FDASIA: Federal Agencies Report on Medical App Regulation

The FDASIA report on Health IT and its impact on mobile medical apps was released today. FDASIA is a combined effort from federal agencies including the FDA, FCC, and HHS.

ACT is pleased that the FDASIA recommendations promote medical app innovation within a risk-based framework that protects patient safety. We welcome the report’s conclusion that functionality should be the key regulatory determinant. A product’s function — as opposed to its platform — should determine how it is regulated. It is essential to keep a clear path for innovation, but we agree this must begin with patient safety. We support the report’s findings that regulation need not be the first approach to provide safe and effective mobile healthcare solutions.

We also strongly support the report’s recommendation to create a Health IT Safety Center. Convening stakeholders to identify sustainable, innovative health IT systems is critical, and ACT will provide significant input through this open and transparent process. We look forward to bringing our expertise in mobile app privacy, security, COPPA, and other regulatory frameworks to this discussion.

Finally, we thank the FDA, ONC, and the FCC for engaging with stakeholders in this discussion and welcoming public input.

[Report text here]