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Clinical Trial Success Relies on Health Data Interoperability

FDA has issued a draft guidance stating that clinical trial leaders must use EHRs that promote health data interoperability in order to see the highest success.

By Sara Heath

Health data interoperability may be the key to enhancing clinical trials, says the Food and Drug Administration.

In its recent draft guide Use of Electronic Health Record Data in Clinical Investigations, the FDA discussed the potential EHR data has in boosting clinical trials, saying that trial success heavily depended upon interoperable technology.

Overall, FDA says EHRs can entirely enhance clinical trial data. Because FDA reviews clinical trial data as part of its assessment of various medications, treatments, and drugs, it holds a considerable stake in ensuring that this data is accurate and of the highest quality.

Because EHRs are nearly ubiquitously adopted across the industry, and because their capabilities are so far-reaching scope, FDA maintains that they can help ensure the quality of clinical trial data.

With the widespread use of EHRs, there are opportunities to improve patient safety, data accuracy, and clinical trial efficiency when data from these systems are used in clinical investigations,” FDA writes in the draft guidance.

“EHRs may have the potential to provide clinical investigators and study personnel access to real-time and longitudinal health care data for review and can facilitate post-trial follow-up on patients to assess long-term safety and efficacy of medical products. There are also opportunities for long-term follow-up of large numbers of patients in studies where primary endpoints are rare, such as in prophylaxis studies,” the agency continues.

However critical these benefits may be, however, they are limited if EHRs are not interoperable with one another, or interoperable with FDA’s technologies.

Further, interoperability between multiple EHRs involved in one clinical trial supports better data transfer.

“The interoperability between EHRs and [electronic data capture] systems may simplify data collection for a clinical investigation by enabling clinical investigators and study personnel to capture source data at the time of a subject’s point-of-care visit,” the draft guidance says. “These interoperable systems may reduce errors in data transcription and provide data that is more accurate and complete allowing for improvement in the quality of clinical investigations and the interpretation of data.”

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.

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.

“FDA encourages sponsors and clinical investigators to work with the entities that control the EHRs, such as health care organizations, to use EHRs and EDC systems that are interoperable. EHRs may be interoperable with EDC systems in a variety of ways depending on supportive technologies and standards,” FDA proposes.

FDA has been discussing health IT a length, recently.

Earlier this year, the agency issued a draft guide regarding medical device interoperability. Through an overarching definition of interoperability and an investigation into how medical devices can become interoperable, FDA sought to determine how these technologies can be integrated into healthcare.

While such motives are important, some industry stakeholders thought the draft left a lot to be desired.

In a public comments letter, HIMSS and the Personal Connected Health Alliance (PCHA) stated the FDA needed to provide further clarification on various fronts, including on its definition of interoperability.

“Given the complex nature of interoperability when applied to medical devices, and the vast diversity in medical device types, the FDA needs to include guidance that will offer appropriate methods to reduce both risks associated with devices and users moving across environments, while maintaining the flexibility to adapt frameworks and guidance to accommodate future technologies and uses of information,” PCHA and HIIMSS wrote.

Likewise, PCHA and HIMSS noted that FDA must include information about how the devices are certified and how they will consider security provisions.




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