All Information (Except Text) for S.2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014113th Congress (2013-2014)
|Sponsor:||Sen. Fischer, Deb [R-NE] (Introduced 02/10/2014)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 02/10/2014 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions)|
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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries
Short Titles - Senate
Short Titles as Introduced
PROTECT Act of 2014
Preventing Regulatory Overreach To Enhance Care Technology Act of 2014
Actions Overview (1)
|02/10/2014||Introduced in Senate|
02/10/2014 Introduced in Senate
All Actions (2)
|02/10/2014||Read twice and referred to the Committee on Health, Education, Labor, and Pensions.|
Action By: Senate
|02/10/2014||Sponsor introductory remarks on measure. (CR S853-854)|
Action By: Senate
02/10/2014 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
02/10/2014 Sponsor introductory remarks on measure. (CR S853-854)
|Sen. King, Angus S., Jr. [I-ME]*||02/10/2014|
|Sen. Rubio, Marco [R-FL]*||02/10/2014|
|Committee / Subcommittee||Date||Activity||Reports|
|Senate Health, Education, Labor, and Pensions||02/10/2014||Referred to|
Subject — Policy Area:
One Policy Area term, which best describes an entire measure, is assigned to every public bill or resolution.
Latest Summary (1)
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.