Bill would exempt regulation of EHRs, CDS

A bipartisan bill would exempt regulation of EHRs and certain types of decision support software.

Senators Michael Bennett (D-Colo.) and Orrin Hatch (R-Utah) drafted the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act that would make 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 exempt from regulation.

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 healthcare 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 also would apply to EHRs “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.”

Read the draft bill.