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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (5)

Short Titles

Short Titles - Senate

Short Titles as Reported to Senate

MEDTECH Act
Medical Electronic Data Technology Enhancement for Consumers' Health Act

Short Titles as Introduced

MEDTECH Act
Medical Electronic Data Technology Enhancement for Consumers' Health Act

Official Titles

Official Titles - Senate

Official Titles as Introduced

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


Actions Overview (2)

Date Actions Overview
04/04/2016Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute and an amendment to the title. Without written report.
04/27/2015Introduced in Senate

All Actions (4)

Date All Actions
04/04/2016Placed on Senate Legislative Calendar under General Orders. Calendar No. 409.
Action By: Senate
04/04/2016Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute and an amendment to the title. Without written report.
03/09/2016Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
04/27/2015Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Action By: Senate

Cosponsors (1)

* = Original cosponsor
CosponsorDate Cosponsored
Sen. Hatch, Orrin G. [R-UT] 05/14/2015

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
Senate Health, Education, Labor, and Pensions04/27/2015 Referred to
03/09/2016 Markup by
04/04/2016 Reported by

No related bill information was received for S.1101.


Subjects (5)


Latest Summary (2)

There are 2 summaries for S.1101. View summaries

Shown Here:
Reported to Senate with amendment(s) (04/04/2016)

Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to exempt certain software from requirements for medical devices. The exemption applies to:

  • administrative software used in health care facilities;
  • software for maintaining or encouraging a healthy lifestyle unrelated to medical care;
  • electronic patient records that are part of certified health information technology;
  • software for transferring, storing, converting, or displaying medical information; and
  • software that provides medical recommendations and the basis for those recommendations to health care professionals.

Software remains subject to regulation as a medical device if: (1) the software acquires, processes, analyzes, or interprets medical information; or (2) the Food and Drug Administration (FDA) identifies use of the software as reasonably likely to have serious adverse health consequences.

When assessing a medical device that includes a software function exempted from medical device requirements, the FDA may assess the impact of the software on the functioning of the device.

The Department of Health and Human Services must report on the health risks and benefits associated with exempted software.

The FDA must classify a medical device accessory based on its intended function, not based on the classification of the medical device with which it is used.