OBJECTIVES: The HL7® fast healthcare interoperability resources (FHIR®) specification has emerged as the leading interoperability standard for the exchange of healthcare data. We conducted a scoping review to identify trends and gaps in the use of FHIR for clinical research. MATERIALS AND METHODS: We reviewed published literature, federally funded project databases, application websites, and other sources to discover FHIR-based papers, projects, and tools (collectively, "FHIR projects") available to support clinical research activities. RESULTS: Our search identified 203 different FHIR projects applicable to clinical research. Most were associated with preparations to conduct research, such as data mapping to and from FHIR formats (n = 66, 32.5%) and managing ontologies with FHIR (n = 30, 14.8%), or post-study data activities, such as sharing data using repositories or registries (n = 24, 11.8%), general research data sharing (n = 23, 11.3%), and management of genomic data (n = 21, 10.3%). With the exception of phenotyping (n = 19, 9.4%), fewer FHIR-based projects focused on needs within the clinical research process itself. DISCUSSION: Funding and usage of FHIR-enabled solutions for research are expanding, but most projects appear focused on establishing data pipelines and linking clinical systems such as electronic health records, patient-facing data systems, and registries, possibly due to the relative newness of FHIR and the incentives for FHIR integration in health information systems. Fewer FHIR projects were associated with research-only activities. CONCLUSION: The FHIR standard is becoming an essential component of the clinical research enterprise. To develop FHIR's full potential for clinical research, funding and operational stakeholders should address gaps in FHIR-based research tools and methods.

OBJECTIVE: The Genomic Medicine Working Group of the National Advisory Council for Human Genome Research virtually hosted its 13th genomic medicine meeting titled "Developing a Clinical Genomic Informatics Research Agenda". The meeting's goal was to articulate a research strategy to develop Genomics-based Clinical Informatics Tools and Resources (GCIT) to improve the detection, treatment, and reporting of genetic disorders in clinical settings. MATERIALS AND METHODS: Experts from government agencies, the private sector, and academia in genomic medicine and clinical informatics were invited to address the meeting's goals. Invitees were also asked to complete a survey to assess important considerations needed to develop a genomic-based clinical informatics research strategy. RESULTS: Outcomes from the meeting included identifying short-term research needs, such as designing and implementing standards-based interfaces between laboratory information systems and electronic health records, as well as long-term projects, such as identifying and addressing barriers related to the establishment and implementation of genomic data exchange systems that, in turn, the research community could help address. DISCUSSION: Discussions centered on identifying gaps and barriers that impede the use of GCIT in genomic medicine. Emergent themes from the meeting included developing an implementation science framework, defining a value proposition for all stakeholders, fostering engagement with patients and partners to develop applications under patient control, promoting the use of relevant clinical workflows in research, and lowering related barriers to regulatory processes. Another key theme was recognizing pervasive biases in data and information systems, algorithms, access, value, and knowledge repositories and identifying ways to resolve them.

Inefficient workflows affect many health care stakeholders including patients, caregivers, clinicians, and staff. Widespread health information technology adoption and modern computing provide opportunities for more efficient health care workflows through automation. The Office of the National Coordinator for Health Information Technology (ONC) led a multidisciplinary effort with stakeholders across health care and experts in industrial engineering, computer science, and finance to explore opportunities for automation in health care. The effort included semistructured key informant interviews, a review of relevant literature, and a workshop to understand automation lessons across nonhealth care industries that could be applied to health care. In this article, we describe considerations for advancing workflow automation in health care that were identified through these activities. We also discuss a set of six priorities and related strategies developed through the ONC-led effort and highlight the role the informatics and research communities have in advancing each priority and the strategies.

Adoption and use of health information technology (IT) was identified as 1 solution to quality and safety issues that permeate the United States health care system. Implementation of health IT has accelerated across the US over the past decade, in part, as a result of legislative and regulatory requirements and incentives. However, adoption of these systems has burdened clinician users due to design, configuration, and implementation issues, resulting in poor usability, challenges to workflow integration, and cumbersome documentation requirements. The path to alleviating these clinician burdens requires a clear understanding of the intent and evolution of pertinent regulations and the context in which they exist. This article reviews the Office of the National Coordinator of Health Information Technology's efforts, documents current regulatory actions, and discusses additional policy opportunities that can further improve clinician satisfaction and effectiveness in providing health care with health IT that is an asset, not an obstacle.

Dear Editor, We are pleased that Dr. Shapiro supports the patient access components of the 21st Century Cures Act (Cures Act) and related regulations and sorry that his mother experienced anxiety from learning about her biopsy findings. Congress passed the Cures Act in 2016 with overwhelming bipartisan and bicameral support. It buttressed earlier statutes in defining the patient’s right of access to their electronic health information in a form convenient to them and is supported by a substantial number of studies regarding sharing results with patients in a variety of ways (ie, the Health Insurance Portability and Accountability Act and Health Information Technology for Economic and Clinical Health Act enacted under the American Recovery and Reinvestment Act of 2009).1–4 The Cures Act included more specific patient access requirements than previous legislation after Congress heard of substantial examples of harm, including from delayed or absent notification of laboratory results. The Office of the National Coordinator for Health Information Technology (ONC) implemented the Cures Act’s provisions regarding information blocking after the required regulatory process, which received input from patients, clinicians, specialty societies, advocacy groups, and other stakeholders. Specifically, ONC was charged with defining the exceptions to the information blocking provisions. These were specified in a draft rule and revised, based on public feedback, in the final rule. Once published, a series of informational webinars and public communication were undertaken. Healthcare organizations were encouraged to educate their ordering clinicians regarding the changes and set the expectation that although the patient has the right to review their results immediately, it may precede the ordering clinician’s review and communication to the patient of their results. Patients have the option, but are not required, to access the portal to review results. The system demands deliberate action on the part of the patient to, first, create a portal account and, subsequently, view the results. Health information technology systems, including patient portals, and their implementation are continuing to evolve by providing patients more control of their notification preferences—which would be a desirable outcome. In the interim, reports from the field are overwhelmingly positive.

Precision medicine can revolutionize health care by tailoring treatments to individual patient needs. Advancing precision medicine requires evidence development through research that combines needed data, including clinical data, at an unprecedented scale. Widespread adoption of health information technology (IT) has made digital clinical data broadly available. These data and information systems must evolve to support precision medicine research and delivery. Specifically, relevant health IT data, infrastructure, clinical integration, and policy needs must be addressed. This article outlines those needs and describes work the Office of the National Coordinator for Health Information Technology is leading to improve health IT through pilot projects and standards and policy development. The Office of the National Coordinator for Health Information Technology will build on these efforts and continue to coordinate with other key stakeholders to achieve the vision of precision medicine. Advancement of precision medicine will require ongoing, collaborative health IT policy and technical initiatives that advance discovery and transform healthcare delivery.

Ensuring that federally funded health research keeps pace with the explosion of health data depends on better information technology (IT), access to high-quality electronic health data, and supportive policies. Because it prominently funds and conducts health research, the U.S. federal government needs health IT to rapidly evolve and has the ability to drive that evolution. The Office of the National Coordinator for Health Information Technology developed the National Health IT Priorities for Research: A Policy and Development Agenda (the Agenda) that identifies health IT priorities for research in consultation with relevant federal agencies. This article describes support for the Agenda from the Food and Drug Administration, the National Institutes of Health, and the Veterans Health Administration. Advancing the Agenda will benefit these agencies and support their missions as well as the entire ecosystem leveraging the health IT infrastructure or using data from health IT systems for research.

The growth of digitized health data presents exciting opportunities to leverage the health information technology (IT) infrastructure for advancing biomedical and health services research. However, challenges impede use of those resources effectively and at scale to improve outcomes. The Office of the National Coordinator for Health Information Technology (ONC) led a collaborative effort to identify challenges, priorities, and actions to leverage health IT and electronic health data for research. Specifically, ONC led a review of relevant literature and programs, key informant interviews, and a stakeholder workshop to identify electronic health data and health IT infrastructure gaps. This effort resulted in the National Health IT Priorities for Research: A Policy and Development Agenda, which articulates an optimized health information ecosystem for scientific discovery. This article outlines 9 priorities and recommended actions to be implemented in collaboration with the research and informatics communities for realizing this vision.

OBJECTIVE: The goal of this paper is to describe the successful application of a use case-based evaluation approach to guide the effective design, evaluation and redesign of inexpensive, commercial, off-the-shelf consumer health informatics (CHI) interventions. DESIGN: Researchers developed four CHI intervention use cases representing two distinct patient populations (patients with diabetes with high blood pressure, post-bariatric surgery patients), two commercial off-the-shelf CHI applications (Microsoft HealthVault, Google Health), and related devices (blood pressure monitor, pedometer, weight scale). Three patient proxies tested each intervention for 10 days. MEASUREMENTS: The patient proxies recorded their challenges while completing use case tasks, rating the severity of each challenge based on how much it hindered their use of the intervention. Two independent evaluators categorized the challenges by human factors domain (physical, cognitive, macroergonomic). RESULTS: The use case-based approach resulted in the identification of 122 challenges, with 12% physical, 50% cognitive and 38% macroergonomic. Thirty-nine challenges (32%) were at least moderately severe. Nine of 22 use case tasks (41%) accounted for 72% of the challenges. LIMITATIONS: The study used two patient proxies and addressed two specific patient populations and low-cost, off-the-shelf CHI interventions, which may not perfectly generalize to a larger number of proxies, actual patient populations, or other CHI interventions. CONCLUSION: CHI designers can employ the use case-based evaluation approach to assess the fit of a CHI intervention with patients' health work, in the context of their daily activities and environment, which would be difficult or impossible to evaluate by laboratory-based studies.