[Congressional Record (Bound Edition), Volume 160 (2014), Part 3]
[Senate]
[Page 3893]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2805. Mrs. FISCHER (for herself, Mr. King, and Mr. Rubio) 
submitted an amendment intended to be proposed by her to the bill S. 
1086, to reauthorize and improve the Child Care and Development Block 
Grant Act of 1990, and for other purposes; which was ordered to lie on 
the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. PREVENTING REGULATORY OVERREACH TO ENHANCE CARE 
                   TECHNOLOGY.

       (a) Findings; Sense of Congress.--
       (1) Findings.--Congress finds as follows:
       (A) 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.
       (B) The United States mobile application economy is 
     responsible for nearly 500,000 new jobs in the United States.
       (C) 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.
       (D) Clinical and health software innovation cycles evolve 
     and move faster than the existing regulatory approval 
     processes.
       (E) 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.
       (F) 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.
       (2) Sense of congress.--It is the sense of Congress that--
       (A) 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;
       (B) 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;
       (C) The National Institute of Standards and Technology 
     should be the Federal agency that has oversight over 
     technical standards used by clinical software; and
       (D) 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.
       (b) Clinical Software and Health Software.--
       (1) 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.''.
       (2) 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.''.
       (c) 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.''.
                                 ______
                                 
  SA 2806. Ms. HIRONO (for herself and Mr. Heller) proposed an 
amendment to the bill S. 1821, to accelerate the income tax benefits 
for charitable cash contributions for the relief of victims of Typhoon 
Haiyan in the Philippines; as follows:

       On page 2, lines 7 and 8, strike ``January 1, 2014, and 
     before March 1, 2014,'' and inserting ``the date of the 
     enactment of this Act, and before April 15, 2014,''.
       On page 2, beginning at line 23, strike all through line 
     25.

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