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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2977 Introduced in Senate (IS)]

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Electronic Data Technology 
Enhancement for Consumers' Health Act'' or the ``MEDTECH Act''.

SEC. 2. REGULATION OF MEDICAL SOFTWARE.

    Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j) is amended by adding at the end the following:
    ``(o) Regulation of Patient Records and Certain Decision Support 
Software.--
            ``(1) In general.--The following are not devices within the 
        meaning of section 201(h):
                    ``(A) Software that is intended solely for 
                administrative or operational support of a health care 
                facility or the processing and maintenance of financial 
                records within a health care setting.
                    ``(B) Products that are intended for use in 
                activities unrelated to the clinical treatment of a 
                disease or disorder and that are for the purpose of 
                maintaining health and conditioning.
                    ``(C) Electronic patient records created, stored, 
                transferred, or reviewed by health care professionals 
                or individuals working under supervision of such 
                professionals that functionally represent a medical 
                chart, including patient history records, but excluding 
                diagnostic image data, provided that software designed 
                for use in maintaining such patient records is 
                validated prior to marketing, consistent with the 
                standards for software validation relied upon by the 
                Secretary in reviewing premarket submissions for 
                devices.
                    ``(D) Software that is intended to format, 
                organize, or otherwise present clinical laboratory test 
                report data prior to analysis, or to otherwise organize 
                and present clinical laboratory test report findings or 
                data and related patient education information.
                    ``(E) Software that is intended to analyze and 
                support the display or printing of patient or other 
                medical information for the purpose of supporting or 
                providing prevention, diagnostic, or treatment 
                recommendations for health care professionals to assist 
                in patient care, and that enables the health care 
                professional to independently review the information on 
                which such recommendations are based such that the 
                intended use of the software is for the health care 
                professional to not rely solely on any specific 
                recommendations or results provided by such software to 
                make a clinical diagnosis or treatment decision, except 
                to the extent that any such software or substantially 
                equivalent product--
                            ``(i) is a component or accessory, or has 
                        the same function as a component or accessory, 
                        of a device subject to regulation under this 
                        Act; or
                            ``(ii) as of the date of enactment of this 
                        subsection, is regulated or subject to 
                        regulation as a device classified as a class II 
                        or class III device or has the same function as 
                        a component or accessory of a device subject to 
                        regulation under this Act.
            ``(2) Rule of construction.--Nothing in this subsection 
        shall be construed as limiting the authority of the Secretary 
        to exercise enforcement discretion as to any device subject to 
        regulation under this Act.''.
                                 <all>
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