AMIA Cautions FDA on Use of EHR Data for Clinical Investigations | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

AMIA Cautions FDA on Use of EHR Data for Clinical Investigations

July 18, 2016
by David Raths
| Reprints
Group says enterprise data warehouses may have better semantic interoperability and data integrity

In May, the U.S. Food & Drug Administration (FDA) issued draft guidance for industry on the use of electronic health record data in clinical investigations such as controlled clinical trials. In a July 18 written response, the American Medical Informatics Association applauded the approach but cautioned the FDA against assuming that most EHRs are readily configurable for clinical investigations, even among more advanced institutions.

AMIA stated that it fully supports FDA’s willingness to consider EHR data as a potential source for FDA-regulated clinical research, but it noted that data collected and used in EHRs are intended to support the care of individual patients, rather than providing research-quality data.

For instance, blood pressure measurements in research studies usually have a strict protocol for how values should be taken, whereas in EHRs, most blood pressures are recorded in the same field no matter how, when, where or by whom they were recorded. “This lack of standardization will be a tremendous challenge for high-quality, rigorous research. Further, 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,” AMIA wrote. “If FDA is interested in which data populated the EDC system or eCRF and where they originated along the continuum of care, the answer could prove extremely difficult and burdensome.”

AMIA encourages FDA to suggest sponsors look toward enterprise data warehouses or translational data warehouses, which may have better semantic interoperability and data integrity compared to sources that remain in the EHR default data model.

AMIA called attention to several other issues, including:

ONC’s Health IT Certification Program. The FDA guidance referenced ONC’s Certification program and suggests certified EHR technology gives “FDA confidence during inspections that the EHR data is reliable…” But AMIA notes that ONC’s program is not designed to ensure data “reliability” or integrity. “We see this guidance overstating the ability of certification to deliver clinical investigation-quality data as a byproduct of care delivery. 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

Audit Trails. FDA’s guidance references “Audit Trails” suggesting that there should be “adequate methods to monitor, track, and document all changes made to information in the EHR pertaining to the conduct of the clinical investigation. AMIA said that while it agrees this would be an important capability to preserve reproducibility and detect any tampering, it questions the capacity of current EHRs to deliver on these kinds of audit logs.

Use of Genomic Data. AMIA foresees a time when genomic data are stored in EHRs as unstructured data that may have relevance to FDA. It said FDA should consider this and related use cases and address potential compliance issues, especially as we move into the precision medicine era.

 

 

 

 

 

 

 

 

Get the latest information on Health IT and attend other valuable sessions at this two-day Summit providing healthcare leaders with educational content, insightful debate and dialogue on the future of healthcare and technology.

Learn More

Topics

News

Healthcare Execs Anticipate High Cost Returns from Predictive Analytics Use

Healthcare executives are dedicating budget to predictive analytics, and are forecasting significant cost savings in return, according to new research from the Illinois-based Society of Actuaries.

Adam Boehler Tapped by Azar to Serve as Senior Value-Based Care Advisor

Adam Boehler, currently director of CMMI, has also been named the senior advisor for value-based transformation and innovation, HHS Secretary Alex Azar announced.

Vivli Launches Clinical Research Data-Sharing Platform

On July 19 a new global data-sharing and analytics platform called Vivli was unveiled. The nonprofit group’s mission is to promote, coordinate and facilitate scientific sharing and reuse of clinical research data.

Survey: More Effective IT Needed to Improve Patient Safety

In a Health Catalyst survey, physicians, nurses and healthcare executives said ineffective information technology, and the lack of real-time warnings for possible harm events, are key obstacles to achieving their organizations' patient safety goals.

Physicians Still Reluctant to Embrace Virtual Tech, Survey Finds

While consumers and physicians agree that virtual healthcare holds great promise for transforming care delivery, physicians still remain reluctant to embrace the technologies, according to a new Deloitte Center for Health Solutions survey.

Geisinger, AstraZeneca Partner on Asthma App Suite

Geisinger has partnered with pharmaceutical company AstraZeneca to create a suite of products that integrate into the electronic health record and engage asthma patients and their providers in co-managing the disease.