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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...

 

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.

 

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...

 

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...

 

HTMLRecent Data Breach Demonstrates the Importance of Attention to Software and IT Systems
Vincenzo Carannante, Dawn R. Crumel, Joan W. Feldman, William J. Roberts; Shipman & Goodwin LLP;
Legal Alert/Article
December 15, 2014, previously published on December 12, 2014
The United States Department of Health and Human Services Office for Civil Rights (“OCR”) announced that it reached a monetary settlement with an Alaskan nonprofit behavioral health care provider after the provider reported that patient health information was compromised due to malware...

 

HTMLFederal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”
Samantha P. Kingsbury, Ellyn L. Sternfield; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
December 15, 2014, previously published on December 5, 2014
In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed one of those cases against OmniCare, Inc., PharMerica Corp., and...

 

HTMLNo Private Right to Recoup Funds Based on Corporate Practice of Medicine Violation
Rachel Irving Pitts; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
December 10, 2014, previously published on November 24, 2014
The United States District Court for the Western District of Washington ruled recently that the state’s corporate practice of medicine doctrine does not provide a private right of action, either express or implied, and dismissed claims brought by State Farm Mutual Automobile Insurance Company...

 

HTMLHealthy Workplaces, Healthy Families Act - California Assembly Bill 1522
Ramina Dehkhoda-Steele; Wong Fleming;
Legal Alert/Article
December 10, 2014, previously published on November 2014
Commencing on July 1, 2015, all employers are required to provide employees working in the State of California with paid sick leave. Employees who are covered by the bill must work in California for 7 or more days in a calendar year and will earn no less than one hour of paid sick leave for every...

 


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