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Medizin-Apps als Medizinprodukt: Regulierung eines Risikoprodukts (Instant Digital Access Code Only)
- Edition : 1st, 2019
- Author(s) : Robert Johannes Ortner
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Medizin-Apps als Medizinprodukt: Regulierung eines Risikoprodukts (Instant Digital Access Code Only)
- ISBN: 9783631772348
- SKU: 261340V
- Format: VitalSource eBook/PDF
- Instant Access!
In diesem Buch werden Medizin-Apps erstmalig detailliert in den Kontext des Medizinprodukterechts als Teil des Produktsicherheitsrechts eingeordnet und der Regulierungsbedarf auf bestimmte Gruppen von Apps konkretisiert. Daran anknüpfend werden Stärken und Schwächen des deutschen MPG unter Berücksichtigung einer vergleichenden Analyse von Leitfäden nationaler Aufsichtsbehörden bei der Erfassung von Medizin-Apps als Medizinprodukt aufgezeigt. Hinsichtlich der behördlichen Überwachung des Medizin-App Marktes werden Herausforderungen aufgrund der fehlenden Körperlichkeit dieser Produkte ermittelt. Zu ihrer Bewältigung werden Vorschläge für Modifikationen der Gesetzeslage unterbreitet. Stets findet dabei auch ein Vergleich mit der MDR statt.