Recital 3

It is necessary to improve the conditions for data sharing in the internal market, by creating a harmonised framework for data exchanges and laying down certain basic requirements for data governance, paying specific attention to facilitating cooperation between Member States. This Regulation should aim to develop further the borderless digital internal market and a human-centric, trustworthy and secure data society and economy. Sector-specific Union law can develop, adapt and propose new and complementary elements, depending on the specificities of the sector, such as the Union law envisaged on the European health data space and on access to vehicle data. Moreover, certain sectors of the economy are already regulated by sector-specific Union law, which includes rules relating to the sharing of or access to data across borders or across the Union, for example Directive 2011/24/EU of the European Parliament and of the Council1 in the context of the European health data space, and relevant legislative acts in the field of transport, such as Regulations (EU) 2019/12392 and (EU) 2020/10563 and Directive 2010/40/EU4 of the European Parliament and of the Council in the context of the European mobility data space.

This Regulation should therefore be without prejudice to Regulations (EC) No 223/20095, (EU) 2018/8586 and (EU) 2018/18077 as well as Directives 2000/31/EC8, 2001/29/EC9, 2004/48/EC10, 2007/2/EC11, 2010/40/EU, (EU) 2015/84912, (EU) 2016/94313, (EU) 2017/113214, (EU) 2019/79015 and (EU) 2019/102416 of the European Parliament and of the Council and any other sector-specific Union law that regulates access to and re-use of data. This Regulation should be without prejudice to Union and national law on the access to and use of data for the purpose of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, as well as international cooperation in that context.

This Regulation should be without prejudice to the competences of the Member States with regard to their activities concerning public security, defence and national security. The re-use of data protected for such reasons and held by public sector bodies, including data from procurement procedures falling within the scope of Directive 2009/81/EC of the European Parliament and of the Council17, should not be covered by this Regulation. A horizontal regime for the re-use of certain categories of protected data held by public sector bodies, the provision of data intermediation services and of services based on data altruism in the Union should be established. Specific characteristics of different sectors may require the design of sectoral data-based systems, while building on the requirements of this Regulation. Data intermediation services providers that meet the requirements laid down in this Regulation should be able to use the label ‘data intermediation services provider recognised in the Union’. Legal persons that seek to support objectives of general interest by making available relevant data based on data altruism at scale and that meet the requirements laid down in this Regulation should be able to register as and use the label ‘data altruism organisation recognised in the Union’. Where sector-specific Union or national law requires public sector bodies, such data intermediation services providers or such legal persons (recognised data altruism organisations) to comply with specific additional technical, administrative or organisational requirements, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law should also apply.

  1. Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). [↩]
  2. Regulation (EU) 2019/1239 of the European Parliament and of the Council of 20 June 2019 establishing a European Maritime Single Window environment and repealing Directive 2010/65/EU (OJ L 198, 25.7.2019, p. 64). [↩]
  3. Regulation (EU) 2020/1056 of the European Parliament and of the Council of 15 July 2020 on electronic freight transport information (OJ L 249, 31.7.2020, p. 33). [↩]
  4. Directive 2010/40/EU of the European Parliament and of the Council of 7 July 2010 on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport (OJ L 207, 6.8.2010, p. 1). [↩]
  5. 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). [↩]
  6. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1). [↩]
  7. Regulation (EU) 2018/1807 of the European Parliament and of the Council of 14 November 2018 on a framework for the free flow of non-personal data in the European Union (OJ L 303, 28.11.2018, p. 59). [↩]
  8. Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1). [↩]
  9. Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p. 10). [↩]
  10. Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45). [↩]
  11. Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1). [↩]
  12. Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73). [↩]
  13. Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1). [↩]
  14. Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, p. 46). [↩]
  15. Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92). [↩]
  16. Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56). [↩]
  17. Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (OJ L 216, 20.8.2009, p. 76). [↩]