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Adobe PDFDriving the Golden Spike: Avoiding Liability with Connected EHR Systems
Peter J. Enko, Mike Foley, Deborah H. Juhnke, Wakaba Y. Tessier; Husch Blackwell LLP;
White Paper
October 23, 2014, previously published on October 2014
The evolution of today’s EHR holds much in common with that of the modern railroad. We all take for granted that railroad cars easily move from one track to another and from one company’s lines to another. So, whether the owner of the rail is Union Pacific or Burlington Northern, the...


HTMLSame-Sex Marriage Recognized in West Virginia - How Will This Impact Employer-Sponsored Health Plans?
Jill E. Hall; Bowles Rice LLP;
Legal Alert/Article
October 22, 2014
Today, the Attorney General and Governor of the State of West Virginia announced that West Virginia will no longer prohibit same-sex marriage, implementing a ruling of the United States Court of Appeals for the Fourth Circuit (the federal appeals court that encompasses West Virginia, Virginia,...


HTMLFront End Changes and, Again, More DIR Columns
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
October 21, 2014, previously published on October 17, 2014
Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS has turned to most often is the direct and indirect remuneration...


HTMLSupreme Court Examines Boundaries of Antitrust Immunity in North Carolina State Board of Dental Examiners v. FTC
Dionne C. Lomax; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
October 20, 2014, previously published on October 15, 2014
On October 14, 2014, the United States Supreme Court heard oral arguments in North Carolina State Board of Dental Examiners v. FTC, a U.S. Court of Appeals Fourth Circuit decision upholding an FTC finding that the North Carolina State Board of Dental Examiners (the “Board”) did not...


HTMLHHS Says New Healthcare Website Will Work
McDonald Hopkins LLC;
Legal Alert/Article
October 19, 2014, previously published on October 10, 2014
Federal health officials say they have reconfigured and rebuilt the enrollment website for the Affordable Care Act to avoid a repeat of last year's disastrous launch.


HTMLThe Employer’s Reference Guide to Information About Ebola
Maria Greco Danaher; Ogletree, Deakins, Nash, Smoak & Stewart, P.C.;
Legal Alert/Article
October 17, 2014, previously published on October 13, 2014
Concerns related to the Ebola outbreak are increasing among both employers and employees in the United States. The outbreak is currently most active in the West African nations of Guinea, Liberia, Nigeria, and Sierra Leone. However, there has been at least one confirmed death from the disease in...


HTMLTelemedicine Advances Allow Remote Patient Care
Sigrid C. Haines; Lerch Early Brewer Chartered;
Legal Alert/Article
October 17, 2014, previously published on September 25, 2014
The field is changing for the use of remotely-provided medical services. While the possibility of remotely-provided medical services received attention in the press some years ago, it has been slow to become a reality. Various issues have contributed to its slow adoption, including the need for...


HTMLOIG Seeks Comment on Recently Published Proposed Rule Expanding Anti-Kickback Safe Harbors
Lynsey Morris Barron, Richard H. Deane, Gerald M. Griffith, Rebekah N. Plowman, Stephen G. Sozio; Jones Day;
Legal Alert/Article
October 16, 2014, previously published on October 2014
The federal Anti-Kickback Statute ("AKS") criminalizes the solicitation or payment of remuneration in order to induce business that is reimbursable under the Medicare and/or Medicaid programs, such as kickbacks, bribes, and certain rebates. The U.S. Department of Health and Human Services...


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...


HTMLCommercially Confidential Information at Risk: The European Medicines Agency Issues Disclosure Policy
Christian B. Fulda; Jones Day;
Legal Alert/Article
October 16, 2014, previously published on October 2014
As if the fight for reasonable returns on investment into drug development, currently exemplified by the discussion on the pricing of innovative products, is not enough, the pharmaceutical industry is facing one of its biggest challenges in Europe: the protection of commercially confidential...


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