[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