Information Technology Reference
In-Depth Information
However, there are also barriers to overcome. There are hospitals that have
limited internet access from the internal network. Due to security reasons, they
protect their internal networks, by limiting the open ports or directly disconnecting
production equipments from Internet. E-IMRT solution uses standard web ports to
avoid this barrier when there is limited connectivity and implements secure methods
to facilitate the acceptation from the internal network managers. In the case of zero
connectivity, the solution can be sold as a product, but this reduces its functionality
(for example, the hospital cannot rent CPUs dynamically and has to adapt to its
internal capacity).
Secondly, e-IMRT is introducing a new way to use computing technology into
the hospitals. Remote services are not a new concept. However, they are new in the
sector which uses mainly local workstations (TPS) to plan the treatments. Usually,
they are very conservative in the introduction of new methods and appliances, and
they have to demonstrate clear benefits before deploying them. So, it is necessary to
convince the hospital managers about their benefits and the availability of the solu-
tion when it is needed. A schema of 7x24 provision must be taken into account in
the business model and in the basic infrastructure. To overcome this initial barrier,
e-IMRT services have been designed as complementary tools to the existing TPS
and do not substitute it. This decreases the risk of initial rejection by the users. At
the beginning, the services can be used only in complex cases to advise the medical
physicists and maybe later, when they trust in the platform results and have enough
experience using it, it can be included in the internal protocols.
A third barrier is the legal regulation. Currently it is not clear if an external
service like the e-IMRT must be approved by the health authorities before being
used in production. There is a new European Directive (2007/47/EC, which modi-
fies 93/42/EEC), which includes software as a medical device in specific cases:
“medical device means any instrument, apparatus, appliance, software, material or
other article, whether used alone or in combination, together with any accessories,
including the software intended by its manufacturer to be used specifically for diag-
nostic and/or therapeutic purposes and necessary for its proper application, intended
by the manufacturer to be used for human beings” (Directive 2007/47/EC). Being
conservative, it is better to apply for the FDA clearance and the CE Mark and try
to follow the strictest regulation. It includes the need of software quality assurance
processes, for example, implementing ISO standards. When this has been done,
the service will be better accepted by the final users. However, the regulation adds
another issue against the usual methods in remote service provisioning: it limits the
continuous evolution and improvement of the platform. New methods and services
must wait for the approval by the authorities and, additionally, the platform must
be prepared to have several versions running simultaneously: the hospitals cannot
migrate automatically and transparently from one version to another, because they
must validate the new software stack. E-IMRT has implemented this possibility, and
the user can select the version of the software or the type of algorithm to be used
for each treatment plan, from among those that have been validated by the hospital
leader.
