Sec. 305. PRECISION MEDICINE INITIATIVE OF DEPARTMENT OF VETERANS AFFAIRS TO IDENTIFY AND VALIDATE BRAIN AND MENTAL HEALTH BIOMARKERS

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## SEC. 305 PRECISION MEDICINE INITIATIVE OF DEPARTMENT OF VETERANS AFFAIRS TO IDENTIFY AND VALIDATE BRAIN AND MENTAL HEALTH BIOMARKERS **[**[38 U.S.C. 1712A note](/us/usc/t38/s1712A)**]** ###

(a)In General Beginning not later than 18 months after the date of the enactment of this Act, the Secretary of Veterans Affairs shall develop and implement an initiative of the Department of Veterans Affairs to identify and validate brain and mental health biomarkers among veterans, with specific consideration for depression, anxiety, post-traumatic stress disorder, bipolar disorder, traumatic brain injury, and such other mental health conditions as the Secretary considers appropriate. Such initiative may be referred to as the “Precision Medicine for Veterans Initiative”. ###

(b)Model of Initiative The initiative under subsection

(a)shall be modeled on the All of Us Precision Medicine Initiative administered by the National Institutes of Health with respect to large-scale collection of standardized data and open data sharing. ###

(c)Methods The initiative under subsection

(a)shall include brain structure and function measurements, such as functional magnetic resonance imaging and electroencephalogram, and shall coordinate with additional biological methods of analysis utilized in the Million Veterans Program of the Department of Veterans Affairs. ###

(d)Use of Data ####

(1)Privacy and security In carrying out the initiative under subsection (a), the Secretary shall develop robust data privacy and security measures, consistent with section 552a of title 5, United States Code (commonly known as the “Privacy Act of 1974”), and regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (parts 160, 162, and 164 of title 45, Code of Federal Regulations, or successor regulations) to ensure that information of veterans participating in the initiative is kept private and secure. ####

(2)Consultation with the national institutes of science and technology The Secretary may consult with the National Institute of Science and Technology in developing the data privacy and security measures described in paragraph (1). ####

(3)Access standards The Secretary shall provide access to information under the initiative consistent with the standards described in section 552a(d)(1) of title 5, United States Code, and section 164.524 of title 45, Code of Federal Regulations, or successor regulations. ####

(4)Open platform #####

(A)Availability of data The Secretary shall make de-identified data collected under the initiative available for research purposes to Federal agencies. #####

(B)Contract The Secretary shall contract with nongovernment entities that comply with requisite data security measures to make available for research purposes de-identified data collected under the initiative. #####

(C)Assistance The Secretary shall provide assistance to a Federal agency conducting research using data collected under the initiative at the request of that agency. #####

(D)Prohibition on transfer of data Federal agencies may not disclose, transmit, share, sell, license, or otherwise transfer data collected under the initiative to any nongovernment entity other than as allowed under subparagraph (B). ####

(5)Standardization #####

(A)In general The Secretary shall ensure that data collected under the initiative is standardized. #####

(B)Consultation The Secretary shall consult with the National Institutes of Health and the Food and Drug Administration to determine the most effective, efficient, and cost-effective way of standardizing data collected under the initiative. #####

(C)Manner of standardization In consultation with the National Institute for Science and Technology, data collected under the initiative shall be standardized in the manner in which it is collected, entered into the database, extracted, and recorded. ####

(6)Measures of brain function or structure Any measures of brain function or structure collected under the initiative shall be collected with a device that is approved by the Food and Drug Administration. ####

(7)De-identified data defined In this subsection, the term “de-identified data” means, with respect to data held by the Department of Veterans Affairs, that the Department— #####

(A)alters, anonymizes, or aggregates the data so that there is a reasonable basis for expecting that the data could not be linked as a practical matter to a specific individual; #####

(B)publicly commits to refrain from attempting to re-identify the data with a specific individual, and adopts controls to prevent such identification; and #####

(C)causes the data to be covered by a contractual or other legally enforceable prohibition on each entity to which the Department discloses the data from attempting to use the data to identify a specific individual and requires the same of all onward disclosures. ###

(e)Inclusion of Initiative in Program The Secretary shall coordinate efforts of the initiative under subsection

(a)with the Million Veterans Program of the Department.

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38 USC 1712A

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Sec. 305

PRECISION MEDICINE INITIATIVE OF DEPARTMENT OF VETERANS AFFAIRS TO IDENTIFY AND VALIDATE BRAIN AND MENTAL HEALTH BIOMARKERS

Cite38 USC 1712A

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