Design and implementation of an informed consent process for a standardized health information exchange solution on the example of the lower saxony bank of health.

OBJECTIVE: Multicenter medical treatment requires health related data to be available across institutions. Since health information exchange solutions are emergent, fulfillment of privacy needs, including patients' informed consent, is vital for successful data exchange.
METHODS: We designed a software supported consent process for the recently founded Lower Saxony Bank of Health (LSBH) with regard to particularities of German law. To implement the application, web technologies and well-described interfaces to IHE XDS profile components have been used.
RESULTS: A two staged process has been developed. A special consent application creates a customized form containing all orally given constraints defined by the patient. The form is printed out and signed by the patient while an electronic policy is created and registered at the LSBH.
CONCLUSION: The process completely reflects a conventional informed consent procedure but increases simplicity, clarity and understandability of the consent form. Technical and legal restrictions in Germany create a media split becoming a media crack in some environments. Availability of signature cards could improve the process by making it completely electronic.