Legislation proposed to remove low-risk software from FDA regulation

On December 4, 2014, Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced legislation that would exempt from US Food and Drug Administration (“FDA”) regulation certain medical software and mobile applications identified as having “low-risk.”

The Medical Electronic Data Technology Enhancement for Consumers’ Health Act or “MEDTECH Act,” would amend the Food, Drug, and Cosmetic Act (the “Act”) to provide that products “intended for use in activities unrelated to the clinical treatment of a disease or disorder and that are for the purpose of maintaining health and conditioning” are not devices subject to regulation under the Act.

This provision in the proposed legislation is intended to remove wellness and lifestyle products, including products that such as ones that track calorie intake and exercise activity, from FDA review.

The proposed legislation would also limit FDA’s ability to regulate software used in the provider setting for administrative and clinical support purposes. The MEDTECH Act would limit the Act’s applicability to software that is “intended solely for administrative or operational support of a health care facility or the processing and maintenance of financial records within a health care setting.”

Also removed from FDA regulatory authority would be software that is intended to “format, organize, or otherwise present clinical laboratory test report data prior to analysis,” or to “organize and present clinical laboratory test report findings or data and related patient education information.”

Finally, the legislation would limit FDA’s ability to regulate electronic patient records constituting medical charts, excluding diagnostic image data, and software intended to analyze and permit the display of patient information for the purpose of supporting diagnostic or treatment recommendations.

In introducing this legislation, Senator Bennet identified these classes of software or mobile applications as “low risk” and such that each category should not require in-depth oversight by the government. Senator Bennet stated that the bill is intended to “[provide] certainty for innovators in the life sciences and the FDA as to which devices and software should be monitored to keep consumers safe.”

Read a copy of the proposed MEDTECH Act legislation.