HIPAA Journal

JANUARY 23, 2024

The Theranos Scandal Theranos was a blood testing startup founded by Elizabeth Holmes in 2003. The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. The company was investigated by the Federal Bureau of Investigation and shut down.

Fraud 83

Fraud FDA Medicaid Medicaid 83

SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

FDA 40

FDA Compliance COVID-19 World Health 40

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 HHS’ Office for Civil Rights in response to a patient complaint or compliance audit. To the Federal Drug Administration to report adverse events and track FDA-regulated products.

HIPAA 74

HIPAA Hospitals Compliance Medical Personnel 74

Healthcare IT Today

JANUARY 3, 2024

Jennifer Hennessy, Partner at Foley & Lardner LLP In 2024, regulators will make efforts to better align laws with modern cybersecurity risk – and organizations will need to assess their cybersecurity programs for compliance with these updates.

US Department of Health and Human Services 130

US Department of Health and Human Services Ransomware Hospitals HIPAA 130

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