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H.R. 3303: SOFTWARE Act of 2013

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H.R. 3303: SOFTWARE Act of 2013

113th Congress · introduced 2013-10-22 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2013-10-22 · official record
  2. Who proposed it: Rep. Blackburn, Marsha [R-TN-7] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

SOFTWARE Act of 2013

Plain 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."

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

SOFTWARE Act of 2013

Source: Congressional Research Service summary (Introduced in House)

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The strongest published arguments

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Blackburn, Marsha [R-TN-7] · 38 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Diana DeGette (D-CO), Juan Vargas (D-CA), Gus M. Bilirakis (R-FL), Robert E. Latta (R-OH), Ami Bera (D-CA), H. Morgan Griffith (R-VA), Brett Guthrie (R-KY), Hakeem S. Jeffries (D-NY), Austin Scott (R-GA), Scott H. Peters (D-CA)

Sponsor's campaign money: Rep. Blackburn, Marsha [R-TN-7] reported raising $3.2 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)
Rulemaking
The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong113-hr3303 · catalog fed-us-congress-bills-cong113 · updated 2026-11-15 by psicol fed-bills-cong113