The term Real World Data is a technical term and is more specific than it sounds. A less catchy but more informative term would be non-clinical trial health data. That is, “real world” contrasts with clinical trials. Not that clinical trials take place in a fictional world, but they do take place in a more restrictive environment than most health care.
Real World Data would include things like electronic health records (EHR) and insurance claims data, data generated from the ordinary course of medical treatment rather than in a controlled scientific study.
Data from randomized controlled trials (RCTs) is great when you can get it. Researchers try to minimize confounding effects and isolate the thing being studied. But maybe nobody has done an RCT to study what you’re interested in. There’s a lot more data out there in the form of claims data than data from RCTs.
Real World Data may even be better than RCT data. In order to conduct an RCT, researchers create a necessarily artificial environment. Patients may be more compliant, for example, while participating in a clinical trial than they would be if they have to pick up their prescriptions from a pharmacy.
Real World Data is typically covered under HIPAA, and so you may need an expert determination in order to use the data. We help clients with this routinely. If you need a HIPAA expert determination, you can contact us to set up a free consultation to discuss your needs. We have helped many companies, large and small, to comply with the HIPAA Privacy Rule via expert determination.
Sometimes data does not need an expert determination because it is covered under HIPAA’s Safe Harbor provision. However, the restrictions of Safe Harbor are typically too restrictive to make the use of real world data practical. Aside from the 18 explicit rules for Safe Harbor, there is an implicit requirement, informally known as the 19th rule, that can be subtle.
The use of real world data involves statistical and legal issues. We are statisticians, not lawyers, but we routinely work with lawyers. We can work with your counsel, or suggest a health care/privacy attorney that you may want to work with.