MEDTECH Act

Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act - Amends the Federal Food, Drug, and Cosmetic Act to exclude from regulation as a medical device:

• administrative, operational, or financial records software used in health care settings;
• products intended for health maintenance outside of medical treatment;
• electronic patient records, excluding diagnostic image data, provided that related software is validated prior to marketing, consistent with the standards for devices;
• software for clinical laboratory test reports; and
• software that provides medical recommendations and the basis for those recommendations to health care professionals, with exceptions for products related to regulated devices.