In early November, the FDA announced they were releasing the open source code and technical information for their MyStudies app. This app was developed and piloted by the FDA as a way for patients enrolled in a clinical trial to enter their own health data which would be matched with the electronic health record data from their trial. The combined data can then be used in the trial’s safety and efficacy assessments.
The agency is releasing the code to enable researchers and developers to customize and rebrand the app. Here are the important features from the website:
- “The data storage environment is secure and supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so it can be used for trials under Investigational New Drug oversight.”
- “The app is configurable for different therapeutic areas, and health outcomes, which reduces software development hurdles for non-FDA users.”
- “The data storage environment is partitioned to support multi-site trials or “distributed database” studies.”
- “The code for MyStudies will be open source so software developers can improve upon its capabilities.”
Source code for both iOS and Android is available, and additional code for enhancements will be released over the next several quarters. It will be interesting to see how the child apps evolve from the parent.
Text Copyright © 2018 Katrina Rogers