(1) Where a digital health application contains a diagnostic instrument, the manufacturer shall, in addition to the evidence under section 10, determine by means of a study the sensitivity and specificity of the digital health application with regard to the specified patient group under section 9 subsection (1) item 2 and subsection (3).
(1) Enthält eine digitale Gesundheitsanwendung ein diagnostisches Instrument, so hat der Hersteller zusätzlich zu den Nachweisen nach § 10 mittels einer Studie die Sensitivität und Spezifität der digitalen Gesundheitsanwendung im Hinblick auf die angegebene Patientengruppe nach § 9 Absatz 1 Nummer 2 und Absatz 3 zu ermitteln.
(2) Section 10 subsections (3) to (7) shall apply mutatis mutandis.
(2) § 10 Absatz 3 bis 7 gilt entsprechend.
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Unofficial translation for information only. Only the German text is legally binding. German text: consolidated version from gesetze-im-internet.de, retrieved 29 October 2026. Where German statutes use “soll”, “shall” denotes an obligation that admits exceptions in atypical cases. Not legal advice.