Upcoming Course: Monitoring Electronic Health Records (EHRs): Frequently Asked Questions - Understanding the NEW May 2016 FDA Draft Guidance!


Date: June 16, 2016

Time: 1:00pm-2:30pm, EDT US

Duration: 90 Minutes - Online

Course Link: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001

This Thursday the Life Science Training Institute has partnered with Clinical Pathways to host a course discussing EHR include discussion of the NEW FDA Draft Guidance “Use of Electronic Health Record (EHR) data in Clinical Investigations”.

Technology has radically redefined our society and the workforce. Our communication is now more extensive – more detailed – than ever, as are the records we keep of such interactions. The utilization of Electronic Health Records (EHRs) allow healthcare professionals to deliver better care for their patients. The Food and Drug Administration has released a draft guidance document on the use of Electronic Health Record (EHR) data. The FDA defines EHRs as “electronic platforms that contain individual electronic health records for patients and are maintained by health care organizations and institutions.” EHRs make information available at any time for a more comprehensive and reliable healthcare system. Access to more complete patient information ensures that providers can make informed treatment decisions more rapidly and efficiently.

There are many different types of EHRs, but usually EHRs include “a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results.” The benefits of widespread EHR use are vast. Patient safety can be improved upon, as well as an increase in accurate record-keeping for data and patient information. Data from different sources can be analyzed from a central, combined space. One important positive implication of this merging of data is there will be opportunities for “long-term follow up” for patients in studies where “primary endpoints are rare.” The data will remain available to these healthcare providers, thus allowing reclamation of data if needed for participant care. 

Interoperability is a term that is of crucial importance to the healthcare community and to the use of EHRs. Interoperability refers to “the ability of two or more systems or components to exchange information and to use the information that has been exchanged.” Many people may not have heard this term widely used. Interoperability can benefit a clinical investigation through the exchange of electronic information and data with the sponsor’s electronic data capture (EDC) system. This exchange can lead to more cohesive and fluid data collection and interpretation, while potentially reducing errors in data transcription. Interoperable technology allows the EDC system to merge with the EHR, so the clinical investigator and the participant’s healthcare providers will have full access to any appropriate care data.  

Ensuring that the use of EHRs adheres to FDA regulations may require some additional preparation, organization, and management. Data should be consistent and sponsors will need to ensure that any software updates will not affect the reliability of the EHR data. Sponsors should make sure their data management plan includes “information about the intended use of the EHR during a clinical investigation and a description or diagram of the electronic data flow between the EHR and the sponsor’s [EDC].” Sponsors will need to ensure the collected data from the clinical trial aligns with the EHRs data. Any modifications made to the EHRs data cannot alter or erase previous data entries. The FDA should have access to any EHR audit trail documentation, which needs to be “retained for a time period that is at least as long as the time period required for the subject’s electronic records.” Any EHR data must be made available to the FDA upon request. Informed consent is necessary and the participant should be made aware of the “extent of access” outside parties may be granted to the EHR data.

This is an exciting time for the healthcare industry. For more detailed information on the purpose and use of EHR data in clinical investigations, please visit: 


Thank you!

-The Clinical Pathways team.