Food and Drug Administration (FDA)

A widely anticipated report from the U.S. Food and Drug Administration and other agencies may finally clear the air on how healthcare IT – and mHealth in particular – will be regulated.  

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As of Tuesday, more than 100 people across the United States have been infected with--and 12 have died from--a fungal form of meningitis contracted from contaminated steroid injections used to treat pain. According to the Centers for Disease Control and Prevention, as many as 13,000 people may have received contaminated medicine, and the number of cases is expected to rise. Read More »

Marc Wine, a supporter of the LHS - Precision Medicine PCOS Project and participant in Learning Health Community initiatives, who attended the summit hosted by the president said, "One goal is to seek collaboration with underserved communities in genomics, open data and integrative medicine. This will result in engaging individual patients in ways that will move them from dependency on fragmented healthcare to the point where patients can use their own evidence-based genetic information to make the very best health decisions." The Precision Medicine PCOS Project is aimed at developing a protocol for women with PCOS while employing an integrative medicine approach to treatment based on the participant's molecular makeup, clinical data and available scientific knowledge.

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Six former employees filed suit with the U.S. District Court for the District of Columbia against the Food and Drug Administration alleging the agency monitored their personal emails warning Congress that risky medical devices had been approved, The Washington Post has reported.

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Frank Baitman is the new chief information officer at the Department of Health and Human Services. John Teeter, the HHS deputy CIO, confirmed Baitman started in mid-February. "We are getting him up to speed and in motion at HHS and I'm sure he'll do a fantastic job," Teeter said. Read More »

Imagine if your life depended on software –and the source code was proprietary? That’s the dilemma faced by recently-appointed GNOME executive director Karen Sandler. who was diagnosed with a serious heart condition in 2006 that required the implantation of a cardioverter defibrillator. Read More »

The [FDA] is worried about what it calls an "important potential public health issue." It could be in your latte or your child's bowl of breakfast cereal. It could be in your refrigerator or freezer. At the very least, the FDA wants to make certain that it's not in any of the 8 million milk-producing cattle in the United States or the 500,000 dairy cows in Idaho. Read More »