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Interview: The iPhone medical app denied 510(k)

March 15, 2010

“The iPhone has created a new direction for our company,” Mark Cain, CTO, MIMvista said in June 2008. “We have taken a complex desktop application removed it from the realm of black art and placed it in the hands of…

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Washington signals possible FDA regulation of mHealth

February 26, 2010

By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.
“Under the Federal, Food, Drug, and Cosmetic Act, HIT software is a medical device.” That’s according to Dr. Jeff Shuren, the new director of the Device Center within FDA. Yikes.…

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Today’s real top ten iPhone medical apps

February 10, 2010

As we have noted with previous “top iPhone medical apps” roundups, the headline of this post is a bit tongue-in-cheek, because this list will change very quickly — tomorrow a new crop of apps will likely unseat today’s most popular…

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How to avoid FDA mHealth regulation

February 8, 2010

Strategies for mHealth Companies Wishing to Avoid FDA Regulation
By Bradley Merrill Thompson
(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or…

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12 EMRs with remote access iPhone apps

January 16, 2010

MobiHealthNews broke the news last week that the mobile EHR product that came out of Apple’s pilot with EMR vendor Epic Systems was an iPhone app called Haiku, but Haiku was not the first EMR to grant iPhone and iPod…

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Should mHealth companies want FDA regulation?

January 14, 2010

By Bradley Merrill Thompson, MBA, JD
(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only…

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Epic Systems launches iPhone EHR app, Haiku

January 13, 2010

After three months of rumors, details surrounding Epic Systems’ partnership with Apple for a mobile phone-based electronic health record (EHR) application have come to light: Just a few days ago, Epic System’s iPhone application, called Haiku, became available on Apple’s…

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The 15 most popular 2009 wireless health stories

December 31, 2009

While our year-end report is a solid snapshot of the state of the industry at the end of 2009, we noticed that a good number of our most popular news posts from the past year did not find their place…

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How to get FDA to clear a mobile health app

December 1, 2009

By Bradley Merrill Thompson, Partner, Epstein Becker & Green
(I would like to thank John Murray of FDA, Scott Thiel of Roche Diagnostics and Russ Gray of the Anson Group for their comments on a draft. The views expressed — right…

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Top Calorie Counting Apps for Thanksgiving

November 23, 2009

It’s the week of Thanksgiving here in the U.S. — a holiday that typically includes over-indulging on turkey, root vegetables and pie followed by a short food induced coma. ‘Tis the season, but for those who would like to keep…

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