Legislation would limit regulation of low-risk health IT

Legislation introduced by Sens. Michael Bennett (D-Colo.) and Orrin Hatch (R-Utah) would limit regulation of low-risk medical software and health apps.

The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act would amend the definition of medical devices under the Federal Food, Drug and Cosmetic Act to exempt low-risk health IT from regulation. The bill is similar to legislation sponsored in 2013 by Rep. Marsha Blackburn called the SOFTWARE Act.

The goal of the bill is to provide greater certainty regarding what software will be regulated by the FDA, according to a press release from the senators. It would limit regulation in five specific areas:

1. Software intended for administrative or operational support of a healthcare facility;

2. Products unrelated to clinical treatment of a disease or disorder;

3. EHRs that "functionally represent a medical chart, including patient history records but excluding diagnostic image data," as long as the EHR system is "validated prior to marketing";

4. Software intended to format, organize or otherwise present clinical laboratory test report data prior to analysis; and

5. Software for analyzing and supporting the display or printing of patient or other medical information for supporting or providing prevention, diagnostic or treatment recommendations to clinicians.

In a statement, Joel White, executive director of the Health IT Now Coalition, lauded the bill. “It is unacceptable that the laws currently governing health software, mobile apps and devices like cell phones and tablets were designed and passed when ABBA was popular and the Watergate scandal was just unfolding. The regulatory framework in place is ill-equipped to adapt to today’s advanced technologies and patients are losing out.”