--- title: "RWD, Real-World Data | MedTech Terms" description: "Data relating to patient health status or care delivery routinely collected from sources other than traditional clinical trials, the inputs from which…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/rwd#term", "name": "Real-World Data", "alternateName": "RWD", "description": "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. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Real-World Data [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)RWD # 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 Cyber](/authors/christian-espinosa) Last 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](/terms/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](/terms/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](/terms/post-market-surveillance), label expansions, [Section 522](/terms/section-522) studies, and increasingly for premarket evidence in [De Novo](/terms/de-novo) and [PMA](/terms/pma) submissions. FDA's [RWE](/terms/real-world-evidence) 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. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Real-World Evidence(RWE) Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. ](/terms/real-world-evidence)[ Software & AI Data Governance (AI/ML) Policies, controls, and documentation for the data used to train, tune, and validate medical AI models. ](/terms/data-governance)[ Post-Market Post-Market Clinical Follow-up(PMCF) Proactive collection of clinical data on a CE-marked device to confirm safety and performance. ](/terms/pmcf)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 1. [1 FDA RWE Program Verified FDA · fda.gov ](https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence) 2. [2 Use of RWE for Medical Devices Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices) 3. [3 FDA - Clinical Trials and Human Subject Protection Verified FDA · fda.gov ](https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. 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On this term Category Clinical & Trials Acronym RWD Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=rwd) Learn in 60 seconds Card Lesson Quiz 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. - · 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. - · 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. Remember this Watch out: Conflating RWD with RWE, RWD is the input, RWE is the analytical conclusion. Related terms - [Real-World Evidence(RWE) ](/terms/real-world-evidence) - [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) - [Data Governance (AI/ML) ](/terms/data-governance) - [Wearables and Remote Patient Monitoring(RPM) ](/terms/wearables-rpm) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Decentralized Clinical Trial(DCT) ](/terms/decentralized-clinical-trial) - [Electronic Data Capture(EDC) ](/terms/edc) - [Sample Size and Statistical Power ](/terms/sample-size-power) - [Health Economics and Outcomes Research(HEOR) ](/terms/heor) - [RWE for Reimbursement ](/terms/real-world-evidence-reimbursement) - [Bayesian Trial Design ](/terms/bayesian-trial) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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