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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Sensible Oversight for 
Technology which Advances Regulatory Efficiency Act’’ or 
the ‘‘SOFTWARE Act’’. 
SEC. 2. HEALTH SOFTWARE. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
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‘‘(ss)(1) The term ‘health software’ means software 
that does not, through use of an in vitro diagnostic device 
or signal acquisition system, acquire, process, or analyze 
an image or physiological signal, is not an accessory, is 
not an integral part of a device necessary to support the 
use of the device, is not used in the manufacture and 
transfusion of blood and blood components to assist in the 
prevention of disease in humans, and— 
‘‘(A) is intended for use for administrative 
or operational support or the processing and 
maintenance of financial records; 
‘‘(B) is intended for use in clinical, labora-
tory, or administrative workflow and related 
recordkeeping; 
‘‘(C)(i) is intended for use solely in the 
transfer, aggregation, conversion (in accordance 
with a present specification), storage, manage-
ment, retrieval, or transmission of data or in-
formation; 
‘‘(ii) utilizes a connectivity software plat-
form, electronic or electrical hardware, or a 
physical communications infrastructure; and 
‘‘(iii) is not intended for use— 
‘‘(I) in active patient monitoring; or 
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‘‘(II) in controlling or altering the 
functions or parameters of a device that is 
connected to such software; 
‘‘(D) is intended for use to organize and 
present information for health or wellness edu-
cation or for use in maintaining a healthy life-
style, including medication adherence and 
health management tools; 
‘‘(E) is intended for use to analyze infor-
mation to provide general health information 
that does not include patient-specific rec-
ommended options to consider in the preven-
tion, diagnosis, treatment, cure, or mitigation of 
a particular disease or condition; or 
‘‘(F) is intended for use to analyze infor-
mation to provide patient-specific recommended 
options to consider in the prevention, diagnosis, 
treatment, cure, or mitigation of a particular 
disease or condition. 
‘‘(2) The term ‘accessory’ means a product that— 
‘‘(A) is intended for use with one or more par-
ent devices; 
‘‘(B) is intended to support, supplement, or 
augment the performance of one or more parent de-
vices; and 
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‘‘(C) shall be classified by the Secretary— 
‘‘(i) according to its intended use; and 
‘‘(ii) independently of any classification of 
any parent device with which it is used.’’. 
SEC. 3. APPLICABILITY AND INAPPLICABILITY OF REGULA-
TION. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 524B. HEALTH SOFTWARE. 
‘‘(a) INAPPLICABILITY OF REGULATION TO HEALTH 
SOFTWARE.—Except as provided in subsection (b), health 
software shall not be subject to regulation under this Act. 
‘‘(b) EXCEPTION.— 
‘‘(1) IN
GENERAL.—Subsection (a) shall not 
apply with respect to a software product— 
‘‘(A) of a type described in subparagraph 
(F) of section 201(ss)(1); and 
‘‘(B) that the Secretary determines poses a 
significant risk to patient safety. 
‘‘(2) CONSIDERATIONS.—In making a deter-
mination under subparagraph (B) of paragraph (1) 
with respect to a product to which such paragraph 
applies, the Secretary shall consider the following: 
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‘‘(A) The likelihood and severity of patient 
harm if the product were to not perform as in-
tended. 
‘‘(B) The extent to which the product is 
intended to support the clinical judgment of a 
medical professional. 
‘‘(C) Whether there is a reasonable oppor-
tunity for a medical professional to review the 
basis of the information or treatment rec-
ommendation provided by the product. 
‘‘(D) The intended user and user environ-
ment, such as whether a medical professional 
will use a software product of a type described 
in subparagraph (F) of section 201(ss)(1). 
‘‘(c) DELEGATION.—The Secretary shall delegate pri-
mary jurisdiction for regulating a software product deter-
mined under subsection (b) to be subject to regulation 
under this Act to the center at the Food and Drug Admin-
istration charged with regulating devices. 
‘‘(d) REGULATION OF SOFTWARE.— 
‘‘(1) IN GENERAL.—The Secretary shall review 
existing regulations and guidance regarding the reg-
ulation of software under this Act. The Secretary 
may implement a new framework for the regulation 
of software and shall, as appropriate, modify such 
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regulations and guidance or issue new regulations or 
guidance. 
‘‘(2) ISSUANCE
BY
ORDER.—Notwithstanding 
subchapter II of chapter 5 of title 5, United States 
Code, the Secretary may modify or issue regulations 
for the regulation of software under this Act by ad-
ministrative order published in the Federal Register 
following the publication of a proposed order. 
‘‘(3) AREAS UNDER REVIEW.—The review of ex-
isting regulations and guidance under paragraph (1) 
may include review of the following areas: 
‘‘(A) Classification of software. 
‘‘(B) Standards for development of soft-
ware. 
‘‘(C) 
Standards 
for 
validation 
and 
verification of software. 
‘‘(D) Review of software. 
‘‘(E) Modifications to software. 
‘‘(F) Manufacturing of software. 
‘‘(G) Quality systems for software. 
‘‘(H) Labeling requirements for software. 
‘‘(I) Postmarketing requirements for re-
porting of adverse events. 
‘‘(4) PROCESS FOR ISSUING PROPOSED REGU-
LATIONS, 
ADMINISTRATIVE
ORDER, 
AND
GUID-
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ANCE.—Not later than 18 months after the date of 
enactment of this section, the Secretary shall consult 
with external stakeholders (including patients, indus-
try, health care providers, academia, and govern-
ment) to gather input before issuing regulations, an 
administrative order, and guidance under this sub-
section. 
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as providing the Secretary with the 
authority to regulate under this Act any health software 
product of the type described in subparagraph (F) of sec-
tion 201(ss)(1) unless and until the Secretary has made 
a determination described in subsection (b)(1)(B) with re-
spect to such product.’’. 
SEC. 4. EXCLUSION FROM DEFINITION OF DEVICE. 
Section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended— 
(1) in subparagraph (2), by striking ‘‘or’’ after 
‘‘or other animals,’’; 
(2) in subparagraph (3), by striking ‘‘and’’ and 
inserting ‘‘or’’; and 
(3) by inserting after subparagraph (3) the fol-
lowing: 
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‘‘(4) is not health software (other than software 
determined to be a risk to patient safety under sec-
tion 524B(b)), and’’. 
Æ 
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