A pair of U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced a bill that aims to cut red tape at the Food and Drug Administration (FDA) in terms of regulatory oversight of health IT software products.
The legislation, the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH), would exempt low-risk medical software and mobile apps from the FDA regulation. It would also clarify which software would be regulated by the agency to protect consumers.
“New and innovative technology is helping our health care providers better take care of their patients, and it’s putting tools into the hands of families that help them manage their own health,” Bennet said in a statement. “Some of these tools, whether a new app to track your calorie intake or an activity tracker to help you while you exercise, are low risk and don’t require in-depth oversight by the government. This bill provides certainty for innovators in the life sciences and the FDA as to which devices and software should be monitored to keep consumers safe.”
MEDTECH is the latest in a long line of efforts from Hatch and other high-profile Senators to limit the regulatory oversight of the health IT industry. In March, Hatch was one of six Senators to send the FDA a letter asking for clarification on the agency’s plans to regulate health IT. In February, Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced legislation that would ensure a wide array of "low-risk" health IT systems would not be subjected to heavy regulatory oversight.
The actual number of mobile health (mHealth) apps that have been regulated by the FDA is minimal. According to a report from the Southern Methodist University (SMU) Dedman School of Law, only 100 of 100,000 apps have been regulated.