News & Analysis as of

Health Care Providers Regulatory Violations Department of Health and Human Services (HHS)

Orrick, Herrington & Sutcliffe LLP

Medical Devices, Cybersecurity & The False Claims Act: What are the Key Takeaways from the Illumina - DOJ Settlement?

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

McDermott Will & Schulte

[Webinar] Regulatory Disputes with HHS: When to Negotiate and When to Litigate - March 25th, 12:00 pm - 1:00 pm EST

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

Bricker Graydon LLP

HHS OCR announces results of most recent round of HIPAA audits

Bricker Graydon LLP on

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

Ballard Spahr LLP

HHS Decreases Maximum HIPAA Penalties

Ballard Spahr LLP on

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

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