VA Precision Medicine Act

I 116TH CONGRESS 2D SESSION H. R. 8149 To direct the Secretary of Veterans Affairs to carry out an initiative to identify and validate brain and mental health biomarkers among veterans. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 1, 2020 Mr. LAMB (for himself and Mr. BOST) introduced the following bill; which was referred to the Committee on Veterans’ Affairs A BILL To direct the Secretary of Veterans Affairs to carry out an initiative to identify and validate brain and mental health biomarkers among veterans. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘VA Precision Medicine 4 Act’’. 5 VerDate Sep 11 2014 17:03 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8149.IH H8149 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8149 IH SEC. 2. PRECISION MEDICINE INITIATIVE OF DEPARTMENT 1 OF VETERANS AFFAIRS TO IDENTIFY AND 2 VALIDATE BRAIN AND MENTAL HEALTH BIO- 3 MARKERS. 4 (a) IN GENERAL.—Beginning not later than two 5 years after the date of the enactment of this Act, the Sec- 6 retary of Veterans Affairs shall develop and implement an 7 initiative of the Department of Veterans Affairs to identify 8 and validate brain and mental health biomarkers among 9 veterans, with specific consideration for depression, anx- 10 iety, post-traumatic stress disorder, bipolar disorder, trau- 11 matic brain injury, and such other mental health condi- 12 tions as the Secretary considers appropriate. Such initia- 13 tive may be referred to as the ‘‘Precision Medicine for Vet- 14 erans Initiative’’. 15 (b) MODEL OF INITIATIVE.—The initiative under 16 subsection (a) shall be modeled on the All of Us Precision 17 Medicine Initiative administered by the National Insti- 18 tutes of Health with respect to large-scale collection of 19 standardized data and open data sharing. 20 (c) USE OF DATA.— 21 (1) PRIVACY AND SECURITY.—In carrying out 22 the initiative under subsection (a), the Secretary 23 shall develop robust data privacy and security meas- 24 ures to ensure that information of veterans partici- 25 pating in the initiative is kept private and secure. 26 VerDate Sep 11 2014 17:03 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8149.IH H8149 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8149 IH (2) OPEN PLATFORM.— 1 (A) RESEARCH PURPOSES.— 2 (i) IN GENERAL.—The Secretary shall 3 make de-identified data collected under the 4 initiative available for research purposes 5 both within and outside of the Department 6 of Veterans Affairs. 7 (ii) RESEARCH.—The Secretary shall 8 assist the National Institutes of Health 9 and the Department of Energy in the use 10 by the National Institutes of Health or the 11 Department of Energy of data collected 12 under the initiative for research purposes 13 under clause (i). 14 (B) DATA MAY NOT BE SOLD.—Data col- 15 lected under the initiative may not be sold. 16 (3) STANDARDIZATION.— 17 (A) IN GENERAL.—The Secretary shall en- 18 sure that data collected under the initiative is 19 standardized. 20 (B) CONSULTATION.—The Secretary shall 21 consult with the National Institutes of Health 22 and the Food and Drug Administration to de- 23 termine the most effective, efficient, and cost- 24 VerDate Sep 11 2014 17:03 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8149.IH H8149 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8149 IH effective way of standardizing data collected 1 under the initiative. 2 (C) MANNER OF STANDARDIZATION.— 3 Data collected under the initiative shall be 4 standardized in the manner in which it is col- 5 lected, entered into the database, extracted, and 6 recorded. 7 (4) MEASURES OF BRAIN FUNCTION OR STRUC- 8 TURE.—Any measures of brain function or structure 9 collected under the initiative shall be collected with 10 a device that is approved by the Food and Drug Ad- 11 ministration. 12 (d) INCLUSION OF INITIATIVE IN PROGRAM.—The 13 Secretary shall assess the feasibility and advisability of co- 14 ordinating efforts of the initiative under subsection (a) 15 with the Million Veterans Program of the Department, 16 while seeking a population-based sample. 17 Æ VerDate Sep 11 2014 17:03 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H8149.IH H8149 pbinns on DSKJLVW7X2PROD with BILLS