EHRs and EDCs —
Future Integration Benefits and Challenges
The use of Electronic Health Records (EHRs) has transformed documentation and delivery of healthcare in the United States (U.S.). An essential contribution to the increasingly digital healthcare infrastructure since their emergence, EHRs have become unanimously integrated into clinical practice, mostly to capture crucial billing data and optimize clinical care. From 2008 to 2016 adoption of EHRs by office-based physicians more than doubled from 42 to 87 percent. Today, four out of five hospitals in the U.S. utilize some basic form of an EHR1. Each EHR contains a wealth of health data and other information such as patient medical history, diagnoses, medications, immunizations, allergies, radiological images, laboratory results, and vital signs. Insurance information, demographic data, and data from personal wellness devices can also be included. Such massive electronic files streamline patient care across authorized health care providers, clinical practices, and healthcare organizations. Examination and extrapolation of these EHR elements for clinical research produces real-world data (RWD), which are then analyzed into real world evidence (RWE) that may inform various elements of drug development.
The aggregate of population-wide EHRs presents a rich, readily available source of health information. For clinical research professionals, this source may contain valuable information regarding population health, disease prevalence, and the usage, side effects, and benefits of medical products. Analysis of RWD in EHRs presents an exciting opportunity to more accurately assess study feasibility, improve patient recruitment, reduce administrative burdens, and centralize data collection. EHRs also hold extensive longitudinal data which may be utilized to conduct observational, embedded pragmatic, post-marketing registry, or comparative effectiveness studies at lower costs in reduced timeframes.
One way that clinical research institutions, sponsors, and pharmaceutical companies can capitalize on EHRs is through integration with Electronic Data Capture (EDC) systems. In the past five years, industry leaders have been looking towards the integration of EDC and EHR systems, where common data elements are often entered repetitively, to optimize clinical trial operations. In July 2018, the FDA released guidance on the use of EHR data in FDA-regulated clinical investigations for Sponsors, Clinical Investigators, Institutional Review Boards, and Contract Research Organizations (CROs). These documents follow a growing trend within the FDA, clinical research community, and pharmaceutical industry to harness information technology and RWD to increase efficiencies and maximize benefits, while minimizing risks to improve patient outcomes. They are also part of the Food and Drug Administration's larger Framework and 2019 initiatives to leverage RWD and RWE.
Benefits of EHR/EDC interoperability range from reduced operational and administrative costs and process improvements, to increased data integrity and site satisfaction. The process of entering patient information into an EDC system is often duplicative to that of healthcare providers entering patient information during a clinical visit. Abstracting existing data from EHRs into EDCs would reduce the burden of basic data collection for research sites and create a single-point capture of source data, which protects data integrity by eliminating manual transcription of data from multiple sources. EDC data inputted from EHRs would provide better data traceability and provenance, while reducing the need for data queries, data cleaning, and source data verification — processes that within themselves hold the potential for errors. Related administrative costs could be allocated elsewhere or saved altogether.
EHR/EDC integration would promote remote accessibility of patient data and allow pharmaceutical and biotechnology companies to reduce on-site monitoring and auditing visits and associated costs. Once recruited into a trial, CROs would have access to a patient's routine health measurements and outcomes gathered during regular in-patient and/or emergency medical visits. With this information, CROs and pharmaceutical companies can gain a more complete picture of a patient's response and experience with a given therapy and indication. Adverse Events (AEs) reporting in an EHR/EDC integrated system could become centralized, leading to more timely and accurate notification of AEs. An EHR-based AE workflow would reduce errors, decrease miscommunications between site staff and study staff, and ultimately increase patient safety.
Access to aggregated EHR data could greatly improve study feasibility assessments and better inform protocol designs. By utilizing EHR data to assess patient populations, Investigators, Sponsors, CROs, and Clinical Research Coordinators could more effectively predict available populations and target potential participants within exclusion and inclusion criteria. Aggregated and de-identified health data from EHRs and EDCs could provide a valuable database for large epidemiological and public health studies.
Integration of EHR and EDC systems fundamentally represents an integration of clinical care and clinical research. Under the current, segregated system practitioners not affiliated with research institutions and patients not seen at these locations have limited access to clinical trials. Only 3 percent of board-certified physicians participate in clinical trials. Integration of EDC/EHR could allow more practicing physicians to learn of clinical research activities in their fields and share trial information and enable recruitment of potential participants from a typically inaccessible patient population.
So why hasn't this beneficial integration come to fruition? EHR and EDC integration lacks clear business drivers and evident return on investment. EHRs are designed and focused on billing and legal metrics for healthcare operations, while an EDC system directs its focus towards the gathering of data for scientific analysis. EHR systems lack certain quality control measures inherent to EDC systems. Practitioners are not prompted to complete all fields and may have the option to replace data fields with free text. Furthermore, a variety of EDC and EHR systems are in widespread use. Clinical research sites may use one EHR and multiple EDC systems. For sponsors, a multi-site trial may include a variety of EHR systems, each with their own data structuring practices. Sites also vary in IT capabilities and support. Privacy and related regulatory concerns also muddy the interoperability waters.
Despite these barriers, industry stakeholders have moved towards investing in EHR and EDC integration. In 2015, the FDA began expressing public support for EHR/EDC integration, through the Center for Drug Evaluation and Research (CDER). After CDER published a notice requesting demonstration projects from interested parties including CROs, pharma, biotech, and academic centers to test and evaluate EHR/EDC single point data capture approaches; the U.S. government funded the creation of SMART — "Substitutable Medical Apps, Reusable Technology"2.
SMART is an open, standards-based technology platform developed by the Boston Children's Hospital Computational Health Informatics Program and the Harvard Medical School Department for Biomedical Informatics. The SMART project builds on Fast Healthcare Interoperability Resource (FHIR) application programming interface (API) and resource definitions, by establishing so-called "profiles" that allow developers to understand varying vocabularies and data-entry formats utilized in EHR systems to express medications, problems, and laboratory and clinical data. The open specifications for the SMART on FHIR platform provide an opportunity for industry stakeholders like CROs to develop in-house applications capable for extracting data from EHR systems2,3. Sponsors, pharmaceutical and biotechnology companies often look to CROs to develop and incorporate such technology to facilitate clinical operations at reduced costs.
Developers can access the public API and open source libraries that simplify the use standards. These standards promote combability and interoperability between SMART developed applications and other health IT infrastructure. A SMART applied to EHR/EDC integration scenario would allow data entered in a compatible EHR system to be abstracted directly into the EDC after launching the developed application. The five largest EHR vendors are currently working with the SMART team and HL7, through the Argonaut Project to build SMART into their products, an important step in facilitating future interoperability2,3.
The obstacles to EHR/EDC integration provide insight into emerging challenges across the healthcare industry as clinical care, clinical research, and therapeutics become increasingly intertwined with and dependent on technology. The challenge of interoperability extends to the collection and transference of all electronically gathered health-related information. As biomedical research trends towards Precision Medicine and the exploration of biotechnologies from electronic personal wellness devices to intestinal microchips, such advances produce mass quantities of data4. Data ownership, data privacy, and how such data are stored, accessed, and shared are important questions and likely topics of heated debates in the years to come. EHR/EDC integration is a small piece in the interoperability puzzle, but for CROs who often face large administrative costs and burdens with data entry, collection, and analysis — it's a good place to start.
- Percentage of office-based physicians using any electronic health record (EHR)/electronic medical record (EMR) system and physicians that have a certified EHR/EMR system, by U.S. state: National Electronic Health Records Survey, 2017, from https://dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php
- What Is SMART? (2018, March 08). Retrieved January 15, 2019, from https://smarthealthit.org/an-app-platform-for-healthcare/about/
- Welcome to The Argonaut Project. (n.d.). Retrieved January 15, 2019, from http://argonautwiki.hl7.org/index.php?title=Main_Page
- Office of the Commissioner. (2017, November 13). FDA approves pill with sensor that digitally tracks if patients have ingested their medication. Retrieved from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm584933.htm
About the Author
Madeline Helwig holds a Master of Science in Biochemistry and Molecular Biology. She has a background as a Communications Specialist and Medical Scribe and experience supporting Safety Oversight Committees and Participant Recruitment and Retention for clinical trials.