The Benefits of Clinical Trial Interoperability and the Potential Dangers Without It

By July 26, 2016 Blog No Comments

fda_imageIn a recent article 1 released from Health IT Interoperability (, the author, Sara Heath, highlights the fact that the “FDA has issued a draft guidance stating that clinical trial leaders must use EHRs that promote health data interoperability in order to see the highest success.”  Heath is quick to point out how EHRs significantly enhance clinical trial data because they help ensure that the data is accurate at the highest quality and support better data transfer.

“FDA notes that EHR interoperability also fosters the ability for providers not involved in the clinical trial to view changes in their patients’ health and adjust course of treatment accordingly” Heath adds. “To that end, FDA supports the adoption and use of interoperable health technology in clinical trials, stating that they should ensure that their technologies adhere to interoperability standards.”

While the benefits of optimized clinical trial interoperability, including cleaner and more accurate data, could be seen in many quantitative and qualitative studies, the opposite could be stated as well. As Lipika Samal, a writer for BioMed Central highlights, the lack of interoperability could lead to costly trials with “inefficient processes and missing data”.  The abstract of her article 2 “Care coordination gaps due to lack of interoperability in the United States: a qualitative study and literature review” reads:

Health information technology (HIT) could improve care coordination by providing clinicians remote access to information, improving legibility, and allowing asynchronous communication, among other mechanisms. We sought to determine, from a clinician perspective, how care is coordinated and to what extent HIT is involved when transitioning patients between emergency departments, acute care hospitals, skilled nursing facilities, and home health agencies in settings across the United States.

We performed a qualitative study with clinicians and information technology professionals from six regions of the U.S. which were chosen as national leaders in HIT. We analyzed data through a two person consensus approach, assigning responses to each of nine care coordination activities. We also conducted a literature review of MEDLINE®, CINAHL®, and Embase, analyzing results of studies that examined interventions to improve information transfer during transitions of care.

We enrolled 29 respondents from 17 organizations and conducted six focus groups. Respondents reported how HIT is currently used for care coordination activities. HIT is currently used to monitor patients and to align systems-level resources with population needs. However, we identified multiple areas where the lack of interoperability leads to inefficient processes and missing data. Additionally, the literature review identified ten intervention studies that address information transfer, seven of which employed HIT and three of which utilized other communication methods such as telephone calls, faxed records, and nurse case management.

Significant care coordination gaps exist due to the lack of interoperability across the United States. We must design, evaluate, and incentivize the use of HIT for care coordination. We should focus on the domains where we found the largest gaps: information transfer, systems to monitor patients, tools to support patients’ self-management goals, and tools to link patients and their caregivers with community resources.


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