3.0.0 3303 2023-01-11T13:23:58Z 2023-01-11T13:23:58Z House H HR 2013-10-22 113 [Pages H7252-H7253]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. JOHNSON of Ohio:H.R. 3542.Congress has the power to enact this legislation pursuantto the following:According to Article I, Section 8, Clause 3 of theConstitution: The Congress shall have power to enact thislegislation to regulate commerce with foreign nations, andamong the several states, and with the Indian tribes.[[Page H7253]]ADDITIONAL SPONSORSUnder clause 7 of rule XII, sponsors were added to public bills andresolutions as follows:H.R. 120: Ms. Edwards.H.R. 259: Mr. Kingston.H.R. 270: Mr. Ellison and Mr. Honda.H.R. 274: Mr. Keating.H.R. 351: Mr. McKeon.H.R. 543: Mr. Bishop of New York.H.R. 647: Mr. Mulvaney, Mr. Austin Scott of Georgia, Mr.Collins of Georgia, and Ms. Jackson Lee.H.R. 669: Mrs. Christensen.H.R. 676: Ms. McCollum.H.R. 685: Mr. Vela, Mr. Messer, Mr. Duncan of Tennessee,and Mrs. McMorris Rodgers.H.R. 713: Mr. Gibbs, Mrs. Wagner, Mr. LaMalfa, and Mr.Honda.H.R. 715: Mr. McNerney and Mr. Perlmutter.H.R. 809: Mr. Fincher.H.R. 919: Mr. Ryan of Ohio.H.R. 997: Mr. Latham and Mrs. Miller of Michigan.H.R. 1020: Ms. Foxx.H.R. 1024: Mr. Barrow of Georgia.H.R. 1124: Mrs. Beatty.H.R. 1179: Mr. Cohen and Mrs. Christensen.H.R. 1199: Mr. Garcia.H.R. 1209: Mr. Gibbs, Mr. Graves of Georgia, Mr. Pittenger,Mr. Ben Ray Lujan of New Mexico, Mr. King of New York, andMs. Fudge.H.R. 1248: Mr. Bachus.H.R. 1310: Mr. Lamborn.H.R. 1339: Mr. Lipinski and Mrs. Capito.H.R. 1428: Mr. Price of North Carolina.H.R. 1429: Mr. Bishop of New York.H.R. 1449: Mr. Ross, Mr. Diaz-Balart, Mrs. Lummis, and Mr.Southerland.H.R. 1461: Mr. Hunter and Mr. Nugent.H.R. 1518: Mr. Rodney Davis of Illinois, Mr. Crenshaw, andMr. Bilirakis.H.R. 1563: Ms. Frankel of Florida, Ms. Wasserman Schultz,and Mr. Graves of Missouri.H.R. 1601: Mr. Cartwright.H.R. 1616: Mr. Gibson.H.R. 1666: Ms. Michelle Lujan Grisham of New Mexico, Mr.Lipinski, and Ms. Eshoo.H.R. 1717: Mr. David Scott of Georgia and Ms. Kuster.H.R. 1726: Ms. Frankel of Florida.H.R. 1761: Mr. Roe of Tennessee.H.R. 1779: Mr. Peterson.H.R. 1830: Ms. Esty.H.R. 1851: Ms. Kuster and Mr. Horsford.H.R. 1852: Mr. Ross, Mr. Diaz-Balart, Mrs. Lummis, Mr.Labrador, and Ms. Brownley of California.H.R. 1869: Mr. Wittman.H.R. 1878: Ms. Frankel of Florida.H.R. 1920: Mr. Rigell.H.R. 1985: Mr. Goodlatte.H.R. 1992: Mr. Kinzinger of Illinois and Mr. Sires.H.R. 2027: Mr. Cassidy.H.R. 2028: Mr. Tierney.H.R. 2144: Mr. Duncan of South Carolina.H.R. 2305: Mr. Thompson of Pennsylvania.H.R. 2385: Mrs. Wagner.H.R. 2446: Mrs. Wagner.H.R. 2553: Ms. Moore, Ms. Schwartz, Ms. Titus, and Mr.George Miller of California.H.R. 2560: Mr. Rangel.H.R. 2607: Mrs. Carolyn B. Maloney of New York, Mr. Israel,and Mr. Pocan.H.R. 2619: Mr. Lowenthal.H.R. 2663: Mr. Ross.H.R. 2697: Mr. Bishop of New York, Ms. Kuster, and Mr.Johnson of Georgia.H.R. 2703: Mr. Doyle.H.R. 2725: Mr. Tiberi, Mr. Stutzman, and Ms. WassermanSchultz.H.R. 2785: Mr. Renacci.H.R. 2791: Mr. Gibson and Mr. Huizenga of Michigan.H.R. 2818: Mr. Grijalva.H.R. 2945: Mr. Roskam.H.R. 3040: Mr. Gene Green of Texas.H.R. 3105: Mr. Goodlatte and Mr. Cotton.H.R. 3111: Mr. Johnson of Ohio.H.R. 3121: Mr. Renacci.H.R. 3125: Mr. Butterfield, Mr. Braley of Iowa, Mr. DannyK. Davis of Illinois, Mr. Clay, Mr. Cohen, Mr. Rodney Davisof Illinois, and Mr. Loebsack.H.R. 3135: Ms. McCollum.H.R. 3143: Mr. Israel.H.R. 3163: Mr. Moran.H.R. 3169: Mr. Burgess.H.R. 3189: Mr. Poe of Texas.H.R. 3206: Ms. Frankel of Florida.H.R. 3211: Mr. Fitzpatrick.H.R. 3240: Mr. Foster.H.R. 3297: Ms. Schakowsky.H.R. 3299: Mr. Ribble, Mr. Harris, Mr. Bentivolio, Mr.Boustany, and Mr. Roskam.H.R. 3303: Mr. Bilirakis.H.R. 3308: Mr. Pittenger.H.R. 3309: Mr. Johnson of Ohio and Mr. Larsen ofWashington.H.R. 3322: Mr. Rangel.H.R. 3327: Mrs. Bustos.H.R. 3333: Mr. Pet[...]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-10-25T15:32:57Z Referred to 2013-10-22T18:01:35Z 2013-10-25 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-10-22 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-10-22 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-10-22 Introduced in House IntroReferral 1000 9 Library of Congress B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 N G000410 Rep. Green, Gene [D-TX-29] GENE GREEN D TX 29 2013-10-22 True W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2013-10-22 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2013-10-22 True B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2013-10-22 True G000550 Rep. Gingrey, Phil [R-GA-11] Phil Gingrey R GA 11 2013-10-22 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2013-11-14 False V000130 Rep. Vargas, Juan [D-CA-51] Juan Vargas D CA 51 2013-11-15 False B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 2013-11-19 False E000291 Rep. Ellmers, Renee L. [R-NC-2] Renee Ellmers R NC L. 2 2013-11-20 False L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2013-11-20 False W000796 Rep. Westmoreland, Lynn A. [R-GA-3] Lynn Westmoreland R GA A. 3 2013-11-21 False F000458 Rep. Fincher, Stephen Lee [R-TN-8] Stephen Fincher R TN Lee 8 2013-11-21 False G000562 Rep. Gardner, Cory [R-CO-4] Cory Gardner R CO 4 2013-11-21 False M001180 Rep. McKinley, David B. [R-WV-1] David McKinley R WV B. 1 2013-12-02 False B001287 Rep. Bera, Ami [D-CA-7] Ami Bera D CA 7 2013-12-03 False T000465 Rep. Tsongas, Niki [D-MA-3] Niki Tsongas D MA 3 2013-12-05 False G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 2013-12-12 False H001051 Rep. Hanna, Richard L. [R-NY-22] Richard Hanna R NY L. 22 2013-12-19 False M001142 Rep. Matheson, Jim [D-UT-4] JIM MATHESON D UT 4 2014-01-09 False K000381 Rep. Kilmer, Derek [D-WA-6] Derek Kilmer D WA 6 2014-01-14 False J000292 Rep. Johnson, Bill [R-OH-6] Bill Johnson R OH 6 2014-01-27 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2014-01-28 False S001193 Rep. Swalwell, Eric [D-CA-15] Eric Swalwell D CA 15 2014-01-28 False C001092 Rep. Collins, Chris [R-NY-27] Chris Collins R NY 27 2014-02-04 False T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2014-02-05 False R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 2014-03-04 False R000053 Rep. Rangel, Charles B. [D-NY-13] CHARLES RANGEL D NY B. 13 2014-03-24 False O000168 Rep. Olson, Pete [R-TX-22] Pete Olson R TX 22 2014-03-24 False J000290 Rep. Jenkins, Lynn [R-KS-2] Lynn Jenkins R KS 2 2014-04-01 False R000593 Rep. Ross, Dennis A. [R-FL-15] Dennis Ross R FL A. 15 2014-04-01 False L000480 Rep. Lowey, Nita M. [D-NY-17] NITA LOWEY D NY M. 17 2014-04-28 False J000294 Rep. Jeffries, Hakeem S. [D-NY-8] Hakeem Jeffries D NY S. 8 2014-05-20 False S001189 Rep. Scott, Austin [R-GA-8] Austin Scott R GA 8 2014-05-20 False P000608 Rep. Peters, Scott H. [D-CA-52] Scott Peters D CA H. 52 2014-05-23 False H001056 Rep. Herrera Beutler, Jaime [R-WA-3] Jaime Herrera Beutler R WA 3 2014-06-10 False H001055 Rep. Heck, Joseph J. [R-NV-3] Joseph Heck R NV J. 3 2014-06-20 False H001064 Rep. Heck, Denny [D-WA-10] Denny Heck D WA 10 2014-06-30 False S001179 Rep. Schock, Aaron [R-IL-18] Aaron Schock R IL 18 2014-07-29 False 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 care quality Health information and medical records Health technology, devices, supplies Health 00 2013-10-22 Introduced in House 2013-12-27T21:57:50Z 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."

]]> SOFTWARE Act of 2013 Display Title SOFTWARE Act of 2013 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide for regulating medical software, and for other purposes. Introduced in House IH Short Titles as Introduced SOFTWARE Act of 2013 Short Titles as Introduced Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 Introduced in House 2013-10-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr3303ih/xml/BILLS-113hr3303ih.xml 2013-10-25 Referred to the Subcommittee on Health. 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.