Tweaked FDA bill Removes Hurdle to Medical App Guidance

Congress has removed a major roadblock to the Food and Drug Administration's regulation of medical mobile apps by modifying a section of the FDA Saftey and Innovation Act (S:3187). According to an article on mHIMSS.org, Section 618 of the bill was modified to allow the FDA to issue its guidelines before submitting a proposed strategy and regulatory framework report that would require input from external stakeholders. Without the change, the guidance likely would have been delayed until at least 2013. The mHealth Regulatory Coalition, whose goal is to work with the FDA and establish guidance for regulations, was happy with the development. "[T]hose who acknowledge that FDA has a legitimate role to play wanted to avoid any delay in the desire to get needed clarity around the scope of FDA regulation so that [the] industry and investors could move forward," said Brad Thompson, an FDA expert who serves as general counsel for the mHealth Regulatory Coalition, in an email to MRC members obtained by FierceMobileHealthcare. As the mobile medical app industry continues to mature, tech innovations can steadily be integrated into existing medical practices and workflows. To read more about the impact of mobile technology on radiology, click here: PACS and the iPad: Possibilities and Potential