A scheduled House committee hearing on the Food and Drug Administration's progress toward implementing a federal law requiring it to develop a regulatory strategy for health information technology was postponed Thursday, as the government shutdown continued into its third day.
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, was scheduled to testify before the Health Subcommittee of the House Energy and Commerce Committee on the Food and Drug Administration Safety Innovation Act.
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PhRMA has sued to block implementation of a rule that lets providers in the 340B drug discount program buy orphan drugs at reduced prices if the drugs are used to treat non-orphan conditions.
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A rule that would require medical devices to be marked with unique identifiers is still stuck in the regulatory process, and the delay is drawing complaints from lawmakers and health systems.
Four House lawmakers sent a letter to the Office of Management and Budget, which has yet to release the final rule for the unique device identification system, urging OMB to provide a status update. It has been six years since Congress mandated the development of a device identification system.
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A new study of electronic cigarettes offers the first clinical evidence of their effectiveness in helping tobacco smokers quit, though it does not address their safety.
The report, published Monday in the medical journal The Lancet, assessed the efficacy of e-cigarettes compared with nicotine patches in helping smokers quit. Patches are one of seven FDA-approved nicotine replacement therapy products. The FDA has not yet issued any assessment of e-cigarettes.
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The Obama administration has basically told House Republican lawmakers to go fly a kite in response to their recent demand that organizations receiving federal funds to help Americans sign up for health coverage on the state insurance exchanges provide extensive information on their operations by Sept. 13.
Navigator groups and Obamacare supporters, including Rep. Henry Waxman (D-Calif.), had accused the Republicans of using the time-consuming information request to delay the navigators' efforts in the crucial run-up to the Oct. 1 launch of open enrollment on the exchanges.
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Patient-safety issues raised by the critics of limits on resident duty hours have not materialized. But concerns about doctors-in-training spending less time with patients appear to be valid, according to two new studies in the Journal of General Internal Medicine.
The Accreditation Council for Graduate Medical Education set an 80-hour weekly work limit (averaged over four weeks) in 2003. Further limits, including restricting first-year residents to 16-hour shifts went into effect in 2011. The movement to limit resident work hours was originally driven by Sidney Zion, a journalist, prosecutor and novelist, whose 18-year-old daughter Libby died a few hours after being admitted to New York Hospital on the night of March 4, 1984. His fight led to New York state limiting residents to an 80-hour workweek and 24-hour shifts in 1989.
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A federally chartered special work group with representatives from three federal agencies has submitted its draft recommendations on establishing a regulatory framework for health IT.
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Fledgling accountable care organizations have faced plenty of challenges. Now a group of economists and lawyers are calling for a close look at issues involving insurance, antitrust and other regulation to avoid “unintended consequences.”
Health policy experts Gary Bacher, Michael Chernew, Daniel Kessler and Stephen Weiner write in the latest issue of the policy journal Health Affairs that ACOs could stifle competition among insurers and providers and potentially drive up prices.
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Stark
The healthcare world is populated by scores of legal experts who strive to keep up with the sprawling compendium of statutes, regulations and legal advisories known collectively as the “Stark law.” But the law's father, Fortney “Pete” Stark, is not one of them.
Stark, in fact, says he would favor repealing the law as it currently exists and getting back to the law's initial intent.
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The for-profit assisted-living industry came under the harsh spotlight of PBS' “Frontline” investigators Tuesday night as the news program took Seattle-based Emeritus Corp. to task for a number of deaths and injuries involving residents with dementia at Emeritus facilities across the country.
Emeritus, which was founded in 1983 and has 483 facilities around the country, is the one of the country's biggest assisted-living operators.
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The for-profit assisted-living industry came under the harsh spotlight of PBS' “Frontline” investigators Tuesday night as the news program took Seattle-based Emeritus Corp. to task for a number of deaths and injuries involving residents with dementia at Emeritus facilities across the country.
Emeritus, which was founded in 1983 and has 483 facilities around the country, is the one of the country's biggest assisted-living operators.
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