Bethany Hills, Chair of Mintz Levin's FDA Practice, discusses the difference between a de novo submissions and 510k submissions, and the benefits of utilizing the de novo pathway.

Federal and state agencies will gain more power to fight health care fraud, waste, and abuse under program integrity regulations recently finalized by the Centers for Medicare & Medicaid Services (CMS).

As we gear up for a busy week in Washington, D.C., our colleagues at ML Strategies have provided a Health Care Weekly Preview.

The Patient Protection and Affordable Care Act fundamentally changes the way that health insurance is regulated in the United States.

This week, Congress returns to Washington with 11 days to finalize a government spending bill.

ML Strategies has posted its weekly Health Care Reform Update.

ML Strategies has posted its weekly Health Care Reform Update.

ML Strategies has posted its weekly Health Care Update.

ML Strategies has posted its weekly Health Care Reform Update.

In an April 22, 2015 letter to the New York State Department of Health, the Federal Trade Commission cautioned that part of the state’s Medicaid reform program may sanction anticompetitive behavior.

In response to a recent lawsuit and outcry from a variety of players in the health care market, the Department of Health and Human Services has committed to issuing guidance by September 23rd on the drug refill provisions in the HIPAA Omnibus Rule.

MSSP accountable care organizations created under the authority of the Affordable Care Act.

The CMS has finally published the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days.

Plaintiffs’ firms looking to capitalize on the growth in whistleblower litigation are turning to smart phone technology to try to gain a competitive edge.

April 1st is rapidly approaching! Last week, we published an alert discussing why it is important to file your H-1B visa petitions and what the cap, or numerical limit on petitions, means for employers.

On February 6, 2015, a US District Court issued a ruling which underscores the territorial nature of trademark rights and the need to seek formal protection for your marks where possible in all countries of interest.

In October 2013, we reported that the EPO had removed the time limits for filing divisonal applications.

According to Cynthia Larose, Chair of our Privacy & Security Practice, mobile app developers have some unique challenges when it comes to preparation and implementation of privacy policies.

Following up on our recent post on the Adobe data breach, I had the opportunity to speak with Colin O’Keefe of LXBN on the subject. In the brief video interview, I explain the details of the data breach and also share my thoughts on potential litigation we may see as a result.

As many are already aware, the City of Harrisburg, Pennsylvania filed a Chapter 9 bankruptcy late Tuesday evening, October 11 in advance of a Pennsylvania state senate vote that may have put the city on the path to a receivership.