[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3303 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 3303

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
          regulating medical software, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 22, 2013

 Mrs. Blackburn (for herself, Mr. Gene Green of Texas, Mr. Walden, Ms. 
 DeGette, Mr. Butterfield, and Mr. Gingrey of Georgia) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
          regulating medical 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 ``Sensible Oversight for Technology 
which Advances Regulatory Efficiency Act of 2013'' or the ``SOFTWARE 
Act of 2013''.

SEC. 2. MEDICAL SOFTWARE.

    (a) Definition of Medical Software.--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) The term `medical software' means software that is intended 
for human or animal use and--
            ``(1)(A) is intended to be marketed to directly change the 
        structure or any function of the body of man or other animals; 
        or
            ``(B) is intended to be marketed for use by consumers and 
        makes recommendations for clinical action that--
                    ``(i) includes the use of a drug, device, or 
                procedure to cure or treat a disease or other condition 
                without requiring the involvement of a health care 
                provider; and
                    ``(ii) if followed, would change the structure or 
                any function of the body of man or other animals;
            ``(2) is not software whose primary purpose is integral to 
        the functioning of a drug or device; and
            ``(3) is not a component of a device.''.
    (b) Regulation.--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. MEDICAL SOFTWARE.

    ``(a) In General.--The provisions of this Act shall apply with 
respect to medical software to the same extent and in the same manner 
as such provisions apply with respect to devices.
    ``(b) Delegation.--The Secretary shall delegate primary 
jurisdiction for regulating medical software to the center at the Food 
and Drug Administration charged with regulating devices.''.

SEC. 3. CLINICAL SOFTWARE AND HEALTH SOFTWARE.

    (a) Definitions.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321), as amended by section 2(a), is further 
amended by adding at the end the following:
    ``(tt)(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 medical 
software or 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.''.
    (b) Prohibition.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section 
2(b), is further amended by adding at the end the following:

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

    ``Clinical software and health software shall not be subject to 
regulation under this Act.''.
    (c) Sense of Congress.--It is the sense of the Congress that--
            (1) clinical software and health software (as defined in 
        section 201(tt) of the Federal Food, Drug, and Cosmetic Act, as 
        added by subsection (a))--
                    (A) advance the goals of enhanced patient safety 
                and continued innovation;
                    (B) hold much promise to lower costs and improve 
                the health of patients; and
                    (C) can improve the quality and efficacy of health 
                care provider services; and
            (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, promotes patient 
        safety, and fosters innovation.

SEC. 4. EXCLUSION FROM DEFINITION OF DEVICE.

    Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) is amended--
            (1) in paragraph (2), by striking ``or other animals, or'' 
        and inserting ``or other animals,'';
            (2) in paragraph (3), by striking ``and''; and
            (3) by inserting after paragraph (3) the following new 
        paragraphs:
            ``(4) is not medical software, or
            ``(5) is not clinical software or health software, and''.
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