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  1. Science and Research Special Topics

Digital Health Technologies for Drug Development: Demonstration Projects

To promote shared learning and understanding with external stakeholders, FDA continues to oversee and support numerous demonstration (i.e., research) projects on Digital Health Technologies (DHTs) through multiple venues and programs including FDA’s Broad Agency Announcement, CERSI Program, and other funding opportunities.

Below lists some of our current FDA-funded projects on DHTs:

  • Using mHealth to Measure Impact in Functionality Behavior, Activity and Sleep Patterns in Children and Adolescents Treated with Psychotropics

    CERSI Program: University of Maryland

    Project Description: This project aims to leverage the power of mobile technology to address three primary objectives: (1) fill the gap in the capture of behavioral, functional and activity data; (2) ease the burden on patients, caregivers, and providers struggling to capture relevant and actionable data related to treatment and care management; (3) identify severity of behavioral changes after treatment initiation or change, rates of adverse events/secondary effects, along with patterns of medication use and adherence. The ultimate goal is to integrate these data with larger data systems and existing data sources to support changes in labeling or in practice patterns.

  • Evaluation Mobile Health Tool Use for Capturing Patient-Centered Outcome Measures in Heart Failure Patients

    CERSI Program: Yale-Mayo

    Project Description: The goal of this project is to test the feasibility and reliability of capturing quantifiable measures of functional capacity and quality of life (QoL) using a wearable sensor in heart failure (HF) patients for a period of 60 days. Acute Decompensated Heart Failure (ADHF) patients will be recruited post-discharge from the National Heart Centre and National University Hospital in Singapore. Patients will be monitored at home using the Biofourmis' BiovitalsHF™ platform which will capture biosensor data from two wearable devices: Everion® and Apple Watch Series 4. Patients will also use the BiovitalsHF™ smartphone application to capture electronic patient reported outcomes (ePROs) such as medication adherence, symptoms, the Kansas City Cardiomyopathy Questionnaire (KCCQ) responses, and perform the guided mobile-based 2-minute-step-test.

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