FDA Selects Cerner Enviza to Develop EHR AI Tools for Drug Safety

FDA’s Sentinel Innovation Center has partnered with John Snow Labs and Cerner Enviza, an Oracle company, to create AI tools to extract critical information from EHR notes for improved drug safety.

The companies will develop a new methodology to support automated queries, or phenotyping, of patient data and clinical notes for pharmacoepidemiology. The two-year project will focus on the asthma drug montelukast and its possibility of mental health side effects.

“Development and evaluation of tools that can enhance our ability to utilize unstructured EHR data is a key strategic priority for the Sentinel Innovation Center,” Rishi Desai, PhD, Mass General Brigham executive leadership team member, Sentinel Innovation Center, said in a press release. “We look forward to this new relationship and exciting initiative led by Cerner Enviza.”

Traditional methods for analyzing clinician notes can be cumbersome for fully understanding the symptoms and outcomes that patients experience at the population level. However, recent advances in AI technology offer a scalable and transportable NLP process. 

“This is an incredible opportunity to work with these exceptional leaders to use Oracle’s de-identified EHR data to help transform unstructured clinical notes into validated and useable data for physicians and researchers,” said Mike Kelly, global head of Cerner Enviza.

“Connected technologies and unified data can accelerate innovation and, in turn, help providers realize better recommendations and outcomes for their patients,” Kelly added.

The project, known as the Multi-source Observational Safety Study for Advanced Information Classification Using NLP (MOSAIC-NLP), is also supported by participation from: Children’s Hospital of Orange County; National Jewish Health; and Kaiser Permanente Washington Health Research Institute, which will provide clinical expertise and consulting.

“We are thrilled to team with Cerner Enviza to apply NLP in such an important real-world evidence project,” said David Talby, CTO of John Snow Labs. “We’re honored by the Sentinel Innovation Center’s vote of confidence in our joint ability to help investigate this use case. Together, Cerner Enviza and John Snow Labs have all the right expertise, data, and technology to make it happen.”