In the 21st Century Cures Act passed by the House this week, Congress took steps to remedy any confusion about the role of the Food and Drug Administration in regulating health information technology.
The 996-page bill includes eight pages “clarifying” — or some might say, limiting — the FDA's role in dealing with healthcare software.
The FDA regulates medical devices that could pose a threat to a patient's life or health if they failed, for example pacemakers. But the growth of mobile medical technology has created a regulatory Wild West when other devices enter the market, such as exercise trackers, because there is no federal agency tasked with regulating them.
And critics of the Cures Act, which aims to expedite drug and device innovation by cutting through red tape, say the bill could weaken federal regulators' ability to protect consumers from new potentially dangerous drugs and medical devices in an effort to get products quickly to market.
In 2013, the agency responsible for regulating drugs and devices clarified – but generally declined to expand – its regulatory scope on health and wellness apps on smartphones and other wireless devices.
Two years later, it again declined to expand its regulatory turf, but issued a guidance to device makers on its expectations for safety and security testing.
Now, the 21st Century Act clarifies that the FDA is not responsible for regulating a number of consumer-facing applications, including those for “maintaining and encouraging a healthy lifestyle.” The bill also included a host of other software "for administrative support of a healthcare facility." That includes financial records, claims, information about patient populations, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management and laboratory workflow.
The bill would also exclude FDA regulation for many types of electronic patient records that serve as an “equivalent” to a paper medical chart, provided the records were created by an EHR or other technology tested and federally certified and if the software does not attempt to analyze the data “for the purpose of diagnosis, cure, mitigation, prevention or treatment.”
Software that stores, displays or transfers lab data — provided it does not interpret it — is also exempt from FDA regulation.
All that said, Congress would give the FDA some wiggle room to step in and regulate an HIT system if the agency finds it would be “reasonably likely to have serious adverse health consequences.”
The FDA is also directed to similarly classify accessories of devices regulated under the proposed law.
