FDA announces new program to improve interoperability between EHRs and EDCs

FDA announces program to improve interoperability between EHRs and EDCs

Electronic health records have been used to improve a number of different aspects concerning patient care delivery and care coordination. Interoperability is a major advancement that the health care industry is working toward with the help of EHR systems. Health IT that allows doctors in different health settings to communicate essential patient health data quickly, safely and efficiently will accelerate the pace of clinical innovation. 

What will improved EHR and EDC connectivity lead to?
The U.S. Food and Drug Administration's Center for Drug Evaluation and Research recently announced that it will be using EHRs with electronic data capture, called EDC systems, in an effort to enhance clinical trials for new medications. It will be sponsoring a program where researchers submit pilot projects that would connect EHR systems that were previously "siloed." There are currently two sets of EHRs involved – one for clinical research and another for patient care. 

"Streamlining clinical research at the source may open up opportunities to improve clinical trial design and execution, speed the cycle of clinical research and get medicines to market faster," the FDA said in a notice published last week in the Federal Register.

The EDC systems are heavily relied upon by researchers to capture clinical trial data. However, they are very different from the EHRs used by physicians, as their data models are disparate, according to the FDA. The new project announced by the agency will lead to a better understanding of the challenges and values that would come from linking EHR and EDC technology.

Although the FDA has not announced funding yet, officials did say that they would use interoperability standards commonly used with health IT to link the two systems. This will enable clinicians to auto-populate researchers' electronic study forms during the normal course of their workflow. 

The FDA is hoping to find that connecting the systems will decrease the amount of effort put into tasks like data entry and eliminate transcription mistakes through the ability to move information between various systems. Meanwhile, using standard-based technology could also work toward making the inspection and reconstruction of clinical investigations easier for the FDA. 

Which aspects need to be improved?
The standards for interoperability and data collection are different for EHR vendors and EDC developers. In order to increase interoperability between them, these standards must first be the same, according to Doug Fridsma, president and CEO of the Maryland-based American Medical Informatics Association and former chief science officer at the Office of the National Coordinator for Health Information Technology. 

Fridsma noted that this could mean some reconfiguring of older standards. He also suggested moving both clinician EHRs and EDC systems away from historic paradigms of documents, as they no longer make up the basic structure of health information exchange for either type of technology. Focusing more on specific data elements will push EHRs and EDCs in the right direction. 

In addition to interoperability, the FDA believes that the new program will also allow the pilot participants to consider other data needs, such as disease surveillance by the Centers for Disease Control and Prevention as well as local and state public health agencies. 

"The electronic capture of data from EHRs and healthcare devices, such as electrocardiogram management systems, digital imaging and mobile health devices, as well as electronic Patient Reported Outcomes Instruments, has the potential to improve the reliability, quality, traceability, provenance and integrity of data from electronic source to regulatory submission," the FDA stated in the notice.

Experts are projecting that if the FDA and its participants are successful, multiple worlds – patients, researchers and clinicians – that are largely separated will come together and enhance communication and engagement throughout the health care industry.