3.0.0 2007 2023-01-11T13:26:55Z 2023-01-11T13:26:55Z Senate S S 2014-02-10 113 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2014-02-10T20:56:49Z 2014-02-10 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2014-02-10 Sponsor introductory remarks on measure. (CR S853-854) IntroReferral B00100 9 Library of Congress 2014-02-10 Introduced in Senate IntroReferral 10000 9 Library of Congress F000463 Sen. Fischer, Deb [R-NE] Deb Fischer R NE N K000383 Sen. King, Angus S., Jr. [I-ME] Angus King I ME S. 2014-02-10 True R000595 Sen. Rubio, Marco [R-FL] Marco Rubio R FL 2014-02-10 True Health Administrative law and regulatory procedures Computers and information technology Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health information and medical records Health technology, devices, supplies Health 00 2014-02-10 Introduced in Senate 2014-04-28T18:00:23Z 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.

]]> Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 Display Title Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 Short Titles as Introduced Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 Short Titles as Introduced PROTECT Act of 2014 Official Title 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. Introduced in Senate 2014-02-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s2007is/xml/BILLS-113s2007is.xml 2014-02-10 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.