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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...

 

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HTMLFDA Issues Draft Guidance on Stem Cell Same Surgery Exception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On October 23, 2014, the FDA’s Center for Biologics Evaluation and Research issued draft guidance for tissue establishments and healthcare professionals who implant stem cells and other cellular or tissue-based products into human patients.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...

 

HTMLStAR Releases Useful Guide to Civil Asset Recovery
Jamie Humphreys; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 21, 2014, previously published on November 5, 2014
In November 2014, the World Bank's Stolen Asset Recovery (StAR) Initiative published Public Wrongs, Private Actions: Civil Lawsuits to Recover Stolen Assets. It is available here. The book provides a step-by-step guide to States embarking on an asset recovery programme. It aims "to explore the...

 

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...

 

HTMLOIG Issues Favorable Advisory Opinion for Medigap “Preferred Hospital” Network Arrangement
Hilary B. Dudley, Tamara A. Klein, Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 20, 2014, previously published on November 11, 2014
On Monday, October 21, 2014, the Office of the Inspector General of the U.S. Department of Health and Human Services (“OIG”) issued a favorable advisory opinion regarding the use of a “preferred hospital” network as part of the Medicare Supplemental Health Insurance...

 

Adobe PDFIRS Announces 2015 Retirement Plan Limitations
Lori A. Basilico; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 10, 2014, previously published on October 2014
The Internal Revenue Service announced the 2015 cost-of-living adjustments to the dollar limitations for qualified retirement plans and other benefits, and the Social Security Administration announced its own cost-of-living adjustments for 2015. The elective deferral contribution limit for 401(k),...

 

HTMLUK Competition Appeal Tribunal Overturns Online Hotel Booking Decision
Jane Elphick, Becket McGrath; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 8, 2014, previously published on October 23, 2014
In its 26 September judgment in Skyscanner Ltd v. Competition and Markets Authority, the UK Competition Appeal Tribunal (CAT) for the first time overturned a commitments decision of the Office of Fair Trading (OFT - since 1 April, the Competition and Markets Authority or CMA). The decision under...

 

HTMLNew California Requirements Shake Up Breach Notification and Data Safeguards
Karen L. Booth, Karen L. Booth, Ellen Marie Giblin, Ellen Marie Giblin, Laurie A. Kamaiko, Laurie A. Kamaiko, Mark E. Schreiber, Mark E. Schreiber, Thomas J. Smedinghoff, Thomas J. Smedinghoff; Edwards Wildman Palmer LLP;
Legal Alert/Article
October 28, 2014, previously published on October 2014
Recent amendments to California statutes governing breach notification and data safeguards impose new obligations by: (1) enhancing breach notification requirements relating to offerings of “identity theft prevention and mitigation services”; (2) expanding the statutory requirement to...

 

HTMLOctober 2014 Update on Federal Budget Sequestration Affecting Build America Bonds and Other Direct Pay Bonds
Joe E. Forrester, Christie Lombard Martin, Antonio D. Martini; Edwards Wildman Palmer LLP;
Legal Alert/Article
October 23, 2014, previously published on October 2014
As described in previous client advisories, direct pay bond subsidy payments are subject to sequestration through fiscal year 2024 unless Congress takes action to modify or eliminate the sequester. In a release issued on October 16, 2014, the Internal Revenue Service confirmed that the...

 


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