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HTMLFDA Issues Draft Guidance on Stem Cell Same Surgery Exception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On October 23, 2014, the FDA’s Center for Biologics Evaluation and Research issued draft guidance for tissue establishments and healthcare professionals who implant stem cells and other cellular or tissue-based products into human patients.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

 

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...

 

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
October 16, 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...

 

HTMLArticle 29 Working Party Gives Insight into its Approach to the ‘Right to be Forgotten’
Annie Clarke, Sarah Pearce; Edwards Wildman Palmer LLP;
Legal Alert/Article
October 16, 2014, previously published on October 13, 2014
The Article 29 Data Protection Working Party (‘the Working Party’), an independent advisory body on data protection and privacy set up under Directive 95/46/EC, last month released its approach to the effects of the Court of Justice of the European Union (‘CJEU’)...

 

HTMLFinal Meaningful Use Regulations Published
Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
September 19, 2014, previously published on September 2014
On September 4, 2014, the U.S. Department of Health and Human Services, the Centers for Medicare & Medicaid Services (CMS), and the Office of the National Coordinator for Health Information Technology (ONC) published in the Federal Register a final rule on meaningful use. Significantly, the...

 

HTMLSenate Commerce Committee Releases Revised Draft of Legislation Extending STELA and Making Other Changes to the Communications Act
Seth A. Davidson, Arthur H. Harding; Edwards Wildman Palmer LLP;
Legal Alert/Article
September 18, 2014, previously published on September 15, 2014
Senators Rockefeller (D-WV) and Thune (R-SD), the chairman and ranking member of the Senate Committee on Commerce, Science and Transportation, have released a revised version of S. 2799, the “Satellite Television Access and Viewer Rights Act” (STAVRA). The full committee is scheduled to...

 


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