1. User's Guide
  2. What can I do with Oracle Healthcare Translational Research?
  3. Regulatory Compliance

Regulatory Compliance

Oracle Healthcare Translational Research is developed with HIPAA regulations in mind. It includes obfuscation rules to protect any patient-identifiable information. Oracle Healthcare Translational Research development also follows the software development guidelines and requirements for FDA 21 CFR Part 11 compliant software.

The origin of any data stored in CDM must be traceable to its source, and all transformations applied to the data must be accessible.

The standard Oracle ADF logger is applied for logging, and by default, it is written in WebLogic diagnostic logs. Logging focuses on the following areas:

  • SQL queries to retrieve cohort count or list and event data - These are constructed dynamically based on user input and may need to be tracked for debugging and diagnostic purposes.
  • DML operation of saved queries - Unlike other parts of the UI that handle read-only data, saving queries writes data into database tables, and the operations are logged.

Parent topic: What can I do with Oracle Healthcare Translational Research?