FDA’s Sentinel Innovation Center chose Cerner Enviza and John Snow Labs to Develop Innovative AI Tools for Drug Safety and Real-World Evidence Studies

Project will demonstrate how the use of machine learning and natural language processing (NLP) technology with unstructured EHR data may help fill gaps in drug safety knowledge.

Cerner Enviza, an Oracle company, along with John Snow Labs, are now helping support the U.S. Food and Drug Administration’s drug safety Sentinel Initiative. By developing artificial intelligence (AI) tools aimed at extracting critical information from clinical notes within electronic health records (EHR), Oracle and John Snow will aid the FDA in better understanding the effects of medicines on large populations. Looking at the asthma drug, montelukast, and its possibility of mental health side effects, this two-year project will demonstrate how the use of machine learning and natural language processing (NLP) technology with unstructured data may help fill gaps in knowledge.

Cerner Enviza leverages decades of life sciences expertise spanning commercial, real world, clinical and regulatory research. This includes working with a broad range of Oracle provider networks to help accelerate the discovery, development, and deployment of health insights and therapies. John Snow Labs is known for its AI and NLP in healthcare and is the developer of the Spark NLP library. Together, Cerner Enviza and John Snow Labs will develop a new methodology to enhance computerized queries, or phenotyping, of digital patient data and clinical notes to support pharmacoepidemiology.

Cerner Enviza, who will lead the team, was chosen by the Sentinel Innovation Center, who is headed by Mass General Brigham and Harvard Pilgrim Health Care Institute.

“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,” said Rishi Desai, Ph.D., Mass General Brigham executive leadership team member, Sentinel Innovation Center.

Traditional manual methods for analyzing clinician notes often can be a bottleneck for fully understanding the symptoms and outcomes that patients experience at the population level. However, advances in AI offer a scalable and transportable NLP processes.

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

“We are thrilled to team with Cerner Enviza to apply NLP in such an important real-world evidence project,” said David Talby, CTO, 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.”

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

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