EHR Data Use In Clinical Investigations- A New FDA Guidance

The Food and Drug Administration or FDA recently released new guidelines or recommendations for the use of EHR data in clinical investigations. The goal of this new guidance is to facilitate the use of EHR data in clinical investigations and to promote interoperability of the EHR and electronic data capture (EDC) systems. 

In a clinical investigation, EHR technology can allow the investigators to access a wide variety of data types, which include, physician orders, clinical notes, radiology labs, and pharmacy records.

 “EHRs may have the potential to provide clinical investigators and study personnel access to real-time data for review and can facilitate post-trial follow-up on patients to assess long-term safety and effectiveness of medical products,” wrote FDA officials in the Guidance for Industry. The authors continued with, “there are opportunities for long-term follow up of large numbers of patients, which may be of particular importance in studies where the outcome of interest occurs rarely, such as in prophylaxis studies.” By improving the EHR data accuracy, you can optimize the efficacy of clinical trials.

FDA officials also acknowledged that problems with diverse clinical data standards may complicate interoperability between EHR and EDC systems. Collaboration between healthcare organizations and system vendors may help to advance interoperability and enable EHR and EDC system integration.

In addition to recommendations about EHR data use and interoperability the FDA also offered guidance related to informed consent, blinded study designs, inspection, recordkeeping, record retention requirements, and other aspects of EHR data use in clinical investigations. To read the full report click here.

Here at Extract, we believe that hospital systems should be using the EHR that best fits them.  When we automate incoming documents, we have a wide range of experience in getting crucial data into whatever downstream system you’re interfacing with.  While we’ve already integrated with large EHRs like Epic and Cerner, we haven’t met an EHR yet that we can’t work with.

If you would like to learn more about how Extract can increase your EHR interoperability and automatically move data from your incoming, unstructured documents directly into your EHR, reach out today!


About the Author: Taylor Genter

Taylor is the Marketing Specialist at Extract with experience in data analytics, graphic design, and both digital and social media marketing.  She earned her Bachelor of Business Administration degree in Marketing at the University of Wisconsin- Whitewater. Taylor enjoys analyzing people’s behaviors and attitudes to find out what motivates them, and then curating better ways to communicate with them.