PROJECT SUMMARY Errors in the administration of children’s medication at home is a significant health problem which disproportionately affects individuals with low health literacy and limited English proficiency. As a result, multiple NIH-designated health disparities populations, including lower socioeconomic status (SES) and minority populations, have a higher incidence of children’s medication errors, which result in poor symptom control, risk of overdose, higher emergency department utilization, and hospitalization. Differences in child health can have a cumulative life-course effect contributing to further inequities in adulthood. Health literacy is a modifiable risk factor which has been shown to improve through digital health tools, including demonstrating a positive effect on child health outcomes through improved parental health literacy. As such, efforts to reduce health disparities in childhood can have a positive effect in adulthood. Pedia-Dose is developing a novel smart phone application that uses a combination of photo image recognition and a custom dosing calculator to instantly calculate an individual child’s over-the-counter (OTC) medication dose. In this Phase I proposal, we plan to use this proof of concept mobile app as the framework for a redesigned Pedia-Dose App targeting root causes of home medication errors to improve health literacy, expand access to high quality health information, and reduce children’s medication errors through the following aims: (1) Implement evidence-based digital innovations targeting root causes of medication errors to improve health literacy and expand access to health information for NIH-designated health disparities populations. (2.1) Conduct a simulated usability study comparing the Pedia- Dose App with traditional dosing tools in a diverse user population to validate this novel approach. (2.2) User feedback will be incorporated into a redesigned mobile app that is intuitive and culturally sensitive. (3) Work with an established regulatory consultant to prepare a pre-submission application to the FDA in preparation for a 510k application for regulatory approval as a mobile medical device. The Pedia-Dose Team has the backing of a wide range of institutional, regulatory, software development, and business partners to successfully complete this Phase I proposal. Successful development and validation of this novel approach providing real-time children’s medication dosing information at home has the potential to fundamentally change how parents and caregivers obtain information about children’s medication. By targeting root causes of medication errors to improve health literacy and expand access to high quality medical information, this project has the potential to positively impact the trajectory of an individual’s health throughout life, most notable for NIH-designated health disparities populations.