,i #aaith ,,congress #ast ,session ,h4 ,r4 #fehc ,,in ,,the ,,house ,,of ,,representatives ,december #aj1 #bjbe,mr4 ,murphy introduced the following bill2 which was referred to the ,committee on ,veterans' ,affairs ,a ,,bill ,to amend title #ch1 ,united ,states ,code1 to establish a centralized research data system for the ,department of ,veterans ,affairs and to make certain improvements to processes applicable to major research projects of the ,department1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,va ,research ,reform ,act of #bjbe4 #b4 ,establishment of ,centralized ,,va ,research ,data ,system2 standards with respect to major research programs of the ,department ,subchapter ,v of chapter #gc of title #ch1 ,united ,states ,code1 is amended by adding at the end the following new sections 7and conforming the table of sections at the beginning of such chapter accordingly73 #gchc4 ,,va ,centralized ,research ,data ,system 7a7 ,establishment ,the ,secretary shall establish and maintain a centralized research data system for the ,department 7to be known as the ,,va ,centralized ,research ,data ,system71 to collect and manage information on all research activities of the ,department4 ,such system shall include data with respect to all programs of medical research conducted under section #gcjc of this title1 including biomedical research1 clinical research1 mental health research1 health services and policy research1 and any other category of research supported by the ,department4 7b7 ,elements of system ,the ,,va ,centralized ,research ,data ,system shall include1 for each research project conducted by or supported by the ,department the following information3 7#a7 ,a summary of the objectives1 scope1 and study design of the project4 7#b7 ,an identification of ,department funding1 and any non-,department funding1 supporting the project1 including amounts and funding mechanisms4 7#c7 ,the name and affiliation of the principal investigator and key staff or collaborators involved in the research4 7#d7 ,the status and dates of all required approvals1 including institutional review board approvals or exemptions1 other regulatory approvals 7including safety or ethical reviews71 and associated assurances of compliance4 7#e7 ,periodic updates on the progress of the project1 including-- 7,a7 the initiation date2 7,b7 the completion of key milestones or phases2 and 7,c7 the anticipated and actual completion dates of the research4 7#f7 ,the results and products of the research1 including any findings1 publications in peer-reviewed journals1 presentations1 patents or inventions1 and noted impacts on clinical care or policy arising from the project4 7c7 ,use and integration ,the ,secretary shall ensure that the ,,va ,centralized ,research ,data ,system is-- 7#a7 used to facilitate oversight and coordination of ,department research2 7#b7 designed to-- 7,a7 allow authorized personnel of the ,department1 including the ,office of ,research and ,development and officials at ,veterans ,health ,administration facilities1 to track research progress and outcomes1 avoid unnecessary duplication of research efforts1 and identify opportunities for translating research findings into clinical practice2 and 7,b7 protect personally identifiable information1 in accordance with applicable laws and regulations2 and 7#c7 compatible with the electronic health record system of the ,department4 7d7 ,regulations ,not later than #ahj days after the date of the enactment of this section1 the ,secretary shall prescribe such regulations or guidance as the ,secretary determines necessary to implement this section1 including-- 7#a7 policies for the submission of information by investigators into the ,centralized ,research ,data ,system2 and 7#b7 protocols for maintaining the accuracy and security of data in the system4 #gchd4 ,research proposal review and approval processes 7a7 ,tiered review based on risk and impact ,the ,secretary shall develop and implement a tiered system for the ethical and scientific review and approval of research proposals conducted by the ,department or using ,department facilities1 data1 or resources4 ,under such system1 the level of review and applicable requirements shall be commensurate with the projected risk to human subjects 7or to animal subjects1 as applicable7 and the expected effect or significance of the research4 7b7 ,level of review 7#a7 ,under the tiered system required by subsection 7a71 the ,secretary shall ensure that research proposals the ,secretary determines pose-- 7,a7 a minimal risk 7as defined by ,secretary in regulations7 to subjects or are of a small scope or short duration are eligible for an expedited or abbreviated review process that is consistent with the protection of human subjects and sound research practice2 and 7,b7 a greater than minimal risk to subjects1 involve invasive procedures1 or have broad potential impact 7including as large clinical trials or multi-site studies7 undergo a full review process4 7#b7 ,the ,secretary may establish intermediate levels of review for-- 7,a7 categories of research the ,secretary determines fall between minimal risk and high risk2 or 7,b7 projects deemed of high scientific importance1 to ensure appropriate scrutiny without unnecessary delay4 7c7 ,standardized national timelines ,for each tier of research review under subsection 7b71 the ,secretary shall establish standardized1 ,department-wide target timelines for completion of the review and approval or disapproval of research proposals4 ,such timelines shall be designed to expedite the initiation of valuable research while maintaining standards for safety and ethics4 ,the ,secretary shall ensure that these review processes and timelines are applied uniformly across all facilities of the ,veterans ,health ,administration1 notwithstanding any local policies4 7d7 ,office of research and development override authority 7#a7 ,the ,under ,secretary for ,health1 acting through the ,chief ,research and ,development ,officer of the ,office of ,research and ,development established under section #gcha of this title1 shall monitor the research proposal review process nationwide to identify any undue delays or barriers to timely approval4 ,if a research proposal subject to ,department review is not approved1 conditionally approved1 or disapproved within the applicable timeline established under subsection 7c71 the ,under ,secretary1 through the ,office of ,research and ,development1 may intervene to ensure a timely decision with respect to the research proposal4 7#b7 7,a7 ,in exercising the authority under paragraph 7#a71 the ,under ,secretary for ,health may1 as appropriate-- 7i7 assume responsibility for or reassign the review of the proposal to an alternative duly constituted institutional review board or other research review body that meets applicable standards2 or 7ii7 issue an approval or disapproval of the proposal after such additional expedited review as the ,under ,secretary determines necessary4 7,b7 ,the ,under ,secretary shall notify the chief research officer of the affected facility and the ,office of ,research ,oversight under section #gcjg of this title of any intervention under subparagraph 7,a7 and the rationale for such intervention4 7,c7 ,any action by the ,under ,secretary under this subsection shall ensure that all requisite ethical and safety reviews are completed4 7#c7 ,nothing in this subsection shall be construed to waive or override any law or regulation protecting human subjects1 animal welfare1 or research integrity4 7e7 ,guidance and oversight ,the ,secretary shall-- 7#a7 issue policies or guidance to implement the tiered review system under this section1 including-- 7,a7 definitions of risk and impact categories2 7,b7 specific timeframes for review at each tier2 and 7,c7 procedures for centralized monitoring of compliance with these timelines2 7#b7 oversee adherence to these processes through the ,office of ,research and ,development2 and 7#c7 provide training to members of institutional review boards and other research review committees on the new requirements to ensure consistent application4 7f7 ,annual review of timeliness ,the ,secretary shall track the performance of the ,department's research approval processes and include in the annual report under section #gchh of this title an analysis of the timeliness of research proposal reviews1 identifying any systemic bottlenecks and steps taken to improve the efficiency of research approvals4 #gche4 ,implementation of high-impact research findings 7a7 ,funding allocation requirement ,of the amounts appropriated or otherwise made available to the ,department each fiscal year for the medical and prosthetic research program authorized under section #gcjc of this title1 the ,secretary shall ensure that funds are allocated for activities to implement the findings of such research program to improve the delivery of care and services to veterans4 7b7 ,use of funds2 high-impact research 7#a7 ,in carrying out subsection 7a71 the ,secretary1 acting through the ,chief ,research and ,development ,officer of the ,office of ,research and ,development under section #gcha of this title1 shall identify completed or ongoing research projects that have produced1 or are likely to produce1 evidence or innovations with high potential to improve veteran health care or quality of life 7in this section referred to as high-impact research74 7#b7 ,the ,secretary shall utilize funds allocated pursuant to subsection 7a7 to accelerate the transfer of such high-impact research findings into clinical practice1 systems of care1 or programmatic improvements4 7#c7 ,activities funded with such amounts may include-- 7,a7 implementation and dissemination studies2 7,b7 the development or updating of clinical practice guidelines2 7,c7 training of health care providers in new evidence-based practices2 7,d7 modification of health information technology or equipment to accommodate new treatments or diagnostic2 7,e7 patient outreach and education regarding new standards of care2 and 7,f7 other actions necessary to integrate research discoveries into routine veterans care4 7c7 ,coordination and avoidance of duplication 7#a7 ,the ,secretary shall ensure that the allocation and use of funds for implementation activities under this section are coordinated with other ,department initiatives in implementation science and quality improvement1 including the ,quality ,enhancement ,research ,initiative and other translational research programs within the ,department to leverage existing expertise and avoid duplicative efforts4 7#b7 ,the ,office of ,research and ,development shall consult regularly with ,veterans ,health ,administration program offices responsible for clinical operations to identify priority areas where research findings are ready to be adopted on a wider scale within the ,department4 7d7 ,accountability ,the ,secretary shall include1 in the annual report required by section #gchh of this title-- 7#a7 the amount of research funding devoted to implementation activities and the outcomes of such investments2 and 7#b7 an analysis of compliance with the funding allocation in subsection 7a7 and a description of major implementation projects undertaken1 the status of such projects1 and the effect of such projects on health care for veterans4 #gchf4 ,veteran impact forecast and translation plan for major research projects required 7a7 ,requirement for major research projects ,the ,secretary shall ensure that any major research project of the ,department includes1 as part of the research protocol and application for funding submitted to the ,secretary-- 7#a7 a veteran impact forecast described in subsection 7b72 and 7#b7 a translation plan described in subsection 7c74 7b7 ,veteran impact forecast ,a veteran impact forecast described in this subsection is a written assessment1 prepared by the investigators or sponsors of a major research project at the time of proposal1 that describes the anticipated benefits and outcomes of the research for veterans and the health care system of the ,department4 ,the veteran impact forecast shall1 to the maximum extent practicable1 quantify or describe the following3 7#a7 ,how the findings or results of successful research is successful are expected to improve health outcomes among veterans1 including-- 7,a7 reductions in morbidity or mortality2 7,b7 improvements to functional status2 and 7,c7 enhancements to the quality of life for veterans from the condition or conditions subject to the research4 7#b7 ,the ways in which the research results could-- 7,a7 be integrated into the clinical practice of the ,veterans ,health ,administration2 or 7,b7 lead to changes in health care policy or programs for veterans 7including adoption of new treatments1 diagnostics1 preventive measures1 or care delivery models7 and an estimate of the magnitude of the veteran population likely to be affected by such changes4 7#c7 ,an explanation of the urgency of the research question for veterans and an estimate of the time frame within which positive findings could be implemented into clinical practice1 given the nature of the study design and any necessary regulatory approvals4 7c7 ,translation plan ,a translation plan described in this subsection is a proactive plan for how positive findings from the research will be disseminated and implemented in the ,department to benefit veterans that includes the following3 7#a7 ,an identification of steps and resources needed to move any successful outcomes of the research into general ,department use4 7#b7 ,a description of how and to whom the research results will be communicated upon completion1 including identification of the relevant entities that should be informed of such results1 including-- 7,a7 program offices2 7,b7 clinical practice leaders2 7,c7 policymakers within the ,department in a position to act on such results2 7,d7 external partners 7including academic affiliates72 and 7,e7 the heads of relevant ,federal agencies4 7#c7 ,specific actions to be taken if the study yields positive results1 including-- 7,a7 the development or revision of clinical protocols and guidelines2 7,b7 pursuing regulatory approvals for new therapies1 if applicable2 7,c7 training clinicians in new practices2 7,d7 updating health information technology systems or decision support tools2 or 7,e7 initiating pilot programs to implement the findings in one or more medical centers of the ,department4 7#d7 ,an identification of potential obstacles to implementation1 including resource needs1 training gaps1 or interoperability issues4 7#e7 ,a description of how the investigators or the ,department might address such obstacles to facilitate timely translation of the research into practice4 7#f7 ,as appropriate1 to ensure that the translation of findings is feasible and sustainable within the ,department1 plans for engaging relevant stakeholders in the implementation process1 including-- 7,a7 the ,under ,secretary for ,health2 7,b7 veterans who would be affected by the change2 7,c7 caregivers2 or 7,d7 external regulatory bodies4 7d7 ,incorporation into approval and funding 7#a7 ,the ,secretary shall ensure that no major research project is approved or funded by the ,department unless the proposal includes a veteran impact forecast and translation plan meeting the requirements of this section4 7#b7 ,the ,office of ,research and ,development shall review the adequacy of the veteran impact forecast and translation plan during the scientific review or funding decision process1 and may provide feedback or require modifications as necessary to strengthen the likelihood that the research1 if successful1 can be readily applied to improve care for veterans4 7e7 ,guidance and waiver 7#a7 ,the ,secretary1 through the ,office of ,research and ,development1 shall issue guidance defining the classes of research projects subject to the requirements of this section and detailing the format and content expectations for veteran impact forecasts and translation plans4 7#b7 ,the ,secretary may exempt a particular project or class of projects from one or both of these requirements only if the ,secretary determines that such project is of a nature for which these planning documents would not be practicable or meaningful4 ,any such exemption shall be documented in writing with a justification and submitted to the ,committees on ,veterans' ,affairs of the ,house of ,representatives and the ,senate as part of the annual report under section #gchh of this title4 7f7 ,updates and post-,study review 7#a7 ,the ,secretary shall establish a mechanism to revisit and update the translation plan as necessary during the course of the research project and immediately following its completion1 in light of the actual findings4 ,investigators conducting a covered project shall1 at the conclusion of the project1 report on how the findings compare to the veteran impact forecast and propose any adjustments to the actions in the translation plan4 7#b7 ,the ,office of ,research and ,development1 in conjunction with relevant clinical operations officials1 shall evaluate these post-study reports to determine what implementation steps will be taken by the ,department and shall track the outcomes of major research projects in terms of uptake into clinical practice or policy4 7g7 ,major research project defined ,in this section1 a major research project means-- 7#a7 a research study or program1 including a clinical trial or multisite study1 that meets criteria indicating substantial size1 scope1 or significance1 as shall be defined by the ,secretary2 and 7#b7 includes-- 7,a7 research projects with projected ,department funding above a threshold amount set by the ,secretary2 and 7,b7 any other research initiatives designated by the ,office of ,research and ,development as having high potential impact on veterans health or health care systems4 #gchg4 ,department of ,veterans ,affairs regional research hubs 7a7 ,establishment 7#a7 ,the ,secretary shall establish a system of regional research hubs of the ,department 7in this section referred to as research hubs7 within the ,veterans ,health ,administration to support and coordinate the research activities of the ,department across multiple medical centers and clinics4 ,the number and locations of such research hubs shall be determined by the ,secretary to ensure that all medical facilities of the ,department with active research programs may access the services of a research hub4 ,in establishing research hubs pursuant to this section1 the ,secretary may consider ,veteran ,integrated ,services ,networks1 or other appropriate regional groupings of facilities4 7#b7 ,each research hub shall be organizationally established under the ,office of ,research and ,development1 and shall operate under the direction of a ,regional ,research ,hub ,director appointed by the ,under ,secretary for ,health1 or a designee of the ,under ,secretary4 ,the ,director of each research hub shall be an individual with experience in managing biomedical or health services research and knowledge of regulatory compliance1 who shall report to the ,office of ,research and ,development with respect to activities of the hub4 7b7 ,functions ,each research hub shall1 in coordination with the ,office of ,research and ,development1 carry out the following functions in support of ,department research within the applicable area of geographic responsibility3 7#a7 ,facilitating the efficient and timely review of research protocols by coordinating institutional review board approvals for multi-site studies1 including-- 7,a7 establishing or utilizing regional or central institutional review boards to serve multiple facilities2 7,b7 harmonizing institutional review board submission requirements2 and 7,c7 ensuring that a single institutional review board of record can be used for multi-site projects when feasible and in accordance with applicable regulations4 7#b7 ,providing technical assistance and support to investigators and research staff at facilities in the region4 ,such support shall include-- 7,a7 guidance on research proposal development2 7,b7 study design and methodology consultation2 7,c7 assistance with regulatory compliance1 including human subjects protections1 animal care1 and safety regulations2 and 7,d7 training or education programs for new investigators and research coordinators to build research capacity4 7#c7 ,coordinating research efforts among the ,department facilities in the region and with affiliated academic institutions or other partners4 ,such research efforts shall identify opportunities for multi-site research projects1 promote sharing of resources 7including research equipment1 specialized laboratories1 or data resources71 and encourage collaboration on studies that address veteran health priorities4 ,pursuant to such research efforts1 the research hub may organize regular regional research meetings or consortia to foster information exchange and partnership among investigators and clinicians4 7#d7 ,assisting investigators in developing strategies for recruitment and enrollment of veteran participants in research studies1 especially for multi-site clinical trials or studies requiring large sample sizes4 ,the hub shall facilitate outreach to veterans in the region who might be eligible for ongoing studies1 in accordance with privacy rules1 and coordinate with local clinical staff to improve awareness and engagement in research opportunities4 7#e7 ,offering centralized administrative support for research projects1 such as budget and grant management assistance1 data management and biostatistical support1 and guidance on using ,department data systems1 including the ,,va ,centralized ,research ,data ,system under section #gchc of this title and other information tools1 for research purposes4 7#f7 ,performing such other research-supporting functions consistent with the goal of enhancing the productivity1 efficiency1 and effects of the research enterprise of the ,department in service of veterans1 as the ,secretary or ,under ,secretary for ,health determine appropriate4 7c7 ,evaluation and oversight 7#a7 ,the ,chief ,research and ,development ,officer of the ,office of ,research and ,development of the ,department shall oversee the performance of the research hubs and ensure such research hubs are meeting the needs of the respective regions in which such research hubs are located4 7#b7 ,the ,under ,secretary for ,health shall establish metrics and goals for the hubs1 including metrics related to institutional review board review times1 number of multi-site studies supported1 training activities conducted1 and improvements in veteran research enrollment4 7#c7 ,the ,under ,secretary shall-- 7,a7 require each research hub to submit periodic reports to the ,under ,secretary with respect to the activities carried out by the research hub and the outcomes of such activities2 and 7,b7 include such periodic reports into the annual report under section #gchh of this title4 7d7 ,consultation and partnerships ,in establishing and operating the research hubs1 the ,secretary may collaborate with ,federal partners1 including the ,department of ,defense and the ,national ,institutes of ,health1 and academic affiliates to co-locate or jointly support resources that benefit both ,department and non-,department research endeavors4 ,the ,secretary may also seek input from investigators1 veterans1 and other stakeholders in each region in which a research hub is located with respect to the research priorities and support needs the research hubs should address4 #gchh4 ,research performance metrics2 annual report 7a7 ,establishment of metrics2 benchmarking program ,the ,secretary shall develop and implement a standardized program of metrics to assess the performance1 productivity1 and impact of research activities at each facility of the ,veterans ,health ,administration 7including ,department medical centers and affiliated clinics7 that conducts research4 ,such metrics shall be used to benchmark ,veterans ,health ,administration facilities against each other and against ,departmental goals to identify best practices and areas for improvement4 ,at a minimum1 such metrics shall include measures of the following3 7#a7 ,the volume of research projects undertaken and completed1 and the efficiency of research processes at the facility1 including-- 7,a7 the number of research proposals submitted1 approved1 and initiated each year2 7,b7 the average or median time from proposal submission to institutional review board approval and project start2 and 7,c7 the number of studies completed or publications produced per year1 normalized to the research staff or funding level4 7#b7 ,the extent of veteran engagement in research at the facility1 including-- 7,a7 the total number of veteran participants enrolled in clinical trials or other research studies2 7,b7 and the percentage of the facility's patient population or eligible population involved in research4 7#c7 ,the degree to which research findings are implemented into clinical care or inform improvements to health care delivery at the facility4 ,this may include-- 7,a7 the number of evidence-based interventions or new clinical practices adopted by the facility that originated from research 7whether ,department-funded or external research72 7,b7 the period of time between research discovery and implementation at the facility2 and 7,c7 qualitative examples of significant changes in patient care driven by research findings4 7#d7 ,if determined relevant by the ,secretary-- 7,a7 the level of collaboration and external support1 including the number of partnerships with academic or industry researchers2 7,b7 the amount of non-,department research funding 7including grants from the ,national ,institutes of ,health or the ,department of ,defense7 managed through the facility2 and 7,c7 the extent of participation in multi-site or nationwide studies4 7#e7 ,any other quantifiable measure that the ,secretary considers appropriate to evaluate research program effectiveness1 including-- 7,a7 compliance with research safety and ethics requirements2 7,b7 training and career development of researchers2 and 7,c7 innovation in research operations4 7b7 ,annual report 7#a7 ,not later than #ahj days after the end of each fiscal year1 and on an annual basis thereafter1 the ,secretary shall submit to the ,committees on ,veterans' ,affairs of the ,house of ,representatives and the ,senate a report on the performance of the research program of the ,department1 with specific emphasis on the facility-level metrics described in subsection 7a74 ,the report shall include1 for the fiscal year during which the report is submitted1 the following3 7,a7 ,a table or summary displaying each medical center of the ,department1 and any other major research site1 and values of such research site for each of the performance metrics in subsection 7a7 for the fiscal year and1 for context1 for at least one prior year4 7,b7 ,an analysis by the ,secretary identifying which facilities represent the highest performers in various categories 7including shortest research approval times1 highest veteran participation rates1 most implementations of findings1 and which facilities are lagging behind benchmarks or averages74 ,the analysis should discuss factors contributing to strong performance1 as well as challenges faced by lower-performing sites4 7,c7 ,a description of efforts of the ,department to improve research performance and address any identified deficiencies4 ,this should include any initiatives to share best practices from high-performing facilities1 targeted support or corrective actions for under-performing facilities1 and progress updates on any ongoing ,department-wide research improvement efforts4 7,d7 ,highlights of significant research accomplishments from the year1 especially instances where research conducted by the ,department led to improvements in veteran care1 new treatments or technologies1 or notable scientific publications1 as well as recognition of any researchers or teams for exceptional contributions4 7#b7 ,the first annual report under this subsection shall be submitted not later than #ah months after the date of the enactment of this section4 7c7 ,public availability 7#a7 ,the ,secretary shall make each annual report under subsection 7b7 publicly available on an internet website of the ,department1 in a format that is readily accessible to veterans1 researchers1 and other stakeholders4 7#b7 ,the publicly released version of the report may aggregate or anonymize data as the ,secretary determines necessary to protect personal privacy and to safeguard confidential research project details4 7#c7 ,the ,secretary is encouraged to include on the website user-friendly visualizations or dashboards that illustrate the performance of the applicable research program on key metrics over time and by facility4 7d7 ,sunset or modification of metrics 7#a7 ,the ,secretary shall continuously evaluate the relevance and effectiveness of the performance metrics established under subsection 7a74 ,the ,secretary may modify the metrics or benchmarking methods under subsection 7a71 as the ,secretary determines appropriate1 to better measure research impact and efficiency4 7#b7 ,any such modifications shall be described in the annual report under subsection 7b74 #gchi4 ,integration of research data and interagency collaboration 7a7 ,improvement of data sharing for research 7#a7 ,the ,secretary may include1 in the plan required under section #ajh7;a77#a7 of the ,senator ,elizabeth ,dole #bast ,century ,veterans ,healthcare and ,benefits ,improvement ,act 7,public ,law #aah-baj2 #ch ,u4,s4,c4 note prec4 #egja71 such actions as may be necessary to facilitate the secure integration and sharing of data for research purposes between the ,department and key research partners1 including other ,federal agencies and academic institutions4 7#b7 ,for purposes of this subsection1 the ,secretary shall ensure that any data in the custody1 possession1 or control of the ,department1 7without regard to the original ownership of such data71 may be shared to the extent permitted under applicable privacy1 security1 and ethical standards4 7#c7 ,the ,secretary may include a description of any actions taken pursuant to this subsection in the reports required under subsection 7c77#b7 of such section4 7#d7 ,in carrying out this subsection1 the ,secretary shall seek to improve interoperability of data systems and ease of collaboration with the following3 7,a7 ,the ,department of ,defense1 to-- 7i7 facilitate research on-- 7,i7 members of the ,armed ,forces assigned to active duty2 and 7,,ii7 veterans across the continuum of military service and post-service life2 and 7ii7 support joint research initiatives of the ,department and the ,department of ,defense4 7,b7 ,the ,department of ,health and ,human ,services1 including the ,national ,institutes of ,health and other components engaged in biomedical and health services research1 to facilitate-- 7i7 mutually beneficial sharing of health data and research results2 and 7ii7 participation of the ,department in national research efforts1 such as clinical trials networks and observational study consortia4 7,c7 ,affiliated universities and other academic research institutions that partner with the ,department or receive research funding from the ,department1 to ensure that researchers can collaborate effectively while maintaining appropriate data security and patient privacy4 7,d7 ,other public or private research entities as determined appropriate by the ,secretary1 including nonprofit research organizations or industry partners1 especially in contexts where cooperation can accelerate the development of treatments or technologies for the benefit of veterans4 7c7 ,privacy and security 7#a7 ,all activities under this section shall be carried out in compliance with applicable ,federal privacy laws1 including the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,,hipaa1 ,public ,law #ajd-aia2 #aaj ,stat4 #aicf7 and the ,privacy ,act of #aigd 7#e ,u4,s4,c4 #eeb;a71 and with regulations governing human subjects research confidentiality4 7#b7 ,in carrying out this section1 the ,secretary shall ensure that robust safeguards are in place to protect personally identifiable information and personal health information of veterans4 ,such safeguards shall include user authentication1 role-based access controls1 encryption of data in transit and at rest1 continuous monitoring for unauthorized access or anomalies1 and regular cybersecurity audits4 7#c7 ,when sharing data with the ,department of ,defense or other agencies1 the ,secretary shall1 to the maximum extent practicable1 use secure ,federal health data exchange frameworks and reciprocal data access agreements that uphold the same or higher standards of privacy and security as those used within the ,department4 7d7 ,consultation ,in carrying out the provisions of this section1 the ,secretary shall consult with relevant ,federal officials and outside experts1 including the ,chief ,information ,officer of the ,department of ,defense or designee1 the ,director of the ,national ,institutes of ,health or designee1 and representatives of academic institutions with expertise in health information tools and data sharing4 4