510k

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.

Alere™ MobileLink Receives 510k FDA Clearance

Alere Hub gets 510(k) approval

Alere™ Connect has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for the Alere™ MobileLink. The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.

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 Likewise, given the current stage of FDA's draft guidance on mobile medical apps, one has to wonder if there might be a more convenient way...or at least one that brings up fewer questions.

User Experience and Usability Consultation

Usability Starts with "You" If you are looking for EHR usability resources including usability testing and user experience professionals to help you with EHR safety-enhanced Design evaluation (for Meaningful Use and the ONC 2015 certification) you have come to the right place!

Usability - The effectiveness, efficiency, and satisfaction with which specified users achieve specified goals in particular environments (ISO 9241-11).

Applications Requested for ZeroTo510 Medical Device Accelerator

logo for zero to 510

Applications are now open for ZeroTo510, an entrepreneurship accelerator program designed to help start-ups bring medical device products and services to market. Applications will be accepted until March 25, 2013.

“Last year, ZeroTo510 was launched as the first-ever program of its kind in the United States focused on medical devices”


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