II 

113TH CONGRESS 

2D SESSION S. 2007 

To amend the Federal Food, Drug, and Cosmetic Act to provide for regulating 

clinical and health software, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 10, 2014 

Mrs. FISCHER (for herself, Mr. KING, and Mr. RUBIO) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

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

provide for regulating clinical and 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 ‘‘Preventing Regulatory 

5 Overreach To Enhance Care Technology Act of 2014’’ or 

6 the ‘‘PROTECT Act of 2014’’. 

7 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

8 (a) FINDINGS.—Congress finds as follows: 


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1 (1) The mobile health and mobile application 

2 economy was created in the United States and is 

3 now being exported globally, with the market ex4 pected to exceed $26,000,000,000 by 2017. 

5 (2) The United States mobile application econ6 omy is responsible for nearly 500,000 new jobs in 

7 the United States. 

8 (3) Consumer health information technologies, 

9 including smart phones and tablets, have the poten10 tial to transform health care delivery through re11 duced systemic costs, improved patient safety, and 

12 better clinical outcomes. 

13 (4) Clinical and health software innovation cy14 cles evolve and move faster than the existing regu15 latory approval processes. 

16 (5) Consumers and innovators need a new risk17 based framework for the oversight of clinical and 

18 health software that improves on the framework of 

19 the Food and Drug Administration. 

20 (6) A working group convened jointly by the 

21 Food and Drug Administration, the Federal Com22 munications Commission, and the Office of the Na23 tional Coordinator for Health Information Tech24 nology identified in a report that there are several 

25 major barriers to the effective regulation of health 


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1 information technology that cannot be alleviated 

2 without changes to existing law. 

3 (b) SENSE OF CONGRESS.—It is the sense of Con4 gress that— 

5 (1) the President and Congress must intervene 

6 to facilitate interagency coordination across regu7 lators that focuses agency efforts on fostering health 

8 information technology and mobile health innovation 

9 while better protecting patient safety, improving 

10 health care, and creating jobs in the United States; 

11 (2) the President and the Congress should work 

12 together to develop and enact legislation that estab13 lishes a risk-based regulatory framework for such 

14 clinical software and health software that reduces 

15 regulatory burdens, fosters innovation, and, most 

16 importantly, improves patient safety; 

17 (3) The National Institute of Standards and 

18 Technology should be the Federal agency that has 

19 oversight over technical standards used by clinical 

20 software; and 

21 (4) The National Institute of Standards and 

22 Technology, in collaboration with the Federal Com23 munications Commission, the National Patient Safe24 ty Foundation, and the Office of the National Coor25 dinator for Health Information Technology, should 


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1 work on next steps, beyond current oversight efforts, 

2 regarding health information technology, such as col3 laborating with nongovernmental entities to develop 

4 certification processes and to promote best practice 

5 standards. 

6 SEC. 3. CLINICAL SOFTWARE AND HEALTH SOFTWARE. 

7 (a) DEFINITIONS.—Section 201 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 

9 adding at the end the following: 

10 ‘‘(ss)(1) The term ‘clinical software’ means clinical 

11 decision support software or other software (including any 

12 associated hardware and process dependencies) intended 

13 for human or animal use that— 

14 ‘‘(A) captures, analyzes, changes, or presents 

15 patient or population clinical data or information 

16 and may recommend courses of clinical action, but 

17 does not directly change the structure or any func18 tion of the body of man or other animals; and 

19 ‘‘(B) is intended to be marketed for use only by 

20 a health care provider in a health care setting. 

21 ‘‘(2) The term ‘health software’ means software (in22 cluding any associated hardware and process depend23 encies) that is not clinical software and— 


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1 ‘‘(A) that captures, analyzes, changes, or pre2 sents patient or population clinical data or informa3 tion; 

4 ‘‘(B) that supports administrative or oper5 ational aspects of health care and is not used in the 

6 direct delivery of patient care; or 

7 ‘‘(C) whose primary purpose is to act as a plat8 form for a secondary software, to run or act as a 

9 mechanism for connectivity, or to store data. 

10 ‘‘(3) The terms ‘clinical software’ and ‘health soft11 ware’ do not include software— 

12 ‘‘(A) that is intended to interpret patient-spe13 cific device data and directly diagnose a patient or 

14 user without the intervention of a health care pro15 vider; 

16 ‘‘(B) that conducts analysis of radiological or 

17 imaging data in order to provide patient-specific di18 agnostic and treatment advice to a health care pro19 vider; 

20 ‘‘(C) whose primary purpose is integral to the 

21 function of a drug or device; or 

22 ‘‘(D) that is a component of a device.’’. 

23 (b) PROHIBITION.—Subchapter A of chapter V of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

25 et seq.) is amended by adding at the end the following: 


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1 ‘‘SEC. 524B. CLINICAL SOFTWARE AND HEALTH SOFTWARE. 

2 ‘‘Clinical software and health software shall not be 

3 subject to regulation under this Act.’’. 

4 SEC. 4. EXCLUSION FROM DEFINITION OF DEVICE. 

5 Section 201(h) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 321(h)) is amended by adding at 

7 the end ‘‘The term ‘device’ does not include clinical soft8 ware or health software.’’. 

Æ 


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