Semantic Web-Based Information Systems: State-of-the-Art ...

Distributed Patient Identification Protocol 249
takes place during the second phase of the protocol when the requestor uses the
modified Retrieve Information for Display protocol to request and access clinical
documents for a specific patient. Correspondingly, there are two places at which
additional barriers can be installed in the protocol, barriers that will be opened
automatically or manually once the patient consent has been demonstrated to the
record repository:
• The requestor may deposit a proof of the patient consent at the RLS when initiating
the query. The RLS would make this document available only to those
record repositories that have been identified as matches in the record linkage
and request permission to report them back to the requestor. Only repositories
granting this permission would ever be reported to the requestor.
• The RID access to clinical documents for a specific candidate may require additional
authorisation at the repository site requiring a prior communication of
the proof of patient consent. It also would be possible to restrict access within
the RID protocol to specific documents or document types (e.g., radiology
reports).
Two different approaches for demonstrating patient consent are conceivable — the
use of a public key infrastructure (PKI) for patients or a conventional out-of-band
communication using possibly digitised letters, telephone, mail, or fax conversation.
A PKI for patients would allow for a solution of the issue of patient consent in a
fully digital manner by providing a digital signature of the patient authorising the
request. This, however, would require that certificates and security tokens for the
private key, such as smartcards, be issued for all patients. While a few countries,
including Belgium, Taiwan, and Germany, have plans for a PKI for the health care
sector (Dietzel & Riepe, 2004), there are no such plans in many other countries, and
there is no sign of a global or at least a European-wide harmonisation of these PKIs
(the European health insurance card does not include PKI functionality).
Since a PKI-based solution will not be available in the foreseeable future for
cross-border communication, a conventional approach needs to be supported. As
an example, the patient may be asked to sign a letter of consent at the requesting
health care institute, and a digitised copy of this letter could be deposited with the
RLS and made available to the record repositories for which matches were found
during the record linkage process. The data protection officer at each health care
institute operating a record repository would check the letter of consent and, if appropriate,
give permission to the RLS to report the location of the record repository
back to the requestor and grant access to certain clinical documents. In cases where
an original handwritten signature is legally required, the digitised document could
be accompanied by a contact address at the requesting health care institute where
a delivery of an original document (e.g., by express service) could be requested.
While it is not realistic to assume a working PKI for patients as a prerequisite to
a digital cross-border exchange of clinical records, a working PKI for the health
Copyright © 2007, Idea Group Inc. Copying or distributing in print or electronic forms without written permission
of Idea Group Inc. is prohibited.