• Posts by Raja Sékaran
    Partner

    Raja Sékaran has practiced in the healthcare industry for twenty-five years. He represents healthcare delivery systems, health plans, hospitals, Federally Qualified Health Centers, dialysis centers, medical groups, medical ...

FDA Policy for Mobile Medical Applications

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify its regulatory stance on digital health tools, the agency released a revised guidance in 2019 entitled, Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (the “Guidance”) ... 

SCOTUS Stretches the Statute of Limitations Period for False Claims

The U.S. Supreme Court is now in its summer recess and we anecdotally have heard of Justice “sightings” in Europe and beyond.  This last session of the Court addressed many issues capturing both the political and popular imagination.  Less headline-grabbing and relatively modest in length (at only nine pages) was Justice Clarence Thomas’ opinion for a unanimous Court in Cochise Consultancy, Inc. et al. v. U.S. ex rel. Hunt.  (587 U.S. ____ (2019))  It directly impacts our healthcare compliance practice here at Nossaman by interpreting the statute of limitations for a False Claims Act (“FCA”) case so as to stretch it as long as possible.

Last Thursday, a jury in federal district court in St. Louis handed down a verdict in a False Claims Act (FCA) case that presents a laundry list of the challenges which can arise in a FCA case.  This one includes kickback allegations, Stark issues, both state and federal claims, individual liability, civil-criminal cooperation, a criminal indictment (later dropped), and even family law.  The defendants are neurologist, Dr. Sonjay Fonn, and his fiancee of nine years, Deborah Seeger, as well as their respective medical practice and medical device distributorship.

The verdict found ...

Our Health Law Ticker is a one-stop resource for everything new and noteworthy in healthcare law.  We cover recent developments in healthcare legislation, healthcare reform, Medicare/Medicaid, managed care, litigation, regulatory compliance, HIPAA, privacy, peer review, medical staffs and general business operations for healthcare companies and licensed healthcare professionals.

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