H.R. 3303: Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013

Introduced:
Oct 22, 2013
Status:
Referred to Committee
Prognosis
2% chance of being enacted
Track this bill
Sponsor
Marsha Blackburn
Representative for Tennessee's 7th congressional district
Party
Republican
Text
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Last Updated
Oct 22, 2013
Length
5 pages
 
Status

This bill was assigned to a congressional committee on October 22, 2013, which will consider it before possibly sending it on to the House or Senate as a whole.

Progress
Introduced Oct 22, 2013
Referred to Committee Oct 22, 2013
Reported by Committee ...
Passed House ...
Passed Senate ...
Signed by the President ...
Prognosis

17% chance of getting past committee.
2% chance of being enacted.

Only 11% of bills made it past committee and only about 3% were enacted in 2011–2013. [show factors | methodology]

 
Full Title

To amend the Federal Food, Drug, and Cosmetic Act to provide for regulating medical software, and for other purposes.

Summary

No summaries available.

Cosponsors
30 cosponsors (20R, 10D) (show)
Committees

House Energy and Commerce

Health

The committee chair determines whether a bill will move past the committee stage.

 
Primary Source

THOMAS.gov (The Library of Congress)

GovTrack gets most information from THOMAS, which is updated generally one day after events occur. Activity since the last update may not be reflected here. Data comes via the congress project.

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Citation

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Notes

H.R. stands for House of Representatives bill.

A bill must be passed by both the House and Senate in identical form and then be signed by the president to become law.

The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

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


10/22/2013--Introduced.
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."

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.


No summary available.

House Democratic Caucus Summary

The House Democratic Caucus does not provide summaries of bills.

So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.

We’ll be looking for a source of summaries from the other side in the meanwhile.

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