I 

114TH CONGRESS 

1ST SESSION H. R. 2396 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

regulation of health software, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 18, 2015 

Mrs. BLACKBURN (for herself and Mr. GENE GREEN of Texas) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the regulation of health software, and for 

other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Sensible Oversight for 

5 Technology which Advances Regulatory Efficiency Act’’ or 

6 the ‘‘SOFTWARE Act’’. 

7 SEC. 2. HEALTH SOFTWARE. 

8 Section 201 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 321) is amended by adding at the end the 

10 following: 


rfrederick on DSK6VPTVN1PROD with BILLS
2 

•HR 2396 IH

1 ‘‘(ss)(1) The term ‘health software’ means software 

2 that does not, through use of an in vitro diagnostic device 

3 or signal acquisition system, acquire, process, or analyze 

4 an image or physiological signal, is not an accessory, is 

5 not an integral part of a device necessary to support the 

6 use of the device, is not used in the manufacture and 

7 transfusion of blood and blood components to assist in the 

8 prevention of disease in humans, and— 

9 ‘‘(A) is intended for use for administrative 

10 or operational support or the processing and 

11 maintenance of financial records; 

12 ‘‘(B) is intended for use in clinical, labora13 tory, or administrative workflow and related 

14 recordkeeping; 

15 ‘‘(C)(i) is intended for use solely in the 

16 transfer, aggregation, conversion (in accordance 

17 with a present specification), storage, manage18 ment, retrieval, or transmission of data or in19 formation; 

20 ‘‘(ii) utilizes a connectivity software plat21 form, electronic or electrical hardware, or a 

22 physical communications infrastructure; and 

23 ‘‘(iii) is not intended for use— 

24 ‘‘(I) in active patient monitoring; or 


rfrederick on DSK6VPTVN1PROD with BILLS
3 

•HR 2396 IH

1 ‘‘(II) in controlling or altering the 

2 functions or parameters of a device that is 

3 connected to such software; 

4 ‘‘(D) is intended for use to organize and 

5 present information for health or wellness edu6 cation or for use in maintaining a healthy life7 style, including medication adherence and 

8 health management tools; 

9 ‘‘(E) is intended for use to analyze infor10 mation to provide general health information 

11 that does not include patient-specific rec12 ommended options to consider in the preven13 tion, diagnosis, treatment, cure, or mitigation of 

14 a particular disease or condition; or 

15 ‘‘(F) is intended for use to analyze infor16 mation to provide patient-specific recommended 

17 options to consider in the prevention, diagnosis, 

18 treatment, cure, or mitigation of a particular 

19 disease or condition. 

20 ‘‘(2) The term ‘accessory’ means a product that— 

21 ‘‘(A) is intended for use with one or more par22 ent devices; 

23 ‘‘(B) is intended to support, supplement, or 

24 augment the performance of one or more parent de25 vices; and 


rfrederick on DSK6VPTVN1PROD with BILLS
4 

•HR 2396 IH

1 ‘‘(C) shall be classified by the Secretary— 

2 ‘‘(i) according to its intended use; and 

3 ‘‘(ii) independently of any classification of 

4 any parent device with which it is used.’’. 

5 SEC. 3. APPLICABILITY AND INAPPLICABILITY OF REGULA6 TION. 

7 Subchapter A of chapter V of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend9 ed by adding at the end the following: 

10 ‘‘SEC. 524B. HEALTH SOFTWARE. 

11 ‘‘(a) INAPPLICABILITY OF REGULATION TO HEALTH

12 SOFTWARE.—Except as provided in subsection (b), health 

13 software shall not be subject to regulation under this Act. 

14 ‘‘(b) EXCEPTION.— 

15 ‘‘(1) IN GENERAL.—Subsection (a) shall not 

16 apply with respect to a software product— 

17 ‘‘(A) of a type described in subparagraph 

18 (F) of section 201(ss)(1); and 

19 ‘‘(B) that the Secretary determines poses a 

20 significant risk to patient safety. 

21 ‘‘(2) CONSIDERATIONS.—In making a deter22 mination under subparagraph (B) of paragraph (1) 

23 with respect to a product to which such paragraph 

24 applies, the Secretary shall consider the following: 


rfrederick on DSK6VPTVN1PROD with BILLS
5 

•HR 2396 IH

1 ‘‘(A) The likelihood and severity of patient 

2 harm if the product were to not perform as in3 tended. 

4 ‘‘(B) The extent to which the product is 

5 intended to support the clinical judgment of a 

6 medical professional. 

7 ‘‘(C) Whether there is a reasonable oppor8 tunity for a medical professional to review the 

9 basis of the information or treatment rec10 ommendation provided by the product. 

11 ‘‘(D) The intended user and user environ12 ment, such as whether a medical professional 

13 will use a software product of a type described 

14 in subparagraph (F) of section 201(ss)(1). 

15 ‘‘(c) DELEGATION.—The Secretary shall delegate pri16 mary jurisdiction for regulating a software product deter17 mined under subsection (b) to be subject to regulation 

18 under this Act to the center at the Food and Drug Admin19 istration charged with regulating devices. 

20 ‘‘(d) REGULATION OF SOFTWARE.— 

21 ‘‘(1) IN GENERAL.—The Secretary shall review 

22 existing regulations and guidance regarding the reg23 ulation of software under this Act. The Secretary 

24 may implement a new framework for the regulation 

25 of software and shall, as appropriate, modify such 


rfrederick on DSK6VPTVN1PROD with BILLS
6 

•HR 2396 IH

1 regulations and guidance or issue new regulations or 

2 guidance. 

3 ‘‘(2) ISSUANCE BY ORDER.—Notwithstanding 

4 subchapter II of chapter 5 of title 5, United States 

5 Code, the Secretary may modify or issue regulations 

6 for the regulation of software under this Act by ad7 ministrative order published in the Federal Register 

8 following the publication of a proposed order. 

9 ‘‘(3) AREAS UNDER REVIEW.—The review of ex10 isting regulations and guidance under paragraph (1) 

11 may include review of the following areas: 

12 ‘‘(A) Classification of software. 

13 ‘‘(B) Standards for development of soft14 ware. 

15 ‘‘(C) Standards for validation and 

16 verification of software. 

17 ‘‘(D) Review of software. 

18 ‘‘(E) Modifications to software. 

19 ‘‘(F) Manufacturing of software. 

20 ‘‘(G) Quality systems for software. 

21 ‘‘(H) Labeling requirements for software. 

22 ‘‘(I) Postmarketing requirements for re23 porting of adverse events. 

24 ‘‘(4) PROCESS FOR ISSUING PROPOSED REGU25 LATIONS, ADMINISTRATIVE ORDER, AND GUIDVerDate Sep 11 2014 00:45 May 23, 2015 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2396.IH H2396

rfrederick on DSK6VPTVN1PROD with BILLS
7 

•HR 2396 IH

1 ANCE.—Not later than 18 months after the date of 

2 enactment of this section, the Secretary shall consult 

3 with external stakeholders (including patients, indus4 try, health care providers, academia, and govern5 ment) to gather input before issuing regulations, an 

6 administrative order, and guidance under this sub7 section. 

8 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec9 tion shall be construed as providing the Secretary with the 

10 authority to regulate under this Act any health software 

11 product of the type described in subparagraph (F) of sec12 tion 201(ss)(1) unless and until the Secretary has made 

13 a determination described in subsection (b)(1)(B) with re14 spect to such product.’’. 

15 SEC. 4. EXCLUSION FROM DEFINITION OF DEVICE. 

16 Section 201(h) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 321) is amended— 

18 (1) in subparagraph (2), by striking ‘‘or’’ after 

19 ‘‘or other animals,’’; 

20 (2) in subparagraph (3), by striking ‘‘and’’ and 

21 inserting ‘‘or’’; and 

22 (3) by inserting after subparagraph (3) the fol23 lowing: 


rfrederick on DSK6VPTVN1PROD with BILLS
8 

•HR 2396 IH

1 ‘‘(4) is not health software (other than software 

2 determined to be a risk to patient safety under sec3 tion 524B(b)), and’’. 

Æ 


rfrederick on DSK6VPTVN1PROD with BILLS