S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act

114th Congress

A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of patient records and certain decision support software.

Sponsor: Sen. Michael Bennet — D — CO

This bill amends the Federal Food, Drug, and Cosmetic Act to exclude from regulation by the Food and Drug Administration (FDA) as a medical device: administrative, operational, or financial records software used in health care settings; software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment; electronic patient records, excluding software for interpreting or analyzing medical image data; software for clinical laboratory testing, excluding software for interpreting or analyzing test data; and software that provides medical recommendations and the basis for those recommendations to health care professionals, excluding software for acquiring, processing, or analyzing medical images or signals. The FDA may assess a software function excluded from regulation above when determining the safety and effectiveness of a medical device with multiple functions. The FDA m...

View the full vote history of this bill on GovTrack.us.