[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2713 Reported in Senate (RS)]
<DOC>
Calendar No. 428
114th CONGRESS
2d Session
S. 2713
To provide for the implementation of a Precision Medicine Initiative.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 17, 2016
Mr. Alexander introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
April 18, 2016
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To provide for the implementation of a Precision Medicine Initiative.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Advancing Precision
Medicine Act of 2016''.</DELETED>
<DELETED>SEC. 2. PRECISION MEDICINE INITIATIVE.</DELETED>
<DELETED> (a) In General.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'') is
encouraged to establish and carry out an initiative, to be known as the
``Precision Medicine Initiative'', to augment efforts to address
disease prevention, diagnosis, and treatment.</DELETED>
<DELETED> (b) Components.--The Initiative described under subsection
(a) may include--</DELETED>
<DELETED> (1) developing a network of scientists to assist
in carrying out the purposes of the Initiative;</DELETED>
<DELETED> (2) developing new approaches for addressing
scientific, medical, public health, and regulatory science
issues;</DELETED>
<DELETED> (3) applying genomic technologies to provide data
on the molecular basis of disease;</DELETED>
<DELETED> (4) collecting information voluntarily provided by
a diverse cohort of individuals that can be used to better
understand health and disease; and</DELETED>
<DELETED> (5) other activities determined appropriate by the
Secretary to advance the goals of the Initiative.</DELETED>
<DELETED> (c) Authority of the Secretary.--In carrying out this
section, the Secretary may--</DELETED>
<DELETED> (1) coordinate with the Secretary of Energy,
private industry, and others determined appropriate by the
Secretary to identify and address the advanced supercomputing
needs for the Initiative described under subsection
(a);</DELETED>
<DELETED> (2) develop and utilize public-private
partnerships; and</DELETED>
<DELETED> (3) leverage existing data sources.</DELETED>
<DELETED> (d) Requirements.--In the implementation of the Initiative
under subsection (a), the Secretary shall--</DELETED>
<DELETED> (1) ensure the collaboration of the National
Institutes of Health, the Food and Drug Administration, and the
Office of the National Coordinator for Health Information
Technology;</DELETED>
<DELETED> (2) comply with existing laws and regulations for
the protection of human subjects involved in research,
including the protection of participant privacy;</DELETED>
<DELETED> (3) implement policies and mechanisms for
appropriate secure data sharing across systems that include
protections for privacy and security of data; and</DELETED>
<DELETED> (4) consider the diversity of the cohort to ensure
inclusion of a broad range of participants, including
consideration of biological, social, and other determinants of
health that contribute to health disparities.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Advancing Precision Medicine Act of
2016''.
SEC. 2. PRECISION MEDICINE INITIATIVE.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') is encouraged to
establish and carry out an initiative, to be known as the ``Precision
Medicine Initiative'', to augment efforts to address disease
prevention, diagnosis, and treatment.
(b) Components.--The Initiative described under subsection (a) may
include--
(1) developing a network of scientists to assist in
carrying out the purposes of the Initiative;
(2) developing new approaches for addressing scientific,
medical, public health, and regulatory science issues;
(3) applying genomic technologies, such as whole genomic
sequencing, to provide data on the molecular basis of disease;
(4) collecting information voluntarily provided by a
diverse cohort of individuals that can be used to better
understand health and disease; and
(5) other activities determined appropriate by the
Secretary to advance the goals of the Initiative.
(c) Authority of the Secretary.--In carrying out this section, the
Secretary may--
(1) coordinate with the Secretary of Energy, private
industry, and others determined appropriate by the Secretary to
identify and address the advanced supercomputing needs for the
Initiative described under subsection (a);
(2) develop and utilize public-private partnerships; and
(3) leverage existing data sources.
(d) Requirements.--In the implementation of the Initiative under
subsection (a), the Secretary shall--
(1) ensure the collaboration of the National Institutes of
Health, the Food and Drug Administration, and the Office of the
National Coordinator for Health Information Technology;
(2) comply with existing laws and regulations for the
protection of human subjects involved in research, including
the protection of participant privacy;
(3) implement policies and mechanisms for appropriate
secure data sharing across systems that include protections for
privacy and security of data; and
(4) consider the diversity of the cohort to ensure
inclusion of a broad range of participants, including
consideration of biological, social, and other determinants of
health that contribute to health disparities.
SEC. 3. PROTECTION OF PRIVACY OF INDIVIDUALS WHO ARE RESEARCH SUBJECTS.
(a) In General.--Subsection (d) of section 301 of the Public Health
Service Act (42 U.S.C. 241) is amended to read as follows:
``(d) Protection of Privacy of Individuals Who Are Research
Subjects.--
``(1) Issuance of certificate.--
``(A) In general.--If a person is engaged in
biomedical, behavioral, clinical, or other research, in
which identifiable, sensitive information is collected
(including research on mental health and research on
the use and effect of alcohol and other psychoactive
drugs), the Secretary, in coordination with other
Departments, as applicable--
``(i) shall issue to such person a
certificate of confidentiality to protect the
privacy of individuals who are the subjects of
such research if the research is funded wholly
or in part by the Federal Government; and
``(ii) may, upon application by a person
engaged in research, issue to such person a
certificate of confidentiality to protect the
privacy of such individuals if the research is
not so funded.
``(B) Result of certificate.--Except as provided in
subparagraph (C), any person to whom a certificate is
issued under subparagraph (A) to protect the privacy of
individuals described in such subparagraph shall not
disclose or provide to any other person not connected
with the research the name of such an individual or any
information, document, or biospecimen that contains
identifiable, sensitive information about such an
individual and that was created or compiled for
purposes of the research.
``(C) Exceptions.--The disclosure prohibition in
subparagraph (B) shall not apply to disclosure or use
that is--
``(i) required by Federal, State, or local
laws, excluding instances described in
subparagraph (D);
``(ii) necessary for the medical treatment
of the individual to whom the information,
document, or biospecimen pertains;
``(iii) made with the consent of the
individual to whom the information, document,
or biospecimen pertains; or
``(iv) made for the purposes of other
scientific research that is in compliance with
applicable Federal regulations governing the
protection of human subjects in research.
``(D) Prohibition on compelling disclosure.--Any
person to whom a certificate is issued under
subparagraph (A) to protect the privacy of an
individual described in such subparagraph shall not, in
any Federal, State, or local civil, criminal,
administrative, legislative, or other proceeding,
disclose or provide the name of such individual or any
such information, document, or biospecimen that
contains identifiable, sensitive information about the
individual and that was created or compiled for
purposes of the research.
``(E) Immunity.--Identifiable, sensitive
information protected under subparagraph (A), and all
copies thereof, shall be immune from the legal process,
and shall not, without the consent of the individual to
whom the information pertains, be admissible as
evidence or used for any purpose in any action, suit,
or other judicial, legislative, or administrative
proceeding.
``(F) Terms of protection.--Identifiable, sensitive
information collected by a person to whom a certificate
has been issued under subparagraph (A), and all copies
thereof, shall be subject to the protections afforded
by this section for perpetuity.
``(G) Minimizing administrative burden.--The
Secretary shall take steps to minimize the burden to
researchers, streamline the process, and reduce the
time it takes to comply with the requirements of this
subsection.
``(2) Rule of construction.--Nothing in this subsection
shall be construed to limit the access of an individual who is
a subject of research to information about himself or herself
collected during such individual's participation in the
research.
``(3) Definitions.--For purposes of this subsection, the
term `identifiable, sensitive information' means information
that is about an individual and that is gathered or used during
the course of research described in paragraph (1)(A) and--
``(A) through which an individual is identified; or
``(B) for which there is a risk, as determined by
current scientific practices or statistical methods,
that some combination of the information, the request,
and other available data sources could be used to
deduce the identity of an individual.''.
(b) Applicability.--Beginning on the date of enactment of this Act,
all persons engaged in research and authorized by the Secretary of
Health and Human Services to protect information under section 301(d)
of the Public Health Service Act (42 U.S.C. 241(d)) prior to the date
of enactment of this Act shall be subject to the requirements of such
section (as amended by this Act).
SEC. 4. PROTECTION OF IDENTIFIABLE, SENSITIVE INFORMATION.
Section 301 of the Public Health Service Act (42 U.S.C. 241) is
amended by adding at the end the following:
``(f)(1) The Secretary may exempt from disclosure under section
552(b)(3) of title 5, United States Code, biomedical information that
is about an individual and that is gathered or used during the course
of biomedical research if--
``(A) an individual is identified; or
``(B) there is a risk, as determined by current scientific
practices or statistical methods, that some combination of the
information, the request, and other available data sources
could be used to deduce the identity of an individual.
``(2)(A) Each determination of the Secretary under paragraph (1) to
exempt information from disclosure shall be made in writing and
accompanied by a statement of the basis for the determination.
``(B) Each such determination and statement of basis shall be
available to the public, upon request, through the Office of the Chief
FOIA Officer of the Department of Health and Human Services.
``(3) Nothing in this subsection shall be construed to limit a
research participant's access to information about such participant
collected during the participant's participation in the research.''.
SEC. 5. DATA SHARING.
Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b))
is amended--
(1) in paragraph (23), by striking ``and'' at the end;
(2) in paragraph (24), by striking the period and inserting
``; and''; and
(3) by inserting after paragraph (24) the following:
``(25) may require recipients of NIH grants or cooperative
agreements to share scientific data, to the extent feasible,
generated from such NIH grants or cooperative agreements in a
manner that is consistent with all applicable Federal laws and
regulations, including such laws and regulations for the
protection of--
``(A) human research participants, including with
respect to privacy, security, informed consent, and
protected health information;
``(B) proprietary interests, confidential
commercial information, and the intellectual property
rights of the funding recipient; and
``(C) national, homeland, and economic security
interests.''.
SEC. 6. HIGH-RISK, HIGH-REWARD RESEARCH.
(a) In General.--Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended by adding at the end the following:
``(m) High-risk, High-reward Research.--
``(1) In general.--The Director of NIH may approve, after
consideration of a proposal under paragraph (2)(A), requests by
the national research institutes and centers, or program
offices within the Office of the Director, to engage in
transactions other than a contract, grant, or cooperative
agreement with respect to projects for high-impact, cutting-
edge research that fosters scientific creativity and increases
fundamental biological understanding leading to the prevention,
diagnosis, or treatment of diseases and disorders.
``(2) Requirements.--The authority provided under this
subsection may be used to conduct or support high-impact,
cutting-edge research described in paragraph (1) using the
other transactions authority described in such paragraph if the
institute, center, or office--
``(A) submits a proposal to the Director of NIH for
the use of such authority before conducting or
supporting the research, including why the use of such
authority is essential to promoting the success of the
project;
``(B) receives approval for the use of such
authority from the Director of NIH; and
``(C) for each year in which the institute, center,
or office has used such authority in accordance with
this subsection, submits a report to the Director of
NIH on the activities of the institute, center, or
office relating to such research.''.
(b) Report to Congress.--Not later than September 30, 2020, the
Secretary of Health and Human Services, acting through the Director of
the National Institutes of Health, shall conduct an evaluation of the
activities under subsection (m) of section 402 of the Public Health
Service Act (42 U.S.C. 282), as added by subsection (a), and submit a
report to the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the House of
Representatives on the results of such evaluation.
(c) Duties of Directors of Institutes.--Section 405(b)(1) of the
Public Health Service Act (42 U.S.C. 284(b)(1)) is amended--
(1) by redesignating subparagraphs (C) through (L) as
subparagraphs (D) through (M), respectively; and
(2) by inserting after subparagraph (B), the following:
``(C) shall, as appropriate, conduct and support
research that has the potential to transform the
scientific field, has inherently higher risk, and that
seeks to address major current challenges;''.
Calendar No. 428
114th CONGRESS
2d Session
S. 2713
_______________________________________________________________________
A BILL
To provide for the implementation of a Precision Medicine Initiative.
_______________________________________________________________________
April 18, 2016
Reported with an amendment