Executive Summary
Electronic health records (EHRs) contain rich clinical details, which are an important source of real-world data. The advantage of using EHRs to generate practical clinical evidence lies in the documented capture of comprehensive patient data across providers, settings, conditions, and treatments. Clinical granularity encompasses patient identifiers, demographics, diagnoses, patient progress notes, current and past medications, vital signs, laboratory test results, allergies, and immunizations — as well as operative, radiology, and pathology reports. With appropriate data security and required Health Insurance Portability and Accountability Act (HIPAA) patient privacy safeguards, EHRs are a potentially robust source for life sciences research, with important caveats.
Use of EHRs as a data source presents challenges for real-world researchers. EHRs may be associated with missing, incomplete, and/or inaccurate records if a patient encounter is not properly documented. Moreover, the incompatibility of EHRs between vendors may make normalizing patient data across disparate health systems difficult. Evaluating data quality for clinical applications includes representativeness, completeness, timeliness, and cleanliness. Poor-quality data is characterized by inconsistent, incomplete, inaccurate, and duplicate data entries; delayed and outdated records; and fragmented information across multiple electronic health records and systems. These examples of deficient data impair the generation of real-world evidence and its reliability and usability by researchers. Bridging these gaps with external solutions that standardize, analyze, and reveal trends from electronic health record (EHR) data is essential.
To fully realize the potential and impact of EHRs for clinical data connectivity and utility, seamless integration of clinical support tools is fundamental. Inovalon®, using cloud-based Software as a Service technologies, provides data governance, standardization, and techniques to improve data quality collected from EHRs. Data cleaning, validation, and harmonization create opportunities for data to be used for healthcare insights and research. A collaboration between Inspira Health, a large healthcare network serving Southern New Jersey, and Inovalon’s VigiLanz Pharmacy Surveillance Pro™ solution illustrates how an innovative integration of a suite of software solutions facilitated the use of the Inspira EHR network to support, advance, and manage an Opioid Stewardship Program initiative inclusive of support from the Substance Abuse and Mental Health Services Administration (SAMHSA).
