80 PART III Rollout of an HCM
✔✔Selection of which data to archive. Since an HCM system should contain
all medical data for a case, there is usually also data present that does not
require archiving. You must therefore decide in advance which data must
be archived. For example, several formats of the same document will exist
in the HCM system, and only one must be archived. As a rule, this should
be the original format, but there are exceptions. For Word documents, for
example, it may be sensible to prefer a format that can be archived longterm
(PDF/A). It is also worth considering archiving data that has been
handed over digitally to recipients outside the healthcare facility.
Remember to coordinate your archiving concept with the data protection expert
in your company and with the management. The next step is execution, which
you either carry out yourself or commission a service provider with. But you
should always remain at the helm. You cannot delegate the responsibility for the
success of the implementation. The same applies to completion: the validation.
Put the established archive through its paces. Do not forget that releasing data
from the archive is also an important factor. If this takes too long, problems will
arise in day-to-day operations.
Also double-check whether data on the WORM really cannot be altered
or deleted; for example, due to incorrect configuration. Can the
HCM system send deletion requests to the WORM during normal
operation? That would be bad. If the WORM works, nothing happens.
If the WORM is switched to rewritable for whatever reason,
you will have a serious problem. So let your imagination run free during
testing. If the test is carried out faster than the setup, you have
not tested thoroughly enough. It is also good practice to create a validation
plan in which you specify in advance how and at what intervals
you will verify the archiving.
Step four: access authorization
For reasons of data protection, users may only access the medical data of a patient
case if they are in a treatment context for this patient. For practical reasons, data
protection law envisages not linking access rights to individual users, but to user
groups that have the same tasks in the same department. As an example, this
would apply to all physicians in a specific department.
Furthermore, there is data of particular importance for protection. This can
originate
from patients with special status or from specific data of a regular
patient
who has an increased need for protection. Before going live, you should
ensure that such cases are taken into account. You therefore also need a good
concept for access authorizations.