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United States · Bill · HR

H.R. 3303 (113th)

SOFTWARE Act of 2013

referredUnited States· United States Congress· EN

Introduced

22 October 2013

Last action

25 October 2013 · Referred

Status

Referred to the Subcommittee on Health.

Sponsors

Sen. Blackburn, Marsha [R-TN], Rep. Green, Gene [D-TX-29], Rep. Walden, Greg [R-OR-2], Rep. DeGette, Diana [D-CO-1], Rep. Butterfield, G. K. [D-NC-1], Rep. Gingrey, Phil [R-GA-11], Rep. Burgess, Michael C. [R-TX-26], Rep. Vargas, Juan [D-CA-52], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Ellmers, Renee L. [R-NC-2], Rep. Latta, Robert E. [R-OH-5], Rep. Westmoreland, Lynn A. [R-GA-3], Rep. Fincher, Stephen Lee [R-TN-8], Sen. Gardner, Cory [R-CO], Rep. McKinley, David B. [R-WV-1], Rep. Bera, Ami [D-CA-6], Rep. Tsongas, Niki [D-MA-3], Rep. Griffith, H. Morgan [R-VA-9], Rep. Hanna, Richard L. [R-NY-22], Rep. Matheson, Jim [D-UT-2], Rep. Kilmer, Derek [D-WA-6], Rep. Johnson, Bill [R-OH-6], Rep. Guthrie, Brett [R-KY-2], Rep. Swalwell, Eric [D-CA-15], Rep. Collins, Chris [R-NY-27], Rep. Tiberi, Patrick J. [R-OH-12], Rep. Roe, David P. [R-TN-1], Rep. Rangel, Charles B. [D-NY-15], Rep. Olson, Pete [R-TX-22], Rep. Jenkins, Lynn [R-KS-2], Rep. Ross, Dennis A. [R-FL-15], Rep. Lowey, Nita M. [D-NY-17], Rep. Jeffries, Hakeem S. [D-NY-8], Rep. Scott, Austin [R-GA-8], Rep. Peters, Scott H. [D-CA-50], Rep. Herrera Beutler, Jaime [R-WA-3], Rep. Heck, Joseph J. [R-NV-3], Rep. Heck, Denny [D-WA-10], Rep. Schock, Aaron [R-IL-18]

Subjects

Healthcare

Source updated

12 August 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 or the SOFTWARE Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to apply it to medical software to the same extent and in the same manner as it applies to devices. Defines "medical software" as software that is intended to be marketed: to directly change the structure or any function of the body of man or other animals; or for use by consumers and makes recommendations for clinical action that includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider and which, if followed, would change the structure or any function of the body of man or other animals. Excludes from such definition software whose primary purpose is integral to the functioning of a drug or device and is not a component of a device. Excludes clinical software and health software (defined as follows) from FDCA regulation. Defines "clinical software" as software 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 of man or other animals; and (2) is intended for use only by a health care provider in a health care setting. Defines "health software" as software that is not medical software or clinical software and that: (1) captures, analyzes, changes, or presents patient or population clinical data or information or supports administrative or operational aspects of health care and is not used in the direct delivery of care; or (2) has as its primary purpose to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data. Expresses the sense of Congress concerning the value of clinical software and health software to health care quality and efficacy and the need for legislation that establishes a risk-based regulatory framework that reduces regulatory burdens, promotes patient safety, and fosters innovation. Excludes medical software, clinical software, and health software from the FDCA definition of "device."

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 22 October 2013

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 22 October 2013

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 22 October 2013

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 25 October 2013

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

3 official files

Introduced in House (text)

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  • Introduced in House (text)

    Introduced in House · EN · 22 October 2013

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  • Introduced in House (PDF)

    Introduced in House · EN · 22 October 2013

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  • Introduced in House

    summary · EN · 22 October 2013

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Sponsors

Related records

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Sources

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