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HTMLOIG Proposed Rule Would Amend Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules; CMS Launches Open Payments Database
Hilary B. Dudley, Tamara A. Klein, Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 25, 2014, previously published on October 17, 2014
On October 3, 2014, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) published a proposed rule that would amend the safe harbors to the anti-kickback statute (“AKS”) and the civil monetary penalty (“CMP”) rules under the...

 

HTMLDistrict of Massachusetts Finds Coverage Under a Professional Liability Policy in Underlying Case Centered on Unfair Competition
Jacquelyn Burke; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 25, 2014, previously published on November 12, 2014
On October 28, the United States District Court for the District of Massachusetts denied an insurer’s motion for summary judgment in a coverage action it had brought against its insured on a professional liability policy, an insurance broker who specialized in the placement of professional...

 

HTMLFDA: Industry Must Address Cybersecurity Risks for Medical Devices.
Theodore P. Augustinos, Sharon A. Blinkoff, Ellen Marie Giblin, Mark E. Schreiber, David S. Szabo; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 25, 2014, previously published on October 2014
On October 1, 2014 the U.S. Food and Drug Administration finalized guidance on recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The purpose of the guidance is to encourage manufacturers to consider possible cybersecurity risks while...

 

HTMLUK: Scottish Appeal Court Upholds Judge¿s Decision to Permit a Time-Barred Claim to Proceed
Edwards Wildman Palmer LLP;
Legal Alert/Article
November 25, 2014, previously published on November 6, 2014
In Betty Sophia Smith Ferguson and others v J & A Lawson (Joiners) Limited [2014] CSIH 82, Lady Paton of the Court of Session Inner House dismissed an appeal from the defendants, who argued that the Lord Ordinary had erred in law at first instance. The judge had permitted a time-barred claim to...

 

HTMLUK: Commercial Court Awards Declaratory Relief and Specific Performance Order to Insurers
Edwards Wildman Palmer LLP;
Legal Alert/Article
November 25, 2014, previously published on October 27, 2014
Following the Supreme Court’s determination as to jurisdiction and the Court of Appeal’s ruling on the substantive issues, the case of Starlight Shipping v Allianz Marine ([2014] EWHC 3068 (Comm)) returned to the Commercial Court for two further issues to be decided.

 

HTMLMassachusetts Federal Court Rules That Insurer’s Decision To Commence Rescission Action Does Not Waive Attorney-Client Privilege
Alexander G. Henlin; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 25, 2014, previously published on November 10, 2014
Insurers can take comfort that their decision to bring a rescission action against a Massachusetts insured will not itself effect a waiver of the attorney-client privilege, at least in cases where the carrier’s process for deciding whether to sue is not relevant to the rescission claim...

 

HTMLUK: Court of Appeal considers application of the doctrine of “fraudulent devices”
Edwards Wildman Palmer LLP;
Legal Alert/Article
November 25, 2014, previously published on November 4, 2014
In Versloot Dredging BV v HDI Gerling Industrie Versicherung AG (The DC Merwestone) ([2014] EWCA Civ 1349) the appellant shipowners appealed a decision made on the basis of the fraudulent devices principle discussed obiter in the case of Agapitos v Agnew (The Aegeon) (No.1) ([2002] EWCA Civ 247)...

 

HTMLSouthern District of New York Holds That Aereo is Not Eligible for the Cable Compulsory License; Grants Preliminary Injunction
Seth A. Davidson, Arthur H. Harding, Glenn G. Pudelka; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 21, 2014, previously published on October 24, 2014
In the latest, but not unexpected, development in the ongoing Aereo saga, the United States District Court for the Southern District of New York has rejected Aereo’s contention that it is a “cable system” eligible for the Copyright Act’s cable compulsory license and has...

 

HTML$840 Million in Grants Available Through New HHS Transformation Initiative
Hilary B. Dudley, Tamara A. Klein, Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 21, 2014, previously published on November 11, 2014
On Thursday, October 23, 2014, the U.S. Department of Health and Human Services (“HHS”) announced it would make available up to $840 million in grants over the next four years through the Transforming Clinical Practice Initiative (“TCPI”), an Affordable Care Act grant...

 

HTMLFDA Issues Draft Guidance on Stem Cell Same Surgery Exception
Hilary B. Dudley, Tamara A. Klein, Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 21, 2014, previously published on November 11, 2014
On October 23, 2014, the FDA’s Center for Biologics Evaluation and Research issued draft guidance for tissue establishments and healthcare professionals who implant stem cells and other cellular or tissue-based products into human patients. The FDA regulates human cells, tissues or cellular...

 


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