The management of clinical documentation obtained in digital format deserves a separate chapter. Here is a series of regulatory guidelines for operators of both public and private health facilities.
The process of managing the entire life cycle
of health documentation and the production of clinical documents in the form of
images occupies a strategic place in digital health. It is essential to apply
the current legislation taking into account the technological development and
the state of the art of entities and institutions in the sector. For this we
will provide a unitary reference, at national level, with practical indications
for the radiologists and the staff involved in the processes in question.
It is important that every aspect of management
is monitored by specific IT mechanisms, in order to be able to apply metadata
to each IT document and record the logs of all the activities carried out
subsequently. Client server based system is more popular system for document storage.
A
premise:
This article will not analyze the
dematerialization of pre-existing analogue and / or digital archives , both
textual and iconographic, due to the different types of formats, often
non-standard, in use by the sector administrations.
The information provided below is addressed to
both public and private health facilities and is directed to the General
Managers, the Health Directors, the Directors / Managers of Information Systems
and the Departments and Operating Units of Diagnostic Imaging, Radiology and
Nuclear Medicine for the management of clinical documentation, obtained
directly in digital format.
· The medical report is to be considered a
document in the same way as a "private writing" and must be composed
of a written declaration, coming from the person concerned and signed by the
latter pursuant.
· Pursuant to the Digital Administration Code,
the digitally signed electronic document has probative value in the same way as
the paper document signed in autograph mode.
· By radiological report we mean the medical
report; by radiological documents we mean images. It is believed that, except
in emergency cases and / or regulated by specific protocols, the images and the
report must be made available at the same time immediately after the digital
signature of the report itself.
Furthermore, as regards the structured report,
it must be kept indefinitely with the selected and linked images.
Metadata
and logs in diagnostic imaging
Therefore, for an adequate management of the
dematerialized Diagnostic Imaging documents , it is desirable to implement a
series of technical measures to ensure the correctness of the procedures and
the control of the processes, measures that are already subject to regulations
( GDPR ) and which must therefore be prepared for the protection of both
patients and operators.
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