[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1101 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 409
114th CONGRESS
  2d Session
                                S. 1101

 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

                             April 27, 2015

 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

                             April 4, 2016

 Reported by Mr. Alexander, with an amendment and an amendment to the 
                                 title
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

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

<DELETED>SEC. 2. REGULATION OF MEDICAL SOFTWARE.</DELETED>

<DELETED>    Section 520 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j) is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(o) Regulation of Medical and Certain Decision Support 
Software.--</DELETED>
        <DELETED>    ``(1) Exclusions from the category of devices.--
        The term `device', as defined in section 201(h), shall not 
        include the following:</DELETED>
                <DELETED>    ``(A) Software that is intended for 
                administrative and operational support of a health care 
                facility or the processing and maintenance of financial 
                records, appointment schedules, business analytics, 
                communication, information about patient populations, 
                and laboratory workflow processes.</DELETED>
                <DELETED>    ``(B) Software that is intended for the 
                purpose of maintaining or encouraging a healthy 
                lifestyle and are unrelated to the diagnosis, cure, 
                mitigation, prevention, or treatment of a disease or 
                disorder.</DELETED>
                <DELETED>    ``(C) Except for software intended to 
                interpret or analyze medical image data for the purpose 
                of diagnosis, cure, mitigation, prevention, or 
                treatment of a disease or condition, electronic patient 
                records, to the extent that such records are intended 
                to transfer, store, convert formats, or display the 
                equivalent of a paper medical chart, which may include 
                patient history records if--</DELETED>
                        <DELETED>    ``(i) such records were created, 
                        stored, transferred, or reviewed by health care 
                        professionals, or by individuals working under 
                        supervision of such professionals; 
                        and</DELETED>
                        <DELETED>    ``(ii) such records are part of 
                        health information technology that is certified 
                        under section 3001(c)(5) of the Public Health 
                        Service Act as being in compliance with 
                        applicable certification criteria adopted under 
                        subtitle A of title XXX of such Act.</DELETED>
                <DELETED>    ``(D) Except for software intended to 
                interpret or analyze clinical laboratory test data, 
                software that is intended to transfer, store, convert 
                formats, or display--</DELETED>
                        <DELETED>    ``(i) clinical laboratory test 
                        report data, results, or findings prior to 
                        analysis or interpretation by a health care 
                        professional; or</DELETED>
                        <DELETED>    ``(ii) clinical laboratory test 
                        report data, results, or findings, or related 
                        patient education information with respect to 
                        such data, to a patient.</DELETED>
                <DELETED>    ``(E) Except for a device accessory and 
                software that is intended to acquire, process, or 
                analyze a medical image or a signal from an in vitro 
                diagnostic device or a pattern or signal from a signal 
                acquisition system, software that--</DELETED>
                        <DELETED>    ``(i) is intended to display, 
                        analyze, or print medical information about a 
                        patient or other medical information (such as 
                        peer-reviewed clinical studies and clinical 
                        practice guidelines);</DELETED>
                        <DELETED>    ``(ii) is intended to support or 
                        provide recommendations to a health care 
                        professional about prevention, diagnosis, or 
                        treatment; and</DELETED>
                        <DELETED>    ``(iii) enables the health care 
                        professional to independently review the basis 
                        for each recommendation that the software 
                        presents such that it is not the intent that 
                        the health care professional rely solely on any 
                        specific recommendations or results provided by 
                        such software to make a clinical diagnosis or 
                        treatment decision.</DELETED>
        <DELETED>    ``(2) Multiple functionality products.--In the 
        case of a product with multiple functionality that contains a 
        software function that is excluded under paragraph (1) from the 
        definition of a device under section 201(h) and a function that 
        meets the definition of device under section 201(h), the 
        Secretary shall not regulate the excluded software function of 
        the product as a device, but the Secretary may assess such 
        software function for the purpose of determining the safety and 
        effectiveness of the device function of the product.</DELETED>
        <DELETED>    ``(3) Rules of construction.--Nothing in this 
        subsection shall be construed as limiting the authority of the 
        Secretary to--</DELETED>
                <DELETED>    ``(A) exercise enforcement discretion as 
                to any device subject to regulation under this Act; 
                or</DELETED>
                <DELETED>    ``(B) regulate software devices used in 
                the manufacture and transfusion of blood and blood 
                components to assist in the prevention of disease in 
                humans.''.</DELETED>

<DELETED>SEC. 3. QUALITY AND STANDARDS.</DELETED>

<DELETED>    The Secretary of Health and Human Services shall ensure 
that software described in subparagraphs (C), (D), and (E) of 
subsection (o)(1) of section 520 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) (as amended by section 3) is consistent 
with appropriate quality principles and standards for software 
development and validation.</DELETED>

<DELETED>SEC. 4. CLASSIFICATION OF ACCESSORIES.</DELETED>

<DELETED>    Subsection 513(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c(b)) is amended by adding at the end the 
following:</DELETED>
        <DELETED>    ``(9) The Secretary shall classify an accessory 
        under this section based on the intended use of the accessory, 
        notwithstanding the classification of any other device with 
        which such accessory is intended to be used.''.</DELETED>

<DELETED>SEC. 5. CONFORMING AMENDMENT.</DELETED>

<DELETED>    Section 201(h) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(h)) is amended by adding at the end ``The term `device' 
does not include medical and decision support software described in 
section 520(o).''.</DELETED>

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.

    (a) In General.--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 Medical and Certain Decisions Support 
Software.--
            ``(1) Regulation of certain software.--The term `device', 
        as defined in section 201(h), shall not include a software 
        function that is intended--
                    ``(A) for administrative support of a health care 
                facility, including the processing and maintenance of 
                financial records, claims or billing information, 
                appointment schedules, business analytics, information 
                about patient populations, admissions, practice and 
                inventory management, analysis of historical claims 
                data to predict future utilization or cost-
                effectiveness, determination of health benefit 
                eligibility, population health management, and 
                laboratory workflow;
                    ``(B) for maintaining or encouraging a healthy 
                lifestyle and is unrelated to the diagnosis, cure, 
                mitigation, prevention, or treatment of a disease or 
                condition;
                    ``(C) to serve as electronic patient records, 
                including patient-provided information, to the extent 
                that such records are intended to transfer, store, 
                convert formats, or display the equivalent of a paper 
                medical chart, so long as--
                            ``(i) such records were created, stored, 
                        transferred, or reviewed by health care 
                        professionals, or by individuals working under 
                        supervision of such professionals;
                            ``(ii) such records are part of health 
                        information technology that is certified under 
                        section 3001(c)(5) of the Public Health Service 
                        Act as being in compliance with applicable 
                        certification criteria adopted under subtitle A 
                        of title XXX of such Act; and
                            ``(iii) such function is not intended to 
                        interpret or analyze patient records, including 
                        medical image data, for the purpose of the 
                        diagnosis, cure, mitigation, prevention, or 
                        treatment of a disease or condition;
                    ``(D) for transferring, storing, converting 
                formats, or displaying clinical laboratory test or 
                other device data and results, findings by a health 
                care professional with respect to such data and 
                results, general information about such findings, and 
                general background information about such laboratory 
                test or other device, unless such function is intended 
                to interpret or analyze clinical laboratory test or 
                other device data, results, and findings; or
                    ``(E) for the purpose of--
                            ``(i) displaying, analyzing, or printing 
                        medical information about a patient or other 
                        medical information (such as peer-reviewed 
                        clinical studies and clinical practice 
                        guidelines);
                            ``(ii) supporting or providing 
                        recommendations to a health care professional 
                        about prevention, diagnosis, or treatment of a 
                        disease or condition; and
                            ``(iii) enabling such health care 
                        professional to independently review the basis 
                        for such recommendations that such software 
                        presents so that it is not the intent that such 
                        health care professional rely primarily on any 
                        of such recommendations to make a clinical 
                        diagnosis or treatment decision regarding an 
                        individual patient;
                unless a function described in subparagraph (E) is 
                intended to acquire, process, or analyze a medical 
                image or a signal from an in vitro diagnostic device or 
                a pattern or signal from a signal acquisition system.
            ``(2) Multiple functionality products.--In the case of a 
        product with multiple functions that contains--
                    ``(A) at least one software function that meets the 
                criteria under paragraph (1) or that otherwise does not 
                meet the definition of `device' under section 201(h); 
                and
                    ``(B) at least one function that does not meet the 
                criteria under paragraph (1) and that otherwise meets 
                the definition of a `device' under section 201(h),
        the Secretary shall not regulate the software function of such 
        product described in subparagraph (A) as a device. 
        Notwithstanding the preceding sentence, when assessing the 
        safety and effectiveness of the device function or functions of 
        such product described in subparagraph (B), the Secretary may 
        assess the impact that the software function or functions 
        described in subparagraph (A) have on such device function or 
        functions.
            ``(3) Exception.--
                    ``(A) In general.--Notwithstanding paragraph (1), a 
                software function shall not be excluded from the 
                definition of `device' under section 201(h) if--
                            ``(i) the Secretary determines that the 
                        software function meets the criteria under 
                        subparagraph (C), (D), or (E) of paragraph (1);
                            ``(ii) the Secretary makes a finding that 
                        use of such software function would be 
                        reasonably likely to have serious adverse 
                        health consequences; and
                            ``(iii) the software function has been 
                        identified in a final order issued by the 
                        Secretary under subparagraph (B).
                    ``(B) Procedures.--Subparagraph (A) shall apply 
                only if the Secretary--
                            ``(i) publishes a notification and proposed 
                        order in the Federal Register;
                            ``(ii) includes in such notification the 
                        Secretary's finding, including the rationale 
                        and identification of the evidence on which 
                        such finding was based, as described in 
                        subparagraph (A)(ii); and
                            ``(iii) provides for a period of not less 
                        than 30 calendar days for public comments 
                        before issuing a final order or withdrawing 
                        such proposed order.
                    ``(C) Considerations.--In making a finding under 
                subparagraph (A)(ii) with respect to a software 
                function, the Secretary shall consider the following:
                            ``(i) The likelihood and severity of 
                        patient harm if the software function were to 
                        not perform as intended.
                            ``(ii) The extent to which the software 
                        function is intended to support the clinical 
                        judgment of a health care professional.
                            ``(iii) Whether there is a reasonable 
                        opportunity for a health care professional to 
                        review the basis of the information or 
                        treatment recommendation provided by the 
                        software function.
                            ``(iv) The intended user and user 
                        environment, such as whether a health care 
                        professional will use a software function of a 
                        type described in subparagraph (E) of paragraph 
                        (1).
            ``(4) Rules of construction.--Nothing in this subsection 
        shall be construed as limiting the authority of the Secretary 
        to--
                    ``(A) exercise enforcement discretion as to any 
                device subject to regulation under this Act;
                    ``(B) regulate software used in the manufacture and 
                transfusion of blood and blood components to assist in 
                the prevention of disease in humans; or
                    ``(C) regulate software as a device under this Act 
                if such software meets the criteria in section 
                513(a)(1)(C).''.
    (b) Report.--The Secretary of Health and Human Services (referred 
to in this subsection as the ``Secretary''), after consultation with 
agencies and offices of the Department of Health and Human Services 
involved in health information technology, shall publish a report, 
every 2 years beginning after the date of enactment of this Act, that--
            (1) includes input from outside experts, such as 
        representatives of patients, consumers, health care providers, 
        startup companies, health plans or other third-party payers, 
        venture capital investors, information technology vendors, 
        health information technology vendors, small businesses, 
        purchasers, employers, and other stakeholders with relevant 
        expertise, as determined by the Secretary;
            (2) examines information available to the Secretary on any 
        risks and benefits to health associated with software functions 
        described in section 520(o)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a) of 
        this Act); and
            (3) summarizes findings regarding the impact of such 
        software functions on patient safety, including best practices 
        to promote safety, education, and competency related to such 
        functions.
    (c) Classification of Accessories.--Subsection 513(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by 
adding at the end the following:
            ``(9) The Secretary shall classify an accessory under this 
        section based on the intended use of the accessory, 
        notwithstanding the classification of any other device with 
        which such accessory is intended to be used.''.
    (d) Conforming Amendment.--Section 201(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the 
end the following: ``The term `device' does not include software 
functions excluded pursuant to section 520(o).''.
            Amend the title so as to read: ``A bill to amend the 
        Federal Food, Drug, and Cosmetic Act to provide for the 
        regulation of patient records and certain decision support 
        software.''.
                                                       Calendar No. 409

114th CONGRESS

  2d Session

                                S. 1101

_______________________________________________________________________

                                 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
  regulation of patient records and certain decision support software.

_______________________________________________________________________

                             April 4, 2016

        Reported with an amendment and an amendment to the title