Q: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
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''.
A:
Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 or the SOFTWARE Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to apply it to medical software to the same extent and in the same manner as it applies to devices. Defines "medical software" as software that is intended to be marketed: to directly change the structure or any function of the body of man or other animals; or for use by consumers and makes recommendations for clinical action that 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 which, if followed, would change the structure or any function of the body of man or other animals. Excludes from such definition software whose primary purpose is integral to the functioning of a drug or device and is not a component of a device. Excludes clinical software and health software (defined as follows) from FDCA regulation. Defines "clinical software" as software that: (1) 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 (2) is intended for use only by a health care provider in a health care setting. Defines "health software" as software that is not medical software or clinical software and that: (1) captures, analyzes, changes, or presents patient or population clinical data or information or supports administrative or operational aspects of health care and is not used in the direct delivery of care; or (2) has as its primary purpose to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data. Expresses the sense of Congress concerning the value of clinical software and health software to health care quality and efficacy and the need for legislation that establishes a risk-based regulatory framework that reduces regulatory burdens, promotes patient safety, and fosters innovation. Excludes medical software, clinical software, and health software from the FDCA definition of "device."