Imputing deductibles in claims data

Many researchers are interested in how cost sharing impacts health care utilization, cost and patient outcomes. This is especially true as high-deductible health plans (HDHP) have become more common in the US. In 2023, 29% of covered workers in the US had a HDHP. One helpful type of data for analyzing HDHPs is claims data.…

Did President Biden backtrack on his pledge for increased public access to Medicare data?

The Biden Administration promised more access to Medicare data. Then the reverse happened. ProPublica explains: In January, the Biden administration pledged to increase public access to a wide array of Medicare information to improve health care for America’s most sick and vulnerable. Some Medicare plans’ lack of transparency “deprives researchers and doctors of critical data…

HARmonized Protocol Template to Enhance Reproducibility (HARPER)

Clinical trials have detailed study protocols and are registered on ClinicalTrials.gov. What level of details are needed for real-world data (RWD) analyses that aim to estimate treatment effects? In Europe, the European Medicines Agency (EMA) requires registration of many study protocols using a template for observational post-authorization safety studies (PASS) conducted by marketing authorization holders.…

What is DARWIN EU?

Real-world data is becoming increasingly important as the amount of data generation increases as does the speed of data processing. In the US, the 21st Century Cures Act was enacted in December 2016 and mandated that the Food and Drug Administration (FDA) create a framework for evaluating the use of real-world data help support the…