Andrew Gettinger, Teresa Zayas-Cabán, HITECH to 21st century cures: clinician burden and evolving health IT policy, Journal of the American Medical Informatics Association, 2021;, ocaa330, https://doi.org/10.1093/jamia/ocaa330

FOUNDATIONS OF FEDERAL HEALTH IT POLICY

Two decades ago, clinicians, researchers, policy makers, and the public were taken aback by a series of well-documented findings from the National Academy of Medicine (previously the Institute of Medicine) regarding health care in the United States. Examples of patient harm, poor quality, disparities, and a general failure to provide sound, evidence-based care were surprising especially since US health care expenditure of resources far exceeded that of any other country in the world. Those observations, examples of improvements in care by pioneer institutions that transitioned from paper-based systems to self-developed health information technology (IT) systems,³ and an estimated $81 billion in savings that would be gained due to expected health IT-related efficiency and safety improvements⁴ provided the impetus for the federal government to step in and encourage adoption of electronic health record (EHR) systems. The US Department of Health and Human Services established financial incentives for adoption by eligible professionals and hospitals, regulated certification of EHRs, and instituted programs to support effective implementation (ie, regional extension centers and workforce development programs) and advanced uses of health IT. It was expected that health IT adoption would address health care deficiencies and result in tools that practicing clinicians would trust and ultimately use to provide better care and outcomes with less effort. More than a decade later, these goals have been met with mixed success and the clinical community is struggling with burnout directly attributed to health IT; in part caused by usability issues, nonintuitive workflows, use of structured forms that impact the ability to construct and interpret a cohesive patient narrative; and an inability to incorporate disparate electronic health data into a single, consolidated, comprehensive, and up-to-date patient view.

Despite documented issues with health IT use, early policy efforts did not account for the extent of the challenges that clinicians would face with EHRs that negatively impacted workflow and creation and subsequent review of documentation. The desire to benefit from standardized, structured data has resulted in “check the box” workflows. When coupled with typing rather than dictation and transcription, this has led to less clear, consistent, and comprehensive documentation, which has resulted in loss of the patient’s narrative, cogent assessments, and plans of care. Addressing these issues will require coordinated attention to improved design of health IT systems, better system configuration decisions, and effective end user training during implementation, all of which can have powerful effects on usability, safety, and clinician satisfaction with their health IT.

ADVANCING HEALTH IT USABILITY THROUGH POLICY AND TECHNICAL DEVELOPMENT

As the lead agency in advancing adoption of health IT and health information exchange, the Office of the National Coordinator for Health Information Technology (ONC) has led the charge in understanding usability issues with health IT. ONC has developed tools to assist with evaluating and improving usability of implemented systems, implemented regulations to address usability of health IT in design, and advanced the national conversation to ensure these systems were usable and useful to end users. The Strategic Health IT Advanced Research Project (SHARP) program funded under the Health Information Technology for Economic and Clinical Health Act was designed to support research on challenging health IT areas. One of the projects was focused on patient-centered cognitive support—specifically examining barriers to use of health IT. The project focused on better understanding cognitive load, usability, and workflow issues associated with the use of EHRs in clinical decision-making. The project developed tools to help health IT developers identify and prioritize usability problems and resources to address identified problems. In addition, research from this project informed National Institutes of Standards and Technology EHR usability guidelines that were subsequently included in the 2014 Edition Health IT Certification Criteria. Referred to as “safety-enhanced design,” these criteria required health IT developers to apply user-centered design (UCD) processes. Subsequently, it was recognized that these criteria had to evolve over time to more adequately account for the complexities of interactions between EHRs and clinicians.

ONC also funded research to examine the efficacy of these policies including UCD processes employed by health IT developers. Study findings showed compliance with the regulations but that health IT developer implementation could be improved. The study described challenges health IT developers faced in incorporating UCD practices into development processes.²⁴ Findings showed that UCD processes and understanding of UCD varied across health IT developers. Opportunities for improvement included conducting usability testing with practicing providers and ensuring adequate numbers of participants in testing. Furthermore, health IT developers needed a knowledge base on specialty workflow and related design needs, as well as a mechanism to share safety concerns. Ratwani et al reported that health IT developers with misconceptions about UCD did not see a business case for employing it in product design, reinforcing the need for incentives such as certification criteria to foster health IT developer use of UCD methods and approaches.

Subsequently, the 2015 Edition Health IT Certification Criteria were expanded to require health IT developers to incorporate UCD principles, safety-enhanced design principles, and real-world testing of the software. Responding to these published reports in the face of future regulations, health IT developers have continued to refine their work in this area as reported by the 4 examples in this issue.

In light of persistent issues with the usability of implemented EHRs, ONC provided funding to develop a resource to support practices and hospitals by aiding them in identifying and improving the usability of their existing EHR systems. The Usability Change Package (UCP) resource, which was released in 2018, was specifically designed to support organizations that did not have ready access to usability experts and resources. The UCP walks users through how to identify a problem, find a tool that can assist with analysis and improvement, and implement a solution. The UCP also includes links to additional resources that practices and hospitals may use to address usability issues with their existing health IT systems.

REDUCING CLINICIAN BURDEN

In 2016, Congress enacted the 21st Century Cures Act (Cures Act), which included requirements for the executive branch to examine and address clinician burden related to the use of EHRs. The Cures Act specifically required this be a collaborative process that includes consultation with many stakeholders and establish burden reduction goals, develop a strategy, and make recommendations.

ONC, partnering with the Centers for Medicare & Medicaid Services (CMS) and other federal collaborators, led a series of outreach initiatives to understand and document the challenges. These included both solicited and nonsolicited feedback from a series of public listening sessions and stakeholder meetings with representatives from the health care community—from clinicians to health IT developers, and implementers to insurers. This effort resulted in a report that identifies 4 major areas of concern: documentation requirements for billing, quality reporting requirements, conflicting federal and state regulations, and issues related to health IT, including usability. We found several key usability issues with current health IT system design and implementation, including ineffective cognitive support for users, issues with interface design and integrating health IT into physical environments, limitations of current functionality, such as order entry; and how configuration and implementation decisions could impact usability and use. In the report, we outline 4 areas that need to be addressed to improve the usability of health IT:

• Improve alignment of EHRs with clinical workflow; including better decision-making and documentation tools;
• Optimize user interface design to improve efficiency, experience, and end user satisfaction;
• Harmonize clinical content to reduce burden; and
• Promote implementation decisions for clinician efficiency, satisfaction, and lower burden.

The report documented areas for improvement of the usability of health IT, provided clarity on the etiology of related challenges, and specified the need for these challenges to be addressed collaboratively and transparently with joint efforts by key stakeholders—not just government regulation. In addition, ONC worked collaboratively with CMS to inform their efforts to reduce burden related to health IT-associated documentation requirements, which CMS is implementing under its Patients over Paperwork initiative, Recently published regulations by both ONC and CMS address some of the concerns from the clinical community. Specifically, the rules will enable better patient matching and sharing of clinical progress notes, which may aid clinicians in obtaining a more complete picture of patient care. Furthermore, the ONC Cures Act Final Rule real-world testing requirements will enable assessment of usability issues in the settings for which health IT developers market their products and not just in a laboratory or simulated environment.

CURRENT LANDSCAPE AND LOOKING AHEAD

The responses by health IT developers in reaction to questions by safety and usability experts regarding usability design and testing practices in this issue demonstrate a commitment to usability, but opportunities to do more exist. We need to continue to build on current efforts to improve user-centered design and use of human factors and ergonomics in design and implementation of health IT. This will become critically important as the recent Cures Act rules are implemented: health IT developers should make design decisions based on a robust understanding of clinician’s cognitive and workflow needs, and providers should make configuration decisions with an understanding of their impact on usability and use of the systems. Technology continues to improve, introducing better methods for clinicians to document and receive patient-related information from health IT. Saccadic eye movements of actual clinicians can pinpoint opportunities for improvement; ambient voice speech-to-text continues to improve and may be combined with machine learning and artificial intelligence into the patient care documentation, assessment, and plan. Better support for clinical end users both in initial training and subsequent monitoring through “time to task” and efficiency can identify clinicians who might benefit from additional support. When coupled with documentation requirements that are consistent with the information needed for clinical care, use of application programming interfaces using the Health Level Seven International (HL7) Fast Healthcare Interoperability Resources standard that download population data “in bulk” may enable automated fulfillment of billing and documentation requirements as a byproduct of clinical documentation rather than its goal. Many more opportunities exist: cogent, facile patient summary screens; hand-off and transition support; incorporation of patient and appropriately authorized family and nonclinical caregiver content; integration of data from vetted internet of things; and the “measured-self” health care devices are but a few examples which can, if thoughtfully developed and implemented, enhance clinical care or, if done poorly, dramatically increase clinician burden and worsen usability. The assessment that “every system is perfectly designed to get the result observed” can be applied to health IT. We should work toward a future state where all clinicians feel that their health IT is so essential to their practice that they cannot provide care without it. In the coming year, ONC will be continuing to develop plans to make that happen by addressing usability challenges identified in our report. We will also continue to collaborate with CMS and other federal partners in reducing health IT-related documentation requirements that add to clinician burden. We at ONC look forward to doing our part in advancing the field through policy and technical development and by continuing to engage the broad community of health IT stakeholders.

Andrew Gettinger, Teresa Zayas-Cabán, HITECH to 21st century cures: clinician burden and evolving health IT policy, Journal of the American Medical Informatics Association, 2021;, ocaa330, https://doi.org/10.1093/jamia/ocaa330