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Foundations of Nursing Informatics

Sarah Collins Rossetti / Susan C. Hull / Suzanne Bakken

INTRODUCTION

In December 2016, the 21st Century Cures Act authorized $6.3 billion in funding for research and drug development; prevention and treatment of mental illnesses and substance abuse; healthcare access and quality improvement; and advancing electronic health record (EHR) interoperability, patient access to health information, and measures to prevent information blocking. The Cures Act provides for (1) the development and use of upgraded health IT capabilities; (2) transparent expectations for data sharing, including through open application programming interfaces (APIs); and (3) improvement of the health IT end-user experience, including reducing administrative burden. The focus on research and drug development includes funds to the National Institute of Health to reduce opioid abuse, and precision medicine and biomedical research. The Act also aims to expedite the drug approval process and update informed consent and human research subjects protections requirements. The U.S. Department of Health and Human Services (HHS) and the Office of the National Coordinator for Health Information Technology (ONC) are charged with improving the interoperability of health information and measures to prevent information blocking.

In January 2018, ONC released the Draft Trusted Exchange Framework that includes principles for trusted exchange framework and common agreement (TEFCA) and minimum required terms and conditions among health information networks nationally to advance interoperability (ONC, 2018a). ONC is leading the revised Electronic Health Record Reporting Program that includes HIT vendors to attest they have not engaged in information blocking, systems have undertaken real-world testing, and that application programming interfaces (APIs) are available which allow for information to be accessed, exchanged, and used without special effort. ONC released a proposed rule (February 2018), “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program proposed rule,” (ONC, 2018b) that calls on the healthcare industry to adopt Fast Healthcare Interoperability Resources (FHIR) as the standard for APIs, while also proposing a provision to require that patients can electronically access all of their data through a new “Electronic Health Information” Export (EHI Export). The proposed rule also implements the information blocking provisions of the Cures Act, proposing seven exceptions to the definition of information blocking. Finally, the rule lays out requirements for Conditions and Maintenance of Certification for health IT and the first version of the U.S. Core Data for Interoperability (USCDI). These recent efforts established by the 21st Century Cures Act build upon key legislation focused on health IT from the prior decade during President Barack Obama’s administration, particularly, the 2010 Patient Protection and Affordable Care Act (ACA) and the American Recovery and Reinvestment Act (ARRA) of 2009 and its key Health Information Technology for Economic and Clinical Health (HITECH) Act provision.

As upheld on June 28, 2012 in a historic and landmark decision by the U.S. Supreme Court, ACA was a hardfought federal statute that represents the sweeping healthcare-reform agenda envisioned by the Democratic 111th Congress and the Obama administration. Despite legal challenges, with some ongoing, that sought to reverse “Obamacare,” the law was and is dedicated to replacing a broken system with one that ensures all Americans access to healthcare that is both affordable and driven by quality standards. It includes broad provisions for the improvement of healthcare access and delivery that, unless declared unconstitutional, will run through the end of the present decade (U.S. Department of Health & Human Services, 2013).

For the Obama administration and the nation, ACA turned a spotlight on the ever-increasing recognition that advanced health IT is—and will be—essential to support the massive amounts of electronic information exhange that are foundation to industry reform. In fact, the universal agreement that meaningful healthcare reform cannot be separated from the national—and arguably global—integration of health IT based on accepted, standardized, and interoperable methods of data exchange provided the linchpin for other critically important legislation that created a glide path for ACA.

It was such consensus that resulted in the broad support and passage into law of ARRA of 2009 and its key HITECH Act provision in the early weeks of Mr. Obama’s presidency. Backed with an allocation of around $22 billion, this legislation authorized the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement incentives for eligible professionals and hospitals that take steps to become “meaningful users” of certified EHR technology to improve care quality and better manage care costs (First Insight^®, n.d.).

The HITECH Act, which provided for the incentivized adoption of EHRs by eligible hospitals and providers across the nation, commonly referred to as Meaningful Use, resulted in widespread adoption of EHRs, a critical foundation for improving care quality, meeting clinical and business needs, and providing capabilities for aggregated, cross-patient data analyses and advanced decision support and discovery. Yet, the lack of exchange of electronic information across health organizations and administrative and usability burdens experienced by clinicians in using EHRs remains a significant barrier to realizing these benefits within the healthcare system. The 21st Century Cures Act aims to advance EHR interoperability, ease of access to information, and real-world user testing.

Equally significant legislation, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), establishes new value-based payment models for Medicare beneficiaries, which may improve administrative EHR burdens and applies to physicians and nonphysician providers, including nurse practitioners, physician assistants, clinical nurse specialists, and Certified Registered Nurse Anesthetists. MACRA served to transition the Medicare EHR Incentive Program (Meaningful Use) to one of the four components of the new Merit-Based Incentive Payment System (MIPS), which itself is part of MACRA. MACRA includes the MeritBased Incentive Payments System (MIPS), Alternative Payment Models (APMs), and Advanced Alternative Payment Models which require use of a certified EHR.

Health Informatics Technology and the Nursing Profession

EHRs manage healthcare data and information in ways that are patient-centered, secure, and information-rich. Improved information access and availability across the continuum of care increasingly enables both the provider and the patient to better manage each patient’s health by using capabilities provided through enhanced clinical decision support and customized education materials.

In this massive transformation from disconnected, inefficient, paper-based “islands” of care delivery to a nationwide, interconnected, and interoperable system driven by EHRs and advancing health IT innovation, the importance of nurses and nursing informatics is difficult to overstate. For decades, nurses have proactively contributed resources to the development, use, and evaluation of information systems. Today, they constitute the largest single group of healthcare professionals and include experts who serve on national committees and participate in interoperability initiatives focused on policy, standards and terminology development, standards harmonization, consumer health, inclusion of social determinants of health, and EHR usability and adoption.

In their front-line roles, nurses continue to have a profound impact on improving the health of individuals, populations and communities as leaders in the effective use of HIT to improve the safety, quality, and efficiency of healthcare services (ANI, 2009). It is informatics nurses who are key contributors to a working knowledge about how evidence-based practices designed in information systems can support and enhance clinical processes and decisionmaking to improve patient safety and outcomes. Nurses are the “glue” across diverse care delivery settings who are responsible for care coordination and promotion of wellness, and as such are often the patient’s primary contact— and the last defensive line in care delivery where medical errors or other unintended actions can be caught and corrected. In addition, as drivers in organizational planning and process reengineering to improve the healthcare delivery system, informatics nurses are increasingly sought out by nurses and nurse managers and executives for leadership as their profession works to bring IT applications into the mainstream healthcare environment (ANI, 2009).

The importance of nursing in healthcare reform was confirmed in the 2010 landmark report, The Future of Nursing: Leading Change, Advancing Health, from the Institute of Medicine (IOM) and the Robert Wood Johnson Foundation (RWJF). Based on the report’s recommendations, the RWJF began the Initiative on the Future of Nursing. Through the Initiative, RWJF continues to support the research agenda set forth by the report and implement the recommendations in the areas of nurse training, education, professional leadership, and workforce policy (Committee on the Robert Wood Johnson Foundation, Initiative on the Future of Nursing at the Institute of Medicine, 2010a). Aligned with this effort, nurses are active in informatics leadership roles and we point to a few examples of “Nursing Firsts” of recent time: the first nurse on HIT Policy Committee (Connie Delaney, PhD, RN, FAAN, FACMI, FNAP); the first nurse on HIT Standards Committee (Judy Murphy, RN, FACMI, FHIMSS, FAAN); the first nurse as Deputy National Coordinator at ONC (Judy Murphy, RN, FACMI, FHIMSS, FAAN), the first nurse president of Integrating the Healthcare Enterprise (IHE) USA (Joyce Sensmeier, RN-BC, MS, CPHIMS, FHIMSS, FAAN); the first nurse to manage the Health Information Technology Standards Panel (HITSC) (Joyce Sensmeier, RN-BC, MS, CPHIMS, FHIMSS, FAAN); the first nurse as Director of the National Library of Medicine (NLM) (Patricia Flatley Brennan, PhD, RN, FAAN, FACMI); the first nurse as editor of the Journal of the American Medical Informatics Association (JAMIA) (Suzanne Bakken, RN, PhD, FAAN, FACMI).

On the ground, it is increasingly essential to the success of today’s healthcare-reform and transformation movement that nurses are involved in every aspect of selecting, designing, testing, implementing, developing, and optimizing health information systems. Further, the growing adoption of EHRs, and other mobile and virtual care technologies across all care settings, must incorporate nursing’s unique body of knowledge with the nursing process at its core in order to support top of license practice.

Major forces of reform are fueling sharply increased demand for a larger health IT workforce across the U.S. healthcare landscape. Reed Abelson of The New York Times wrote in late 2011, “… health care in America has changed in ways that will not be easily undone. Provisions already put in place, like tougher oversight of health insurers … are already well cemented and popular” (Abelson, Harris, & Pear, 2011).

In a similar article, USA Today concurred, reporting that health IT job growth is being driven by the general restructuring of the health care industry. This includes not only ACA, but also 2009 federal stimulus funding, new government regulations, and increasing use of health IT across the industry (Mitchell, 2011). Supporting this viewpoint, the Bureau of Labor Statistics projected that employment growth in the health IT area will increase overall by 20% through 2020 and up to another 13% through 2026, with some segments like network and computer systems administrators expanding by up to 28% (U.S. Bureau of Labor Statistics, 2013).

Information privacy and security concerns are also increasing as patient health data for care, research, wellness, and community proliferate across a diverse, yet fragmented digital care ecosystem. The addition of rich contextual data about patients—and supplied by patients—including environmental, geographic, sociobehavioral, and genomic data are adding digital definition to patients’ stories with significant benefits for nursing and clinical care (AMIA Policy Invitational Planning Committee, 2017).

The life cycle of patient health data is changing, including its novelty, velocity, use, reuse, and exchange. Healthcare organizations realize that as the landscape of patient health data management is rapidly changing, current privacy and security measures are often insufficient to protect the privacy of growing volumes of patients’ protected healthcare information (PHI). These dynamics are further complicated by upgrades to health IT systems, switching to newer, faster, and more mobile networks, and transitions into proprietary, public, and increasingly open clouds.

As a major factor in such dynamics, the growing commitment by health systems and physician practices to the implementation and demonstrated meaningful use of certified EHR systems will also continue to create new opportunities for health IT professionals. As of 2017, over 96% of hospitals eligible for the CMS EHR Incentive Program have achieved meaningful use of certified health IT, and over 60% of all U.S. office-based physicians (MD/DO) have demonstrated meaningful use of certified health IT in the CMS EHR Incentive Programs. Over 20% of nurse practitioners (NPs) and 2% of physician assistants (PAs) have demonstrated meaningful use of certified health IT. By 2017, 96% of all non-federal acute care hospitals possessed certified health IT. Small rural and critical access hospitals had the lowest rates at 93%. Nearly 9 in 10 (86%) of officebased physicians had adopted any EHR, and nearly 4 in 5 (80%) had adopted a certified EHR (ONC, 2019a).

The CMS renamed the EHR Incentive Programs to the Promoting Interoperability (PI) Programs in April 2018. More than $24.8 billion in Medicare PI Program payments have been made between May 2011 and October 2018. More than $6 billion in Medicaid PI Program payments have been made between January 2011 (when the first set of states launched their programs) and October 2018 (CMS, 2019).

All in all, some 50,000 qualified health IT workers will be needed to meet the demands of hospitals and physicians as they move to adopt EHRs and connect to statewide health information exchanges (HIEs). In fact, the Bureau of Labor Statistics, Department of Education, and independent studies estimated a workforce shortfall. One recent study, conducted by PwC’s Health Research Institute and released in March 2013, shows that the growing shortage appears greater than previously reported. According to the report, nearly 80% of global healthcare CEOs surveyed expect to increase technology investments in 2013, yet more than half (51%) fear their staff cannot keep up with the pace of technological change. Seventy-seven percent say they are revisiting their hiring and promotion strategies to address gaping holes in health IT (Monegain, 2013).

OVERVIEW

Given the critical importance of nurses and health IT professionals to the future of healthcare transformation, it is important to understand the key components driving change in the industry: the primary influencers, organizations, programs, and processes that have shaped or defined policies for the integration of health IT that will affect all segments of healthcare. Therefore, the purpose of this chapter is to identify and define the historic and present roles of such influencers, including sections on the following:

•   Forces of Change in Today’s National Healthcare System

•   Mandate for Reform: From ARRA and the HITECH Act to 21st Century Cures and MACRA

•   State and Regional Health IT Programs

•   Health IT Federal Advisory Committees and Agencies

•   Nursing Informatics and Healthcare Reform

•   The Road Ahead

FORCES OF CHANGE IN TODAY’S NATIONAL HEALTH CARE SYSTEM

The long journey to the passage of ACA, ARRA, the HITECH Act, MACRA, and 21st Century Cures Act goes back several decades. In 1991, IOM concluded that computerization could help to improve patient records and information management leading to higher quality of care in its landmark report, The Computer-Based Patient Record: An Essential Technology for Healthcare (Dick & Steen, 1997). That was followed nearly a decade later with other groundbreaking reports calling for the use of health IT to improve the efficiency, safety, and quality of the U.S. healthcare system—To Err Is Human in 1999 (Institute of Medicine, 1999) and Crossing the Quality Chasm in 2001 (Institute of Medicine, 2001). These reports were a call to action for a paradigm shift from reliance on paper and verbal communication for managing patient care to a new era where healthcare professionals are supported in their clinical decision-making by technology while providing patient care.

The IOM followed up on these reports in 2012 with Best Care at Lower Cost: The Path to Continuously Learning Health Care in America, which urged systemic transformation to reduce inefficiencies in the health system (Institute of Medicine, 2013b). The report said the complexity and inefficiencies in American’s healthcare system are a threat not only to quality health care, but also to the nation’s economic stability and global competitiveness.

Further, the early report on the computer-based patient record called for an urgent across-the-board commitment to continuous improvement; incremental upgrades by individual hospitals and other providers would no longer suffice. One of the main points of the report was that better data management, including EHRs and mobile technologies, would be a key method in upgrading healthcare while reducing inefficiency and lowering costs (Dick & Steen, 1997).

Multiple volumes in the National Academy of Medicine’s Learning Health System series reflect the fundamental role of informatics in a learning health system: Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good (Institute of Medicine, 2010a), Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care—Workshop Series Summary (Institute of Medicine, 2011), Digital Data Improvement Priorities for Continuous Learning in Health and Health Care—Workshop Summary (Institute of Medicine, 2013a), and Optimizing Strategies for Clinical Decision Support: Summary of Meeting Series (Tcheng et al., 2017). In the last, Tcheng et al. identified priorities for collaborative action that are of particular relevance to nursing informatics: create a national clinical decision support (CDS) repository, develop tools to assess CDS efficacy, publish performance evaluations, promote financing and measurement to accelerate CDS adoption, develop a multi-stakeholder CDS learning community to inform usability, and establish an investment program for CDS research (Tcheng et al., 2017).

The Birth of ONC to Present Day

On January 20, 2004, President George W. Bush in his State of the Union address called for “… an Electronic Health Record for every American by the year 2014 … By computerizing health records, we can avoid dangerous medical mistakes, reduce costs, and improve care” (Bush, 2004a). He went on to issue an executive order that same year: “Incentives for the Use of Health Information Technology and Establishing the Position of the National Health Information Technology Coordinator,” which has had an impact on every healthcare entity, provider, and informatics professional in the United States (Bush, 2004b).

Components of the order were to (1) establish a national health IT coordinator position; (2) develop a nationwide interoperable health IT infrastructure; and (3) develop, maintain, and direct implementation of a strategic plan to guide implementation of interoperable health IT in both public and private sectors. Dr. David Brailer was appointed as the first national coordinator by Tommy Thompson, the then Secretary of HHS. ONC is organizationally located within the Office of the Secretary for the HHS.

The ONC remains today the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health IT and the electronic exchange of health information. ONC was a key player in the execution of ARRA and its HITECH Act provision and now the execution of interoperability efforts as part of the 21st Century Cures Act. ARRA authorized the creation of two committees—the Health IT Policy Committee and the Health IT Standards Committee— that make recommendations to the ONC. Today, these two committees have been replaced by the Health IT Advisory Committee (HITAC) (ONC, 2019b), as part of the 21st Century Cures Act, to recommend to ONC “policies, standards, implementation specifications, and certification criteria, relating to the implementation of a health information technology infrastructure, nationally and locally, that advances the electronic access, exchange, and use of health information” (ONC, 2019b).

Dr. Robert Kolodner served as interim leader for a year after Brailer left before being officially appointed in April 2007 to the position of Coordinator, and served through January 2009.

Dr. Farzad Mostashari, who was appointed by HHS Secretary Kathleen Sebelius in May 2011, succeeded Dr. David Blumenthal as the National Coordinator who served from April 2009 to April 2011. Mostashari stepped down in October 2013. Dr. Jacob Reider served as Interim Coordinator from October 2013 until January 2014. Dr. Karen DeSalvo was appointed as National Coordinator by Secretary Sebelius in January 2014. Vindell Washington served as National Coordinator from August 2016 to January 2017 followed by Jon White, MD who briefly served as acting National Coordinator from January 2017 to April 2017. Donald Rucker, MD, MBA, MS was appointed as National Coordinator in April 2017.

Health IT Training Programs: An Essential Element of Reform

As discussed in the introduction, today’s urgent need for health IT experts is challenged by a shortage of the very professionals who are best positioned to carry transformation forward. With consensus around the essential requirement for advanced health IT and the mounting pressures of shortages in nursing, health IT experts, and other medical professions, the U.S. government through HHS has enlisted the talent and resources of some of the nation’s leading universities, community colleges, and major research centers to advance the widespread adoption and meaningful use of health IT. These schools are offering a wide variety of training programs that are helping to build the depth and breadth of the health IT workforce as a critical component in the transformation of American healthcare delivery.

Both on-campus and online programs in health IT are available at the certificate, associate, bachelor’s, and master’s degree levels. Such programs complement the traditional National Institutes of Health (NIH)-funded doctoral and postdoctoral training programs such as those supported by the NLM. Certificate programs typically consist of between 15 and 30 credit hours and are often designed for working professionals. The American Medical Informatics Association (AMIA) created a revolutionary “10 × 10” Program in 2005, with the goal of training 10,000 healthcare professionals in applied health informatics within 10 years, and became a model for certificate-based programs (AMIA, n.d.).

Through an ARRA-funded cooperative agreement program, federal awards and grants totaling some $118 million to 16 universities and 82 community colleges provided incentives for health IT education to speed the growth of a new pool of health IT professionals. These programs supported the training and development of more than 20,000 new health IT professionals. For more information, see Workforce Training in the next section on the ARRA.

The Health IT Workforce Development workgroup of the Health IT Policy Committee (now the Health IT Advisory Committee) was formed in July 2012 to make recommendations so that within one year health IT training needs and competencies were identified and tools for implementation were recommended. The workgroup recommended that ONC-funded programs and their core competencies be summarized and publicized along with the many resources available for education and best practices.

The workgroup also recommended new programs and funding to address emerging needs, such as team-based care, population health, and patient engagement, and studies to assess the impact of health IT on the incumbent workforce. Last, health IT needs to be represented in the Standard Occupational Classification (SOC), and the Committee is seeking input to have it included in the next edition, due out in 2018 (Health IT Workforce Development Sub Group, 2013). The SOC codes include Health Information Technology and Management, Health Informatics Practitioners, Health Informatics Specialists, and Health Informatics Analysts (Bureau of Labor Statistics, n.d.).

The Health Insurance Portability and Accountability Act: Privacy and Security

The Health Insurance Portability and Accountability Act (HIPAA), which was passed in 1996, required HHS to develop regulations protecting the privacy and security of electronic health information as well as facilitate its efficient transmission. HIPAA’s goals are to allow the flow of health information needed to provide and promote high-quality healthcare while protecting the public’s health and wellbeing. Prior to HIPAA, no generally accepted set of standards or requirements for protecting health information existed in the healthcare industry. At the same time, new technologies were evolving to move the healthcare industry away from paper processes and to increase the reliance on electronic information systems to conduct a host of administrative and clinically based functions, such as providing health information, paying claims, and answering eligibility questions (All Things Medical Billing, n.d.).

To comply with the requirements of the Act, HHS published what are commonly known as the HIPAA Privacy Rule and the HIPAA Security Rule. The rules apply to all health plans, healthcare clearinghouses, and any healthcare provider that transmits health information in electronic form.

The HIPAA Privacy Rule The HIPAA Privacy Rule, which took effect on April 14, 2003, established national standards for the protection of individually identifiable health information. As such, the rule regulates the use and disclosure of an individual’s health information, referred to as Protected Health Information (PHI), and sets forth standards for individuals’ privacy rights to understand and control how their health information is used. The rule applies to those organizations identified as “covered entities,” which include healthcare clearinghouses, employersponsored health plans, health insurers, and other medical service providers that engage in the transfer of PHI. PHI is defined broadly and includes any part of an individual’s medical record or payment history (U.S. Department of Health & Human Services, 2013).

The final HIPAA/HITECH Act Privacy, Security, Enforcement, Breach Notification Rules were published in the Federal Register on January 25, 2013. The final omnibus rule greatly enhances a patient’s privacy protections and provides individuals new rights to their health information. While the original HIPAA Privacy and Security Rules focused on healthcare providers, health plans, and other entities that process health insurance claims, the changes expanded many of the privacy requirements to business associates of these entities that receive protected health information, such as contractors and subcontractors. In addition, the rule increased penalties for noncompliance based on the level of negligence with a maximum penalty of $1.5 million per violation (HHS Press Office, 2013).

The HIPAA Security Rule The HIPAA Security Rule took effect on April 21, 2003 with a compliance date of April 21, 2005 for most covered entities. The Security Rule complements the Privacy Rule; while the Privacy Rule pertains to all PHI including paper and electronic records, the Security Rule deals specifically with electronic protected health information (ePHI). Still, a major goal of the Security Rule is to protect the privacy of individuals’ PHI while allowing covered entities to adopt new technologies to improve the quality and the efficiency of patient care. Given the diversity of the healthcare marketplace, the Security Rule is designed to be flexible and scalable so that a covered entity can implement policies, procedures, and technologies that are appropriate for the entity’s particular size, organizational structure, and risks to consumers’ electronic ePHI (U.S. Department of Health & Human Services, n.d.).

In the years following its passage and implementation, HIPAA regulations have had a significant impact on health informatics. For example, under HIPAA, patients must be permitted to review and amend their medical records. Healthcare providers have expressed concern that patients who choose to access their records could experience increased anxiety. Other studies, however, have determined that counter-benefits already include enhanced doctor–patient communications and only minimal risks in increasing patients’ access to their records.

The passage of ARRA expanded HIPAA’s mandate to impose new privacy and security requirements. One of the greatest changes to HIPAA presently affecting the healthcare community and health IT professionals are the modifications published on January 16, 2009 in the HIPAA Electronic Transaction Standards Final Rule.

As originally framed, the old version of the American National Standards Institute (ANSI) X12 Standards for HIPAA transactions were to be replaced by Version 5010, which regulates the transmission of certain healthcare transactions among hospitals, physician practices, health plans, and claims clearinghouses. In addition, the old version of the National Council for Prescription Drug Program (NCPDP) standard for pharmacy and supplier transactions was to be replaced by Version D.0 (Blue Cross Blue Shield Blue Care Network of Michigan, n.d.).

As the first major change since HIPAA’s implementation, the introductions of these new standards are meant to enhance business functionality, clarify ambiguities, and better define situational and required data elements. The new rules apply to all physicians, providers, and suppliers who bill Medicare carriers, fiscal intermediaries, Medicare administrative contractors (MACs), and durable medical equipment MACs for services provided to Medicare beneficiaries (Medicare Leadership Network, n.d.).

When first announced, the switch to the 5010 standards was supposed to be in place on January 1, 2012. In November 2011, however, CMS decided that, although it would not change the actual deadline for complying with the standards, it would not initiate enforcement action until March 31. Soon thereafter, in continued reconsideration of what it called “a number of outstanding issues and challenges impeding full implementation,” CMS pushed the enforcement date back to July 1, 2012 (Robeznieks, 2012). The conversion to the HIPAA 5010 standards was seen as key to the larger switch from the ICD-9 clinical coding system to the vastly more detailed ICD-10 system in 2015.

The final rule to HIPAA, as mentioned in the previous section, also enhances the HITECH Breach Notification requirements by clarifying when breaches of unsecured health information must be reported to HHS. The changes also strengthen the government’s ability to enforce the law. Recent efforts have focused on the individual right of access, and continued challenges for consumers to easily view download and transmit their health information, using technology of their own choosing. Mobile health apps are proliferating to make it easy for consumers to access and aggregate their health data, and be active mediators of their own health exchange.

The HHS Office of Civil Rights (OCR) recognizes the need to improve care coordination and reduce the regulatory burdens of the HIPAA Rules, especially the HIPAA Privacy Rule, to promote coordinated, value-based healthcare. While seeking public comments, it is expected that HIPAA modernization will be forthcoming and a major topic as digital technologies accelerate transparency and new care delivery and payment models (Health and Human Services, 2018).

EHR Certification and Testing

With the passage of ARRA and the HITECH Act, ONC has become the driving force behind the definition of meaningful use of EHRs and the certification of EHR systems. This new reality changed the operating environment for the Certification Commission for Healthcare Information Technology (CCHIT), which until 2009 had been the sole organization to certify EHR systems.

The CCHIT was founded in 2004 with support from three industry associations in healthcare information management and technology: the American Health Information Management Association (AHIMA), the Healthcare Information and Management Systems Society (HIMSS), and the National Alliance for Health Information Technology (NAHIT). In September 2005, HHS awarded CCHIT a contract to develop the certification criteria and inspection process for EHRs and the networks through which they interoperate. The certification criteria were developed through a voluntary, consensus-based process engaging diverse stakeholders. Many health IT professionals were involved in this process—helping to define the certification criteria for the hospital and ambulatory environments as well as to outline the testing processes used by CCHIT (Certification Commission for Healthcare Information Technology, n.d.).

However, in the months following the 2009 passage of ARRA, questions surfaced about CCHIT’s unique role going forward. On March 2, 2010, ONC confirmed the merits of this debate when it issued a new Notice of Proposed Rulemaking, which proposed the establishment of two certification programs for the purposes of testing and certifying EHRs—one temporary and one permanent. These new programs were not limited to CCHIT. Then, on June 24, 2010, ONC published the Final Rule on the Temporary Certification Program for EHRs.

Under the temporary program, ONC authorized approved organizations, called ONC-Authorized Testing and Certification Bodies (ONC-ATCBs), to both test and certify EHRs and EHR modules, thereby assuring the availability of Certified EHR Technology prior to the beginning of the reporting period defined under ARRA. After the first year, the permanent certification program replaced the temporary program and now separates the responsibilities for performing testing and certification— now called Authorized Test Labs (ATLs) and Authorized Certification Bodies (ACBs). In addition to EHR and EHR module certification, the permanent program includes the certification of other types of heath IT, such as personal health records (PHRs) and HIE networks. With the launch of the ONC Health IT Certification Program, the Temporary Certification Program sunset on October 4, 2012 (The Office of the National Coordinator for Health Information Technology, n.d.).

Standards and the eHealth Exchange

The eHealth Exchange, formerly known as the Nationwide Health Information Network, or NwHIN Exchange, is managed by the Sequoia Project, a nonprofit, nongovernment entity (The Sequoia Project, n.d.). The eHealth Exchange was developed under the auspices of the ONC and is now managed by a nonprofit industry coalition called the Sequoia Project as a public–private partnership to increase HIE innovation in the private sector.

The work on this exchange originated in late 2005 when the HSS commissioned the Healthcare Information Technology Standards Panel (HITSP) to assist in developing NwHIN, which would create a nationwide, interoperable, private, and secure exchange of health information between EHRs (Enrado, 2011). The Sequoia Project assumed stewardship of the NwHIN Exchange, now known as the eHealth Exchange, from ONC in 2012 (The Sequoia Project, n.d.).

As envisioned then and now, the eHealth Exchange is intended to provide a set of standards that regulate the connections among providers, consumers, and others involved in supporting health and healthcare. The purpose of these standards is to enable normalized health information to follow the consumer; it is intended to make health records, laboratory results, medication information, and related medical data readily available and accessible to providers, pharmacists, and even consumers over the Internet, thereby helping to achieve the goals of the HITECH Act and more currently 21st Century Cures Act. At the same time, the eHealth Exchange is also dedicated to ensuring that consumers’ health information remains secure and confidential in the electronic environment.

The eHealth Exchange is a set of standards, services, and policies that enable secure health information exchange over the Internet. These standards have been used by at least three federal initiatives: The Direct Project, NwHIN Exchange, and the CONNECT software project. The eHealth Exchange, when still known as NwHIN, continued to evolve with the government acting as a facilitator—not as an infrastructure builder. In fact, its development depended on an environment of collaboration, transparency, and buy-in from the bottom up, including small as well as large physician groups and health systems that are working to share patient records with other care delivery entities across the continuum of care.

In October 2012, ONC launched the NwHIN Exchange, which includes federal and nonfederal agencies that share patient information for care. Currently the exchange is active in all 50 states and is the principal network that connects federal agencies and nonfederal organizations to improve patient care and public health (eHealth Exchange, n.d.). According to the ONC, more than half of the nation’s health information exchanges are part of the eHealth Exchange common agreement for trusted exchange (eHealth Exchange, n.d.).

Interoperability

According to section 4003 of the 21st Century Cures Act, the term “interoperability,” with respect to health IT, means such health IT that “(A) enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; (B) allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and (C) does not constitute information blocking as defined in section 3022(a)” (Barr, 2008; Connor, 2007; ONC, 2018c).

Under a statutory requirement in ARRA of 2009 HITECH Act, ONC provides an annual report to Congress on the Adoption of the System for the Electronic Use of and Exchange of Health Information. The report reflects progress on the implementation of the Federal Health IT Strategic Plan 2015–2020 and the Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap (ONC, 2015a, , 2015b). The 2018 report recognizes that despite 10 years of progress (1) patients often lack access to their own health information, which hinders their ability to manage their health and shop for medical care at lower prices; (2) healthcare providers often lack access to patient data at the point of care, particularly when multiple healthcare providers maintain different pieces of data, own different systems, or use health IT solutions purchased from different developers; and (3) payers often lack access to clinical data on groups of covered individuals to assess the value of services provided to their customers (ONC, 2018d). Recommendations for future actions include the following (ONC, 2018d):

•   Improving interoperability and upgrading technical capabilities of health IT, so patients can securely access, aggregate, and move their health information using their smartphones (or other devices) and healthcare providers can easily send, receive, and analyze patient data.

•   Increase transparency in data sharing practices and strengthen technical capabilities of health IT so payers can access population-level clinical data to promote economic transparency and operational efficiency to lower the cost of care and administrative costs.

•   Prioritize improving health IT and reducing documentation burden, time inefficiencies, and hassle for healthcare providers, so they can focus on their patients rather than their computers.

HIE Governance and Information Blocking In May 2012, ONC released to the public a request for information (RFI) on the governance of the Nationwide Health Information Network, believing this would constitute a critical step toward enabling trusted and interoperable electronic health information exchange nationwide. ONC saw a common set of “rules of the road” for privacy, security, business, and technical requirements as a means of laying the necessary foundation to enable our nation’s electronic health information exchange capacity to grow. It could also help achieve the Bush and Obama administration’s vision for an electronically connected health system for the 21st century that delivers efficient and quality healthcare for all Americans.

The RFI asked for public feedback on how a governance mechanism would best provide confidence to patients that their health information is being shared appropriately and securely; reassure providers they are dealing with trusted entities when sending or receiving patient information; promote an open and competitive market for electronic health information exchange; and enable innovation to thrive. The response to the RFI was a desire not to regulate, but to let the market mature and follow a nonregulatory approach. As such, the Governance Framework for Trusted Electronic Health Information Exchange (the Governance Framework) was released in May 2013 and was intended to serve as guiding principles on HIE governance (ONC, n.d.-a). It was meant to provide a common conceptual foundation applicable to all types of governance models and express the principles ONC believes are most important for HIE governance. The Governance Framework does not prescribe specific solutions but lays out milestones and outcomes that ONC expects for and from HIE governance entities as they enable electronic HIE (Mostashari, 2013).

The exchange standards were specified by ONC to correspond with the CMS meaningful use measures to promote the use of EHRs to improve healthcare by providing complete and accurate patient information and increased access to information as well as to encourage patients’ involvement in their own healthcare. Stage 1 of Meaningful Use provided incentives to help providers implement EHRs. Stage 2 of Meaningful Use focused on health information exchange to improve the flow of information between providers and with patients. Health Information Exchange achieved through exchange of a summary of care record was one of eight objectives in Stage 3 Meaningful Use, which was overall focused on using certified electronic health record technology (CEHRT) to improve health outcomes. In April 2018, CMS’s Meaningful Use EHR Incentive Program was renamed the Promoting Interoperability (PI) Programs.

On January 5, 2018, ONC released the Draft Trusted Exchange Framework, which includes Part A and Part B. Part A is the Principles for Trusted Exchange, which are “guardrails and general principles that Qualified Health Information Networks (QHINs) and Health Information Networks (HINs) should follow to engender trust amongst Participants and End Users” (ONC, 2018a). Part B is the Minimum Required Terms and Conditions for Trusted Exchange which are “specific terms and conditions that will be incorporated into a single Common Agreement by a Recognized Coordinating Entity (RCE)” (ONC, 2018a).

Integrating the Healthcare Enterprise (IHE), Health Level Seven (HL7) International, and HL7 Fast Healthcare Interoperability Resources (FHIR) Standard Integrating the Healthcare Enterprise (IHE) is a global initiative, now in its twelfth year, to create the framework for passing vital health information seamlessly from application to application, system to system, and setting to setting across multiple healthcare enterprises. IHE brings together health IT stakeholders to demonstrate the implementation of standards for communicating patient information efficiently throughout and among healthcare enterprises by developing a framework of interoperability. Because of its proven process of collaboration, demonstration, and realworld implementation of interoperable solutions, IHE is in a unique position to significantly accelerate the process for defining, testing, and implementing standards-based interoperability among EHR systems (Health Information and Management Systems Society, n.d.).

Multiple stakeholders including EHR vendors have collaborated to establish simplified mechanisms for supporting interoperability. The Fast Health Interoperability Resource (FHIR) is an HL7 standard that has increased in recent years as mechanism for information exchange using a well-defined and limited set of resources. Built upon FHIR, the Substitutable Medical Applications and Reusable Technologies (SMART) platform enables EHR systems to behave as “iPhone-like platforms” through an application programming interface (API) and a set of core services that support easy addition and deletion of thirdparty apps (Mandel, Kreda, Mandl, Kohane, & Ramoni, 2016). In this approach, the core system (i.e., EHR) is stable and the apps are substitutable (Mandel et al., 2016). CDS Hooks is designed to invoke external CDS services from within the EHR workflow based upon a triggering event. Services take three forms: (a) information cards—provide text for the user to read; (b) suggestion cards—provide a specific suggestion via a clickable EHR button resulting in subsequent population of the change into the EHR user interface; and (c) app link cards—provide a link to an app.

Documentation Burden As per provisions of the 21st Century Cures Act, ONC and CMS are actively developing a strategy to reduce clinician documentation burden, a barrier to interoperability. The draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs was published at the end of 2018 and outlines three overarching goals designed to reduce clinician burden (The Office of the National Coordinator for Health Information Technology, 2018):

1.   Reduce the effort and time required to record health information in EHRs for clinicians;

2.   Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and healthcare organizations; and

3.   Improve the functionality and intuitiveness (ease of use) of EHRs.

The Alliance for Nursing Informatics (ANI) provided public comments to the ONC’s draft strategy, pointing out that the nursing profession was “largely ignored in this strategy and conversation around documentation burden” ( ANI, n.d.-a). ANI’s response continued that “ONC must expand their focus on documentation burden to include nurses practicing in many different clinical roles and settings … this requires the use of inclusive language and the consideration of all the members of the healthcare team and how they contribute to care provision, as well as documentation and reporting. In addition, nurses must be involved in the design of the EHR functions they use and nursing informaticists are experts in user centered design.” ANI also highlighted that “nurse practitioners are considered eligible providers and have independent practice authority in 25 states and one of the US territories.”

Research investigations have quantified the significant documentation burden experienced by nurses, including entering flowsheet data every 1 to 2 minutes during a 12-h shift (Collins et al., 2018) and that more than 20% of nurse documentation is conducted outside working hours (Ahn, Choi, & Kim, 2016). Physicians and other types of health professionals also experience significant documentation burden (Cox et al., 2018; Mishra Kiang & Grant, 2018; Sinsky et al., 2016; Tai-Seale et al., 2017). These rates are not sustainable and have been linked to burnout in nurses and physicians (Rao et al., 2017). Moreover, there is a lack of standard approaches to reliably measure documentation burden. In summary, there is a recognition of the need to address documentation burden from a policy perspective. Evidence demonstrates that it is a problem experienced by nurses as well as physicians, highlighting the need for inclusive language in policy strategies and multifaceted solutions.

Nonprofit Organizations and Public–Private Partnerships Driving Reform

Among the many nonprofits and public–private partnerships today advancing health IT and nursing informatics, few have had such positive impact on the industry than AMIA and HIMSS. Both organizations have significant numbers of health IT professionals, including nurse informaticists, who are expert informaticists as well as committees, task forces, and working groups for the health IT community.

AMIA AMIA is dedicated to promoting the effective organization, analysis, management, and use of information in healthcare to support patient care, public health, teaching, research, administration, and related policy. For more than 30 years, the 5,600+ members of AMIA and its honorific college, the American College of Medical Informatics (ACMI), have sponsored meetings, education, policy, and research programs.

The AMIA regularly engages with the federal government by providing agency and congressional officials unbiased, evidence-based policy recommendations through public comments, in-person meetings, and briefings. As a result of this engagement AMIA is routinely sought after by agency and congressional leaders to provide input on pressing policy issues, ranging from the use of emerging clinical standards in EHRs and payment incentives to leverage health IT in new and novel ways, to how changes in technology will necessitate changes to the clinical workforce. The AMIA recognizes that Health Informatics Policy is a distinct policy domain that seeks to optimize care delivery and care experience, improve population and public health, and advance biomedical research through the collection, analysis, and application of data. A set of policy principles continue to evolve with resultant policy positions, supported through evidence-based peer review literature.

AMIA’s overall mission is to advance the science of informatics, the education of informatics, and the profession of informatics to assure that health IT is used most effectively to promote health and healthcare. AMIA champions the use of health information and communications technology in translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics. The association is also dedicated to expanding the size and strengthening the competency of the U.S. health informatics workforce and supporting the continued development of the health informatics profession.

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