11. Recipients patient's information
11.1 Anonymizing or pseudonymizing patient’s information
If Berlin Heart receives patient information, e.g., from contractual partners (in particular from clinics treating patients), Berlin Heart will immediately pseudonymize or anonymize the patient's data.
11.2 Legality of processing patient’s information
Patient information, including health data, will only be processed by Berlin Heart if this is permitted by law.
11.3 Explicit consent of the patient
This is the case in particular if the patient has expressly consented to the processing of personal data or information for the purposes stated in the declaration of consent (legal basis for health data: Art. 9 para. 2 subpara. a GDPR; otherwise: Art. 6, para. 1, subpara. a, GDPR).
11.4 Processing purpose
Furthermore, processing is carried out for necessary quality assurance measures (legal basis for health data: Art. 9, para. 2, subpara. h, i GDPR and Section 22, para. 1, no. 1, subpara. b,, c BDSG; otherwise: Art. 6, para. 1, subpara. a, f, GDPR) as well as for any necessary medical support of the patient, in particular in an emergency (legal basis for health data: Art. 9, para. 2, subpara. c, h, GDPR; otherwise: Art. 6, para. 1, subpara. a, f GDPR).
11.5 Reporting obligations
As a manufacturer of medical devices, Berlin Heart is also subject to statutory reporting obligations to state supervisory authorities. This applies, for example, to incidents that may have led to a serious deterioration in a patient's state of health. These obligations also apply in part to the competent supervisory authorities in third countries, i.e., those outside the European Union, in accordance with national law. Patient information is always transmitted pseudonymously or, if possible and legally permissible, anonymously. (Legal basis for health data: Art. 9, para. 2, subpara. f, h, i, GDPR and Section 22, para. 1, no. 1 subpara. b, c, BDSG; otherwise: Art. 6, para. 1, subpara. a, f, GDPR).
