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(53)
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It is also important to clarify that there may be specific cases in which AI
systems referred to in pre-defined areas specified in this Regulation do not lead to
a significant risk of harm to the legal interests protected under those areas because they
do not materially influence the decision-making or do not harm those interests substantially.
For the purposes of this Regulation, an AI system that does not materially influence the outcome
of decision-making should be understood to be an AI system that does not have an impact on the
substance, and thereby the outcome, of decision-making, whether human or automated. An AI system
that does not materially influence the outcome of decision-making could include situations in
which one or more of the following conditions are fulfilled. The first such condition should be
that the AI system is intended to perform a narrow procedural task, such as an AI system
that transforms unstructured data into structured data, an AI system that classifies incoming
documents into categories or an AI system that is used to detect duplicates among a large
number of applications. Those tasks are of such narrow and limited nature that they pose only
limited risks which are not increased through the use of an AI system in a context that is
listed as a high-risk use in an annex to this Regulation. The second condition should be
that the task performed by the AI system is intended to improve the result of a previously
completed human activity that may be relevant for the purposes of the high-risk uses listed in
an annex to this Regulation. Considering those characteristics, the AI system provides only an
additional layer to a human activity with consequently lowered risk. That condition would,
for example, apply to AI systems that are intended to improve the language used in previously
drafted documents, for example in relation to professional tone, academic style of language or
by aligning text to a certain brand messaging. The third condition should be that the AI
system is intended to detect decision-making patterns or deviations from prior decision-making
patterns. The risk would be lowered because the use of the AI system follows a previously
completed human assessment which it is not meant to replace or influence, without proper human
review. Such AI systems include for instance those that, given a certain grading pattern of
a teacher, can be used to check ex post whether the teacher
may have deviated from the grading pattern so as to flag potential inconsistencies or anomalies.
The fourth condition should be that the AI system is intended to perform a task that is
only preparatory to an assessment relevant for the purposes of the AI systems listed in an annex
to this Regulation, thus making the possible impact of the output of the system very low in
terms of representing a risk for the assessment to follow. That condition covers, inter
alia, smart solutions for file handling, which include various functions from indexing,
searching, text and speech processing or linking data to other data sources, or AI systems used
for translation of initial documents. In any case, AI systems used in high-risk use-cases listed
in an annex to this Regulation should be considered to pose significant risks of harm to the
health, safety or fundamental rights if the AI system implies profiling within the meaning of
Article 4, point (4) of Regulation (EU) 2016/679 or Article 3, point (4) of
Directive (EU) 2016/680 or Article 3, point (5) of Regulation (EU) 2018/1725. To ensure
traceability and transparency, a provider who considers that an AI system is not high-risk
on the basis of the conditions referred to above should draw up documentation of the assessment
before that system is placed on the market or put into service and should provide that
documentation to national competent authorities upon request. Such a provider should be
obliged to register the AI system in the EU database established under this Regulation. With
a view to providing further guidance for the practical implementation of the conditions
under which the AI systems listed in an annex to this Regulation are, on an exceptional basis,
non-high-risk, the Commission should, after consulting the Board, provide guidelines specifying
that practical implementation, completed by a comprehensive list of practical examples of
use cases of AI systems that are high-risk and use cases that are not.
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