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1. The ECDC shall ensure the continued development of the digital platform for surveillance, after conducting data protection impact assessments and having mitigated any risks to the rights and freedoms of the data subjects, as appropriate, through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. The ECDC shall ensure that the operation of the digital platform for surveillance is subject to human oversight and shall minimise the risks that may emerge from the transfer of inaccurate, incomplete or ambiguous data from one database to another, as well as establish robust procedures for data quality review. The ECDC, in close cooperation with Member States, shall also ensure the interoperability of the digital platform for surveillance with national systems.

2. The digital platform for surveillance shall:

(a) enable the automated collection of surveillance and laboratory data, make use of relevant non-personal health data from a previously defined and authorised list from electronic health records and health databases, and of media monitoring, and apply artificial intelligence for data validation, analysis and automated reporting, including statistical reporting; and (b) allow for the computerised handling and exchange of information, data and documents.

3. Member States shall be responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely, complete and accurate information, data and documents transmitted and exchanged through the digital platform. Member States may promote the automation of this process between the national and the Union surveillance systems.

4. The ECDC shall monitor the functioning of the integrated surveillance system and share regular monitoring reports with the Member States and the Commission.

5. For epidemiological surveillance purposes, the ECDC shall also have access to relevant health data accessed or made available through digital infrastructure enabling the use of health data for research, policy-making advice and regulatory purposes.

6. The Commission shall adopt implementing acts for the functioning of the digital platform for surveillance which lay down:

(a) the technical specifications of the digital platform for surveillance, including the electronic data exchange mechanism for exchanges with existing international and national systems, identification of applicable standards, definition of message structures, data dictionaries, exchange of protocols and procedures;

(b) the specific rules for the functioning of the digital platform for surveillance, including for the protection of personal data and security of exchange of information;

(c) contingency arrangements including secure data backups to be applied in the event of unavailability of any of the functionalities of the digital platform for surveillance; and (d) arrangements for promoting standardisation of the infrastructure for storage, processing and analysis of data. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).

7. The Commission shall adopt delegated acts in accordance with Article 31 to supplement this Regulation concerning:

(a) the cases where, and the conditions under which, the third countries and international organisations concerned may be granted partial access to the functionalities of the digital platform for surveillance and the practical arrangements for such access;

(b) the cases where, and the conditions under which, the data, information and documents referred to in Article 13 are to be transmitted using the digital platform for surveillance and the list of such data, information and documents; and (c) the conditions under which the ECDC can participate and be granted access to health data accessed or exchanged through the digital infrastructure referred to in paragraph 5.