ABSTRACT
Hospital AI applications can be developed in several different ways: they can be developed by an external software development company (SDC), they can be developed internally in the hospital, or a hospital can work together with an SDC to jointly develop an AI application. The chosen arrangement has ramifications for the liability of the involved parties. The EU product liability directive, for example, hinges on considerations such as when the product is released to the market, which party qualifies as manufacturer, which level of control the manufacturer has over the released product and what constitutes a substantial modification of the product. As the directive is aimed at maximum harmonization across the EU, designating a party as manufacturer could have large effects both up and down the value chain, and on the competence of Member States to operate concurrent national regimes.
The contribution of this paper is threefold: (i) further the conceptual understanding of the key concepts of market release, manufacturer, substantial modification, manufacturer’s control, open-source software and component/related service as regards co-creation of medical AI, (ii) study how involved parties could contractually shape these concepts, and (iii) analyse whether the rationale underlying the PLD is compatible with a value chain perspective through reviewing the impact such concepts and agreements could have on related claims along the value chain and on concurrent national regimes.
van Staalduinen, Jan H, Is There a Manufacturer in the House? On Contractually Shaping European Product Liability for Co-Created Medical AI (August 4, 2025).
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