Health IT Now Letter to FDA on Mobile Medical Applications 10 19 11

The popularity of mobile medical applications reflects the desire of many Americans to use technology to actively engage in their own health. The undersigned organizations believe that the FDA’s Draft Guidance for Industry and FDA Staff: Mobile Medical Applications issued on July 21, 2011 is a first step to establishing regulations for mobile medical apps, but more work needs to be done. Without additional detail and clarity, we believe the draft guidance would inhibit innovation in the mobile medical app market. We believe that the draft guidance should be refined based on stakeholder input. To this end we encourage FDA to modify and clarify its regulatory framework in the draft guidance (particularly adding detail for issues that were unaddressed) consistent with the interests of all stakeholders to ensure patient safety and innovation that improves patient care.