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The Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act contain an express preemption provision, namely 21 U.S.C. ' 360k(a), which prohibits states from imposing requirements different from, or in addition to, the specific federal requirements imposed on medical devices by FDA regulations. However, the U.S. Supreme Court has held, in a case involving ' 360k(a), that traditional state law claims are permissible and are not preempted if the common law duties involved parallel the duties statutorily imposed in the federal law and do not impose higher standards.
New York Attorney General Andrew M. Cuomo recently spearheaded a statewide New York investigation into health insurers' use of physician-ranking programs. The investigation, which has made inquiries to insurers including United Healthcare, Aetna, CIGNA Healthcare, Empire Blue Cross Blue Shield, Preferred Care and HIP Health Plan of NewYork/GHI, has now produced a settlement with CIGNA. Although the investigation is specific to New York, the issues raised are national in scope and worth serious consideration, since health insurers nationwide are increasingly utilizing physician-ranking systems.
Your hospital and physicians have the opportunity to conduct a study on a new method for the early detection of a disease. They go through the necessary procedures of obtaining patients at risk for the disease, and those patients knowingly agree to participate in the program. However, there may be one problem with this scenario. According to a recent case out of New York, your hospital and physicians may have just established a hospital-patient and/or physician-patient relationship with each of the study participants, exposing all of them to the risk of multiple medical malpractice lawsuits.
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Microsoft is moving against alleged counterfeiters who use online auction sites like PriceGrabber.com and eBay to sell software that is packaged to look like the real thing, but is far from it.
Last year, the Federal Communications Commission ('FCC') announced plans to auction off spectrum on the public airwaves suitable for wireless phone and Internet transmissions. In response, a collection of nonprofit technology and consumer groups suggested that the winning bidder be required to provide access to its network for the public benefit. Then in May, just a few months before the auction rules were settled, something unexpected happened: Internet giant Google joined the fray ' and aligned itself with the nonprofits.
This final part addresses issues that affect not only those types of promotions, but also other types of online marketing and promotional activities; namely, the enforceability of online agreements and terms of use, consumer privacy and data security, the use of third-party Web sites and online services, commercial e-mails and special concerns relating to children.