Below is Cerner’s statement to the Investigative Fund regarding adverse event reports submitted to the FDA about its health information technology devices.

The FDA actively regulates some Cerner solutions as medical devices. As a result, these solutions are subject to the regulations imposed by the FDA under the Food, Drug and Cosmetics Act. Other Cerner solutions are not actively regulated by the FDA and are not subject to these regulatory obligations. Over the last decade, however, Cerner has voluntarily implemented post-market surveillance processes in accordance with the FDA regulations and has publicly disclosed issues that might impact public safety by reporting through the FDA’s MedWatch program. These reports are part of the public record. Cerner is one of the few HIT suppliers in the U.S. that voluntarily reports safety related incidents for non-FDA regulated medical devices. Cerner believes such disclosures provide much-needed transparency into the successes and challenges of these types of systems.

Additionally, Cerner has an internal process for all client complaints. We continue to follow this process that has been in place for many years and investigate all claims Cerner receives or are filed with the FDA.

• Related Topics: Electronic Medical Records, Electronic Medical Records

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