LITIGATION ROUND-UP

Settlements Sanofi-Aventis reached a settlement in August 2013 with the Maryland Attorney General and other states for alleged violations of federal and state anti-kickback statutes related to its osteoarthritis drug Hyalgan.  The government alleged that Sanofi provided free Hyalgan units with knowledge that doctors could receive Medicaid reimbursement and/or were expected to buy additional quantities […]

Constitutional Challenge to HIPAA: HHS Responds

The U.S. Department of Health and Human Services (“HHS”) has responded to a legal challenge filed last week alleging that the Final HIPAA Omnibus Rule (the “Omnibus Rule”) is unconstitutional because it infringes on the First Amendment.  Adheris, Inc. (“Adheris”), a company that sends patients prescription refill reminders and educational […]

Constitutional Challenge to HIPAA

On September 6, 2013, Adheris, Inc. (“Adheris”), an inVentiv company that works with pharmacies and pharmaceutical manufacturers to send medication refill reminders and educational information regarding diseases to patients, filed suit against the U.S. Department of Health and Human Services (“HHS”).  Adheris alleges that certain provisions of the Final HIPAA Omnibus […]

Innovator Spotlight: Sally Poblete, Founder & CEO, Wellthie, Inc. — http://wellthie.com

We will be posting feature articles from time to time in an effort to showcase various industry leaders and their exciting contributions to the health care and life sciences industries. When Sally Poblete decided to start Wellthie, Inc., she had one primary goal in mind: to make health care delivery […]

Resource Launch: Introducing Cooley’s HIPAA Privacy and Security Enforcement Tracking Chart

Today, we added an exciting new resource to our blog: a tracking chart that provides an overview of select privacy and security settlements related to the Health Insurance Portability and Accountability Act (HIPAA). Included in the tracking chart are summaries of allegations, settlement amounts, descriptions of corrective action plans, and […]

Mobile Health Apps Implicate Data Privacy and Security Laws

Privacy concerns regarding mobile devices in health care are raising eyebrows and making headlines. The Telegraph reports that “health and fitness apps have been harvesting sensitive personal data and passing it on to insurance and pharmaceutical companies” although “apps companies . . . have denied that the information is personally […]

Final Rule Released on ACA’s Individual Shared Responsibility Payment

On August 27, 2013, the Internal Revenue Service (“IRS”) and the U.S. Department of Treasury (the “Treasury Department”) released a final rule, Shared Responsibility Payment for Not Maintaining Minimum Essential Coverage, (the “Final Rule”), which was published in the Federal Register today, to implement the individual shared responsibility provision provided for under […]