Eye to eye

In­dus­try of­fi­cials ap­plaud FDA’S mo­bile med­i­cal app guide­lines

Modern Healthcare - - The Week in Healthcare - Joseph Conn

It’s a rare phe­nom­e­non at the in­ter­sec­tion of pol­i­tics and busi­ness: The fed­eral gov­ern­ment an­nounces plans to cre­ate new in­dus­try guide­lines, and those in the tar­geted in­dus­try say they’re glad to hear it.

That ap­pears to be the case for the U.S. Food and Drug Ad­min­is­tra­tion, how­ever, af­ter the agency’s re­lease last week of “draft guid­ance” for de­vel­op­ers of mo­bile med­i­cal ap­pli­ca­tions for smart­phones and other mo­bile de­vices.

“The use of mo­bile med­i­cal apps on smart­phones and tablets is rev­o­lu­tion­iz­ing health­care de­liv­ery,” Dr. Jef­frey Shuren, di­rec­tor of the FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health, said in a news re­lease an­nounc­ing the reg­u­la­tory ad­vi­sory. “Our draft ap­proach calls for over­sight of only those mo­bile med­i­cal apps that present the great­est risk to pa­tients when they don’t work as in­tended.”

The FDA’s 29-page pro­posal does not es­tab­lish legally en­force­able re­spon­si­bil­i­ties for app and de­vice de­vel­op­ers—though it sig­nals a likely move in that direc­tion. A 90day pub­lic com­ment pe­riod on the rec­om­men­da­tions is now open.

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