Biomedical Engineering Reference
In-Depth Information
needs to be de-identifi ed before leaving the hospital premises, so that it may
not be reassociated with a particular individual. The challenge of de-
identifi cation arises when the personal information is passed outside the orga-
nizational premises. For example, a personal health record transferred from a
medical center to a research center needs to be de-identifi ed since the medical
information contains personal information which is protected by the privacy
laws. Currently, there are quite a few algorithms to solve certain parts of the
de - identifi cation problem, although most of the algorithms are proprietary and
address only certain parts of the de-identifi cation task on a given health stan-
dard with given de-identifi cation rules.
18.8
CLINICAL E - MAIL SYSTEM
Good old e-mail will still play a role in the world of the new medicine, though
privacy and security become even more important for protection of personal
privacy and also nonrepudiation—an assured mechanism to prevent an indi-
vidual from denying one's involvement in an activity, whether it is a commer-
cial or legal transaction, and security audit become critical functions. In
addition, the network infrastructure needs to provide suffi cient bandwidth for
an exchange of large volumes of data such as medical images.
The electronic messaging system for electronic mail exchange among health
care professionals is referred to as a “clinical electronic mail” system. This
implies that management of “good old e-mail” has to be enhanced for clinical
use. When the electronic messaging or mail system is used among the health
care professionals, there is a set of unique additional requirements. This is
because health care professionals most likely exchange sensitive personal
information and so necessarily “disclose” (hopefully to an accredited recipi-
ent) personal information. Disclosure of such information is of course pro-
tected by the statutory requirements for protection of privacy, such as the
U.S. HIPAA, PIPEDA and FIPPA in Canada, and the EU Privacy Directive
in Europe. That does not mean that you can not send e-mail about a patient,
but it does mean that the appropriateness to do so is a matter which IT
can manage.
For clinical trials involving participants across multiple organizations and
multiple geographies, incompatible electronic mail systems may require a
signifi cant amount of time and effort to provide
gateway functions
for valida-
tion of credentials and transformation of messages among the disparate e-mail
systems. These are literally the systems that allow the e-mail in and out and in
theory at least let it in or out with censorship of parts of the e-mail. The
primary function is to assess the originator of a message and its validity and
integrity of the message.
For assurance of validity and integrity of messages, that is, to ensure that
the messages were sent from the legitimate sources and that the messages are
delivered to the intended destination without being tampered with, the fol-
lowing capabilities need to be provided for clinical e-mail systems:
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