The electronic health record as a clinical trials tool: Opportunities and challenges.

Clinical trials provide evidence essential for progress in health care, and as the complexity of medical care has increased, the demand for such data has dramatically expanded. Conducting clinical trials has also become more complicated, evolving to meet increasing challenges in delivering clinical care and meeting regulatory requirements. Despite this, the general approach to data collection remains the same, requiring that researchers submit clinical data in response to study treatment protocols, using precisely defined data structures made available in study-specific case report forms. Currently, research data management is not integrated within the patient's clinical care record, creating added burden for clinical staff and opportunities for error. During the past decade, the electronic health record has become standard across the US healthcare system and is increasingly used to collect and analyze data reporting quality metrics for clinical care delivery. Recently, electronic health record data have also been used to address clinical research questions; however, this approach has significant drawbacks due to the unstructured and incomplete nature of current electronic health record data. This report describes steps necessary to use the electronic health record as a tool for conducting high-quality clinical research.

Status Update on Data Required to Build a Learning Health System.

Wide adoption of electronic health records (EHRs) has raised the expectation that data obtained during routine clinical care, termed "real-world" data, will be accumulated across health care systems and analyzed on a large scale to produce improvements in patient outcomes and the use of health care resources. To facilitate a learning health system, EHRs must contain clinically meaningful structured data elements that can be readily exchanged, and the data must be of adequate quality to draw valid inferences. At the present time, the majority of EHR content is unstructured and locked into proprietary systems that pose significant challenges to conducting accurate analyses of many clinical outcomes. This article details the current state of data obtained at the point of care and describes the changes necessary to use the EHR to build a learning health system.

Synthea: An approach, method, and software mechanism for generating synthetic patients and the synthetic electronic health care record.

OBJECTIVE: Our objective is to create a source of synthetic electronic health records that is readily available; suited to industrial, innovation, research, and educational uses; and free of legal, privacy, security, and intellectual property restrictions. MATERIALS AND METHODS: We developed Synthea, an open-source software package that simulates the lifespans of synthetic patients, modeling the 10 most frequent reasons for primary care encounters and the 10 chronic conditions with the highest morbidity in the United States. RESULTS: Synthea adheres to a previously developed conceptual framework, scales via open-source deployment on the Internet, and may be extended with additional disease and treatment modules developed by its user community. One million synthetic patient records are now freely available online, encoded in standard formats (eg, Health Level-7 [HL7] Fast Healthcare Interoperability Resources [FHIR] and Consolidated-Clinical Document Architecture), and accessible through an HL7 FHIR application program interface. DISCUSSION: Health care lags other industries in information technology, data exchange, and interoperability. The lack of freely distributable health records has long hindered innovation in health care. Approaches and tools are available to inexpensively generate synthetic health records at scale without accidental disclosure risk, lowering current barriers to entry for promising early-stage developments. By engaging a growing community of users, the synthetic data generated will become increasingly comprehensive, detailed, and realistic over time. CONCLUSION: Synthetic patients can be simulated with models of disease progression and corresponding standards of care to produce risk-free realistic synthetic health care records at scale.