Cerner Enviza Collaborates with FDA to Develop Innovative AI Tools for Drug Safety and Real-World Evidence Studies

Rhea-AI Summary

Cerner Enviza, an Oracle company, in partnership with John Snow Labs, has been selected by the FDA's Sentinel Innovation Center to develop AI tools aimed at enhancing drug safety evaluations. This collaboration will focus on analyzing electronic health records (EHR) to better understand the effects of medications like montelukast. The two-year project, named MOSAIC-NLP, aims to leverage machine learning and natural language processing (NLP) for improved insights into patient outcomes, addressing limitations of traditional methods. The initiative is supported by clinical partners including Children’s Hospital of Orange County and Kaiser Permanente, and is seen as a critical step in advancing real-world evidence studies for drug safety.

Positive

• Collaboration with FDA's Sentinel Innovation Center enhances credibility and potential for impactful results.
• Project focuses on using AI and NLP to improve understanding of drug effects on large populations, particularly for montelukast.
• Involvement of multiple clinical partners strengthens research capabilities and data validation.

Negative

• Potential challenges in integrating AI tools into existing healthcare systems may delay effectiveness.
• Dependence on accurate EHR data might pose risks if data quality is compromised.

FDA's Sentinel Innovation Center chose Cerner Enviza and John Snow Labs for electronic health record and natural language processing expertise

AUSTIN, Texas, April 10, 2023 /PRNewswire/ -- 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.

To learn more about how Oracle is transforming healthcare, visit Booth #921 at the 2023 HIMSS Global Health Conference in Chicago, April 17-21, 2023 and book a meeting here.

About Oracle
Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at www.oracle.com.

Trademarks
Oracle, Java, MySQL and NetSuite are registered trademarks of Oracle Corporation. NetSuite was the first cloud company--ushering in the new era of cloud computing.

About John Snow Labs
John Snow Labs is an AI and NLP company that provides software, models, and data to help healthcare and life science organizations put AI to good use. The company is the developer of Spark NLP and host of the NLP Summit.

 

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SOURCE Oracle

FAQ

What is the goal of the Cerner Enviza and John Snow Labs project with the FDA?

The project aims to develop AI tools to enhance drug safety evaluations using electronic health records.

When was the collaboration between Cerner Enviza and the FDA announced?

The collaboration was announced on April 10, 2023.

What technology will be used in the MOSAIC-NLP project?

The project will utilize machine learning and natural language processing (NLP) to analyze EHR data.

What drug is specifically being studied in this project?

The project is focusing on the asthma drug montelukast and its potential mental health side effects.

Who are the other partners involved in the MOSAIC-NLP project?

The project involves partnerships with Children’s Hospital of Orange County, National Jewish Health, and Kaiser Permanente Washington Health Research Institute.