Digitalisering af sundhedssektoren: En analyse af den retlige kvalifikation og gevinstfordeling i et tværorganisatorisk samarbejde

Abstrakt

This Master’s thesis examines the implementation of software as digital solutions in the healthcare sector, from the point of view of the private tech-company providing the solutions. The thesis includes an analysis of the scopes of use of 1) treatment, 2) statistical purpose and quality development, and 3) research, for assessing the legal qualification of a digital solution. The legal qualification is of significant importance due to the complexity of the regulation in the area of software in the healthcare industry, namely with respect to the collection and processing of personal data. The scope of use is crucial for the assessment of which rules apply to the digital solution in question and hereby to the software provider. The legal qualification additionally includes an assessment of the circumstances under which the digital solution can be considered a medical device in accordance with the medical device regulation. Based on the elements of strategic contracting, the theory of relational rent is included to analyze the possible additional value generated from inter-organizational collaborative relationships. An agreement concerning the digitalization of public healthcare, necessitates the inclusion of the perspective of the public health authorities and the relevance of the public interest and cost efficiency. For the private party there is a clear incentive of collaboration due to the basic assumption of profit maximization. In regard to the contracting aspect of the collaboration, the parties are recommended to establish proactive contractual clauses ex ante, to ensure the longevity and profitability of the collaboration agreement. When establishing the distribution of copyrights of the final digital solution for commercial exploitation, the parties’ respective contribution for the collaboration should be taken into account. From a commercialization perspective, it is argued that TechNordic A/S is most suitable to be commercializing the final product, and thus should keep the copyrights. Finally, the commercial exploitation opportunities of the software, and relevant business models for the different scopes of application of the software, are analyzed in a sequential order, from the stage of precompetitive development to the absolute commercial exploitation stage. The models take into account the value-proposition for possible stakeholders, in the assessment of possible funding options for the solution.