Recommendations aim to protect information security and integrity

EHRs are now the industry standard, resulting in a wide range of improvements in healthcare, namely patient safety.  Other benefits include improvements to clinical trial efficiency and enabling clinical investigators, research organizations, and IRBs to combine data from a variety of sources.  The use of EHR data, however, presents its own set of challenges, particularly with information security and reliability.

Responding to these challenges, the U.S. Food and Drug Administration has issued a set of comprehensive recommendations to clinical investigators in its recent draft document, “Use of Electronic Health Record Data in Clinical Investigations”.


The document contains guidance on whether and how to use EHRs as a source of data in clinical investigations, using EHRs that are interoperable with electronic systems supporting those investigations, and ensuring the quality and the integrity of any EHR data that is collected and used as electronic source data in said investigations.

Finally, says the document, the guidelines aim to “(ensure) that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements.”

“In general, EHRs are not under the control of FDA-regulated entities (e.g., sponsors, clinical investigators), because in most instances, these systems belong to health care organizations and institutions,” according to the document.  “However, FDA’s acceptance of data from clinical investigations for decision-making purposes depends on FDA’s ability to verify the quality and the integrity of data during FDA on-site inspections and audits.”


The new guidance covers the use of EHR data in prospective clinical investigations of human drugs and biological products, medical devices, and combination products.  Says the document, “This includes foreign clinical studies not conducted under an investigational new drug application (IND) or an investigational device exemption (IDE) that are submitted to FDA in support of an application for the marketing approval of a medical product.”

“Sponsors are responsible for assessing the validity, reliability, and integrity of any data used to support a marketing application for a medical product,” the document goes on to say.

Providing feedback

The document, released in May, is a draft.  At this point its recommendations are nonbinding.  Generally, when the FDA issues guidance in this way, the agency invites commentary from the industry on its findings and recommendations.  More information on how to submit commentary in response to FDA proposed regulations and draft guidances, as well as on page 1 of the document itself, specific to this proposed guidance can be found on the website.

Raintree Systems works as in leader in healthcare IT to stay ahead of trends and be an innovator in the industry.  To learn more about how Raintree Systems is responding to and using the FDA’s new guidance, contact us today at 800-333-1033 and speak directly with one of our professionals.