LegalizeCommission Regulation (EU) 2022/2294 of 23 November 2022 implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council as regards statistics on healthcare facilities, healthcare human resources and healthcare utilisation (Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (1), and in particular Article 9(1) and Annex II, point (d), thereof,
Whereas:
(1) Regulation (EC) No 1338/2008 sets out the subjects covered in the healthcare domain for which data and metadata are to be provided for the production of European statistics. In particular data and metadata on healthcare facilities, healthcare human resources, healthcare utilisation, individual and collective services, and the reference periods, intervals and time limits for the data provision should be set out by implementing measures.
(2) Pursuant to Article 6(1) of Regulation (EC) No 1338/2008, in 2015 and 2018, the Commission launched pilot studies that were completed voluntarily by Member States. The Commission also discussed the needs of users of the statistics with Member States. The outcome of those pilot studies and those discussions was that Union-wide data are needed to strengthen the evidence-base on healthcare information, hence benefitting decisions on public health and social policy.
(3) In accordance with Article 6(2) of Regulation (EC) No 1338/2008, the Commission carried out a cost-benefit analysis, taking into account the benefits of the availability of variables on healthcare facilities, healthcare human resources and healthcare utilisation in relation to the cost of data collection. It follows from that analysis that those variables should be collected to ensure the comparability and availability of Union-wide data.
(4) The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee, established by Article 7 of Regulation (EC) No 223/2009 of the European Parliament and of the Council (2),
HAS ADOPTED THIS REGULATION:
Article 1
Scope
This Regulation lays down rules for the development and production of European statistics in the area of healthcare facilities, healthcare human resources and healthcare utilisation and individual and collective services, as referred to in Annex II, point (d), first, second and third indent, to Regulation (EC) No 1338/2008.
Article 2
Definitions
For the purpose of this Regulation, the definitions set out in Annex I shall apply.
Article 3
Data required
Member States shall transmit to the Commission (Eurostat) data for the list of variables, the characteristics and breakdowns as set out in Annex II.
Article 4
Metadata
Member States shall provide the Commission (Eurostat) with the necessary reference metadata and quality reports, in particular concerning:
(a) the data sources and their coverage;
(b) the compilation methods used;
(c) information on features of national healthcare facilities, healthcare human resources and healthcare utilisation specific to the Member States that deviate from the definitions set out in Annex I and the variables set out in Annex II;
(d) information on any changes to the statistical concepts mentioned in Annex I and Annex II.
Article 5
Reference period
The reference period shall be the calendar year.
The first reference year shall be 2021.
By derogation from paragraph 2, the first reference year for data on health employment, hospital care and surgical procedures referred to in points 1, 6 and 7 of Annex II shall be 2023.
Article 6
Provision of data and metadata to the Commission (Eurostat)
Member States shall provide the data and reference metadata referred to in Articles 3 and 4 respectively to the Commission (Eurostat) on an annual basis within 14 months after the end of the reference year.
By way of derogation from paragraph 1, Member States shall provide the data and reference metadata on hospital care and surgical procedures referred to in points 6 and 7 of Annex II within 20 months after the end of the reference year.
Data and reference metadata shall be transmitted to the Commission (Eurostat) using the single entry point or be made available for retrieval by the Commission (Eurostat) by electronic means.
Article 7
Data sources
The data shall be compiled mainly from administrative records, as referred to in Article 17a of Regulation (EC) No 223/2009 and shall cover the whole Member State.
Where administrative records are not available or of insufficient quality or coverage, use of other sources, methods or innovative approaches shall be accepted insofar as they enable the production of data that are comparable and compliant with the requirements laid down by this Regulation.
Article 8
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 November 2022.
For the Commission The President Ursula VON DER LEYEN
(1) OJ L 354, 31.12.2008, p. 70.
(2) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).
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