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

Titles (3)

Short Titles

Short Titles - Senate

Short Titles as Introduced

PROTECT Act of 2014
Preventing Regulatory Overreach To Enhance Care Technology Act of 2014

Official Titles

Official Titles - Senate

Official Titles as Introduced

A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for regulating clinical and health software, and for other purposes.

Actions Overview (1)

Date Actions Overview
02/10/2014Introduced in Senate

All Actions (2)

Date All Actions
02/10/2014Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Action By: Senate
02/10/2014Sponsor introductory remarks on measure. (CR S853-854)
Action By: Senate

Cosponsors (2)

* = Original cosponsor
CosponsorDate Cosponsored
Sen. King, Angus S., Jr. [I-ME]* 02/10/2014
Sen. Rubio, Marco [R-FL]* 02/10/2014

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 Pensions02/10/2014 Referred to

No related bill information was received for S.2007.

Latest Summary (1)

There is one summary for S.2007. View summaries

Shown Here:
Introduced in Senate (02/10/2014)

Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 or the PROTECT Act of 2014 - Expresses the sense of Congress concerning:

  • interagency coordination to foster health information technology and mobile health innovation,
  • development of legislation to establish a risk-based regulatory framework for clinical software and health software,
  • oversight by the National Institute of Standards and Technology (NIST) of technical standards used by clinical software, and
  • work by NIST on next steps regarding health information technology, such as collaborating with nongovernmental entities to develop certification processes and to promote best practice standards.

Excepts clinical software and health software from regulation under the Federal Food, Drug, and Cosmetic Act and excludes the terms from the meaning of "device."

Defines "clinical software" as clinical decision support software or other software intended for human or animal use that: (1) captures, analyzes, changes, or presents patient or population clinical data or information and may recommend courses of clinical action, but does not directly change the structure or any function of the body; and (2) is intended to be marketed for use only by a health care provider in a health care setting.

Defines "health software" as software: (1) that captures, analyzes, changes, or presents patient or population clinical data or information; (2) that supports administrative or operational aspects of health care and is not used in the direct delivery of patient care; or (3) whose primary purpose is to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.