S. 2007Senate113th Congress (2013-2015)In Committee

PROTECT Act of 2014

Introduced February 10, 2014

Legislative Activity

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SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

February 10, 2014

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SenateIntro Referral

Introduced in Senate

February 10, 2014

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S853-854)

February 10, 2014

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

February 10, 2014

Floor Debate

15 members

What members said about S. 2007 on the floor

4 Republicans10 Democrats1 Independent
Tom Harkin
Sen. Tom HarkinD-IA · Feb 10, 2014

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I want to talk today about a subject that has immense implications for America's future. In…

Jeff Sessions
Sen. Jeff SessionsR-AL · Feb 10, 2014

Mr. President, we find ourselves today considering legislation to fix a problem that Congress and the President created only 2 short months ago. We knew from the Ryan-Murray spending deal that it cut…

Mark  Begich
Sen. Mark Begich D-AK · Feb 10, 2014

Madam President, I ask unanimous consent that the order for the quorum call be rescinded. Madam President, I am one of the sponsors of the bill pending before the Senate at this moment. As we know,…

Christopher Murphy
Sen. Christopher MurphyD-CT · Feb 10, 2014

I ask unanimous consent that the order for the quorum call be rescinded. I try to come down to the floor every week or so to give voices to the victims of gun violence. All across this country, every…

Heidi  Heitkamp
Sen. Heidi HeitkampD-ND · Feb 10, 2014

Madam President, most of the country watched with a great deal of interest right before the new year, when we unfortunately had a train derailment in Casselton, ND. What was unique about this train…

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Roger F. Wicker
Sen. Roger F. WickerR-MS · Feb 10, 2014

Madam President, I ask unanimous consent that the order for the quorum call be rescinded. Madam President, I wish to speak as if in morning business. Madam President, I see that S. 1963, a bill to…

Patrick J. Leahy
Sen. Patrick J. LeahyD-VT · Feb 10, 2014

Mr. President, the National Security Agency continues its indiscriminate collection of a massive number of phone records about Americans under section 215 of the USA PATRIOT Act. I have said over and…

Mark L. Pryor
Sen. Mark L. PryorD-AR · Feb 10, 2014

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, today I rise in support of S. 1963, the Military Pay Restoration Act. Last year, the Senate…

Harry Reid
Sen. Harry ReidD-NV · Feb 10, 2014

Mr. President, I now move to proceed to Calendar No. 298. Mr. President, at 5:30 p.m. there will be a rollcall vote on the motion to invoke cloture on the motion to proceed to S. 1963. Measures…

Kay  R. Hagan
Sen. Kay R. HaganD-NC · Feb 10, 2014

Mr. President, I rise today to speak in support of S. 1963. I ask unanimous consent that after my remarks, Senator Brown from Ohio follow me for a time not to exceed 10 minutes. Mr. President, this…

Angus S. King Jr.
Sen. Angus S. King Jr.I-ME · Feb 10, 2014

Mr. President, it is a pleasure to join the Senator from Nebraska. I love the idea of the surf-and-turf caucus reaching across the country to try to find commonsense solutions. I often think about…

Angus S. King Jr.
Sen. Angus S. King Jr.I-ME · Feb 10, 2014

Mr. President, it is a pleasure to join the Senator from Nebraska. I love the idea of the surf-and-turf caucus reaching across the country to try to find commonsense solutions. I often think about…

Deb Fischer
Sen. Deb FischerR-NE · Feb 10, 2014

Mr. President, I rise today to speak about rapid advancements in health care information technology or health IT. Health IT holds amazing potential to transform Americans' everyday lives for the…

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Deb Fischer
Sen. Deb FischerR-NE · Feb 10, 2014

Mr. President, I rise today to speak about rapid advancements in health care information technology or health IT. Health IT holds amazing potential to transform Americans' everyday lives for the…

Sherrod Brown
Sen. Sherrod BrownD-OH · Feb 10, 2014

Mr. President, I appreciate the words of Senator Hagan, who has been a leader in the Senate on issues for our veterans, for their health care and Camp Lejeune and so many other ways, looking out for…

John Cornyn
Sen. John CornynR-TX · Feb 10, 2014

The following Senators are necessarily absent: the Senator from Oklahoma (Mr. Coburn), the Senator from Tennessee (Mr. Corker), the Senator from South Carolina (Mr. Graham), the Senator from…

Bill Nelson
Sen. Bill NelsonD-FL · Feb 10, 2014

Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Bill Text

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Introduced in SenateIssued February 10, 2014

II

113th CONGRESS

2d Session

S. 2007

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.

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.

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.

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:

524B.

Clinical software and health software

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

.

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..