FDA

FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

Shock therapy

The U.S. Food and Drug Administration recently announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.

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Global Mobile Health Market Estimated To Reach $49B by 2020

The global mobile health market is expected to grow at a rate of 49.7% over the next six years, with revenue expected to reach more than $49 billion in 2020, up from $1.2 billion in 2012, according to a report conducted by Grand View Research, Healthcare IT News reports (McCann, Healthcare IT News, 3/4).
Report Findings
The report found that in 2012:

FDA issues final guidance on mobile medical apps!

U.S. Food and Drug Administration issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.

For $199.00, the AliveCor Heart Monitor turns your iPhone into an ECG

Alivecor Heart Monitor for iPhone

The AliveCor Heart Monitor gives you instant, portable screening opportunities. Utilize the device anytime, anywhere to evaluate heart rate and rhythm. The AliveCor Heart Monitor is cleared by the FDA for sale in the U.S. to licensed medical professionals and prescribed patients to record, display, store,
and transfer single-channel electrocardiogram (ECG) rhythms.

For more info check out their site: http://www.alivecor.com/en

FDA's Regulation of Mobile Medical Apps Will Probably Confuse You

Patel on stage (via RP-VITA) at WLSA 2013. Image via Twitter

FDA's Bakul Patel took the stage at the WLSA Wireless Convergence Summit 2013 using an iRobot RP-VITA to speak with the audience on the status of FDA's mobile health application regulations. It was a gesture as symbolic as it was quasi-futuristic. Patel could have just as easily conferenced in using Skype or Facetime (but then again this is a health conference). Likewise, given the current stage of FDA's draft guidance on mobile medical apps, one has to wonder if there might be a more convenient way...or at least one that brings up fewer questions.

FDA reaches out on Usability of EHRs

The use of Healthcare Information Technology/Systems continues to grow and affect patient care and patient safety. In efforts to support a safe environment, the FDA's MedSun program is exploring problems related to Healthcare Information Technology/Systems that may affect patient safety.These problems may be detected within the hospital environment by IT/IS professionals, end-users, super-users, management or others.

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The Usability People work with you on improving the Usability of Healthcare IT.

For expert 2015 ONC Safety-enhanced Design (aka Usability) evaluation of your EHR: contact The Usability People

The Usability People

Together we may save a life! #SafeHealthIT