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S. 2007 (113th): Preventing Regulatory Overreach To Enhance Care Technology Act of 2014


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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.


2/10/2014--Introduced. 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.