“There is just no way to skirt around HIPAA privacy rules,? says Scott wolf, CEO of Grace Century. ?While the mobile phone manufactuers like Apple are keen to supply you with as many health related apps as they can, regulation is the engine?s governor with regulation?s web and ‘patients? rights’ concerns.?
WSJ OPINION Why Your Phone Isn’t as Smart as It Could Be
Silicon Valley is eager to produce health-related apps, but fear of FDA regulation is slowing innovation.
By SCOTT GOTTLIEB and COLEEN KLASMEIER
Aug. 6, 2014 7:52 p.m. ET
There’s growing frustration among entrepreneurs in Silicon Valley who are finding that the road to improving medical technology ends not in Palo Alto but in White Oak, Md.?at the headquarters of the Food and Drug Administration. “Health is just so heavily regulated,” Google co-founder Sergey Brin complained last month to a group of high-tech CEOs, “it’s just a painful business to be in.”
The pain has become especially acute in the burgeoning field of mobile medical apps and health-care “wearables.” Apple is reportedly making a health-information platform a key component of its next iPhone operating system?which is expected to be in the new iPhone it will unveil next month. Other handset makers are following similar paths. But these smartphones will be purposely dumbed down, according to early reports on their features, in order to manage the uncertain risk of unwieldy FDA regulation.
According to the tech publication Apple Toolbox, the FDA recently released (under a Freedom of Information Act request) a document describing its meeting with Apple executives last December. Senior agency officials told Apple that the FDA “would be more likely to regulate the software that puts [a medical] sensor to use, if use of the software alters the device’s use to be a medical device.” The officials also told Apple that “apps that actively measure something” health-related, like glucose meters used by diabetics, are “diagnostic” and are likely to make the entire tool subject to regulation.
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