The 2026 Pillar Guide
Real-World Data: The 2026 Guide
Real-world data (RWD) is the health information collected outside clinical trials, during routine care and daily life, from records, claims, devices and more.
This guide covers what real-world data is, where it comes from, how it is used and what makes it fit for evidence, ahead of RWE Connect 2026 in Boston.
Free. Instant download. No obligation.
The definition
What Is Real-World Data?
Analysed, real-world data becomes real-world evidence. Under the FDA real-world evidence framework, established through the 21st Century Cures Act, fit-for-purpose real-world data now informs regulatory, payer and clinical decisions worldwide.
Clearing it up
Real-World Data vs Real-World Evidence
The two terms are used interchangeably, but they are not the same. One is the input, the other is the conclusion.
Real-World Data (RWD)
- The raw inputs
- EHR, claims, registries, devices, wearables
- Collected during routine care and daily life
- Describes what happened
Real-World Evidence (RWE)
- The analysed output
- Derived from studying real-world data
- Answers a clinical or economic question
- Informs a decision
Real-world data is the input; see the full real-world evidence guide for how it becomes evidence.
Where it comes from
The Sources of Real-World Data
Real-world data is only as strong as its sources. These are the main streams, each capturing a different slice of the patient picture.
See the real-world data companies that source and license these datasets.
Applications
How Real-World Data Is Used
The same source can answer very different questions. These are the decisions real-world data supports across the product lifecycle.
Fit for purpose
What Makes Real-World Data Fit for Evidence
Not all data can carry a decision. These are the qualities that separate decision-grade real-world data from the rest.
The state of the field
The State of Real-World Data in 2026
The data landscape is moving fast, and it decides what evidence is possible. These are the shifts defining real-world data in 2026, and themes at RWE Connect.
Who is in the room
Who Attends RWE Connect 2026
A senior, focused audience of the people who source, curate and apply real-world data.
Seniority is confirmed: 150+ attendees, around 60% at Director or VP level and above. The functional mix shown is indicative; confirmed registration splits are shared with sponsors from the live delegate list.
Glossary
Key Real-World Data Terms
Explore
The Real-World Data Ecosystem
The companies, platforms and methods that source real-world data and turn it into decisions. Explore the landscape and meet them in Boston.
Sponsor RWE Connect 2026
Meet the Real-World Data Buyers in Boston
RWE Connect 2026 brings 150+ real-world evidence, HEOR and data leaders together, around 60% at Director or VP level and above. Sponsors reach them directly.
RWE Connect 2026
Get the 2026 RWE Pipeline Report
The people, data and methods shaping real-world evidence, in one download. See the landscape ahead of two days in Boston.
- The 2026 RWE vendor and data landscape
- Where the field is heading
- How to take part in RWE Connect 2026
Free. Instant download. No obligation.
Real-World Data: Common Questions
What is real-world data?
Real-world data (RWD) is the health data collected outside conventional clinical trials, during routine care and daily life, including electronic health records, administrative claims, registries, tokenized and linked data, genomic data, and patient-generated and wearable data.
What is the difference between real-world data and real-world evidence?
Real-world data is the raw information collected during routine care and daily life. Real-world evidence is the analysed output: the clinical or economic conclusions derived from studying that data.
What are the main types of real-world data?
Electronic health records, administrative claims, disease and product registries, tokenized and linked data, genomic and molecular data, and patient-generated and wearable data.
What is tokenized or linked real-world data?
Tokenization replaces identifiers with a privacy-preserving token so the same patient can be connected across separate datasets, such as electronic health records, claims and labs, without sharing protected health information.
What makes real-world data fit for purpose?
Documented provenance and governance, sufficient scale and recency, linkage and interoperability, regulatory-grade quality, a representative population, and privacy compliance, all relevant to the research question.
What is the difference between structured and unstructured real-world data?
Structured data is coded and organized, such as diagnosis codes, labs and prescriptions. Unstructured data is free text, such as clinician notes and pathology reports, increasingly unlocked with natural language processing.
How is the quality of real-world data assessed?
By its relevance to the research question and its reliability: provenance, completeness, accuracy, consistency and documentation, assessed before a study begins.
Is real-world data identifiable?
Real-world data used for research is de-identified under standards such as HIPAA, and privacy-preserving techniques including tokenization allow linkage without exposing protected health information.
What is the OMOP common data model?
The OMOP common data model standardizes real-world data so it can be analysed consistently across different sources and networks.
How does real-world data support regulatory decisions?
Under the FDA real-world evidence framework, fit-for-purpose real-world data can support certain regulatory decisions such as label expansions and post-approval safety, alongside its wide use in HEOR, market access and pharmacovigilance.
What is RWE Connect 2026?
RWE Connect 2026 is a two-day real-world evidence summit in Boston bringing together the RWE, HEOR, data and analytics leaders who source and apply real-world data, with 40+ speakers and 150+ attendees.
When and where is RWE Connect 2026?
14 to 15 October 2026 at the Hampton Inn by Hilton, Boston Seaport District, Boston, MA.
