journal of biomedical informatics
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Consequences of the EU Ker-Optika Case for e-commerce in Physical Medical Devices and Apps for eHealth Services

Author(s): Erik Vollebregt

This article analyses the reasoning of the European Court with respect to the interpretation of the e-commerce directive and the free movement of goods provisions to the Internet sale of medical devices as goods in the Ker-Optika case. It draws conclusions from that analysis for e-commerce in medical devices as goods in the EU, which are extrapolated to the sale of medical devices as services such as apps for home treatment or monitoring in the context of eHealth services. The article finds that eHealth services constituting medical devices are regulated identically under EU law to physical medical devices and analyses the consequences of this.