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S. 2977

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.

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sen. Bennet, Michael F. [D-CO](D-CO)Sponsor
1 cosponsor1 R
1cosponsors1committees2actions4subjects
  • Introduced in SenateDec 4, 2014
  1. IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  2. IntroReferral10000

    Introduced in Senate