Recently, health insurance claims have regained the attention of the scientific community as
a source of real-world evidence in health care research and quality improvement. To date, very
few studies are available which investigate the validity of health insurance claims; these may
be affected by bias from several sources, such as possible upcoding of co-morbidities and
complications for reimbursement advantages. The IDOMENEO study investigates the inpatient
treatment of peripheral arterial disease (PAD) comprehensively using various data sources with
a consortium involving experts from health care research and data privacy, a large health
insurance fund, biostatisticians, jurists, and computer scientists. Prospective registry data
were collected from 30–40 vascular centres in Germany using the GermanVasc registry. In
addition, health insurance claims data were prospectively collected from BARMER, the second
largest health insurance fund in Germany. The consortium is currently developing a data privacy
compliant method of health insurance claims data validation, the methodological foundations of
which are described here.