Health IT Now Coalition Issues Statement on FDA Final Guidance

On September 23, the FDA published its final guidance to developers of mobile medical applications. 

“We are currently reviewing the document and its implication on policy,” said Joel White, Executive Director of Health IT Now. “We don’t want to lose sight of the longer term goal, which is rationalizing the regulatory framework so that innovation and patient safety are protected, and duplication and regulatory burdens are reduced.   By issuing the final guidance, FDA has endorsed an old framework.   We think the Administration and Congress ought to work together on updating the 1970s era law to meet the needs of the 2013 and beyond mobile health economy.  So we look forward to the HHS report with recommendations on a new framework for health IT regulation.”

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