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Healthy Skeptic

Health care news and research

 

FDA’s Review of the 510(k) Process

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The Food and Drug Administration has been reviewing its 510(k) process, which is used for many medical device approvals. Two preliminary reports contain a series of recommendations designed to provide greater predictability in the process, while ensuring identification of significant safety concerns.

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2010 Potpourri XXIX

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Another Saturday, another Potpourri, featuring the acquisition of a hospital medical necessity company, Americans’ online health usage, analysis of prescriptions, California workers’ compensation, home monitoring of elderly parents, remote psychiatric evaluations and telemedicine to treat depression.

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GAO Report on Genetic Testing

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Personalized medicine relies on genetic testing for much of its information. Direct-to-consumer genetic testing firms are widespread and a GAO report reveals that much of their work appears shoddy and their marketing deceptive. More regulation appears needed and on the way.

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Accountable Care Organizations

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A Health Affairs/Robert Wood Johnson Issue Brief examines the accountable care organization concept, particularly as embodied in the recent federal health legislation. While there may be potential, as ACOs are structured for Medicare there will be many challenges on the road to meeting expectations.

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2010 Potpourri XXVIII

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Summer begins to wane, but not our Potpourris. Another one full of useful data, including health insurance costs for 2011, a new telehealth joint venture, use of kiosks in physician offices, prostate cancer screening, health care use cutbacks, teledermatology and sharing of physician notes with patients.

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