Lawmakers have modified a portion of the FDA user fee bill (S 3187) to help FDA move forward on its plan to regulate mobile medical applications, mHIMSS reports (Wicklund, mHIMSS, 6/19).
Earlier this week, House and Senate leaders reached a bipartisan agreement on the legislation to reauthorize and modify FDA's prescription drug and medical device user-fee programs (Baker, "Healthwatch," The Hill, 6/19).
Lawmakers incorporated the agreement into the Senate bill after holding a conference committee to reconcile the House bill (HR 5651) with the Senate legislation (Ethridge, CQ Today, 6/18).
The House is expected to vote on the final legislation Wednesday and the measure is expected to reach the Senate floor next week ("Healthwatch," The Hill, 6/19).
Details on the Modification
Initially, the Senate bill would have required FDA to outline its proposed strategy for the regulation of mobile medical apps and convene a work group of external stakeholders to provide feedback on the strategy before FDA could issue guidelines (Bowman, FierceMobileHealthcare, 6/20).
Following the modification, the bill would require HHS -- with input from FDA and other stakeholders -- to publish a report on an "appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications that promotes innovation, protects patient safety and avoids regulator duplication."
The bill would allow FDA to move forward on issuing guidelines on mobile medical apps while HHS prepares the report (mHIMSS, 6/19).
Brad Thompson -- an FDA expert with the law firm Epstein Becker Green and general counsel for the mHealth Regulatory Commission -- praised the modification to the bill, saying, "Last night, the mobile health industry avoided a big stumbling block with the help of Congress." He added, "[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" (FierceMobileHealthcare, 6/20)
The compromise FDA user fee bill also includes a provision that would establish a deadline for FDA to create a unique device identification system to track problematic medical equipment (Goedert, Health Data Management, 6/19).