FDA guidance encourages EHR use but doesn’t solve interoperability challenges: Industry responds
The US Food and Drug Administration (FDA) recently published a guidance for industry on the use of electronic health record (EHR) data in FDA-regulated clinical investigations, with the goal of modernizing studies by using EHR data and including real-world data.
The guidance in part satisfies the mandate under the 21st Century Cures Act to issue guidance about the use of real-world evidence (RWE) in regulatory decision-making. It also encourages sponsors and health care organizations to work with EHR and electronic data capture (EDC) system vendors to further the interoperability and integration of EHR and EDC systems.
According to the guidance, sponsor data management plans should include a list of EHR systems used by investigative sites. Additionally, informed consent must describe a study monitors’ access to all relevant patient information that pertains to a clinical investigation.
Wayne Walker, vice president, product lead for Rave, Medidata, said the guidance is further recognition by regulators that “the data source landscape in clinical trials needs to be more flexible.”
“The content of the guidance is one of the most prescriptive in recent memory,” he told us.
While much appreciated, John Lewis, an independent industry consultant, noted that technology will always be ahead of regulation.
“Unfortunately the guidance by itself, and the FDA as a whole, cannot solve the interoperability problem between EHR and EDC systems, which FDA acknowledges, although hopefully this will continue to apply pressure to have these systems integrated with common data standards,” he told us.
For blinded study designs, the guidance notes that sponsors should consider whether using interoperable EHR and EDC systems has potential to unblind the treatment allocation.
Jacylyn Bodmer, chief innovation officer at Elligo Health Research said the guidance is a step forward towards interoperability between health care and clinical research. “Health care sites can take advantage of data they already have in their EHR systems instead of re-entering data into EDC,” she said.
“The issue is whether the health care interoperability standards can be broadly adopted and adequately support global research standards and provenance requirements,” Bodmer told us. “The guidance further moves the industry towards data standards in order to achieve interoperability.”
The guidance does not apply to data from mobile and telehealth technology, medical devices and remote monitoring devices, assistive technologies, and sensors. “I think an unanswered question is what to do with this data,” Lewis said, though further guidance is expected.
Lewis explained that this places a new responsibility on sponsors or contract research organization (CROs) to be vigilant about which EHR systems comply with the Office of the National Coordinator for Health Information Technology (ONC).
The ONC is the federal entity tasked with coordinating efforts to implement and use health information technology. The office is organizationally located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS).
For systems not ONC-certified, sponsors should consider whether the systems have privacy and security controls in place to ensure data confidentiality, integrity, and security, according to the guidance.
