Opinion: FDA Regulation of Mobile Health Apps Would Be 'Death Blow'

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In a Washington Times opinion piece, Joel White -- executive director of the Health IT Now Coalition -- warns that "innovation and growth in mobile medical applications could come to a screeching halt if" FDA "moves forward with its proposed regulation" of mobile health apps.

He writes, "At this formative stage of emerging mobile medical applications, complicated and expensive new regulatory structures through FDA would dampen prospects for future life-saving innovations."

White notes that the "average time to approve a medical device is about three years and can cost upward of $75 million," adding, "In the software market, that is a lifetime."

In addition, if mobile apps are regulated as medical devices, they will be subject to a 2.3% tax under the federal health reform law, according to White.

He warns, "Constraints on speed to market and increased regulatory costs combined with tax-driven price increases may cause developers to move on to other, less burdensome endeavors."

White concludes, "The administration should go back to the drawing board and creatively design a 21st-century regulatory framework for innovative products," adding, "We need smart regulation for health information technology, not the same old, same old. We can and must do better" (White, Washington Times, 2/7).

Michael Milne
For software, if approval takes more than 4 weeks and a couple of thousand dollars, it will mean only existing technology FOREVER, period. What regulators don't understand is software is publishing, it is like saying an author of a book can not publish the book and people can not read it until it is "approved." The book author has to pay a fee to governemnt so people can buy their book. It would mean only Steven King novels FOREVER and no new books.

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