On July 9, 2012 President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). [At press-time, a public law version of the bill was not available. The link provided here leads to the "enrolled bill" version of the law which was approved by both the House and Senate and submitted for the President's signature.] The law provides for a host of changes to the existing FDA regulatory framework, including much-debated provisions relating to user fees, altered regulatory processes, and some incentive programs. One section, however, has drawn little attention but may have an outsized impact on the large-and-rapidly-growing mobile health care technology (mHealth) industry.
Section 618 of FDASIA provides that the FDA, within 18 months, must produce (and make publicly available) "a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication." The law requires that the FDA develop this report in consultation with the Office of the National Coordinator for Health Information Technology (the "ONC," which is also tasked with setting technical standards for the EHR Incentive program) and the Federal Communications Commission (FCC). The report will be published jointly on all three agencies' web pages.
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