FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States

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An FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is warning health care providers and people with diabetes of risks associated with use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices. These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.

OCR Guidance on Ensuring Equal Access to Emergency Services During Hurricane Florence

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Official guidance from the Office for Civil Rights

As Hurricane Florence makes landfall, the HHS Office for Civil Rights (OCR) and its federal partners remain in close coordination to help ensure that emergency officials effectively address the needs of at-risk populations as part of disaster response. If you believe that a person or organization covered by the Privacy and Security Rules (a "covered entity") violated your health information privacy rights or otherwise violated the Privacy or Security Rules, you may file a complaint with OCR. For additional information about how to file a complaint, visit OCR's web page on filing complaints at http://www.hhs.gov/ocr/privacy/hipaa/complaints/index.html.

Why are wearables not better targeted toward the people who might need them the most?

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Analysis of the J.C. Herz article at Wired.com

SUBJECTIVE: Abstract from the article titled, "Wearable Are Totally Failing The People Who Need Them Most" posted on Wired Magazine: "As the Internet of Things becomes an actual thing, more steps are being counted, more sleep patterns are being logged, more activities are being appified. What isn’t appearing in the data is much common sense or ambition. Instead, developers continue flocking to a saturated market filled with hipster pet rocks, devices that gather reams of largely superficial information for young people whose health isn’t in question, or at risk."

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