OpenLegislation

Division 2 Each healthcare provider authorised to access CPMS shall be responsible for:F1

United Kingdom

Original text. Later amendments are not shown.

  1. (i)

    selecting the patients whose personal data are processed through the CPMS;

  2. (ii)

    collecting and maintaining explicit, informed, freely-given and specific consent(s) of the patients whose data are processed through the CPMS in compliance with the mandatory minimum requirements for the consent form specified in Annex IV;

  3. (iii)

    acting as the contact point for its patients, including when they exercise their rights, responding to the requests of patients or their representatives and ensuring that patients whose data are processed through the CPMS are enabled to exercise their rights in compliance with data protection legislation, using, where necessary, the technical means provided by the Commission in line with point 1(ii);

  4. (iv)

    reviewing, at least every 15 years, the necessity of processing specific patients' personal data through the CPMS;

  5. (v)

    ensuring the security and confidentiality of any processing of patients' personal data outside the CPMS done by that healthcare provider, where such data is processed for the purposes of or in connection to processing patients' personal data through the CPMS;

  6. (vi)

    communicating any personal data breaches with regard to patient data processed through the CPMS to the Commission, to the competent supervisory authorities and, where so required, to patients, in accordance with Articles 33 and 34 of Regulation (EU) 2016/679 or if requested by the Commission;

  7. (vii)

    identifying, in compliance with access criteria referred to in point 1(vii) of this Annex, staff and other individuals affiliated to them, whom shall be granted access to patients' personal data within the CPMS and communicating it to the Commission;

  8. (viii)

    ensuring that their staff and other individuals affiliated to them, who have access to patients' personal data within the CPMS, are adequately trained to ensure that they perform their tasks in compliance with the rules applicable to the protection of personal data, and are subject to the obligation of professional secrecy in accordance with Article 9(3) of the Regulation (EU) 2016/679.

Annotations

Textual amendments

F1

Inserted by Commission Implementing Decision (EU) 2019/1269 of 26 July 2019 amending Implementing Decision 2014/287/EU setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks (Text with EEA relevance).