In this Deliverable raw device data are seen as the electronic signals which a device generates before
they are via software translated into human intelligible data. This Deliverable discusses the legal
possibilities to open up such raw data for research outside the context of a research plan and consortium
agreement where the manufacturers had agreed in advance that the raw data would be shared. Such
projects are rare while with the digital transformation in health care more and more devices will come
onto the market. There will always be a certain loss of information in the translation of raw data into
human intelligible data. The Deliverable assumes that in certain research projects one would need the
full data for a better clinical understanding or simply to control the software which translates raw data
to the human understandable data or clinical interventions as happens which devices such as ICD’s.
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