Earlier this week, FDA announced the availability of a draft guidance regarding the use of electronic health record (EHR) data in clinical trials. The guidance, which was published on May 12, 2016, provides sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties with recommendations for using EHRs in FDA-regulated clinical trials.
Although the draft guidance includes recommendations on a number of topics, there is an abundance of information concerning best practices for the use of EHR data in clinical investigations. As such, when using EHRs as a source of clinical trial data, FDA states that “sponsors should ensure that the EHRs they use and the processes and policies for their use provide electronic source data that are attributable, legible, contemporaneous, original, and accurate (ALCOA).”
As required by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), the Office of the National Coordinator for Health Information Technology (ONC) has established a voluntary health IT certification program. The ONC program “supports the availability of certified health IT for its encouraged and required user under other federal, state and private programs.”
EHR technology that is certified under the ONC Health IT Certification Program must be in compliance with the provisions of 45 CFR part 170. EHR technology with certified capabilities provides numerous advantages to users because the certification’s requirements are aimed at keeping electronic data confidential and reliable. Accordingly, FDA states that the “use of such certified EHR technology is encouraged and, if used, would give FDA confidence during inspections that the EHR data is reliable and that the technical and software components of privacy and security protection requirements have been met.”
As long as adequate controls are in place to guarantee the confidentiality, integrity, and reliability of data, non-certified EHRs can still provide FDA with the data needed to make informed regulatory decisions. To ensure the confidentiality, integrity, and reliability of data, FDA advises sponsors to implement the following security safeguards:
FDA notes that “Sponsors should consider these factors when determining the suitability of EHRs not certified by ONC for use in clinical investigations. If the clinical investigation site is using a system that does not contain the adequate controls previously described in the bulleted items, sponsors should consider the risks of employing such systems.”
In its draft guidance, FDA provides a number of additional considerations that should be taken when using data from EHRs in clinical investigations.
For additional information on best practices regarding the use of EHRs in clinical trials, view the full draft guidance.
May 18, 2016
On Tuesday, May 17, FDA announced the availability of a new draft guidance, entitled “Use of Electronic Health Record Data in Clinical Investigations.” The document, which expands on the...
March 9, 2016
As a part of its ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), the FDA has announced its plans to review the proposed Nonclinical Study Data Reviewer’s Guide (SDRG)...
September 12, 2016
On Friday, September 9th, FDA announced the availability of a revised draft guidance, entitled “Health Document Submission Requirements for Tobacco Products.” The document was initially published in...