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KATEGORIE: CLASSIFICATION

Digitale Gesundheit

Die breite Kategorie umfasst Mobile-Health-Apps, Gesundheits-IT, Telemedizin, Wearables und SaMD.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

Digital health spans SaMD, connected devices, telehealth tools, and AI/ML—regulated when medical claims and patient risk meet device definitions.

PROCESS / STEPS

  1. Determine if the software/device is regulated.
  2. Apply software lifecycle, cybersecurity, and clinical validation.
  3. Select premarket path; plan change control for algorithm updates.
  4. Monitor postmarket performance and safety signals.

EXAMPLES

  • Wellness apps without medical claims may fall outside device regulation; diagnostic claims usually do not.

RELATED GUIDES & TOOLS

SOURCES

Track regulatory signals related to Digitale Gesundheit across 27 authorities in real time.

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VERWANDTE BEGRIFFE

Software als Medizinprodukt (SaMD)KI/ML-basiertes MedizinproduktIEC 62304 (Medizinproduktesoftware)