Legislation for Open-Source Medical Devices: Current Scenario, Risks and Possibilities

Since the appearance of its first definition at the end of the 1990s, the open-source (OS) approach to software technology embodied a different way of conceiving our life on the Internet and a new route for researchers. The sharing of individuals’ ideas as a way of improving knowledge, the encounter of minds made possible by the openness and the impulse of maximizing individual potentialities would constitute the background for the construction of a digital environment in which innovation is truly at once the motor and the aim. The availability of flexible licensing method – preferred to rigid proprietary schemes – is the juridical translation of this “philosophy of the openness”, with considerable advantages whenever an OS software is applied to a related hardware. The interaction of many people who work on the same source code eases the process of innovation: since the costs in terms of money and time are cut, the costs of end products can be sensibly reduced too.