Abstract
—This paper investigates legal approaches towards
protecting the data generated in medical research. One of the
core features of the rules for the processing and sharing of data
generated in medical research is their complexity. Thus, data
containing personally identifiable information would qualify as
personal data and the processing of such data would be subject
to the law on data protection. Equally, the generation of data in
the course of medical research may involve considerable
investment or effort and have an economic or scientific value for
the researcher or right holder, including through use in
publications, and may well be considered as Intellectual
Property (IP). Contractual approaches may also define the rules
how the data may be used and shared.
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