9. Processing of Patient Data
9.1 If data of a patient is transmitted to Berlin Heart, e.g. by contract partners (in particular by clinics where the patient receives the medical treatment), Berlin Heart will immediately pseudonymize or anonymize the patient’s data.
9.2 The patient’s data (including data concerning health) will only be processed by Berlin Heart, if this is permitted according to statutory provisions.
9.3 This is particularly the case if the patient has given his/her explicit consent to the processing of personal data for the purposes mentioned in the declaration of consent. Legal basis is Art. 9 para. 2 lit. a GDPR (for data concerning health), for other data Art. 6 para. 1 phr. 1 lit. a GDPR.
9.4 In addition, we will process personal data for necessary measures of quality assurance (Legal basis for data concerning health: Art. 9 para. 2 lit. h, i GDPR as well as § 22 para. 1 No. 1 lit. b, c BDSG – German Federal Data Protection Act; for other data: Art. 6 para. 1 phr. 1 lit. f GDPR) and the eventually necessary medical support of the patient, especially in case of emergency (Legal basis for data concerning health: Art. 9 para. 2 lit. c, h; for other data: Art. 6 para. 1 phr. 1 lit. a, f GDPR).
9.5 As a producer of medical devices Berlin Heart also has to fulfill legal reporting obligations towards public regulatory authorities. As an example, this applies for (adverse) events that may have led to a serious deterioration in the state of a patient’s health. These reporting obligations are also applicable towards public authorities in third countries (countries outside the European Union). We will only transfer patient data in a pseudonymized or, if possible and legally permitted, anonymized form (Legal basis for data concerning health: Art. 9 para. 2 lit. f, h, i GDPR as well as § 22 para. 1 No. 1 lit. b, c BDSG – German Federal Data Protection Act; for other data: Art. 6 para. 1 phr. 1 lit. a, f GDPR).