EIDAS 2014/0910 EN

1. Member States shall designate a supervisory body established in their territory or, upon mutual agreement with another Member State, a supervisory body established in that other Member State. That body shall be responsible for supervisory tasks in the designating Member State.

Supervisory bodies shall be given the necessary powers and adequate resources for the exercise of their tasks.

2. Member States shall notify to the Commission the names and the addresses of their respective designated supervisory bodies.

3. The role of the supervisory body shall be the following:

(a)

to supervise qualified trust_service providers established in the territory of the designating Member State to ensure, through ex ante and ex post supervisory activities, that those qualified trust_service providers and the qualified trust_services that they provide meet the requirements laid down in this Regulation;

(b)

to take action if necessary, in relation to non-qualified trust_service providers established in the territory of the designating Member State, through ex post supervisory activities, when informed that those non-qualified trust_service providers or the trust_services they provide allegedly do not meet the requirements laid down in this Regulation.

4. For the purposes of paragraph 3 and subject to the limitations provided therein, the tasks of the supervisory body shall include in particular:

(a)	to cooperate with other supervisory bodies and provide them with assistance in accordance with Article 18;

(b)	to analyse the conformity assessment reports referred to in Articles 20(1) and 21(1);

(c)	to inform other supervisory bodies and the public about breaches of security or loss of integrity in accordance with Article 19(2);

(d)	to report to the Commission about its main activities in accordance with paragraph 6 of this Article;

(e)	to carry out audits or request a conformity_assessment_body to perform a conformity assessment of the qualified trust_service providers in accordance with Article 20(2);

(f)	to cooperate with the data protection authorities, in particular, by informing them without undue delay, about the results of audits of qualified trust_service providers, where personal data protection rules appear to have been breached;

(g)	to grant qualified status to trust_service providers and to the services they provide and to withdraw this status in accordance with Articles 20 and 21;

(h)	to inform the body responsible for the national trusted list referred to in Article 22(3) about its decisions to grant or to withdraw qualified status, unless that body is also the supervisory body;

(i)	to verify the existence and correct application of provisions on termination plans in cases where the qualified trust_service provider ceases its activities, including how information is kept accessible in accordance with point (h) of Article 24(2);

(j)	to require that trust_service providers remedy any failure to fulfil the requirements laid down in this Regulation.

5. Member States may require the supervisory body to establish, maintain and update a trust infrastructure in accordance with the conditions under national law.

6. By 31 March each year, each supervisory body shall submit to the Commission a report on its previous calendar year’s main activities together with a summary of breach notifications received from trust_service providers in accordance with Article 19(2).

7. The Commission shall make the annual report referred to in paragraph 6 available to Member States.

8. The Commission may, by means of implementing acts, define the formats and procedures for the report referred to in paragraph 6. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).

Article 19

Security requirements applicable to trust_service providers

1. Qualified and non-qualified trust_service providers shall take appropriate technical and organisational measures to manage the risks posed to the security of the trust_services they provide. Having regard to the latest technological developments, those measures shall ensure that the level of security is commensurate to the degree of risk. In particular, measures shall be taken to prevent and minimise the impact of security incidents and inform stakeholders of the adverse effects of any such incidents.

2. Qualified and non-qualified trust_service providers shall, without undue delay but in any event within 24 hours after having become aware of it, notify the supervisory body and, where applicable, other relevant bodies, such as the competent national body for information security or the data protection authority, of any breach of security or loss of integrity that has a significant impact on the trust_service provided or on the personal data maintained therein.

Where the breach of security or loss of integrity is likely to adversely affect a natural or legal person to whom the trusted service has been provided, the trust_service provider shall also notify the natural or legal person of the breach of security or loss of integrity without undue delay.

Where appropriate, in particular if a breach of security or loss of integrity concerns two or more Member States, the notified supervisory body shall inform the supervisory bodies in other Member States concerned and ENISA.

The notified supervisory body shall inform the public or require the trust_service provider to do so, where it determines that disclosure of the breach of security or loss of integrity is in the public interest.

3. The supervisory body shall provide ENISA once a year with a summary of notifications of breach of security and loss of integrity received from trust_service providers.

4. The Commission may, by means of implementing acts,:

(a)	further specify the measures referred to in paragraph 1; and

(b)	define the formats and procedures, including deadlines, applicable for the purpose of paragraph 2.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).

SECTION 3

Qualified trust_services

Article 20

Supervision of qualified trust_service providers

1. Qualified trust_service providers shall be audited at their own expense at least every 24 months by a conformity_assessment_body. The purpose of the audit shall be to confirm that the qualified trust_service providers and the qualified trust_services provided by them fulfil the requirements laid down in this Regulation. The qualified trust_service providers shall submit the resulting conformity assessment report to the supervisory body within the period of three working days after receiving it.

2. Without prejudice to paragraph 1, the supervisory body may at any time audit or request a conformity_assessment_body to perform a conformity assessment of the qualified trust_service providers, at the expense of those trust_service providers, to confirm that they and the qualified trust_services provided by them fulfil the requirements laid down in this Regulation. Where personal data protection rules appear to have been breached, the supervisory body shall inform the data protection authorities of the results of its audits.

3. Where the supervisory body requires the qualified trust_service provider to remedy any failure to fulfil requirements under this Regulation and where that provider does not act accordingly, and if applicable within a time limit set by the supervisory body, the supervisory body, taking into account, in particular, the extent, duration and consequences of that failure, may withdraw the qualified status of that provider or of the affected service it provides and inform the body referred to in Article 22(3) for the purposes of updating the trusted lists referred to in Article 22(1). The supervisory body shall inform the qualified trust_service provider of the withdrawal of its qualified status or of the qualified status of the service concerned.

4. The Commission may, by means of implementing acts, establish reference number of the following standards:

(a)	accreditation of the conformity assessment bodies and for the conformity assessment report referred to in paragraph 1;

(b)	auditing rules under which conformity assessment bodies will carry out their conformity assessment of the qualified trust_service providers as referred to in paragraph 1.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).

Article 21

Initiation of a qualified trust_service

1. Where trust_service providers, without qualified status, intend to start providing qualified trust_services, they shall submit to the supervisory body a notification of their intention together with a conformity assessment report issued by a conformity_assessment_body.

2. The supervisory body shall verify whether the trust_service provider and the trust_services provided by it comply with the requirements laid down in this Regulation, and in particular, with the requirements for qualified trust_service providers and for the qualified trust_services they provide.

If the supervisory body concludes that the trust_service provider and the trust_services provided by it comply with the requirements referred to in the first subparagraph, the supervisory body shall grant qualified status to the trust_service provider and the trust_services it provides and inform the body referred to in Article 22(3) for the purposes of updating the trusted lists referred to in Article 22(1), not later than three months after notification in accordance with paragraph 1 of this Article.

If the verification is not concluded within three months of notification, the supervisory body shall inform the trust_service provider specifying the reasons for the delay and the period within which the verification is to be concluded.

3. Qualified trust_service providers may begin to provide the qualified trust_service after the qualified status has been indicated in the trusted lists referred to in Article 22(1).

4. The Commission may, by means of implementing acts, define the formats and procedures for the purpose of paragraphs 1 and 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).

Article 22

trusted lists

1. Each Member State shall establish, maintain and publish trusted lists, including information related to the qualified trust_service providers for which it is responsible, together with information related to the qualified trust_services provided by them.

2. Member States shall establish, maintain and publish, in a secured manner, the electronically signed or sealed trusted lists referred to in paragraph 1 in a form suitable for automated processing.

3. Member States shall notify to the Commission, without undue delay, information on the body responsible for establishing, maintaining and publishing national trusted lists, and details of where such lists are published, the certificates used to sign or seal the trusted lists and any changes thereto.

4. The Commission shall make available to the public, through a secure channel, the information referred to in paragraph 3 in electronically signed or sealed form suitable for automated processing.

5. By 18 September 2015 the Commission shall, by means of implementing acts, specify the information referred to in paragraph 1 and define the technical specifications and formats for trusted lists applicable for the purposes of paragraphs 1 to 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).

Article 23

EU trust mark for qualified trust_services

1. After the qualified status referred to in the second subparagraph of Article 21(2) has been indicated in the trusted list referred to in Article 22(1), qualified trust_service providers may use the EU trust mark to indicate in a simple, recognisable and clear manner the qualified trust_services they provide.

2. When using the EU trust mark for the qualified trust_services referred to in paragraph 1, qualified trust_service providers shall ensure that a link to the relevant trusted list is made available on their website.

3. By 1 July 2015 the Commission shall, by means of implementing acts, provide for specifications with regard to the form, and in particular the presentation, composition, size and design of the EU trust mark for qualified trust_services. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).

whereas

(10) Directive 2011/24/EU of the European Parliament and of the Council (6) set up a network of national authorities responsible for e-health.
To enhance the safety and the continuity of cross-border healthcare, the network is required to produce guidelines on cross-border access to electronic health data and services, including by supporting ‘common identification and authentication measures to facilitate transferability of data in cross-border healthcare’.
Mutual recognition of electronic_identification and authentication is key to making cross-border healthcare for European citizens a reality.
When people travel for treatment, their medical data need to be accessible in the country of treatment.
That requires a solid, safe and trusted electronic_identification framework.

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(45) In order to allow an efficient initiation process, which should lead to the inclusion of qualified trust_service providers and the qualified trust_services they provide into trusted lists, preliminary interactions between prospective qualified trust_service providers and the competent supervisory body should be encouraged with a view to facilitating the due diligence leading to the provisioning of qualified trust_services.

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(46) trusted lists are essential elements in the building of trust among market operators as they indicate the qualified status of the service provider at the time of supervision.

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keyboard_tab EIDAS 2014/0910 EN

EIDAS 2014/0910 EN