Tuesday, November 26, 2024

FDA RFI: Data Requirements for Outpatient Prescription and Patient Level Drug Utilization Data

The Contractor shall provide the required personnel, materials, services, facilities, and otherwise do all things required for or incident to the performance of the work as described below.

Data Requirements for Outpatient Prescription and Patient Level Drug Utilization Data

  1. The Contractor shall provide continuous automated access to nationally-based, prescription-level outpatient information. The data shall include historic prescription information at a national level for trend analyses.
  2. The prescription-level data shall be a currently existing, commercially available, HIPAA-compliant product that shall provide immediate automated access
  3. Prescription-level data shall provide the ability of analyzing current and historical aggregate national and sub-national dispensed prescription information at a minimum of monthly-level, with the ability to aggregate data by time periods specified by the user. Patient-level data shall provide the ability to analyze unique patients utilizing drug products in an outpatient setting, with the capability of stratifying by patient age and sex. Patient-level data shall link to prescription-level data, allowing for the assessment of new versus continuing use of drugs…

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Jackie Gilbert
Jackie Gilbert
Jackie Gilbert is a Content Analyst for FedHealthIT and Author of 'Anything but COVID-19' on the Daily Take Newsletter for G2Xchange Health and FedCiv.

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