Patient Consent
Legal basis for processing
Section titled “Legal basis for processing”Consent (GDPR Art. 9(2)(a)): If recordings and AI are used for purposes beyond direct patient treatment, explicit consent must be obtained.
Legal Obligation (GDPR Art. 9(2)(b)): If recordings and AI are an integral part of the documentation process and thus necessary to fulfill health legal requirements for record-keeping, processing can occur without separate consent.
Dermloop software does not perform medical analysis or provide diagnostic output. Clinical evaluation is performed by qualified healthcare professionals. Seranote is a documentation assistant; all clinical content in generated notes must be reviewed and approved by the treating clinician before use. The dermoscope integrated in the Dermkit system pack is a CE-marked Class I medical device manufactured by a third party and supplied as part of the Dermkit MDR Article 22 system pack.