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When Apple announced ResearchKit in March 2015, and unveiled the first five apps to test-drive the company’s new approach to clinical research, the announcement made a big splash. Via Bruno Demay 
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The FDA is creating a largely automated surveillance system to monitor safety of high-risk medical devices, and has authorized a cellphone app for doctors to simplify reporting deaths and injuries to the agency. Via Seth Bilazarian, MD, Lionel Reichardt / le Pharmageek
Seth Bilazarian, MD's curator insight,
April 24, 2013 4:25 PM
"There's an app for that." Physicians are often criticized for not doing a better job reporting adverse events and this is largely because the method for reporting to the FDA has been burdensome and difficult. An easy to use reporting strategy from a smartphone will increase my reporting dramatically. The speed of reporting and analysis by FDA for actionable items should be significantly shortened.
Seth Bilazarian, MD's comment,
April 24, 2013 4:27 PM
#app, medical app, #chealth, #mHealth, FDA, adverse event reporting, Bilazarian
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Take Home: UMass Medical School and WPI have developed an app that can detect atrial fibrillation. This moves connected and mobile health closer to reality. The really important development with this approch might allow us to treat patients who have AF intermittently (paroxysmal) differently than we currently do. Because we are worried about stroke, patietns now get blood thinners all the time because we are concerned that they will have recurrences without knowing about it. With this technology, in the future, we might see validation of a strategy that allows use of blood thinners when patients are in AF only, sometimes called a pill in the pocket. Via Seth Bilazarian, MD, Lionel Reichardt / le Pharmageek
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This article is part of the “2014 Top Tech to Watch” series, IEEE Spectrum’s annual prediction of technologies that will make headlines in the coming year. This year, when patients throughout the United States begin downloading the world’s first doctor-prescribed smartphone app, mobile health care will finally get what big-time medicine most requires: a way to get insurance companies to pay for it. The app, called BlueStar, helps people with Type 2 diabetes (the most common kind) by suggesting, in real time, when to test their blood sugar and how to control it by varying medication, food, and exercise. That it requires a physician’s prescription is actually an advantage, because it means insurance companies will reimburse BlueStar’s fee. “This is a piece of software getting the same treatment as a medical device,” says Sonny Vu, cofounder of Misfit Wearables in San Francisco, a maker of wearable computing devices. “It’s pretty world-changing.” The U.S. Food and Drug Administration cleared BlueStar for market in 2010, in line with its recent determination to regulate devices that provide a diagnosis or recommend a treatment, not those that simply track activity, like calories consumed or steps taken. The success that WellDoc, the app’s manufacturer, has had with the FDA may inspire other mobile health companies to go the regulatory route. “It gives us hope that you can pull something like this off,” says Vu. The European Commission has also issued guidance on regulations for mobile health apps, but countries such as China and India have not. WellDoc, based in Baltimore, began a regional launch last fall and plans to do a national push in 2014. The success of the app hinges on how many physicians prescribe it. “[WellDoc] will have to convince providers that it’s valuable,” says Athena Philis-Tsimikas, corporate vice president at the Scripps Whittier Diabetes Institute in San Diego. Read more: http://spectrum.ieee.org/biomedical/devices/bluestar-the-first-prescriptiononly-app Via Parag Vora
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Researchers at the Mayo Clinic have given a boost to telemedicine proponents with the publication of a new study that highlights smartphones' efficacy and quality in capturing medical images to evaluate stroke patients. The study, published in the September issue of Stroke is the first to test the effectiveness of smartphone teleradiology applications in a real-world telestroke network, according to Mayo Clinic officials. Via Seth Bilazarian, MD, Lionel Reichardt / le Pharmageek
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