The Countdown to October 1, 2013: HHS Builds Partnerships to Increase Enrollment in the Marketplace

The Secretary of the U.S. Department of Health and Human Services  (HHS), Kathleen Sebelius, recently announced partnerships with pharmacies to increase enrollment in the Health Insurance  Marketplace, which is scheduled to open for enrollment on October 1, 2013. According to the announcement, these pharmacies will “take an active role in outreach and education to […]

Regulator Panel at FDLI’s Advertising & Promotion Conference

The Food and Drug Law Institute (FDLI) is hosting its annual Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologic & Veterinary Medicine Industries this week in Washington DC. The conference kicked off this morning with the highly anticipated Food and Drug Administration (FDA) regulator panel that included Thomas […]

Available Now: FDA’s Final Guidance on Wireless Medical Devices

While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical […]

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 […]