(1)

Article 14 of Directive 2011/24/EU assigned the Union to support and facilitate cooperation and the exchange of information among Member States working within a voluntary network connecting national authorities responsible for eHealth (the ‘eHealth Network’) designated by the Member States.

(2)

Commission Implementing Decision (EU) 2019/1765 (2) provides for the rules for the establishment, the management and the functioning of the network of national authorities responsible for eHealth. Article 4 of that Decision entrusts the eHealth Network with the task of facilitating greater interoperability of the national information and communications technology systems and cross-border transferability of electronic health data in cross-border healthcare.

(3)

In the light of the public health crisis caused by the COVID-19 pandemic, several Member States have developed mobile applications that support contact tracing and enable the users of such applications to be alerted to take appropriate action, such as testing or self-isolating, if they have been potentially exposed to the virus through proximity to another user of such applications, who has reported a positive diagnosis. These applications rely on Bluetooth technology to detect proximity between devices. As restrictions on travel between Member States have been lifted since June 2020, greater interoperability of the national information and communications technology systems should be achieved between the Member States in the eHealth Network, by implementing a digital infrastructure enabling interoperability between national mobile applications supporting contact tracing and warning.

(4)

The Commission has been supporting Member States as regards the mobile applications mentioned above. On 8 April 2020, the Commission adopted a Recommendation on a common Union toolbox for the use of technology and data to combat and exit from the COVID-19 crisis, in particular concerning mobile applications and the use of anonymised mobility data (the ‘Commission Recommendation’) (3). The Member States in the eHealth Network adopted, with the Commission’s support, a Common EU toolbox for Member States on mobile applications to support contact tracing (4) as well as interoperability guidelines for approved contact tracing mobile applications in the EU (5). The toolbox explains the national requirements for national contact tracing and warning mobile applications, in particular that they should be voluntary, approved by the respective national health authority, privacy-preserving, and dismantled as soon as no longer needed. Following the most recent developments of the COVID-19 crisis, the Commission (6) and the European Data Protection Board (7) have each issued guidance on mobile applications and contact tracing tools in relation to data protection. The design of Member States’ mobile applications and of the digital infrastructure enabling their interoperability builds upon the Common EU toolbox, the above-mentioned guidance, and the technical specifications agreed in the eHealth Network.

(5)

In order to facilitate the interoperability of national contact tracing and warning mobile applications, a digital infrastructure was developed with the support of the Commission by the Member States participating in the eHealth Network which decided to advance their cooperation in this area on a voluntary basis, as an IT tool for exchange of data. This digital infrastructure is referred to as ‘the federation gateway’.

(6)

This Decision lays down provisions on the role of the participating Member States and of the Commission for the functioning of the federation gateway for the cross-border interoperability of national contact tracing and warning mobile applications.

(7)

Processing of personal data of application users of contact tracing and warning mobile applications, which is done under the responsibility of the Member States or other public organisations or official bodies in the Member States, should be carried out in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (8) (‘the General Data Protection Regulation’) and Directive 2002/58/EC of the European Parliament and of the Council (9). Processing of personal data under the responsibility of the Commission for the purpose of managing and ensuring the security of the federation gateway should comply with Regulation (EU) 2018/1725 of the European Parliament and of the Council (10).

(8)

The federation gateway should consist of a secure IT infrastructure providing a common interface, where designated national authorities or official bodies can exchange a minimum set of data in relation to contacts with persons infected by SARS-CoV-2, in order to inform others on their potential exposure to that infection and promoting effective cooperation on healthcare between Member States by facilitating the exchange of relevant information.

(9)

This Decision should therefore lay down modalities for the cross-border exchange of data between designated national authorities or official bodies through the federation gateway within the EU.

(10)

The participating Member States, represented by the designated national authorities or official bodies determine together the purpose and means of processing of personal data through the federation gateway and are therefore joint controllers. Article 26 of the General Data Protection Regulation places an obligation on joint controllers of personal data processing operations to determine, in a transparent manner, their respective responsibilities for compliance with the obligations under that Regulation. It also provides for the possibility to have those responsibilities determined by Union or Member State law to which the controllers are subject. Each of the controllers should ensure that they have a legal basis at national level for processing in the federation gateway.

(11)

The Commission, as a provider of technical and organisational solutions for the federation gateway, processes pseudonymised personal data on behalf of the participating Member States in the federation gateway as joint controllers and is therefore a processor. Pursuant to Article 28 of the General Data Protection Regulation and Article 29 of Regulation (EU) 2018/1725, the processing by a processor shall be governed by a contract or a legal act under Union or Member State law which is binding on the processor with regard to the controller and which specifies the processing. This Decision sets out rules on processing by the Commission as a processor.

(12)

When processing personal data in the framework of the federation gateway, the Commission is bound by Commission Decision (EU, Euratom) 2017/46 (11).

(13)

Taking into account that the purposes for which controllers process personal data in the national contact tracing and warning mobile applications do not necessarily require the identification of a data subject, the controllers may not always be in a position to ensure the application of data subjects’ rights. The rights referred to in Articles 15 to 20 of the General Data Protection Regulation may therefore not apply when the conditions pursuant to Article 11 of that Regulation are fulfilled.

(14)

The existing Annex to Implementing Decision (EU) 2019/1765 needs to be renumbered due to the addition of two new annexes.

(15)

Implementing Decision (EU) 2019/1765 should therefore be amended accordingly.

(16)

Considering the urgency of the situation provoked by the COVID-19 pandemic, this Decision should apply from the day following that of its publication in the Official Journal of the European Union.

(17)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 9 July 2020.

(18)

The measures provided for in this Decision are in accordance with the opinion of the Committee set up under Article 16 of Directive 2011/24/EU,

(1)

in Article 2(1), the following points (g), (h), (i), (j), (k), (l), (m), (n) and (o) are inserted:

(*1)  Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).’;"

(2)

in Article 4(1), the following point (h) is inserted:

(3)

in Article 6(1), the following points (f) and (g) are inserted:

(4)

Article 7 is amended as follows:

(5)

the following Article 7a is inserted:

(6)

the Annex becomes Annex I;

(7)

Annexes II and III are added, the text of which is set out in the Annex to this Decision.