Legal requirements on secondary use of medical data in the EU and USA – A case study

The use of secondary data in health care research has become a very important issue over the past few years. Data from the treatment context are being used for evaluation of medical data for external quality assurance, as well as to answer medical questions in the form of registers and research databases. Additionally, the establishment of electronic clinical systems like data warehouses provides new opportunities for the secondary use of clinical data. Because health data is among the most sensitive information about an individual, the data must be safeguarded from disclosure.