Informatics experts express caution over EHR readiness for research in response to FDA draft guidance
(BETHESDA, MD) — In comments submitted to the Food & Drug Administration (FDA) today, the nation’s leading biomedical and clinical informaticians said new draft guidance is well-timed and can serve as a valuable signal to industry, and other stakeholders, on how to orient technical functionalities and organizational policies to leverage electronic health record (EHR) data for FDA-regulated research. However, the American Medical Informatics Association (AMIA) questioned the state of readiness for most EHRs to provide research quality data, especially for prospective randomized controlled trials.
“With more than 96 percent of U.S. hospitals and 83 percent of U.S. office-based physicians using EHRs to deliver clinical care, we have an unprecedented opportunity to utilize digitized healthcare data for supplemental uses, such as clinical investigations,” AMIA said in comments. “However, we strongly caution the FDA from assuming EHRs are readily configurable for clinical investigations, even among more advanced institutions.”
Citing a lack of technical standards and an overreliance on the assurances resulting from ONC’s Health IT Certification Program, AMIA said data generated through the routine course of clinical care would likely fall short of more rigid research standards for data quality and integrity. EHR data is meant to support the care of individual patients, rather than generate research quality data, the organization noted.
“Ensuring data integrity and tracking data provenance in clinical settings is incredibly complicated because multiple, authorized individuals contribute to the EHR and the specificity of audit logs varies widely,” the association said in comments. “If the FDA is interested in which data populated the electronic data capture (EDC) system or electronic case reporting form (eCRF) and where they originated along the continuum of care, the answer could prove extremely difficult and burdensome.”
AMIA recommended FDA update the guidance by pointing clinical investigation sponsors towards data warehouses – which underpin EHR systems – that utilize a common data model, such as OHDSI, i2b2 SHRINE, or mini-Sentinel, amongst others. “These sources may have better semantic interoperability and data integrity compared to sources that remain in the EHR default data model,” the group said.
AMIA also noted some concern with FDA’s reference to ONC’s Health IT Certification Program. The group said data reliability and integrity fall outside the scope of certification, and “we see this guidance overstating the ability of certification to deliver clinical investigation-quality data as a byproduct of care delivery.” Comments continued, “Further, our members note a general lack of consensus on IT standards used by private sector actors to render clinical data useful for research, which adds to the variability of data quality and potential approaches meant to mitigate data integrity deficiencies.”
“If we want to reach the goal of a learning health system, connecting our care systems to our research systems is essential, but we must do it right,” said AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACMI. “Ultimately, we want every patient encounter recorded in the EHR to add to our knowledge about how to do a better job with all patients.”
Click here for AMIA’s full response to FDA’s draft guidance.
AMIA, the leading professional association for informatics professionals, is the center of action for 5,000 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.