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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2007 Introduced in Senate (IS)]

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.

    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 ``Preventing Regulatory Overreach To 
Enhance Care Technology Act of 2014'' or the ``PROTECT Act of 2014''.

SEC. 2. FINDINGS; SENSE OF CONGRESS.

    (a) Findings.--Congress finds as follows:
            (1) The mobile health and mobile application economy was 
        created in the United States and is now being exported 
        globally, with the market expected to exceed $26,000,000,000 by 
        2017.
            (2) The United States mobile application economy is 
        responsible for nearly 500,000 new jobs in the United States.
            (3) Consumer health information technologies, including 
        smart phones and tablets, have the potential to transform 
        health care delivery through reduced systemic costs, improved 
        patient safety, and better clinical outcomes.
            (4) Clinical and health software innovation cycles evolve 
        and move faster than the existing regulatory approval 
        processes.
            (5) Consumers and innovators need a new risk-based 
        framework for the oversight of clinical and health software 
        that improves on the framework of the Food and Drug 
        Administration.
            (6) A working group convened jointly by the Food and Drug 
        Administration, the Federal Communications Commission, and the 
        Office of the National Coordinator for Health Information 
        Technology identified in a report that there are several major 
        barriers to the effective regulation of health information 
        technology that cannot be alleviated without changes to 
        existing law.
    (b) Sense of Congress.--It is the sense of Congress that--
            (1) the President and Congress must intervene to facilitate 
        interagency coordination across regulators that focuses agency 
        efforts on fostering health information technology and mobile 
        health innovation while better protecting patient safety, 
        improving health care, and creating jobs in the United States;
            (2) the President and the Congress should work together to 
        develop and enact legislation that establishes a risk-based 
        regulatory framework for such clinical software and health 
        software that reduces regulatory burdens, fosters innovation, 
        and, most importantly, improves patient safety;
            (3) The National Institute of Standards and Technology 
        should be the Federal agency that has oversight over technical 
        standards used by clinical software; and
            (4) The National Institute of Standards and Technology, in 
        collaboration with the Federal Communications Commission, the 
        National Patient Safety Foundation, and the Office of the 
        National Coordinator for Health Information Technology, should 
        work on next steps, beyond current oversight efforts, regarding 
        health information technology, such as collaborating with 
        nongovernmental entities to develop certification processes and 
        to promote best practice standards.

SEC. 3. CLINICAL SOFTWARE AND HEALTH SOFTWARE.

    (a) Definitions.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(ss)(1) The term `clinical software' means clinical decision 
support software or other software (including any associated hardware 
and process dependencies) intended for human or animal use that--
            ``(A) captures, analyzes, changes, or presents patient or 
        population clinical data or information and may recommend 
        courses of clinical action, but does not directly change the 
        structure or any function of the body of man or other animals; 
        and
            ``(B) is intended to be marketed for use only by a health 
        care provider in a health care setting.
    ``(2) The term `health software' means software (including any 
associated hardware and process dependencies) that is not clinical 
software and--
            ``(A) that captures, analyzes, changes, or presents patient 
        or population clinical data or information;
            ``(B) that supports administrative or operational aspects 
        of health care and is not used in the direct delivery of 
        patient care; or
            ``(C) whose primary purpose is to act as a platform for a 
        secondary software, to run or act as a mechanism for 
        connectivity, or to store data.
    ``(3) The terms `clinical software' and `health software' do not 
include software--
            ``(A) that is intended to interpret patient-specific device 
        data and directly diagnose a patient or user without the 
        intervention of a health care provider;
            ``(B) that conducts analysis of radiological or imaging 
        data in order to provide patient-specific diagnostic and 
        treatment advice to a health care provider;
            ``(C) whose primary purpose is integral to the function of 
        a drug or device; or
            ``(D) that is a component of a device.''.
    (b) Prohibition.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
the end the following:

``SEC. 524B. CLINICAL SOFTWARE AND HEALTH SOFTWARE.

    ``Clinical software and health software shall not be subject to 
regulation under this Act.''.

SEC. 4. EXCLUSION FROM DEFINITION OF DEVICE.

    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 clinical software or health software.''.
                                 <all>
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