Cerner Enviza, a company of Oracle, together with healthcare AI company John Snow Labs, is set to support the US Food and Drug Administration’s drug safety initiative, Sentinel.

Sentinel is the FDA’s national electronic system which helps researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices.

The two-year project, dubbed Multi-source Observational Safety Study for Advanced Information Classification Using NLP (MOSAIC-NLP), will be led by Cerner Enviza.

Under the MOSAIC-NLP project, the two companies will develop AI tools for extracting key information from clinical notes within electronic health records (EHR).

The project will also use machine learning and natural language processing (NLP) technology to help FDA better understand the effects of medicines on large populations.

The MOSAIC-NLP project will initially evaluate the asthma drug, montelukast, and its possibility of mental health side effects.

Cerner Enviza global head Mike Kelly said: “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.

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

John Snow Labs CTO David Talby said: “We’re honoured 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.”

For the MOSAIC-NLP project, Cerner Enviza will leverage its decades of life sciences expertise across commercial, real-world, clinical and regulatory research.

It will work with a wide range of Oracle provider networks to help advance the discovery, development, and deployment of health insights and therapies.

John Snow Labs is focused on healthcare AI and NLP and has developed the Spark NLP library.

The two companies will jointly develop a new methodology to enhance computerised queries, or phenotyping, of digital patient data and clinical notes to support pharmacoepidemiology.

Cerner Enviza was selected by the Sentinel Innovation Center, headed by Mass General Brigham and Harvard Pilgrim Health Care Institute.

Sentinel Innovation Center Mass General Brigham executive leadership team member Rishi Desai said: “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. We look forward to this new relationship and exciting initiative led by Cerner Enviza.”

Furthermore, the Children’s Hospital of Orange County, National Jewish Health, and Kaiser Permanente Washington Health Research Institute will support the project.