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Reintroduced Bill Focuses on Medical Software, mHealth Apps

By Kyle Murphy, PhD

- Reintroduced legislation aims to address the negative impact Food and Drug Administration (FDA) regulation could have on health IT innovations in medical software and mobile health (mHealth) applications.

On Monday, Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) again introduced the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act with the purpose "to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of patient records and certain decision support software."

"Some tools, whether a calorie counter or an activity tracker to monitor your exercise routines, are low risk and don't require in-depth oversight by the government," Bennet said in a public statement. "Our bill provides certainty for innovators in the life sciences and the FDA by clarifying which devices and software should be monitored to keep consumers safe."

According to the joint statement from Bennet and Hatch, the bill would place limits on the FDA in regulating healthcare software and mHealth applications that do not pose a significant risks to patient safety.

An earlier version of the bill (S 2977) failed to even reach a vote during the 113th Congress in December 2014. The contents of the reintroduced legislation are not yet available, but those of its predecessor are. Low-risk technologies fall into five categories in the proposed legislation.

The first comprise administrative and operational systems and services that provide "support of a health care facility or the processing and maintenance of financial records within a health care setting."

The second category includes non-clinical technology "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."

The next category focuses on components of the electronic health record (EHR) and patient charts:

Electronic patient records created, stored, transferred, or reviewed by health care professionals or individuals working under supervision of such professionals that functionally represent a medical chart, including patient history records, but excluding diagnostic image data, provided that software designed for use in maintaining such patient records is validated prior to marketing, consistent with the standards for software validation relied upon by the Secretary in reviewing premarket submissions for devices.

The fourth deals with software "intended to format, organize, or otherwise present clinical laboratory test report data prior to analysis, or to otherwise organize and present clinical laboratory test report findings or data and related patient education information."

The final category of low-risk technology comprises clinical decision support:

Software that is intended to analyze and support the display or printing of patient or other medical information for the purpose of supporting or providing prevention, diagnostic, or treatment recommendations for health care professionals to assist in patient care, and that enables the health care professional to independently review the information on which such recommendations are based such that the intended use of the software is for the health care professional to not rely solely on any specific recommendations or results provided by such software to make a clinical diagnosis or treatment decision, except to the extent that any such software or substantially equivalent product…

The reintroduced bill currently sits with the Committee on Health, Education, Labor, and Pensions as of earlier this week.


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