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
Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class action complaint in the Central District of California on August 30, 2023, by users of Medtronic’s InPen® system. The lawsuit alleges...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
Renown Health, P.C. (Renown), a non-profit health system in Nevada, settled with the U.S. Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services in a matter resulting from an enforcement action for...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
In 2019, the Department of Health and Human Services Office of Civil Rights (OCR) announced the Right of Access Initiative, promising to vigorously enforce the rights of patients to receive copies of their medical records...more
Although the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) may yet announce one or two year-end settlements, it appears that 2019 will be known more for the implementation of changes in...more
The U.S. Department of Health and Human Services Office of Civil Rights (OCR) imposed $2,154,000 in civil monetary penalties against Jackson Health System in Florida for failing to meet HIPAA privacy and security...more
The latest HIPAA resolution agreement by the U.S. Department of Health and Human Services Office for Civil Rights (OCR) is a reminder that healthcare providers must take the high road when responding to unflattering online...more
The Office for Civil Rights (OCR) at the Department of Health and Human Services announced it reached a settlement with Elite Dental Associates of Dallas (Elite) to resolve a complaint alleging Elite impermissibly disclosed a...more
Over the past several years, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) has taken various steps to ensure compliance with the right of access by covered entities. The Phase 2 audits...more
On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual...more
Uber went big on Thursday. Unfortunately, for everyone (including fans of cinnamon gum and oversized gingers) it was Big Red, as the ride-hailing company posted a $5.2 billion loss for Q2—its largest ever since it began...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
On Friday, April 26, the Department of Health and Human Services (HHS) issued a notice regarding maximum penalties for HIPAA violations. HHS has now stated that it is exercising its discretion in how it applies the assessment...more
HIPAA penalties vary depending on the type of conduct involved. (45 CFR § 160.404). Under HHS’s prior interpretation, the types of violations were all subject to an annual maximum penalty of $1,500,000 for identical types of...more
In December 2018, twelve state Attorneys General ("AGs") jointly filed suit against Medical Informatics Engineering, Inc. (“MIE”) claiming it violated the Health Insurance Portability and Accountability Act and its related...more
Imagine a breach in the privacy of protected health information. The violation of an individual’s HIPAA rights may be clear, but the individual cannot sue under HIPAA. Courts have consistently held that HIPAA provides no...more
The Second Circuit has affirmed a lower court decision that a flu shot reminder sent by text message by a medical provider did not violate the Telephone Consumer Protection Act (the “TCPA”). The decision is important because...more