the reality is that it will take a significant amount of time to bridge this gap.

US Department of Health and Human Services 130

US Department of Health and Human Services Ransomware Hospitals HIPAA 130

HIPAA Journal

APRIL 5, 2023

The page reveals that, since 2003, the agency has received more than 300,000 complaints alleging violations of HIPAA. To the Federal Drug Administration to report adverse events and track FDA-regulated products. To personal representatives of adult patients and unemancipated minor patients.

HIPAA 74

HIPAA Hospitals Compliance Medical Personnel 74

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. Both talk a fair amount about “commerce” and the respective roles of the states and federal government. 644 (2003), but not to Pike. Walsh , 538 U.S.

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

DECEMBER 12, 2022

The allegations in the complaint thus fell within the scope of the Vaccine Act, which governs all claims “for damages arising from a vaccine-related injury or death associated with the administration of a vaccine.” 2003), and Doe v. that they would not have received otherwise.” at *2 (citation to complaint omitted). Merck & Co.

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

JANUARY 26, 2024

Medical products based on human tissue have been around for a long time, and they are regulated by the FDA. 18, 2024), which applied the Illinois statute governing blood and organ transactions to dismiss strict liability and warranty claims. 2d 640, 653 (2003)). That is the holding of Zydek v. Aziyo Biologics, Inc. ,

FDA 52

FDA Governance 52

Drug & Device Law

NOVEMBER 16, 2023

GlaxoSmithKline , 2023 IL App (1st) 221666 (2003). Information disclosed in JAMA’s privilege log revealed that JAMA had communicated with an unidentified government official in connection with its decision to drop the original version of the article at issue. The court granted the motion and JAMA appealed.

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FDA Governance 64