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Gesetzgebung für Open-Source-Medizinprodukte: Aktuelles Szenario, Risiken und Möglichkeiten

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Entwicklung von Open-Source-Medizinprodukten

Zusammenfassung

Seit dem Erscheinen seiner ersten Definition Ende der 1990er-Jahre verkörperte der Open-Source-Ansatz (OS-Ansatz) in der Softwaretechnologie eine andere Art, unser Leben im Internet zu begreifen, und einen neuen Weg für die Forscher. Die gemeinsame Nutzung der Ideen von Einzelpersonen als Mittel zur Verbesserung des Wissens, die durch die offene Begegnung von Köpfen und der Impuls, die individuellen Möglichkeiten zu maximieren, bilden den Hintergrund für den Aufbau eines digitalen Umfelds, in dem Innovation wirklich sowohl der Motor als auch das Ziel ist. Die Verfügbarkeit flexibler Lizenzierungsmethoden – die starren proprietären Schemata vorgezogen werden – unterstützt die rechtliche Umsetzung dieser „Philosophie der Offenheit“, mit erheblichen Vorteilen, wann immer eine Betriebssystemsoftware auf eine entsprechende Hardware angewendet wird. Das Zusammenspiel vieler Menschen, die am gleichen Quellcode arbeiten, erleichtert den Innovationsprozess: Da die Kosten in Form von Geld und Zeit gesenkt werden, können auch die Kosten der Endprodukte deutlich reduziert werden.

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Correspondence to Valentina Calderai .

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Lippi, M.E., Morello, F., Di Pietro, L., De Maria, C., Calderai, V. (2023). Gesetzgebung für Open-Source-Medizinprodukte: Aktuelles Szenario, Risiken und Möglichkeiten. In: Ahluwalia, A., De Maria, C., Díaz Lantada, A. (eds) Entwicklung von Open-Source-Medizinprodukten. Springer, Cham. https://doi.org/10.1007/978-3-031-26028-5_7

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