Senators Michael Bennett (D-Colo.) and Orrin Hatch (R-Utah) have drafted a bill to exempt regulation of electronic patient records and certain types of decision support software.

The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act would ostensibly exempt software intended solely for administrative or operational support as well as software and health IT products intended for use in activities unrelated to clinical treatment.

The exemption would apply to software that is:

 *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, and;

*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 healthcare professionals to assist in patient care, and that enables the healthcare 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.

The exemption would also apply to electronic patient records “created, stored, transferred, or reviewed by healthcare 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.”

According to Bradley Merrill Thompson, general counsel for the Clinical Decision Support (CDS) Coalition, the MEDTECH Act takes a “straightforward and clean approach” that “very clearly carves out several categories of low risk technology that should not be regulated.” In particular, Thompson argues that with regard to CDS, where “the issues start to get murky,” it limits FDA jurisdiction to software that lacks transparency, meaning: FDA would not regulate software if the user can see through the software to the original data and clinical intelligence and make the decision for themselves.

“If the software is simply doing what software does best, which is retrieving data and doing calculations, but the user has all of the information at his or her fingertips, the decision-making of the user is really governed under the practice of medicine and is not something into which FDA should intrude,” he asserts. “The CDS Coalition has been advocating that very point for several years now. So we were delighted to hear that the Hatch/Bennett bill takes that same approach.”

At the same time, Thompson believes the legislation is also “attentive to the need to protect patients in that it retains for FDA regulation software which is in either class II or class III now, which is medium and high risk software, or software that serves as an accessory to a medical device.”

Thompson says it is unclear whether the proposed legislation will be introduced before the end of the year or in 2015. Text of the draft bill can be found here.


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