Research-related payments and the Physician Payment Sunshine Act: how reporting works and what applicable manufacturers should consider *

USA - March 6 2013
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and…

Co-authors: Elinor L. Hart, Frederick R. Ball.

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FCC releases decision on new funding program for rural health: broadband connectivity prioritized and the expansion of telemedicine and mHealth continues *

USA - January 2 2013
Federal Communications Commission (FCC; the "Commission") decision making continues to be active in the area of telemedicine. Recently, on December 21…

Co-authors: C. Mitchell Goldman, Lisa W. Clark, William K. Keane.

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FDA suspends Sunland, Inc.; major peanut butter producer hit with first food facility suspension under the Food Safety Modernization Act of 2011 *

USA - November 30 2012
On November 26, 2012, the U.S. Food and Drug Administration (FDA) announced the suspension of the registration of Sunland, Inc., a producer of nuts, and nut and seed spreads, pursuant to the FDA's authority under Section 102 of the Food Safety Modernization Act of 2011.

Co-authors: Elinor L. Hart, Frederick R. Ball.

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Alivecor veterinary ECG model paves FDA-friendly path to the market *

USA - November 14 2012
In a recent move that mobile medical application developers may want to emulate, AliveCor—the developer of a mobile electrocardiogram (ECG) system awaiting U.S. Food and Drug Administration (FDA) blessing for human use—has introduced what appears to be essentially the identical product for the veterinary market, and without getting FDA's permission.

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D.C. Circuit affirms HHS power to disqualify corporate officials convicted of misdemeanors under the Responsible Corporate Official (RCO) doctrine *

USA - August 8 2012
On July 27, 2012, the U.S. Court of Appeals for the D.C. Circuit issued the long-anticipated decision in Friedman v. Sebelius.

Co-authors: Frederick R. Ball.

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