Episode 315 - Boeing Pays $51 Million for ITAR Violations
Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more
AI is hungry for data. Training and testing the machine-learning tools to perform desired tasks consumes huge lakes of data. More data often means better AI....more
For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...more
On January 14, 2021, the U.S. Court of Appeals for the Fifth Circuit overturned a $4.348 million penalty for alleged HIPAA violations assessed by the U.S. Department of Health & Human Services (HHS) against the University of...more
On December 17, 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued its Industry Report on the HIPAA audits it conducted in 2016 and 2017. OCR found widespread noncompliance with...more
The Department of Health and Human Services has announced that it is lowering the maximum amount it will assess for most types of HIPAA violations. Although the change is couched as an exercise of discretion, HHS states that...more