Introduction This report provides background on Department of Defense's legacy Electronic Health Record (EHR) systems, reviews previous EHR modernization efforts, and describes DOD's process to acquire and implement a new EHR system known as MHS Genesis . DOD's new EHR system presents several potential issu es for Congress, including how to conduct oversight on a program that spans three federal departments, how to ensure an adequate governance structure for the program, and how to monitor the program's cost and effectiveness. Although this report mentions EHR modernization efforts by the Department of Veterans Affairs (VA) and U.S. Coast Guard (USCG), as well as DOD's Joint Operational Medical Information System (JOMIS); it does not provide an in-depth discussion of these programs. Appendix A provides a list of acronyms used throughout this report. Background For decades, the Department of Defense (DOD) has developed, procured, and sustained a variety of electronic systems to document the health care services delivered to servicemembers, military retirees, and their family members. DOD currently operates a number of legacy EHR systems and is, at the direction of Congress, in the process of implementing a new EHR called MHS Genesis. DOD's new EHR system is to be integrated with other EHR systems utilized by the VA, USCG, and civilian health care providers. DOD operates a Military Health System (MHS) that delivers to military personnel, retirees, and their families certain health entitlements under chapter 55 of Title 10, U.S. Code. The MHS administers the TRICARE program, which offers health care services worldwide to over 9.5 million beneficiaries in DOD hospitals and clinics â also known as military treatment facilities (MTFs) â or through participating civilian health care providers (i.e., TRICARE providers). There are currently 723 MTFs located in the United States and overseas that provide a range of clinical services depending on size, mission, and level of capabilities. Health care services delivered in MTFs or by TRICARE providers are documented in at least one of the following components of the DOD health record: service treatment record (STR) â documentation of all medical and dental care received by a servicemember through their military career; nonservice treatment record (NSTR) â documentation of all medical and dental care received by a nonservicemember beneficiary (i.e., military retiree, family member); and occupational health civilian employee treatment record (OHTR) â documentation of all occupational-related care provided by DOD (typically to DOD civilian or contractor employees). DOD maintains numerous legacy EHR systems that allow health care providers to input, share, and archive all documentation required to be in a beneficiary's health record. MTF or TRICARE providers can document medical and dental care directly in a DOD legacy EHR system, or can scan and upload paper records. Servicemembers and their families frequently change duty stations; the DOD health record can be accessed at most MTFs. However, sometimes beneficiaries are relocated to an area that lacks access to DOD's legacy EHR systems. In such cases, beneficiaries are required to maintain a paper copy of the health record. Brief History of DOD's Electronic Health Record (EHR) Since 1968, DOD has used various electronic medical information systems that automate and share patient data across its MTFs. Between 1976 and 1984, DOD invested $222 million to "acquire, implement, and operate various stand-alone and integrated health-care computer systems." Over the next three decades, DOD continued to invest and to implement numerous electronic medical information systems to allow health care providers to input and review patient data across all MTFs, regardless of military service or geographic location. In 1998, DOD began to incorporate a series of efforts to increase interoperability with the VA's EHR systems (see Figure 1 ). DOD Legacy EHR Systems DOD operates numerous legacy EHR systems as described below. Together, health care data documented and archived in the legacy EHR systems contribute to a beneficiary's overall medical and dental record, also known as the DOD health record. MHS Genesis is intended to replace these legacy systems and produce one comprehensive EHR. Composite Health Care System (CHCS) CHCS is a medical information system that has been in operation since 1993. CHCS primarily functions as the outpatient component of the EHR, with additional capabilities to order, record, and archive data for laboratory, radiology, and pharmacy services. Administrative functions such as patient appointment and scheduling, medical records tracking, and quality assurance checks, were also incorporated into CHCS. In March 1988, DOD awarded Science Applications International Corporation (SAIC) a contract to "design, develop, deploy, and maintain CHCS." SAIC continues to provide ongoing sustainment and technical support for CHCS. The estimated life-cycle cost of CHCS is $2.8 billion. Armed Forces Health Longitudinal Technology Application (AHLTA) After deploying CHCS, DOD identified a need for integrated health care data that could be portable and accessible at any MTF. CHCS was developed as a facility-specific system that archived its data using regional network servers. However, accessing data across each server became a "time- and resource-intensive activity." In 1997, DOD began planning for a new "comprehensive, lifelong, computer-based health care record for every servicemember and their beneficiaries." The program would be known as CHCS II, later renamed the Armed Forces Health Longitudinal Technology Application (AHLTA). DOD intended to replace CHCS with AHLTA and initially planned to deploy the new system in 1999. However, the program sustained several delays resulting from "failure to meet initial performance requirements" and changes to technical and functional requirements. The implementation plan was later revised to reflect AHTLA deployment from July 2003 to September 2007. In 2010, the Government Accountability Office (GAO) reported that DOD's AHLTA life-cycle cost estimate through 2017 would be $3.8 billion. Essentris Essentris is the inpatient component of the current EHR that has been used in certain military hospitals since 1987. As a commercial-off-the-shelf (COTS) product developed by CliniComp International, Inc. (CliniComp), Essentris allows health care providers to document clinical care, procedures, and patient assessments occurring in the inpatient setting, as well as in emergency departments. In 2009, DOD selected CliniComp to deploy Essentris at all military hospitals. This deployment was completed in June 2011. DOD maintains an ongoing contract with CliniComp and LOUi Consulting Group, Inc. to provide sustainment, technical and customer support, training, and ongoing updates for Essentris. Corporate Dental System (CDS) CDS, formerly named the Corporate Dental Application, is a web-based application that serves as DOD's current electronic dental record system. CDS allows DOD dental providers to document, review, and archive clinical information. The system also serves several administrative functions, such as tracking dental readiness of servicemembers, patient appointments and scheduling, and data reporting. CDS was initially developed as the Army's alternative dental solution to the AHLTA dental module. In 2000, all Army dental clinics implemented CDS. By 2016, Navy and Air Force dental clinics also transitioned to CDS as their electronic dental record system. In the same year, DOD awarded a four-year, $30 million contract to the Harris Corporation to sustain CDS. Paper Medical Records Paper medical records are another component of the DOD health record. While certain health care data are recorded and archived electronically, some administrative processes and clinical documentation exist only on paper forms. For example, clinical documentation from TRICARE providers, accession medical records, or medical evacuation records are usually in paper form. In such cases, DOD policy requires the scanning and archiving of paper medical records in an electronic repository called the Health Artifact and Image Management Solution (HAIMS). After being digitized, certain paper medical records are submitted to the National Archives and Records Administration while other documents are disposed of locally. Other DOD legacy systems document and archive various administrative and clinical data, such as: Referral Management System (RMS). An administrative information system that allows MTF staff to create and track referrals between health care providers. HAIMS. An electronic repository that stores DOD health care data, including digitally transmitted or scanned medical documentation. Data housed in HAIMS is also incorporated into a servicemember's official service treatment record , which is accessible to the VA. Medical Readiness Tracking Systems. Each military department utilizes an electronic information system that documents and tracks certain medical and dental readiness requirements, such as periodic health assessments, immunizations, dental exams, and laboratory tests. Theater Medical Information ProgramâJoint (TMIP-J). A suite of electronic systems, including modules for health care documentation and review, patient movement, and medical intelligence used in deployed or austere environments. Joint Legacy Viewer (JLV). A web-based, read-only application that allows DOD and VA health care providers to review certain real-time medical data housed in each department's EHR systems. Armed Forces Billing and Collection Utilization Solution (ABACUS). A web-based electronic system that allows MTFs to bill and track debt collection for health care services provided to certain beneficiaries. Developing an EHR Modernization Solution After Operation Desert Storm concluded in 1991, concern about deficient interoperability between DOD and VA health record systems began to grow. A number of committees and commissions issued reports highlighting the need for DOD and VA to standardize record-keeping; to improve health data sharing; and to develop a comprehensive, life-long medical record for servicemembers. Table 1 summarizes their recommendations. Between 1998 and 2009, DOD and VA established various methods to exchange limited patient health information across both departments, including: Federal Health Information Exchange (FHIE). Completed in 2004, the FHIE enables monthly data transmissions from DOD to VA comprised of patient demographics, laboratory/radiology results, outpatient pharmacy, allergies, and hospital admission data. Bidirectional Health Information Exchange (BHIE). Completed in 2004, the BHIE enables real-time, two-way data transmissions (DOD-to-VA and VA-to-DOD) comprised of FHIE information, additional patient history and assessments, theater clinical data, and additional inpatient data. Clinical Data Repository/Health Data Repository (CHDR). Completed in 2006, CHDR enables real-time, two-way data transmissions comprised of pharmacy and drug allergy information and a capability to add information to the patient's permanent medical record in the other department's repository. Virtual Lifetime Electronic Record (VLER). Initiated in 2009, the VLER enables real-time, health information exchange between DOD and VA, as well as certain civilian health care providers. While these information exchange systems enable DOD and VA health care providers to view or modify limited health care data, both departments continue to operate separate, disparate health record systems. Congress Mandates Interoperability In 2008, Congress began legislating mandates for DOD and VA to establish fully interoperable EHR systems that would allow for health care data sharing across departments. Section 1635 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2008 ( P.L. 110-181 ) directed DOD and VA to jointly: (1) "develop and implement electronic health record systems or capabilities that allow for full interoperability of personal health care information," and (2) "accelerate the exchange of health care information" between both departments. Additionally, Congress directed the establishment of an interagency program office (IPO) that would serve as a "single point of accountability" for rapid development and implementation of EHR systems or capabilities to exchange health care information. The FY2008 NDAA also directed the IPO to implement the following, no later than September 30, 2009: "â¦electronic health record systems or capabilities that allow for full interoperability of personal health care information between the Department of Defense and Department of Veterans Affairs, which health records shall comply with applicable interoperability standards, implementation specifications, and certification criteria (including for the reporting quality measures) of the Federal Government." In the conference report accompanying the Department of Defense Appropriations Act, 2008 ( H.Rept. 110-434 , P.L. 110-116 ), Congress also directed DOD and VA to "issue a joint report" by March 3, 2008, that describes the "actions being taken by each department to achieve an interoperable electronic medical record (EMR)." On April 17, 2008, the IPO was established with temporary staff from DOD and VA. On December 30, 2008, the Deputy Secretary of Defense delegated oversight authority for the IPO to the Under Secretary of Defense for Personnel and Readiness (USD[P&R]). The FY2008 NDAA also directed the Secretary of Defense (SECDEF) to appoint the IPO Director, with concurrence of the Secretary of Veterans Affairs (SECVA); and the SECVA to appoint the IPO Deputy Director, with concurrence of the SECDEF. Establishing Interoperability Goals To meet Congress's mandate on interoperability, the IPO established a mutual definition of interoperability. They posited it as the "ability of users to equally interpret (understand) unstructured or structured information which is shared (exchanged) between them in electronic form." Shortly after, both departments identified and adopted six areas of interoperability capabilities intended to meet the requirements and deadline established by Congress: Expand Essentris implementation across DOD. Demonstrate the operation of the Partnership Gateways in support of joint DOD and VA health information sharing. Enhance sharing of DOD-captured social history with VA. Demonstrate an initial capability for DOD to scan medical documents into the DOD EHR and forward those documents electronically to VA. Provide all servicemembers' health assessment data stored in the DOD EHR to the VA in such a fashion that questions are associated with the responses. Provide initial capability to share with the VA electronic access to separation physical exam information captured in the DOD EHR. As a result of each department's work on interoperable capabilities, DOD and VA reported to Congress in 2010 that all requirements for "full" interoperability were met. The Integrated EHR Initiative DOD and VA continued to work on integrating their respective EHR systems through individual initiatives, while considering a larger EHR modernization strategy. Three strategy options were considered: 1. develop a new, joint EHR; 2. upgrade and adopt an existing legacy system across both departments (i.e., AHLTA or VistA); or 3. pursue separate solutions that would have "common infrastructure with data interoperability." In March 2011, the SECDEF and SECVA agreed to work cooperatively to develop an integrated electronic health record (called the iEHR ) that would eventually replace each department's legacy systems. The IPO was assigned the oversight role for the iEHR initiative, which was then set to begin implementation no later than 2017. In February 2013, SECDEF and SECVA announced that they would no longer pursue the iEHR initiative. In making this decision, DOD and VA determined that the initial cost estimates for implementing the iEHR would be "significant," given the "constrained Federal Budget environment." After reevaluating their approach and considering alternatives, both departments decided to pursue other ongoing efforts to "improve data interoperability" and to preserve and develop separate EHR systems with a core set of capabilities that would allow for integrated sharing of health care data between DOD, VA, and private sector providers. Congressional Mandate for an EHR After DOD and VA announced their change to the iEHR strategy in 2013, Congress expressed its sense that both departments had "failed to implement a solution that allows for seamless electronic sharing of medical health care data." Given some Members' apparent frustration, Congress established a new deadline for both departments to deploy a new EHR solution. Section 713(b) of the NDAA for FY2014 ( P.L. 113-66 ) directed DOD and VA to implement an interoperable EHR with an "integrated display of data, or a single electronic health record" by December 31, 2016 (see text box below). The law also required DOD and VA to "jointly establish an executive committee" to support development of systems requirements, integration standards, and programmatic assessments to ensure compliance with Congress's direction outlined in Section 713(b). MHS Genesis Given Congress's new mandate for both departments to implement an interoperable EHR, DOD conducted a 30-day review of the iEHR program in order to "determine the best approach" to meeting the law. While conducting its review, DOD identified two EHR modernization options that would support healthcare data interoperability with the VA: (1) adopt VistA and (2) acquire a commercial EHR system. DOD Acquisition Strategy On May 21, 2013, the Secretary of Defense issued a memorandum directing the department's pursuit of "a full and open competition for a core set of capabilities for EHR modernization." The directive also delegated certain EHR responsibilities to various DOD leaders. Under Secretary of Defense for Acquisition, Technology, and Logistics (USD[AT&L]), whose office was later reorganized as the Under Secretary of Defense for Acquisition and Sustainment (USD[A&S]). Responsible for exercising milestone decision authority (MDA) and also holds technical and acquisition responsibilities for health records interoperability and related modernization programs; Under Secretary of Defense for Personnel and Readiness (USD[P&R]). Lead coordinator on DOD health care interactions with the VA. Assistant Secretary of Defense for Health Affairs (ASD[HA]). Responsible for functional capabilities of the EHR. Given the significant investments required to modernize DOD's EHR, MHS Genesis is a designated Defense B usiness S ystem (DBS). Because it is a DBS, certain decision reviews and milestones are required as part of the overall acquisition process. DBS programs are subject to significant departmental and congressional oversight activities. Requirements Development and Solicitation From June 2013 to June 2014, USD(AT&L) directed the Defense Healthcare Management Systems Modernization Program Management Office (DHMSM PMO) to oversee the EHR requirements development process, draft an acquisition strategy and request for proposal (RFP), and conduct activities required by DOD policy for DBS acquisitions. The ASD(HA) directed the Defense Health Agency (DHA) to establish various working groups to identify and develop the clinical and nonclinical functional requirements for the new EHR. The DHA led each working group, which included representatives from each military service medical department. Keeping in alignment with DOD's guiding principles for EHR modernization (see Figure 2 ), the working groups identified approximately 60 overarching capabilities to be required of a new EHR. An initial draft RFP incorporated functional capability requirements with certain technical requirements for interoperability, information security, and suitability with DOD infrastructure. The DHMSM PMO published three draft RFPs between January and June 2014 for interested contractors to review, provide comments, and submit questions for clarification on functional requirements. Additionally, the DHMSM PMO hosted four industry days that allowed interested contractors to "enhance their understanding of the DHMSM requirement," gain insight on DOD's requirements development process, and provide feedback on particular aspects of the draft RFP. These activities also allowed the DHMSM PMO to conduct market research that would inform further revision of MHS Genesis functional requirements or its overall acquisition strategy. Between June 2014 and August 2014, DOD leaders certified that certain acquisition milestones had been achieved, allowing DOD to proceed with the solicitation process, including finalizing and approving all user-validated function requirements, approving the overall acquisition strategy, and issuing an authority to proceed . On August 25, 2014, DOD issued its official solicitation for proposals. The solicitation period concluded on October 9, 2014. Source Selection Process The source selection process took place from October 2014 to July 2015. DOD reportedly had received five proposals during the solicitation period. Most of the proposals were from partnered vendors consisting of health information management, electronic medical records, information technology, and program management organizations. These partnerships included: Allscripts, Computer Sciences Corporation, and Hewlett-Packard; IBM and Epic Systems; Cerner, Leidos, and Accenture Federal; PricewaterhouseCoopers, General Dynamics, DSS, Inc., MedSphere; and InterSystems. Consistent with DOD source selection procedures, DOD experts were assigned to review and apply the evaluation criteria published in the RFP, to each proposal. Figure 3 illustrates a general overview of the evaluation and source selection process. Contract Award On July 29, 2015, DOD awarded the MHS Genesis contract to Leidos Partnership for Defense Health (LPDH) to replace its legacy EHR systems with a commercial-off-the-shelf (COTS) EHR system. The contract has a potential 10-year ordering period that includes a two-year base period, two three-year optional ordering periods, and an award term period of up to two years. The initial total award ceiling for MHS Genesis was $4.3 billion. On June 15, 2018, DOD approved a contract modification to increase the award ceiling by $1.2 billion. According to the Justification and Approval for Other than Full and Open Competition documentation, the purpose of this increase was to "support the incorporation of the United States Coast Guard (USCG) into the [DOD] MHS Genesis Electronic Health Record (EHR) implementation" and "establish a common standardized EHR baseline with the USCG and the [VA]." The current award ceiling for MHS Genesis is more than $5.5 billion. Leidos Partnership for Defense Health (LPDH) Leidos leads LPDH with its core partners: Accenture Federal Services, Cerner, and Henry Schein One. The full partnership, through sub-contracts of the core partners, is comprised of over 34 businesses (see Figure 4 ). Capabilities According to a redacted version of DOD's contract award documents, LPDH is required to meet the following overarching contract requirements: "unify and increase accessibility of integrated, evidence-based healthcare delivery and decision making"; "support the availability of longitudinal medical records for 9.6 million DoD beneficiaries and approximately 153,000+ MHS personnel globally"; "enable the application of standardized workflows, integrated healthcare delivery, and data standards for improved and secure electronic exchange of medical and patient data between the DoD and its external partners, including the [VA] and other Federal and private sector healthcare providers"; and "leverage data exchange capabilities in alignment with the [IPO] for standards-based health data interoperability and secure information sharing with external partners to include the VA." Additionally, there are over 95 specific capability requirements across four concepts of operations (i.e., health service delivery, health system support, health readiness, and force health protection) that MHS Genesis must support (see Appendix B ). Governance Ultimately, the Secretary of Defense is accountable for MHS Genesis. Various DOD entities, described below, have assigned responsibilities for MHS Genesis oversight, implementation, and sustainment (see Figure 5 ). While each entity has a separate chain of command, DOD chartered numerous governance groups to synchronize efforts across the department, delegate certain decisionmaking authorities, and provide direction on implementation and use of MHS Genesis. Program Executive Office, Defense Healthcare Management Systems (PEO DHMS) PEO DHMS was established in 2013. Its mission is to "transform the delivery of healthcare and advance data sharing through a modernized electronic health record for service members, veterans, and their families." It responsible for implementing MHS Genesis as the assigned acquisition authority and currently reports to the Under Secretary of Defense for Acquisition and Sustainment (USD[A&S]). Under the PEO DHMS, three program management offices (PMOs) are tasked with modernizing DOD's EHR system and ensuring health data interoperability with the VA. DOD Healthcare Management System Moderniza tion (DHMSM) PMO. "Oversees the deployment of MHS Genesis and the operations and sustain of the Joint Legacy Viewer." DOD/VA Interagency Program Office (IPO). "Oversees the efforts of the DOD and VA to implement national health data standards for interoperability." Joint Operational Medicine Information Systems (JOMIS) PMO. "Develops, deploys, and sustains MHS Genesis and other integrated operational medicine information systems to deployed forces." Defense Health Agency (DHA) In 2013, the Secretary of Defense established the DHA to manage the TRICARE program; execute appropriations for the Defense Health Program; coordinate management of certain multi-service health care markets and MTFs in the National Capital Region; exercise management responsibility for shared services, functions, and activities within the Military Health System; and support DOD's medical mission. DHA is a designated Combat Support Agency that is scheduled to soon administer and manage all MTFs. DHA serves as the lead entity for MHS Genesis requirements development, in coordination with the military service medical departments, and currently reports to the ASD(HA). Military Service Medical Departments The military service medical departments are established under each respective military department to organize, train, and equip military medical personnel, maintain medical readiness of the Armed Forces, and administer, manage and provide health care in MTFs. The medical departments are led by a Surgeon General, who also functions as the principal advisor to their respective military service secretary and service chief for all health and medical matters. The three service medical departments are the Army Medical Command (MEDCOM), the Navy Bureau of Medicine and Surgery (BUMED), and the Air Force Medical Service (AFMS). Each service medical department provides subject-matter expertise, functional support, and consultation to the DHMSM PMO. Senior Stakeholders Group (SSG) and the Configuration Steering Board (CSB) The SSG and the CSB are DOD-chartered working groups established to provide oversight, recommendations, and "direction on health-related acquisition programs," including those within PEO DHMS. The SSG is chaired by the USD(A&S) and is responsible for receiving updates on DHMS acquisition programs, ensuring adherence to DOD's EHR guiding principles, and providing recommendations and feedback on key EHR and interoperability decisions. The CSB is co-chaired by the USD(A&S) and the USD(P&R) and is specifically responsible for oversight on DHMSM and JOMIS programs. Figure 6 outlines the membership of each group. Executive Steering Board (ESB) The ESB, previously named the Functional Champion Leadership Group (FLCG), is a governance body led by the DHA's Chief Health Informatics Officer with representation from each service medical department. The ESB's role is to: consider changes to standardized clinical, business, or technical processes; serve as a forum to validate, prioritize, and recommend modifications or new functional requirements for MHS Genesis; and oversee numerous working groups of subject matter experts and end-users. Office of the Chief Health Informatics Officer (OCHIO) The OCHIO represents the "voice of the customer" to PEO DHMS. The office solicits input and recommendations from the ESB and coordinates with PEO DHMS to revise or modify MHS Genesis contract requirements. OCHIO is also responsible for "change management, early adoption activities, standardization of functional workflows, functional collaboration with the [VA], management of configuration changes to MHS Genesis, adjudication of functional trouble tickets, sustainment training, current state workflow assessments, and coordination of DHA policy to support the use of MHS Genesis." Deployment DOD is using a phased implementation strategy to deploy MHS Genesis. Deployment began with its initial operational capability (IOC) sites in 2017. After the IOC sites, MHS Genesis is to be deployed at over 600 medical and dental facilities, grouped geographically into 23 waves (see Appendix F ). DOD anticipates "full operational capability" and implementation of MHS Genesis at all MTFs by the end of 2024. Pre-Deployment Activities During the approximately 17 months between the July 2015 contract award date and Congress's December 2016 deadline to implement a new EHR system, DOD conducted certain pre-deployment activities (e.g., systems engineering, systems integration, and testing prior to deploying MHS Genesis). DOD acquisition policies and certain contract requirements mandate these activities. Some of the initial requirements include: contractor site visits to "analyze operations, infrastructure, and detailed information for EHR System design and testing"; gap analyses between existing site infrastructure, system requirements, and the contractor's system architecture; development of solutions to fill identified infrastructure gaps; testing interoperability with legacy systems; delivering various contractor plans to the government (e.g., integrated master plan, risk management plan, data management plan, disaster recovery plan, and cybersecurity vulnerability management plan); EHR system testing in government approved labs, including those conducted by the contractor, government independent testing and evaluation teams, and operational test agencies; and receiving authorization to proceed (ATP) with limited fielding at the IOC sites and to conduct an Initial Operational Test and Evaluation (IOT&E). Concurrently, the DOD Inspector General (DODIG) conducted a performance audit on the DHMSM PMO. The purpose of the audit was to determine if DOD had approved system requirements and if the MHS Genesis acquisition strategy was "properly approved and documented." The audit was conducted from June 2015 through January 2016, with a final report issued on May 31, 2016. Overall, the DODIG found that the MHS Genesis requirements and acquisition strategy were properly approved and documented. However, the report raised concerns about the program's execution schedule (i.e., implementation timeline) not being "realistic" to meet Congress's deadline. The DODIG recommended that the PEO DHMS conduct a "schedule analysis" to determine if IOC would be achievable by December 2016, and to continue monitoring program risks and report progress to Congress quarterly. In response to the DODIG's recommendation, the PEO DHMS asserted, "we remain confident we will achieve [IOC] later this year in accordance with the NDAA." Initial Deployment As part of the implementation strategy, DOD selected MTFs in the Pacific Northwest as its IOC sites (see Table 2 ). On February 9, 2017, MTFs at Fairchild Air Force Base, Washington, were the first sites to transition to MHS Genesis. The purpose of fielding MHS Genesis at the IOC sites before full deployment was to observe, evaluate, and document lessons-learned on whether the new EHR was usable, interoperable, secure, and stable. DOD used several evaluation methods to measure MHS Genesis success at the IOC sites, including the Health Information Management Systems Society's (HIMSS) Electronic Medical Record Adoption Models (EMRAM) and the DOD IOT&E. The results of these assessments would later inform PEO DHMS in its decision to proceed with further deployments. EMRAM Findings The EMRAM includes two commercially developed assessment tools that health systems and facilities can use to measure adoption of an electronic medical record (EMR) system. The general EMRAM is for inpatient facilities and O-EMRAM is for outpatient facilities. Both tools consist of a self-administered survey, which is then analyzed by HIMSS to produce an EMRAM score. The score, ranging from Stage 0 to Stage 7, describes the level of adoption and utilization of an EMR within a health care organization (see Appendix C ). Generally, Stage 0 indicates minimal or no EMR adoption in a health care facility or clinic, whereas Stage 7 indicates complete EMR adoption, including demonstrated data sharing capabilities and eliminated use of paper charts. Prior to the go-live dates at the IOC sites and while using its legacy systems, DOD's average score was 1.59 for the EMRAM and 2.38 for the O-EMRAM. After all IOC sites transitioned to MHS Genesis, DOD reassessed each IOC site and observed increased EMRAM scores (see Figure 7 and Figure 8 ). MTFs at Fairchild Air Force Base received a score of 6.13 on the O-EMRAM, whereas all other IOC sites scored 5.04. In comparison to U.S. civilian hospitals, the IOC sites scored higher than the national average for the EMRAM (2.00) and O-EMRAM (3.00). However, media reports on EMRAM scoring trends at the end of 2017 note that 66.7% of U.S. hospitals participating in the EMRAM reached "either Stage 5 or Stage 6." For the O-EMRAM, most participating outpatient facilities remained at Stage 1. IOT&E Findings DOD policy requires DBS programs to undergo an IOT&E to determine program or systems effectiveness and suitability. IOT&E findings provide the USD(A&S) and relevant acquisition or functional leadership with recommendations on whether a program, generally those with total contract values exceeding certain thresholds, should proceed with further implementation. Between September 2017 and December 2017, the Joint Interoperability Test Command (JITC) conducted an IOT&E at each IOC site, with the exception of Madigan Army Medical Center (MAMC). PEO DHMS postponed the MAMC IOT&E to 2018 in order to resolve issues identified at the other IOC sites. While at each site, the JITC conducted initial cybersecurity testing, evaluated interoperability data, observed MTF staff performing day-to-day tasks using MHS Genesis, and administered user surveys on performance and suitability. The Director of Operational Test and Evaluation (DOT&E) reviewed JITC's IOT&E findings and applied them to the following criteria: Does MHS Genesis provide the capabilities to manage and document health-related services? Do MHS Genesis interfaces support or enable accomplishment of mission activities and tasks? Does MHS Genesis usability, training, support, and sustainment ensure continuous operations? On April 30, 2018, DOT&E issued a partial IOT&E report asserting that MHS Genesis was "neither operationally effective nor operationally suitable." DOT&E found that: MHS Genesis is not operationally effective because it does not demonstrate enough workable functionality to manage and document patient care. Users successfully performed only 56 percent of the 197 tasks used as Measures of Performance. MHS Genesis is not operationally suitable because of poor system usability, insufficient training, and inadequate help desk support. Survivability is undetermined because cybersecurity testing is ongoing. See Appendix D for IOT&E summary results by measure of effectiveness and measure of performance evaluation. Based on these preliminary findings, DOT&E recommended to the USD(A&S) a delay in further deployment of MHS Genesis until a full IOT&E was completed and the DHMSM PMO corrected "outstanding deficiencies." Additional recommendations for the DHMSM PMO included: "Fix all Priority 1 and 2 [incident reports] with particular attention given to those that users identified as potential patient safety concerns, and verify fixes through operational testing. Improve training and system documentation for both users and Adoption Coaches. Increase the number of Adoption Coaches and leave them on site until users are more comfortable with the new processes. Complete cybersecurity operational testing and continue to fix known deficiencies. Work with users to document, reduce, and standardize operational workarounds. Improve interoperability, focusing on interfaces identified as problematic during IOT&E. Monitor reliability and availability throughout the system lifecycle. Work with the Defense Health Agency and DISA to isolate network communications problems and reduce latency. Conduct operational testing at MAMC to evaluate untested functionality and corrective actions taken by the [DHMSM] PMO. Conduct follow-on operational testing at the next fielding site to evaluate revised training and Go-Live process improvements." On November 30, 2018, DOT&E issued a final IOT&E report, incorporating results from delayed testing at MAMC. DOD has not made the final report publicly available. DOT&E acknowledges ongoing improvements, but maintains that MHS Genesis is "not yet effective or operationally suitable." A summary of the IOT&E released by the department describes several ongoing issue themes previously identified and described in the partial IOT&E report (e.g., continued incident reports, staff training, change management, and workflow adoption). With regard to cybersecurity, DOT&E described MHS Genesis as "not survivable in a cyber-contested environment." In conjunction with the IOT&E, DOD "successfully executed" three cyberspace test attacks against MHS Genesis, highlighting potential security gaps and vulnerabilities with the new EHR system. Notwithstanding DOT&E's findings and recommendations, the DOD Chief Information Officer issued a conditional Authorization to Operate , valid for 12 months. Additionally, PEO DHMS concurred with DOT&E's recommendation for a follow-on operational test and evaluation "at the next fielding to evaluate corrective actions and revised training, to inform future fielding decisions." Selected Initial Deployment Issues Since February 2017, DOD has documented numerous issues requiring mitigation strategies prior to deploying the first wave. Selected issues reported by various DOD entities, LPDH, MHS Genesis users, and media outlets are summarized below. Trouble Ticket Backlog During the initial deployment, DHMSM PMO established a single process for all IOC sites to identify, document, and report MHS Genesis issues. Users encountering system inconsistencies, technical errors, or clinical inaccuracies must submit a "trouble ticket" to a global service center (GSC). Users can also submit recommendations for changes to current workflows or system configurations to the GSC, as well as through their chain of command. The GSC is a contracted service that reviews, sorts, and assigns technical trouble tickets to LDPH or its sub-contractors for resolution. The GSC also assigns trouble tickets relating to functional capabilities, requirements, or workflows to DHMSM PMO or DHA for further review and adjudication. In April 2018, PEO DHMS reported that 1,000 of approximately 7,000 total trouble tickets generated by users throughout all IOC sites from January 2018 to that point had been resolved. Of the remaining trouble tickets, DHMSM PMO approved 2,000 for "work by the Leidos Partnership," while 2,500 were in review for further adjudication. CRS is unable to ascertain the status of the remaining 1,500 trouble tickets and the timeline in which they may have been resolved. In December 2018, PEO DHMS estimated that 3,607 open trouble tickets remained for resolution. As of October 14, 2019, PEO DHMS estimated 3,238 open trouble tickets from the IOC sites and 787 open trouble tickets from the first wave sites remained for resolution. Lengthy Issue Resolution Process MHS Genesis users at IOC sites described the issue resolution process as lengthy and lacking transparency. User concerns included: (1) tickets submitted to the GSC were resolved in a period of time that was "not acceptable for all issues"; (2) the length of time for decisionmakers to determine a solution; and (3) discovering that a solution had been implemented during a periodic system update, rather than being notified by DHMSM PMO, DHA, or LPDH. Unlike DOD's legacy systems, MHS Genesis is to be a standardized EHR platform across all military treatment facilities and is not customizable for each site. Technical or functional changes to MHS Genesis require DHA-led working groups and DHMSM PMO to review and approve such changes before directing LPDH to implement a solution. Changes exceeding the scope of the MHS Genesis contract require additional review, resourcing, and approval by the acquisition authority. Inadequate Staff Training Users reported that initial training provided four months prior to go-live was inadequate and did not allow super users to "absorb/fully grasp one role before being introduced to the next role." Staff members were required to complete computer-based training, followed by instructor-led courses. Course curricula varied by user roles (e.g., clinician, clinical support, administrative staff). Users reported that the LPDH training focused primarily on navigating the various modules and features of MHS Genesis and did not include training on clinical or administrative workflows. For example, primary care clinic nurses were trained on the applicable MHS Genesis modules that would likely be found in the primary care setting. They said they were not trained on accessing other modules that would typically be used outside of the primary care setting, as part of a patient assessment or development of a treatment plan. Capability Gaps and Limitations Users reported having little or no ability to track military medical and dental readiness requirements in MHS Genesis. Pre-built reports to monitor certain health care quality and access metrics were available to MTF staff. Users defaulted to developing local, "home-grown" work-around tools in Microsoft Office products in order to meet specific DOD and military service requirements for tracking medical and dental readiness. For example, certain dental data documented in MHS Genesis were not available for data-mining or viewing in legacy dental readiness reporting systems. To compensate for this, dental clinic staff at each IOC site transcribed or manually maintained dental readiness reports by reviewing dental data in both Dentrix (MHS Genesis' dental module) and CDS (the legacy dental system). Future Deployments In reviewing the experience and challenges documented during MHS Genesis deployment at the IOC sites, DOD noted that they "captured lessons learned, collaborated with our stakeholders, and optimized the system to enhance user adoption. Specific areas of improvement include network optimization, change management, and training enhancements." As such, DOD commenced the first wave of MHS Genesis deployments in September 2019. The deployment began with four MTFs in California and Idaho. Each wave is to last 18 months and is to include three major phases: pre-deployment planning with each MTF (3 months), deployment activities (12 months), and post go-live activities (3 months). As outlined in DOD's deployment schedule (see Appendix F ), a new wave is to begin every three months at designated MTFs through late 2022, with wave 23 scheduled to conclude in 2024. Issues for Congress Congressional Oversight Since mid-1980s, Congress has kept abreast of DOD's efforts to implement, sustain, or modernize its EHR systems. Previous congressional oversight activities have primarily focused on (1) understanding DOD's EHR modernization strategy and how the strategy would integrate interoperability and improve coordination with the VA, or (2) describing certain barriers that delayed previous modernization initiatives. Currently, 12 congressional committees may exercise oversight authority of the broader EHR modernization efforts taking place in DOD, VA and USCG. The committees include: House Appropriations Committee. House Armed Services Committee. House Committee on Oversight and Reform. House Committee on Transportation and Infrastructure. House Veterans Affairs Committee. Senate Appropriations Committee. Senate Armed Services Committee. Senate Committee on Commerce, Science, and Transportation. Senate Committee on Homeland Security and Governmental Affairs. Given the complexity, size, and timeline of DOD's EHR modernization effort, as well as parallel efforts by the USCG and VA, a coordinated oversight strategy may be necessary. Such a strategy could allow Congress to conduct a wide range of oversight activities without creating redundancies for committee staff and executive branch officials and could facilitate information-sharing among congressional stakeholders. Since the initial deployment of MHS Genesis, there have been no congressional oversight hearings held solely on DOD's EHR modernization effort. On June 20, 2018, the House Committee on Veterans' Affairs established the Subcommittee on Technology Modernization. The role of the new subcommittee is to "focus on conducting oversight of the EHR Modernization program and other major technology projects at the Department of Veterans Affairs." Both DOD and VA officials testified before the subcommittee at its June 2019 oversight hearing. Interagency Governance In September 2018, then-SECDEF James Mattis and current SECVA Robert Wilkie signed a joint statement (see Appendix G ) that outlined each department's commitment to "implementing a single, seamlessly integrated [EHR] that will accurately and efficiently share health data â¦ and ensure health record interoperability with our networks of supporting community healthcare providers." On April 3, 2019, DOD announced plans to re-charter the IPO into the "Federal Electronic Health Record Modernization (FEHRM)" program office. The new office would serve as an interagency governance group that provides oversight on DOD and VA's EHR modernization efforts and would have the "authority to direct each Department to execute joint decisions for technical, programmatic, and functional functions." DOD stated that the FEHRM Director and Deputy Director will be appointed positions and will report to both the Deputy SECDEF and Deputy SECVA. While Congress directed the creation of the IPO in 2008, neither DOD nor VA has indicated if additional authorities, funding, or changes to current law are required to sustain the FEHRM program office. Congress may also examine the relationships between existing interagency governance groups (e.g., Joint Executive Committee), PEO DHMS, VA EHR Modernization Office, and the newly established FEHRM program office. Limited Competition in Future Procurement Because MHS Genesis is being deployed across all MTFs and all USCG sites, as well as VA sites transitioning to a Cerner-based EHR system, observers have noted that this is the "largest EHR undertaking in the country." Implementing a single EHR platform across three federal departments can produce certain economies of scale and standardization. However, the scale of these efforts can also result in future acquisition challenges particularly with conducting a full and open competition to procuring new requirements, or with follow-on contracts to sustain each EHR system. Congress may seek to understand how DOD and VA exercised their statutory authorities, provided through the Competition in Contracting Act of 1984 ( P.L. 98-369 ), to procure their EHR systems, as well as the possible impact of limited competition in future procurement activities needed to sustain both MHS Genesis and the VA's new EHR system. Generally, all federal departments procuring property, goods, or services are required to employ an acquisition process that allows for full and open competition. This process permits all potential vendors to "submit sealed bids or competitive proposals on the procurement." For MHS Genesis, DOD's initial acquisition process included full and open competition. However, the process was not employed for subsequent requirements that were discovered after the initial award to LPDH. These additional requirements included upgrading DOD network infrastructure; incorporating USCG-specific requirements and clinic sites; and establishing common standards among DOD, VA, and USCG. The estimated value of the additional requirements was over $1.2 billion. DOD exercised its statutory authority to award a sole source contract modification to LPDH, citing that contracting with any other vendor would potentially "create significant redundancies, inefficiencies, and other issues." DOD's acquisition strategy anticipates "one or more competitive follow-on contracts to sustain the EHR solution, for which the Government owns a perpetual license, at the conclusion of the performance of the basic contract." However, Cerner declined DOD's request to enter into negotiations regarding the rights of its intellectual property. If DOD does not retain certain intellectual property rights on MHS Genesis, the Department may be limited in what EHR vendors it can consider when it becomes necessary to solicit for an MHS Genesis sustainment contract. Appendix A. Acronyms Appendix B. MHS Genesis Functional Capability Requirements Appendix C. Stages of Electronic Medical Record Adoption and Utilization Appendix D. IOT&E Summary Results Appendix E. Methodology for CRS Focus Groups on MHS Genesis Background On July 8-13, 2018, analysts from the Congressional Research Service (CRS) participated in a congressional staff delegation visit to various DOD facilities in the Puget Sound area of Washington State. DOD facilities visited were Madigan Army Medical Center, Naval Hospital Bremerton, and the Puyallup Community Medical Home. The purpose of the visit was to: review milestones, achievements, and challenges associated with the implementation of MHS Genesis; and understand implementation and continuous improvement processes utilized at initial operational capability sites. Methodology At each site, CRS conducted numerous focus groups comprised of various MTF staff members. Each focus group was comprised of 5â15 staff members selected by the MTF commander or his/her designee. Madigan Army Medical Center Focus Group #1: Patient Administration Division, Managed Care and Scheduling, and Patient Satisfaction Department representatives Focus Group #2: Health care providers (e.g., physicians, dentists, psychologists, physicians assistants) Focus Group #3: Nurses Naval Hospital Bremerton Focus Group #1: Nurses Focus Group #2: Health care providers (e.g., physicians, dentists, psychologists, physicians assistants) Focus Group #3: Enlisted personnel Focus Group #4: Patient Administration, Referral Management, and Patient Relations representatives Puyallup Community Medical Home Focus Group #1: Health care providers, nurses, health care administrators, enlisted personnel Prior to each site visit, CRS provided each MTF with questions for discussion during each focus group. CRS documented the themes and responses to each of the following questions: What challenges have you experienced with implementing MHS Genesis? How have you locally mitigated these issues? Are the mitigation processes in place working? Have these challenges impacted force readiness, access to care, quality of care, cost of care, or patient experience? Appendix F. MHS Genesis Deployment Schedule Appendix G. DOD and VA EHR Joint Commitment Statement Background On July 8-13, 2018, analysts from the Congressional Research Service (CRS) participated in a congressional staff delegation visit to various DOD facilities in the Puget Sound area of Washington State. DOD facilities visited were Madigan Army Medical Center, Naval Hospital Bremerton, and the Puyallup Community Medical Home. The purpose of the visit was to: review milestones, achievements, and challenges associated with the implementation of MHS Genesis; and understand implementation and continuous improvement processes utilized at initial operational capability sites. Methodology At each site, CRS conducted numerous focus groups comprised of various MTF staff members. Each focus group was comprised of 5â15 staff members selected by the MTF commander or his/her designee. Madigan Army Medical Center Focus Group #1: Patient Administration Division, Managed Care and Scheduling, and Patient Satisfaction Department representatives Focus Group #2: Health care providers (e.g., physicians, dentists, psychologists, physicians assistants) Focus Group #3: Nurses Naval Hospital Bremerton Focus Group #1: Nurses Focus Group #2: Health care providers (e.g., physicians, dentists, psychologists, physicians assistants) Focus Group #3: Enlisted personnel Focus Group #4: Patient Administration, Referral Management, and Patient Relations representatives Puyallup Community Medical Home Focus Group #1: Health care providers, nurses, health care administrators, enlisted personnel Prior to each site visit, CRS provided each MTF with questions for discussion during each focus group. CRS documented the themes and responses to each of the following questions: What challenges have you experienced with implementing MHS Genesis? How have you locally mitigated these issues? Are the mitigation processes in place working? Have these challenges impacted force readiness, access to care, quality of care, cost of care, or patient experience?


Introduction This report provides context for Congress about the U.S. teen birth rateâor the number of births per 1,000 females aged 15 to 19 each yearâand its changes since the 1950s. Over this period, the teen birth rate has generally been in decline. This decline has been most significant in recent years, with the rate reaching a record low in 2018. Multiple factors have likely contributed to the decrease, though the influence of any single factor is not fully known. Reduced teen sexual activity, particularly among younger adolescents, could be one explanation. Increases in use of contraceptives, including highly effective and multiple methods, among sexually active teens could be another. Other factors, such as broader social and economic trends, may also be at play. Despite the decline in the teen birth rate, Congress continues to be interested in the issue of teen birth because of its high social and economic costs for both individual families and society more generally. Further, disparities persist in teen birth rates among racial and ethnic subgroups and across states. This report accompanies CRS Report R45183, Teen Pregnancy: Federal Prevention Programs , which discusses Congress's current approach of supporting programs that seek to prevent pregnancy among teens. Teen Births in the United States Data on births are distinct from data on pregnancies. The teen birth rate refers to the number of live births per 1,000 teen girls aged 15 through 19. The teen pregnancy rate includes the number of pregnancies per 1,000 teen girls aged 15 through 19, which encompasses live births, abortions, and fetal losses . Birth data account for nearly every birth in the United States, whereas pregnancy data are based on estimates of miscarriages and abortion numbers that draw on various reporting systems and surveys. The Centers for Disease Control and Prevention (CDC), the federal government's lead public health agency, reports birth data on an annual basis (most recently for 2018). The CDC and the Guttmacher Institute publish teen pregnancy rates. These rates are usually published a year or two after birth data because of the time required to incorporate data from the various data sources. This report focuses on the teen birth rate. The CDC tracks birth rates by age and other characteristics of birth mothers. In 2018, there were approximately 3.8 million births in the United States. About 180,000 of these births (4.7%) were to teenagers aged 15 to 19. Figure 1 shows the U.S. teen birth rate from 1950 through 2018 (the rate excludes the territories). The rate ticked up in the baby boom era of the 1950s, peaking in 1957 at 96.3. It then decreased in most years from the 1960s through the 1980s. From 1991 onward, the teen birth rate declined except in two years, 2006 and 2007. The rate dropped by 72% from 1991 (61.8) to 2018 (17.4). In other words, about 6% of teens aged 15 to 19 gave birth in 1991 compared to less than 2% in 2018. The greatest decline in the teen birth rate occurred in recent years. For example, from 2007 to 2018, the rate declined by about 58%. The 2018 teen birth rate of 17.4 was a historical low since CDC began collecting and reporting birth data in the 1940s. The CDC began tracking subgroup data for teens in 1960, when the teen birth rate was highest for both teens aged 15 to 17 (43.9 per 1,000) and teens aged 18 to 19 (166.7 per 1,000). Figure 1 indicates that the birth rate was higher in each year for the older teens compared to the younger teens. The 2018 birth rates for 15- to 17-year-olds (7.2 per 1,000) and 18- to 19-year-olds (32.3 per 1,000) were the lowest on record. Repeat teen births have also declined over time. CDC found the number of subsequent teen births among youth aged 15 to 19 declined nationally by nearly 54% from 2004 to 2015 (the most recent analysis available). The prevalence of teen births that were repeat births was highest among Hispanic youth, followed by non-Hispanic black and non-Hispanic white youth. Over this same period, the largest declines in the number of repeat births were among black teens (21.8%), followed by Hispanic (16.8%) and white (13.9%) teens. Teen mothers have also been less likely to be married than in previous years. In 2018, the birth rate for unmarried teens aged 15 to 19 was 16.0 per 1,000. This is compared to 31.0 per 1,000 in 2010. Despite the overall decline in the teen birth rate, the rates for certain racial and ethnic groups remain relatively high. Teen birth rates in 2018 varied based on race and ethnicity, with three groupsâHispanic (26.7), non-Hispanic black (26.2), and non-Hispanic American Indian/Alaska Native (29.4) teensâhaving more than double the teen birth rate for non-Hispanic white (12.2) and non-Hispanic Asian or Pacific Islander (4.0) teens. Figure 2 shows the teen birth rate by race and Hispanic origin over three key years: 1991, when the teen birth rate started a long-term decline; 2007, the most recent year when the teen birth rate had ticked back up slightly; and 2018, the most recent year for which CDC compiled historical teen birth rate data by race and ethnicity. In nearly each year from 1991 through the recent period, the teen birth rate decreased for all racial and ethnic groups; however, the rates declined more for certain groups compared to others. From 2007 to 2018, birth rates fell by 55% for non-Hispanic white teens, 40% for non-Hispanic American Indian/Alaska Native teens, 58% for non-Hispanic black teens, 73% for non-Hispanic Asian/Pacific Islander teens, and 65% for Hispanic teens. While the birth rates for two groups (non-Hispanic black and Hispanic) had a greater decline than the rate for white teens, their birth rates remained higher. In 2018, the birth rate for teens aged 15 to 19 varied considerably by state and territory. The state with the lowest reported rate was Massachusetts (7.2); the state with the highest reported rate was Arkansas (30.4). Figure 3 shows a map with 2018 teen births rates in four data categories for the 50 states, the District of Columbia, and three of the territories. Eighteen states had rates of less than 15 per 1,000 teens aged 15 to 19: California, Colorado, Connecticut, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, Utah, Vermont, Virginia, Washington, and Wisconsin. Ten states had the highest teen birth rates (25 or higher): Alabama, Arkansas, Kentucky, Louisiana, Mississippi, New Mexico, Oklahoma, Tennessee, Texas, and West Virginia. The rates for the territories ranged from 19.3 in Puerto Rico to 34.4 in Guam. From 2007 (when the birth rate last ticked up) to 2018, the teen birth rate decreased in each state or territory by between 19% and 67%. Teen birth rates have also declined in rural areas over time but remain relatively higher than rates in urban areas. While the U.S. teen birth rate has decreased over time, it has been higher than that of most other industrialized countries. For comparison, the U.S. teen birth rate of 18.8 was about 50% higher than the rate of the United Kingdom, 12.6, in 2017 (based on the most recent international data available). The reasons for the high teen birth rate in the United States relative to other industrial countries have not been fully explored. Economic conditions and income inequality within and between countries may play a role. Further, the research literature, which is somewhat dated and limited, indicates that use of contraceptives among teens appears to be greater in other developed countries compared to the United States. Factors Likely Contributing to the Declining Risk of Teen Pregnancy Researchers suggest that multiple trends have driven down U.S. teen pregnancy and teen birth rates. They point to certain factors as the reason for declines over the 1990s through 2007. Research indicates that over this period, the risk of teen pregnancy decreased primarily because of improved contraceptive use, including an increase in the use of certain contraception methods (e.g., condoms), an increase in the use of multiple methods of contraception, and substantial declines in foregoing contraception. In addition, some of the risk of pregnancy decreased among younger teens, those ages 15 to 17, because of decreased sexual activity. A primary factor for more recent declines in the risk of teen pregnancy has also been the increasing use of contraceptives among sexually active teens. From 2007 through 2014, teens increased their contraceptive use, including the use of any method, the use of long-acting reversible contraceptives (LARCs; e.g., intrauterine devices, or IUDs, and birth control implants), and the use of the withdrawal method along with another method. Broad economic and social variables may influence teen behaviors, such as whether they will abstain from sex or use contraceptives. Behavioral changes may have been driven by a confluence of factors, such as expanded educational and labor market opportunities for women and improvements in contraceptive technology. Some observers theorize that the long-term downward trend in teen birth rates is attributable to the recession that began in 2007. They contend that during economic downturns the decrease in teen birthsâlike the decrease in overall birthsâis partly due to teenagers being more careful as they witness the economic difficulties faced by their families. Despite this rationale, the teen birth rate continued to diminish after the recession (as well as during periods of economic expansion in the 1990s). Another possible explanation for the decline is the role of social media and increased use of the internet in teens' knowledge about sex and birth control. One analysis found that there were more rapid declines in rates of teen childbearing in places where the MTV show 16 and Pregnant was more widely viewed. The study extrapolated that teens changed their behavior (e.g., increasing the use of contraceptives) after viewing the show. Still, teen birth rates declined even after ratings for the show peaked. Some observers contend that teen pregnancy prevention programs, such as those supported with federal funding, could potentially play a role in the declining birth rate for teenagers. However, the extent to which these programs have caused a decline in the teen birth rate is not fully known. Financial and Social Costs of Teen Births Teen pregnancy has high costs for the families of teen parents and society more generally. Teenage mothers and fathers tend to have less education and are more likely to live in poverty than their peers who are not teen parents. For example, nearly one-third of teen girls who have dropped out of high school cite pregnancy or parenthood as a reason, about 7 out of 10 teen mothers who have moved out of their family's household live below the poverty level, and more than 60% of teen mothers receive some type of public benefits within the first year after their children are born. Lower levels of education reduce teen parents' potential for economic self-sufficiency. At the same time, being impoverished and having less education can also increase the likelihood of teens becoming pregnant in the first place. These poorer outcomes may be explained in part by underlying differences between those who give birth as teens and those who delay childbearing: teen mothers often come from more disadvantaged backgrounds (e.g., family more likely to receive public welfare benefits, parents have lower levels of education) than their counterparts who have children at a later age. In addition, teen sexual activity even among those who do not become pregnant can increase the risk of sexually transmitted infections (STIs), which can led to long-term health issues. Adolescents aged 15 to 19 have certain STIs at a rate that is among the highest of sexually active individuals. Further, teen childbearing can also affect the offspring of teen parents. Children of teenage mothers have poorer outcomes than children of mothers who give birth in their early 20s or later. They are generally more likely to (1) have chronic medical conditions, (2) use public health care, (3) have lower school readiness scores, (4) do poorly in school, (5) give birth during their teen years (females), and (6) be incarcerated (males). In addition to the consequences for teens and their families, teen childbearing has societal impacts. One study examined these societal impacts, specifically estimating the cost savings to public programs that were associated with avoiding unintended pregnancies during the teen years. The Power to Decide did a simulation analysis to estimate the number of births to teenagers that had been averted due to the decrease in teen fertility rates from 1991 to 2015. The analysis then estimated total savings of $4.4 billion for this period, taking into consideration the cost savings to Medicaid that would have been associated with labor and delivery, postpartum care for the mother, and infant care; and receipt of Temporary Assistance for Needy Families (TANF), Supplemental Nutrition Assistance Program (SNAP), and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits. Additional research of decreased or delayed teenage pregnancy and childbearing could help to inform the impacts for teen parents, their children, and society more generally. Appendix. Additional Data on Teen Pregnancy


Introduction Three-dimensional (3D) printing is a manufacturing process used to create real-world parts from digital 3D design files. This process is of particular relevance to Congress because of its use in federal programs; economic potential; continued applications in scientific research and development; roles in national security; and potential areas of concern, including weapons development and intellectual property law. This report describes the basic parts common to 3D printers and explains the operation of the technology. It also provides a snapshot of current materials and capabilities, traces the historical development of the technology since 1980, provides information on the federal role in 3D printing, communicates the primary properties of 3D printing with reference to manufacturing, explains secondary manufacturing impacts that stem from these properties, and highlights particular issues relevant to Congress. 3D printing is sometimes known as additive manufacturing . The term additive refers to the construction of a final part through the addition of consecutive layers of material on a build plate. In contrast, subtractive manufacturing processes carve out a final part from an initial block by removing unwanted material. Computer-controlled additive and subtractive manufacturing originated in the 1980s and 1970s, respectively. Yet, the basic techniques underlying these manufacturing methodsâthat is, addition or removal of material to create a productâhave existed for millennia. 3D printing is used in a wide variety of applications, including aerospace, medicine, defense, custom manufacturing, prototyping, art, hobbies, and education (see Table 1 ). The prices, capabilities, and dimensions of 3D printers also vary widely. For more information, see " Current Materials and Capabilities " section below. Technical Overview In general, 3D printers have five common parts: input material, print head, build plate, axes, and 3D design file (see Figure 1 ). Input material â3D-printed parts begin as input material. This material can be in the form of solid filament, pellets, liquid, or powder. Print head âThe input material is deposited at the tip of the print head. This process can occur through a variety of methods, including pushing filament or pellets through a metal extruder, using a laser to melt powder, or using a light to solidify liquid. Build plate âThe build plate is the base (flat surface) upon which the part is constructed. At the beginning of the 3D printing process, the print head is nearly touching the build plate. As more layers are added to the part, the distance between the print head and the build plate increases. Axes âThe axes move the print head relative to the build plate. This enables the 3D printer to create a particular pattern for each new layer of material. The final part is made up of the patterns in each layer, stacked on top of each other. 3D design file âThe 3D printing process is governed by a digital 3D design file. This file provides instructions to the 3D printer that describe how to move the axes, which in turn move the position of the print head relative to the build plate. The file controls exactly what patterns are produced in each layer; this determines which kind of part is produced by the 3D printer (see Figure 2 ). Current Materials and Capabilities The prices and capabilities of 3D printers span a wide range of options. Prices vary from several hundred dollars to millions of dollars. More specifically, 3D printers at the price range of $5,000 and below (known as consumer printers ) often are designed to print plastic parts. Several different plastics are available, each with different capabilities and costs. These materials include tough nylon plastics; flexible, rubber-like plastics; plastics reinforced with carbon fiber; dissolvable plastics; clear plastics; and decorative plastics with the appearance of wood or metal. Some 3D printers in this price range can also print using materials such as ceramic or chocolate. Structural metal-infused plastic, as opposed to decorative metal-infused plastic, also can be used in 3D printers at this price range. However, structural metal-infused 3D-printed parts require additional high-temperature post-processing to burn off the plastic. This process leaves an entirely metal product behind. The necessary high temperatures for post-processing can be attained using pottery kilns, sintering machines, or other specialized devices. Commercial services are available that offer high-temperature post-processing of metal-infused 3D-printed parts. 3D printers at the price range of $5,000 and up (known as industrial printers) are able to use a wider variety of materials in an even greater variety of applications. These 3D printers can create structures that are larger, more detailed, or more reliable than structures created by consumer printers, or they can print in materials that are unavailable at lower price ranges. For example, medical biofabrication printers can print structures made of living cells. Metal 3D printers can create parts out of titanium, steel, and other metals, which may cost less than traditional subtractive machining processes. Large-format plastic 3D printers can create parts that are more than 6 feet tall. Some concrete 3D printers can manufacture the walls of an entire building. History The development and growth of 3D printing can be described in three major periods. The period spanning 1980 to 2010 marks the creation of the technology, its industrial use, and the beginning of the consumer 3D printing movement. Between 2010 and 2015, the 3D printing market continued to expand, despite signs of weakening in 2014. Since 2015, prices for consumer 3D printers have fallen, while sales of consumer and industrial 3D printers have continued to rise as the technology has matured. Early 3D Printing (1980-2010) The first major patents for 3D printing methods were filed in the 1980s, creating a nascent 3D printing market for industrial clients. In the 1990s, 3D printers using plastic, metal, paper, ceramic, and wax became available at prices from thousands of dollars to hundreds of thousands of dollars. In the early 2000s, the 3D printer market expanded into specialized industries, including medicine, dentistry, and jewelry. At the same time, new plastic printing materials were developed. The first decade of the 21 st century marked the expiration of several key 1980s 3D printing patents. In the same period, consumers gained access to improved web connectivity and user-friendly computer-aided design (CAD) tools. These factors contributed to the birth of the consumer 3D printing movement. Key developments in this movement included the formation of the open-source 3D printer community; the 2007 release of the first website for print-on-demand custom 3D prints (Shapeways); and the 2008 creation of the popular 3D printing file-sharing website Thingiverse. In 2009, MakerBot, one of the first consumer 3D printing companies, released a $750 3D printer that incorporated some of the off-patent technologies from the 1980s. Expansion of 3D Printing (2010-2015) The consumer market for 3D printers expanded in the 2010s, fueled in part by the continued expiration of 20 th -century patents. Offerings included branded 3D printers, unbranded kits sold on eBay, and 3D printers funded on crowdfunding sites. Prices of bare-bones consumer 3D printers fell to $500-$600. Higher-end consumer printers gained advanced features that made them easier to use and maintain. Innovations in 3D design software and improvements in printer reliability contributed to the spread of consumer and industrial 3D printers in shared makerspaces, commercial establishments, libraries, and universities. 3D file sharing also became widespread, both for paid and free models. One 3D file website, Thingiverse, had more than 2 million active users in 2015. Transmission of 3D design files occurred not only through mainstream file-sharing sites such as Thingiverse, 3DShook, and Cults but also through anonymous channels, including internet torrents (a distributed, hard-to-trace online file-sharing method). At the same time, materials for consumer and industrial 3D printers grew more diverse and were sold by more companies, helping to reduce 3D printing costs. Print-on-demand services also expanded in this period, offering a wide variety of materials, including plastics, precious metals, and ceramics. These services allowed consumers to purchase a 3D-printed part made from their own 3D design file but fabricated by a third party. Some of the early print-on-demand services offered the ability to purchase printing services from a peer-to-peer network of individually owned desktop 3D printers. The 3D printing industry began to show signs of weakening in 2014 after a period of growth and consolidation. In June 2015, Time magazine reported that the stocks of four leading 3D printing companies had "lost between 71% and 80% of their market value in the past 17 months." Between January and October 2015, the 3D printing company Stratasys laid off 36% of staff in its MakerBot division. At the same time, annual grants of 3D printing-related patents more than doubled between 2010 and 2015, from 247 to 545. In 2015, industrial unit sales of 3D printers declined by 2.3% while consumer unit sales increased by 49.4%. Unit sales of both industrial and consumer 3D printers generally have shown sustained upward trends (see Figure 3 and Figure 4 ). Total 3D printing industry revenues increased year-over-year since 1993, with the exception of 2001, 2002, and 2009. On average, 3D printing industry revenues have grown annually over the past 30 years by 26.9%. Recent 3D Printing History (2015-Present) The period from 2015 to 2019 has seen renewed 3D printing investment, in terms of both research and development and investment in growing companies. Corporations (such as General Electric, Google Ventures, Alcoa, and Norsk Titanium AS) and federal departments and agenciesâsuch as the Department of Defense (DOD) and the National Institutes of Health (NIH)âhave invested a combined total of hundreds of millions of dollars in 3D printing initiatives over this period. At the same time, the price of consumer 3D printers has continued to fall. As of July 2019, a basic 3D plastic printer can be purchased online for less than $150. 3D printers in the low hundred-dollar range generally can be used after simple assembly or directly out of the box. The input material for these basic 3D printers is usually a spool of plastic filament, which can be purchased for less than $9 per pound. Sales of both industrial and consumer 3D printers have continued to rise. According to one market analysis, 19,285 industrial 3D printers and 591,079 consumer 3D printers were sold in 2018 (see Figure 3 and Figure 4 ). Further, that analysis estimates that a total of more than 140,000 industrial 3D printers and 2 million consumer 3D printers have been sold worldwide. This may be an underestimation of consumer 3D printers, because it does not include those assembled from parts or those purchased as kits. 3D-print-on-demand services now serve the consumer and industrial markets. These services provide access to industrial-grade 3D printers, allowing users to create high-precision parts out of plastic or other materials. In general, individuals do not have to create their own files for 3D printing; many online databases of 3D design files are available. Users also may join online 3D printing communities, some of which have hundreds of thousands to millions of users. The Wohlers Report estimates that annual 3D printing industry revenues reached $9.975 billion globally in 2018. However, 3D printing makes up less than 1% of manufacturing revenues worldwide. Further, analysts predict that most future products will be created through traditional manufacturing methods, even when 3D printing is technologically mature. Some estimates predict that 3D printing will eventually account for 5%-10% of total global manufacturing revenues. Several issues may limit the overall effectiveness and utility of current 3D printing technologies, including quality control, cybersecurity, and relative production speed as compared to traditional manufacturing. New evaluation methods, certification programs, cybersecurity advances, and research and development programs may help to address these limiting issues. Federal Role in 3D Printing Private industry has long been the primary innovator in 3D printing technology, accounting for an estimated 90% of additive manufacturing patents through 2015. DOD's Institute for Defense Analysis (IDA) found that the federal government played a relatively small but instrumental role in the creation of 3D printing technology, providing "direct funding for developing early phases of the technology and later refinements in two of the four processes." According to IDA, [Federal] support of early research ... created the knowledge, technologies, and tools later adopted in the [additive manufacturing] field and applied by inventors to develop foundational AM patents and technologies. The knowledge generated from federally sponsored [research and development] from the early 1970s influenced the patents filed in the 1980s and 1990s and later innovations. Observations from the backwards citations analysis of the foundational patents show that some of the earliest investors in AM were the Department of Defense Office of Naval Research (ONR) and the Defense Advanced Research Projects Agency (DARPA), which provided steady, continual streams of funding for both academic and industry-based researchers. NSF support was also instrumental in the development of early relevant AM research in the 1970s. The IDA report further credited federal "support of knowledge diffusion from the foundational patents to improve the technologies and develop new applications." The report also noted that the National Science Foundation (NSF) participated in the development of four of six foundational 3D printing processes developed in the 1980s and 1990s. According to the 2015 report, NSF "provided almost 600 grants for [additive manufacturing] research and other activities over the past 25 years, amounting to more than $200 million (in 2005 dollars) in funding." In 2012, President Obama announced the establishment of the National Additive Manufacturing Innovation Institute (NAMII) in Youngstown, OH, as a pilot institute under the National Network of Manufacturing Innovation (NNMI, now referred to as Manufacturing USA). Under NAMII, the Departments of Defense, Energy, and Commerce; the National Science Foundation; the National Aeronautics and Space Administration (NASA); 40 companies; 9 research universities; 5 community colleges; and 11 nonprofit organizations collaborated to share resources, move basic research toward product development, and provide workforce education and training. The National Center for Defense Manufacturing and Machining was selected to manage the NAMII pilot institute through a competitive selection process. In 2013, NAMII was rebranded as America Makes. The Manufacturing USA program's four stated goals are to increase the competitiveness of U.S. manufacturing; facilitate the transition of innovative technologies into scalable, cost-effective, and high-performing domestic manufacturing capabilities; accelerate the development of an advanced manufacturing workforce; and support business models that help the Manufacturing USA institutes to become stable and sustainable after the initial federal startup funding period. The Government Accountability Office (GAO) estimates that America Makes was to receive $56 million in federal funding and $85 million in nonfederal funding from August 2012 to August 2019. As of December 2018, America Makes had 225 members. Many national laboratories use 3D printing, including Oak Ridge National Laboratory, Lawrence Livermore National Laboratory, Sandia National Laboratories, Los Alamos National Laboratory, and Fermi National Accelerator Laboratory. The U.S. government also purchases 3D-printed products in several capacities; a 2016 report by the General Services Administration (GSA) notes that the Department of Defense purchases an especially wide variety of 3D-printed parts for defensive and medical purposes. The GSA offers a specific procurement subcategory for federal purchases of 3D printing technology. The federal government is involved in the creation of 3D printing standards, as well. Among other initiatives, the U.S. Air Force granted a private U.S. company $6 million in 2016 to develop standards for 3D-printed rocket engines. This grant was intended to reduce U.S. reliance on foreign-made launch vehicle components. Similarly, the Federal Aviation Administration (FAA) is working with industry organizations to develop certification methods for 3D-printed parts. The FAA published a road map in September 2018 that "includes training and education, development of regulatory documents, Research and Development (R&D) plan and interagency communication." Further, the National Institute of Standards and Technology and the Food and Drug Administration operate several projects in pursuit of improved process qualification for 3D printing. At the same time, standards have been developed privately by Committee F42, a technical group formed in 2009 by ASTM International and the Society of Manufacturing Engineers. Manufacturing Impacts In some cases, 3D printing offers advantages when compared to traditional methods of manufacturing, such as injection molding, drilling, or welding. These benefits stem from the particular design of the technology (see " Technical Overview ") and have changed the national security, manufacturing, and economic landscapes. The following list of properties provides an overview of ways in which 3D printing deviates from previously established manufacturing technologies. Properties of 3D Printing Reduced waste â In general, the additive manufacturing process uses only the approximate amount of material needed to produce a product; subtractive manufacturing processes remove materials to produce a product, which inherently generates waste. Accordingly, less input material may be wasted in additive manufacturing. To the extent that some input material is wasted in 3D printing, that material can sometimes be recycled into new stock for use in making other 3D-printed parts. Capacity to create parts with high internal complexity â 3D-printed parts are constructed layer by layer, which means complex internal geometries (such as hidden cavities or small channels) can be constructed easily. Cost-effectiveness of small production runs â 3D printers do not require significant retooling when a new or modified part is manufactured. In contrast, manufacturing technologies such as injection molding or die casting incur significant retooling costs when a part design is modified. Ease of design modification â Digital 3D design files can be easily modified and transmitted. Associated Manufacturing Impacts Potential reduction in discrete parts per product â The high internal complexity of 3D-printed parts means that several distinct manufacturing processes (e.g., machining and welding) can often be integrated into a single 3D printing operation. This has supported manufacturing of parts that previously would have been impossible or prohibitively expensive. Single-piece construction can also result in parts that have fewer weak spots. Potential reduction in manufacturing costs â 3D printing provides an alternative for companies considering investments in machine tools. In some cases, 3D printing may be more cost-effective than traditional options; this is particularly true for short-run, custom, or complex parts. 3D printing may be less cost-effective for parts that would require fewer post-processing steps if manufactured using traditional methods. The smaller size of a 3D printer compared to traditional manufacturing equipment may also reduce required physical plant size and related costs. Improved prototyping abilities â Easy modification of design files, combined with the cost-effectiveness of short runs of parts, supports the ability to rapidly prototype parts using 3D printing. This rapid prototyping ability allows designs to be optimized and adjusted quickly. Potential reduction in part weight or improvement in part strengthâ The capacity to create complex internal structures using 3D printing has improved manufacturers' ability to create parts that are lighter or stronger. This has shown particular promise in the aerospace and automotive industries. Potential reduction in inventory â Large production runs usually are pursued in traditional manufacturing to minimize fixed costs per part. Often, many of the goods produced must be held in storage as inventory. The ability to create 3D-printed parts on demand may allow manufacturers to reduce their inventory of parts. Low set-up costs associated with additive manufacturing allow for smaller production runs, reducing the amount of capital tied up in inventory as well as overhead costs such as storage and insurance. Mass customization â 3D-printed parts may be individually customized on a large scale. Additive manufacturing allows for the production of unique parts, sometimes modified from a basic design, to suit the needs of individual consumers. Potential environmental efficiency â Reduced waste and the lack of a need for retooling 3D printers supports environmental efficiency in manufacturing. Energy costs also can be reduced by "re-manufacturing" parts using 3D printingâthat is, creating salable products by reconstructing worn-out areas of old parts, instead of manufacturing parts from entirely new input materials. Decentralized manufacturing â 3D printers can be used to develop parts in a decentralized capacity. This may reduce the time required to provide parts to consumers, as well as the cost, energy, and environmental impacts of shipping. Low barriers to entry â The comparatively low cost of 3D printing equipment may lower the barrier to entry to manufacturing. This may cause positive or negative impacts; although productivity in legal industry may increase, 3D printing also may be used to support manufacturing of contraband items, including light weapons or parts of nuclear weapons. Low barriers to entry also may create potential negative impacts for established businesses facing new competitors. Issues for Congress 3D printing is a relatively new approach to manufacturing, and the number of 3D printers in use has expanded greatly over the past 15 years. Some industry leaders and policymakers have expressed optimism about the potential of this technology to address certain manufacturing needs. 3D printing is seen as a tool for enabling cost-effective, customized, local production of parts, and in some cases, it allows for the production of parts that cannot be made using traditional manufacturing processes. 3D printing is also seen as enabling innovation and entrepreneurship by lowering the cost of entry into manufacturing. The federal government has played an important R&D role in the development and improvement of 3D printers. In addition, some agenciesâsuch as DOD, NASA, and NIHâare using 3D printing capabilities to accomplish their missions, such as by making or acquiring parts that are no longer available, custom parts, or prototypes for testing and evaluation. As 3D printing technology matures, Congress may face a variety of related issues. Among these issues are how much funding to provide for R&D on 3D printing technology and materials; how much funding to provide for education and training activities focused on preparing scientists, engineers, technicians, and others for careers related to 3D printing; whether federal acquisition strategies need to be modified to reflect the availability of 3D-printed parts; how to ensure that U.S. regulatory agencies can appropriately address 3D printing processes and products; and whether and how the federal government can facilitate the development of industry standards and systems for testing and certification of 3D printing. One of the federal government's flagship efforts focused on 3D printing is the America Makes manufacturing institute, the first institute established as part of the Manufacturing USA program. America Makes is a public-private partnership that seeks to "[accelerate] the adoption of additive manufacturing technologies in the United States to increase domestic manufacturing competitiveness." Some have raised concerns over the long-term sustainability of the Manufacturing USA institutes after their period of initial federal financial assistance, which extends for five to seven years. According to the GAO, the agency sponsors of the institutesâDepartment of Commerce, Department of Energy, and DODâ"have taken steps to support their institutes' sustainability planning but have not developed criteria to evaluate whether institutes are on track to sustain their operations beyond the initial period of federal financial assistance." Institute representatives have expressed concern that the institutes may seek or accept support from foreign corporations, potentially undermining the competitiveness goals of the institutes. Congress may monitor the progress of the America Makes institute toward sustainability and consider whether the federal government should provide continuing financial support. Current bills in the 116 th Congress related to this issue include H.R. 2397 . Some have expressed concern about the potential use of 3D printing in the manufacture of firearms or other contraband material by individual criminals, criminal organizations, terrorists, or others precluded from the possession of such devices. Congress may wish to consider approaches to limiting or preventing such uses of 3D printing. Current bills in the 116 th Congress related to this issue include S. 1831 and H.R. 3265 . 3D printing may raise intellectual property (IP) issues. For example, the U.S. Army has stated that IP difficulties may impede the fabrication of 3D-printed parts in the field. A 2014 industry survey also indicated that manufacturers consider the "threat to intellectual property" to be a major concern created by the proliferation of 3D printing. Congress may explore how IP issues could impede the legitimate use of 3D printing, particularly its use by the federal government, and what options may be available for addressing such barriers. Current bills in the 116 th Congress related to this issue include H.R. 3313 . Conclusion 3D printing is an alternative manufacturing process with particular strengths and weaknesses. Although the technology is not suitable for all types of manufacturing, it is used in a wide variety of industries, including aerospace, medicine, and custom manufacturing. 3D printing has remained in wide use by the federal government, as well. The technology is likely to grow in usage as new materials become available, material and machine costs continue to fall, and quality issues are addressed. The influences that 3D printing has on the U.S. manufacturing landscape stem from an improved capacity for relatively inexperienced users to create extremely complex parts. This may create regulatory, IP, or safety challenges. At the same time, the manufacturing abilities provided by 3D printers also promote economic development and new avenues of scientific and medical exploration. For these reasons, 3D printing is likely to offer both challenges and opportunities over the coming years.