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    Clinical & TrialsClinical EvidenceRWD

    Real-World Data

    Data relating to patient health status or care delivery routinely collected from sources other than traditional clinical trials, the inputs from which Real-World Evidence is derived.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    Definition

    Real-World Data (RWD) is data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources outside the traditional clinical trial setting. Sources include electronic health records (EHRs), medical claims and billing data, product and disease registries, patient-generated data from wearables and patient-reported outcome instruments, and data gathered from other sources such as mobile devices. RWD is distinct from Real-World Evidence (RWE), which is the clinical evidence about a medical product's usage, benefits, or risks derived from analysis of RWD.
    What the regulation says
    FDA's 'Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products' guidance and 'Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices' guidance set the methodological expectations.

    What this means in practice

    RWD has become foundational for post-market surveillance, label expansions, Section 522 studies, and increasingly for premarket evidence in De Novo and PMA submissions. FDA's RWE Program (mandated by 21st Century Cures Act §3022) provides framework guidance. The quality of RWD matters enormously: data provenance, relevance to the clinical question, completeness, and fitness for the regulatory purpose are what distinguish usable RWD from data that won't withstand FDA review.
    Common pitfalls
    • •Conflating RWD with RWE, RWD is the input, RWE is the analytical conclusion.
    • •Assuming claims data alone supports clinical effectiveness conclusions, claims rarely capture outcomes; usually claims + EHR linkage is needed.
    • •Treating wearable or patient-generated data as ready for regulatory submission without validation of the underlying sensors and data pipeline.

    Primary references

    3 sources
    Link health: 3 bot-blocked· last checked 2026-06-20
    1. 1
      FDA RWE Program
      Bot-blocked
      FDAfda.gov
    2. 2
      Use of RWE for Medical Devices Guidance
      Bot-blocked
      FDAfda.gov
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Bot-blocked
      FDAfda.gov

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