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GDPR in Urgent Healthcare Setting

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
GDPR for health data requires Explicit Consent. We sell a wearable temp monitor which runs from a smart phone application. How in the EU in a emergency health care situation can a patient give explicit consent for a blood pressure cuff, pulse ox, etc?


Quite Involved in Discussions
A consent from a subject is not the only means to lawfully process the data.

In your case, it's the hospital that is required to demonstrate the lawful basis of processing and consent.
Specifically, Rec.46; Art.6(1)(d) states that processing is permitted if it is necessary in order to protect the vital interests of the data subject or of another natural person.

Article 6 of the GDPR describes other lawful basis for processing.
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