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Health data in a system of intellectual property rights

Publikation: Qualifikations-/Studienabschlussarbeit › Dissertation

Autorschaft

  • Iryna Lishchuk

Organisationseinheiten

Details

OriginalspracheEnglisch
QualifikationDoctor iuris
Gradverleihende Hochschule
Betreut von
  • Nikolaus Forgó, Betreuer*in
Datum der Verleihung des Grades7 März 2024
ErscheinungsortHannover
PublikationsstatusVeröffentlicht - 6 März 2025

Abstract

Das Konzept vom Datenaustausch ist schön. Das gilt insbesondere für die Gesundheitsdaten – eine Ressource von einem hohen wirtschaftlichen Wert i.a. für die Politikgestaltung, die Patientensicherheit und Innovation. Die Eröffnung der Möglichkeiten für die Verarbeitung personenbezogener Gesundheitsdaten für die Forschung durch die DSGVO hat die datengetriebene Innovation und Schutz der R&D-Outputs durch Rechte des Geistigen Eigentums hervorgebracht. Insbesondere relevant sind Sui-generis Rechte an Datenbanken, Software-Urheberrechte, datengenerierende Patente und das Schutzregime vertraulichen Know-hows. Als Belohnung für Innovationen erhält die R&D exklusive Rechte des Geistigen Eigentums an R&D-Outputs, die wirtschaftlich und exklusiv von der Rechtsnatur sind. Im Gegensatz dazu, haben die Dateninhaber, typisch aus dem medizinischen Sektor, die Daten für die Forschung bereitstellen, durch die personenbezogene Natur der Gesundheitsdaten keine anerkannten Eigentums- oder ausschließlichen Rechte an den Daten ut sic und können solche Rechte nicht gegen Rechte des Geistigen Eigentums an datenbasierten R&D-Outputs austauschen, als Belohnung für diejenigen, die in die Datenübergabe für die Forschung eingewilligt haben. Aus wirtschaftlicher Sicht, wenn die Vermögensrechte an einer wertvollen Ressource nicht oder schlecht verteilt sind, kann der Ressource-Inhaber via faktischer Exklusivität an der Ressource de facto ausschließliche Rechte an der Ressource geltend machen und diese Rechte vertraglich austauschen. Vor dem gegebenen Hintergrund untersucht die Dissertation die rechtlichen Voraussetzungen, unter denen die Dateninhaber via technische und vertragliche Mittel faktische Exklusivität an den Gesundheitsdatensätzen verschaffen können, faktische ausschließliche Rechte geltend machen und diese via unechten Lizenzen in die R&D eintauschen können. Die Dissertation untersucht und schlägt das vertragliche Modell der Daten als Gegenleistung, nämlich „Daten als unechte Lizenz gegen IP-Lizenz an datenbasierten R&D-Outputs“ in Analogie zur Kreuzlizenzierung im IP-Recht vor. Im Rahmen des Europäischen Gesundheitsdatenraums und Minderung der Transaktionskosten, alsbald die Rechte an den Gesundheitsdaten spezifisch und übertragbar formiert sind soll laut Coase Theorem eine effiziente Verteilung der Gesundheitsdaten zwischen Gesundheitssektor und R&D ermöglichen.

Zitieren

Health data in a system of intellectual property rights. / Lishchuk, Iryna.
Hannover, 2025. 307 S.

Publikation: Qualifikations-/Studienabschlussarbeit › Dissertation

Lishchuk, I 2025, 'Health data in a system of intellectual property rights', Doctor iuris, Gottfried Wilhelm Leibniz Universität Hannover, Hannover. https://doi.org/10.15488/18642
Lishchuk, I. (2025). Health data in a system of intellectual property rights. [Dissertation, Gottfried Wilhelm Leibniz Universität Hannover]. https://doi.org/10.15488/18642
Lishchuk I. Health data in a system of intellectual property rights. Hannover, 2025. 307 S. doi: 10.15488/18642
Lishchuk, Iryna. / Health data in a system of intellectual property rights. Hannover, 2025. 307 S.
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abstract = "The concept of data sharing is beautiful. It is particularly true in relation to health data – a resource of high economic value for the policymaking, patient safety and innovation. As the GDPR created avenues for the processing of personal health data for research, it gave rise to data-driven innovation and creation of data-driven outputs protectable by IP rights. In particular, sui generis rights in databases, software copyrights, data generating patents and the legal regime of undisclosed information are or relevance. As a reward for innovation, the R&D obtain exclusive IP rights protecting data-driven R&D outcomes, economic and exclusive by nature. By contrast, due to the nature of health data as personal data, the data holders from the medical sector, who provide health data into research do not have any property-like or exclusive legal rights in data as such and cannot exchange such rights against IP rights in data-driven outcomes to reward subjects who agreed to share the data. From economic perspective, when property rights in a resource of high economic value are not defined or ill-defined, the holder of de facto exclusivity over a resource will be able to effectuate de facto property rights in the resource and exchange such rights by a contract. Against the given legal and economic background, the thesis examines the legal premises on which the data holders, who by virtue of technical and contractual means, can ensure factual exclusivity over the health data sets, effectuate de facto exclusive rights and share into R&D by virtue of untrue licenses. The thesis explores and proposes the contractual reciprocal data sharing model “data as untrue license against IP license in data-driven R&D outcomes” in analogy to cross-licensing in IP law. In the context of the creation of the European Health Data Space, what should lower the transaction costs, once the rights formed in relation to health data are clearly distinct and assignable, shall according to Coase theorem render the efficient allocation of health data as a resource between medical sector and R&D.",
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