II 

113TH CONGRESS 

2D SESSION S. 2977 

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

regulation of patient records and certain decision support software. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 4, 2014 

Mr. BENNET (for himself and Mr. HATCH) 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 the regulation of patient records and certain 

decision support software. 

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 ‘‘Medical Electronic 

5 Data Technology Enhancement for Consumers’ Health 

6 Act’’ or the ‘‘MEDTECH Act’’. 


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1 SEC. 2. REGULATION OF MEDICAL SOFTWARE. 

2 Section 520 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 360j) is amended by adding at the end 

4 the following: 

5 ‘‘(o) REGULATION OF PATIENT RECORDS AND CER6 TAIN DECISION SUPPORT SOFTWARE.— 

7 ‘‘(1) IN GENERAL.—The following are not de8 vices within the meaning of section 201(h): 

9 ‘‘(A) Software that is intended solely for 

10 administrative or operational support of a 

11 health care facility or the processing and main12 tenance of financial records within a health care 

13 setting. 

14 ‘‘(B) Products that are intended for use in 

15 activities unrelated to the clinical treatment of 

16 a disease or disorder and that are for the pur17 pose of maintaining health and conditioning. 

18 ‘‘(C) Electronic patient records created, 

19 stored, transferred, or reviewed by health care 

20 professionals or individuals working under su21 pervision of such professionals that functionally 

22 represent a medical chart, including patient his23 tory records, but excluding diagnostic image 

24 data, provided that software designed for use in 

25 maintaining such patient records is validated 

26 prior to marketing, consistent with the standVerDate Sep 11 2014 00:35 Dec 06, 2014 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2977.IS S2977

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1 ards for software validation relied upon by the 

2 Secretary in reviewing premarket submissions 

3 for devices. 

4 ‘‘(D) Software that is intended to format, 

5 organize, or otherwise present clinical labora6 tory test report data prior to analysis, or to 

7 otherwise organize and present clinical labora8 tory test report findings or data and related pa9 tient education information. 

10 ‘‘(E) Software that is intended to analyze 

11 and support the display or printing of patient 

12 or other medical information for the purpose of 

13 supporting or providing prevention, diagnostic, 

14 or treatment recommendations for health care 

15 professionals to assist in patient care, and that 

16 enables the health care professional to inde17 pendently review the information on which such 

18 recommendations are based such that the in19 tended use of the software is for the health care 

20 professional to not rely solely on any specific 

21 recommendations or results provided by such 

22 software to make a clinical diagnosis or treat23 ment decision, except to the extent that any 

24 such software or substantially equivalent prod25 uct— 


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1 ‘‘(i) is a component or accessory, or 

2 has the same function as a component or 

3 accessory, of a device subject to regulation 

4 under this Act; or 

5 ‘‘(ii) as of the date of enactment of 

6 this subsection, is regulated or subject to 

7 regulation as a device classified as a class 

8 II or class III device or has the same func9 tion as a component or accessory of a de10 vice subject to regulation under this Act. 

11 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

12 this subsection shall be construed as limiting the au13 thority of the Secretary to exercise enforcement dis14 cretion as to any device subject to regulation under 

15 this Act.’’. 

Æ 


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