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.


CONCLUSIONS
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.
Peter L. Reichertz Institute for Medical Informatics, University of Braunschweig - Institute of Technology and Hannover Medical School, Germany.
Jonas
J
Schwartze
Birger
B
Haarbrandt
Maike
M
Rochon
Markus
M
Wagner
Reinhold
R
Haux
Thorsten
T
Kleinschmidt
Maik
M
Plischke
Christoph
C
Seidel
D016494:Computer Security / Q000592:standards*; D003219:Confidentiality / Q000592:standards*; D032962:Consent Forms / Q000592:standards*; D005858:Germany; D066275:Health Information Exchange / Q000592:standards*; D008498:Medical Record Linkage / Q000592:standards*; D017410:Practice Guidelines as Topic; D014584:User-Computer Interface