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HTMLBlack Lung Disease Makes a Terrifying Comeback
Brayton Purcell LLP;
Legal Alert/Article
December 17, 2014
Coal miners and other workers exposed to coal dust have experienced the debilitating condition at rates not seen in 40 years.

 

HTMLFDA Voices Privacy Concerns and Promotes Medical Device Cybersecurity with New Guidance, Collaborative Information-Sharing
Laurie A. Clarke, Alexis Slagle Gilroy, Colleen Heisey, Kevin D. Lyles, Mauricio F. Paez; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on November 2014
Cybersecurity of medical devices poses unique challenges for industry and regulators, because of potential risks in device malfunction, disruption of medical care, and compromised patient data, as well as the challenge of balancing countervailing needs, such as patient safety and ensuring that...

 

HTML2015 HHS OIG Work Plan Focuses on Payment Accuracy, Privacy Concerns, and Insurance Marketplaces
Laura F. Laemmle-Weidenfeld, Heather M. O'Shea, Rebekah N. Plowman, Stephen G. Sozio, Heidi Ann Wendel; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on November 2014
On October 31, 2014, the Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") published its Work Plan for Fiscal Year 2015 ("2015 Work Plan") to provide an annual summary of new and ongoing OIG audit activities related to HHS programs....

 

HTMLJury Finds for Drug Manufacturers in First Post-Actavis "Reverse Payment" Trial
Jonathan Berman, Benjamin H. Cheng, Aimee E. DeFilippo, Kevin D. McDonald; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on December 2014
In the first "reverse payment" trial since the U.S. Supreme Court’s Actavis decision held that "reverse payment" settlements potentially could be found anticompetitive under a rule of reason analysis, a federal jury in Massachusetts has returned a verdict in favor of the...

 

Adobe PDFAmendment to Drugs and Medical Devices Law in Japan Takes Effect
Laurie A. Clarke, Colleen Heisey, Scott T. Jones, Mark Mansour, Mitsutaka Okano; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on December 2014
A material amendment to the law regulating drugs and medical devices in Japan has recently been implemented. The amendment mainly covers (i) establishing a fast-track authorization process for regenerative medicine products (described below), (ii) restructuring medical device regulations, and (iii)...

 

HTMLEbola Guidance for Schools: Focusing on the Basics
Vincenzo Carannante, Julie C. Fay; Shipman & Goodwin LLP;
Legal Alert/Article
December 15, 2014, previously published on November 24, 2014
In light of Ebola’s potential impact on educational facilities and their students and staff, as well as the large volume of information and misinformation that has been disseminated about this virus, educators should focus on a select group of resources to stay on top of the latest...

 

HTMLCMS Issues Proposed Rule Addressing Changes to Medicare Shared Savings Program
Jenna K. Shedd, Lawrence J. Tabas; Obermayer Rebmann Maxwell & Hippel LLP;
Legal Alert/Article
December 15, 2014, previously published on December 4, 2014
The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule (the “Proposed Rule”) on December 1, 2014 regarding certain changes to the Medicare Shared Savings Program (the “Program”). The Proposed Rule, spanning 429 pages, discusses proposed...

 

HTMLAnchorage Community Mental Health Services to Pay $125,000 in Newest HIPAA Settlement: Covered Entities and Business Associates Must Update Unpatched and Unsupported Software, Says OCR
Jenna K. Shedd, Lawrence J. Tabas; Obermayer Rebmann Maxwell & Hippel LLP;
Legal Alert/Article
December 15, 2014, previously published on December 10, 2014
Anchorage Community Mental Health Services, Inc. (“ACMHS”) will pay $125,000 to the United States Department of Health and Human Services, Office for Civil Rights (“OCR”) to settle alleged violations of the Health Insurance Portability and Accountability Act...

 

HTMLNew Jersey Court Supports Peer Review Immunity for Hospital
Nili S. Yolin; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
December 15, 2014, previously published on December 2, 2014
On November 24, 2014, the New Jersey Appellate Division affirmed a lower court’s decision to dismiss a physician’s lawsuit against a hospital based on federal and state statutory immunity provisions that shield hospitals and their peer review participants from monetary damages.

 

HTMLGPO Fees Under Scrutiny by the GAO
Thomas S. Crane, Lauren Moldawer; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
December 15, 2014, previously published on December 4, 2014
Last week, the Government Accountability Office (GAO) released a report examining group purchasing organization (GPO) practices. The GAO questioned whether the current structure of GPO funding through administrative fees is appropriate and urged the Department of Health and Human Services (HHS) to...

 


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