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Access to and Re-use of Government Data and the Use of Big Data in Healthcare

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Regulating New Technologies in Uncertain Times

Part of the book series: Information Technology and Law Series ((ITLS,volume 32))

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Abstract

Data availability is a huge challenge for the use of big data in healthcare. Although the government is in the possession of valuable data for big data applications of private healthcare actors, a lot of these data remain out of their reach. A major reason are the limitations resulting from the legislation regulating access to and re-use of government information. This legal framework intends to strike a balance between the interest of the citizen to be informed by being granted access to data or to be able to re-use data and other interests such as the protection of private life and personal data, (intellectual) property rights and the confidentiality of business information, or the use of data by the government for monitoring and enforcement tasks. This contribution aims to demonstrate that some of the aforementioned legal limitations unnecessarily or disproportionally hinder the use of big data by private healthcare actors. To this end, the implications of the relevant European (e.g. the Council of Europe Convention on Access to Documents and the PSI Directive), as well as Belgian and Dutch legislation are discussed (e.g. the Belgian Federal Act of 11 April 1994 relating to access to government information). In this context, this chapter also analyses the modifications proposed by the European Commission in its recent revision proposal regarding the PSI Directive. Furthermore, it considers what measures the legislator could take to improve access to and re-use of its data by private healthcare actors for big data purposes.

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Notes

  1. 1.

    This is an own definition, which is first of all based on the 3 V’s of big data (i.e. Volume, Variety and Velocity), which are according to the analysts of Gartner its main characteristics (See Laney D (2001) 3D Data Management: Controlling Data Volume, Velocity, and Variety. https://blogs.gartner.com/doug-laney/files/2012/01/ad949-3D-Data-Management-Controlling-Data-Volume-Velocity-and-Variety.pdf. Last accessed on 7 August 2018). It is also inspired by extensive research on the topic of De Mauro, Greco and Grimaldi (See De Mauro et al. 2016, p. 122).

  2. 2.

    Proposal (European Commission) for a revision of the Directive 2003/98/EC on the re-use of public sector information, 25 April 2018, COM(2018), p. 2.

  3. 3.

    A public institution with legal personality established by the Belgian Federal Act of 31 March 2010 on damage indemnification resulting from healthcare (BS 2 April 2010).

  4. 4.

    In Belgium, access to electronic health records is complex and regulated by diverse acts and decrees such as the Royal Decree of 3 May 1999 concerning the general medical record (BS 30 July 1999), the Royal Decree of 3 May 1999 concerning the general minimal requirements of the medical records to be kept by hospitals (BS 30 July 1999), the Federal Act of 21 August 2008 on the establishment and organisation of the eHealth platform (BS 13 October 2008) and the Flemish Act of 25 April 2014 concerning the organisation of a network for datasharing between the actors involved in care (BS 20 August 2014).

  5. 5.

    See Data.gov.be. https://data.gov.be/en. Last accessed 7 August 2018.

  6. 6.

    See Opendata.vlaanderen.be. http://opendata.vlaanderen.be/dataset?q=gezondheid. Last accessed 7 August 2018.

  7. 7.

    See Dataportaal van de Nederlandse overheid. https://data.overheid.nl/. Last accessed 7 August 2018.

  8. 8.

    For instance, the Dutch open data website classifies only one dataset as a “high value dataset”.

  9. 9.

    This scope is discussed in Sects. 11.2.2 and 11.3.3.

  10. 10.

    “Dynamic data” are defined as “documents in an electronic form, subject to frequent or realtime updates” in Article 2.6 of the PSI Directive Revision Proposal.

  11. 11.

    According to Article 2.6 of the PSI Directive Revision Proposal “high value data” are “documents the re-use of which is associated with important socio-economic benefits, notably because of their suitability for the creation of value-added services and applications, and the number of potential beneficiaries of the value-added services and applications based on these datasets”. It is the European Commission which can adopt by delegated act a list of such datasets. Data on healthcare could be qualified as such “high value data”.

  12. 12.

    Article 2.7 of the PSI Directive Revision Proposal defines “research data” as “documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results”.

  13. 13.

    This chapter analyses Belgian legislation, because the author is most familiar with it. It also discusses Dutch legislation, since its administrative law is well thought out and not as fragmented as its Belgian counterpart.

  14. 14.

    Council of Europe Convention of 18 June 2009 on Access to Official Documents, CETS no. 205.

  15. 15.

    Federal Act of 11 April 1994 relating to access to government information, BS 30 June 1994.

  16. 16.

    Flemish Act of 26 March 2004 relating to access to government information, BS 1 July 2004.

  17. 17.

    Act of 31 October 1991 containing regulations governing public access to government information, Stb. 1991, no. 703.

  18. 18.

    Directive 2003/98/EC of 17 November 2003 on the re-use of public sector information, OJ L 345, 31 December 2003, pp. 90–96, which entered into force on 31 December 2003. It was revised by Directive 2013/37/EU of 26 June 2013 amending Directive 2003/98/EC on the re-use of public sector information, OJ L 175, 27 June 2013, pp. 1–8, which entered into force on 17 July 2013.

  19. 19.

    PSI = Public Sector Information.

  20. 20.

    Rijksoverheid (2016) Handleiding Wet hergebruik van overheidsinformatie, p. 9. https://open-overheid.nl/wp-content/uploads/2016/05/WEB_90943_BZK_Handleiding-Who-versie2.pdf. Last accessed 7 August 2018.

  21. 21.

    Federal Act of 4 May 2016 on the re-use of public sector information, BS 3 June 2016.

  22. 22.

    Flemish Act of 27 April 2007 on the re-use of public sector information, BS 5 November 2007.

  23. 23.

    Flemish Act of 18 April 2008 on the electronic exchange of administrative information, BS 29 October 2008. This act will not be discussed in this contribution, since it regulates the exchange of information between governmental bodies and not between the government and private actors.

  24. 24.

    Both acts were amended by the Flemish Act amending the Act of 27 April 2007 on the re-use of public sector information and the Flemish Act of 18 July 2008 on the electronic exchange of administrative information of 12 June 2015, BS 30 June 2015.

  25. 25.

    Act of 24 June 2015 laying down rules on the re-use of public sector information, Stb. 2015, no. 271.

  26. 26.

    Proposal (European Commission) for a revision of the Directive 2003/98/EC on the re-use of public sector information, 25 April 2018, COM(2018).

  27. 27.

    European Court of Human Rights = ECtHR.

  28. 28.

    Article 10.1 ECHR (European Convention on Human Rights) states: “Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers. This article shall not prevent States from requiring the licensing of broadcasting, television or cinema enterprises.”

  29. 29.

    ECtHR 8 November 2016, no. 18030/11, Magyar Helsinki Bizottsag v. Hungary; ECtHR 25 June 2013, no. 48315/06, Youth Initiative for Human Rights v. Serbia; ECtHR 29 May 2009, no. 31475/05, Kenedi v. Hungary; ECtHR 14 April 2009, no. 37374/05, Tarsasaga Szabadsagjogokert v. Hungary; ECtHR 10 July 2006, no. 19101/03, Sdruzeni Jihoceszke Matky v. Czech Republic). In Magyar Helsinki Bizottsag v. Hungary (para 156), the ECtHR considers “that Article 10 does not confer on the individual a right of access to information held by a public authority nor oblige the Government to impart such information to the individual. However, […] such a right or obligation may arise, firstly, where disclosure of the information has been imposed by a judicial order which has gained legal force […] and, secondly, in circumstances where access to the information is instrumental for the individual’s exercise of his or her right to freedom of expression, in particular “the freedom to receive and impart information” and where its denial constitutes an interference with that right.”

  30. 30.

    Own translation.

  31. 31.

    Until now, only nine of the 15 States who signed, ratified the Convention. See Council of Europe (2018) Chart of signatures and ratifications, of Treaty 205. www.coe.int/en/web/conventions/full-list/-/conventions/treaty/205/signatures?p_auth=ylsG4jgX. Last accessed 7 August 2018.

  32. 32.

    Explanatory Report to the Council of Europe Convention on Access to Official Documents, CETS no. 205, p. 1.

  33. 33.

    “Everyone has the right to consult any administrative document and to obtain a copy, except in the cases and conditions stipulated by the laws, federate laws or rules referred to in Article 134.” (own translation).

  34. 34.

    “In the exercise of their duties government bodies shall observe the right of public access to information in accordance with rules to be prescribed by Act of Parliament.” (own translation).

  35. 35.

    Besides legislation on the general access right to government data, in certain matters, specific legislation exists. In case of conflict, Article 13 of the Federal Access Acts states the legislation granting broader access rights prevails. If the specific legislation limits the access, the situation is more complex and the doctrine does not always agree on which legislation applies (see Schram 2018, pp. 257–261).

  36. 36.

    Federal Act of 12 November 1997 relating to access to government information in the provinces and municipalities, BS 19 December 1997; Federal Act of 11 April 1994 relating to access to government information, BS 30 June 1994; Flemish Act of 26 March 2004 relating to access to government information, BS 1 July 2004; Act of the Walloon Region of 30 March 1995 relating to access to government information, BS 28 June 1995; Act of the French-speaking Community of 22 December 1994 relating to access to government information, BS 31 December 1994; Act of the German-speaking Community of 16 October 1995 relating to access to government information, BS 29 December 1995; Act of the Brussels-Capital Region of 30 March 1995 relating to access to government information, BS 23 June 1995.

  37. 37.

    Article 2, b, (ii) Access Convention.

  38. 38.

    The Belgian Federal Access Act uses the concept “administrative authority” (Article 1, limb 2, 1° Federal Access Act), which is hard to delineate since it is not defined in the law, but has been shaped by case law of the Council of State (Raad van State or abbreviated RvS; the highest administrative court in Belgium) and the Court of Cassation (Hof van Cassatie or abbreviated Cass.) (see De Somer 2011–2012, p. 1638; Opdebeek and De Somer 2017, p. 301; Schram 2018, pp. 92–105). The jurisprudence uses organic, as well as functional criteria. Article 3, 1° of the Flemish Access Act introduced the broader notion “administrative body” (see Schram 2018, p. 105). It refers to “a) a legal person which is founded by or by virtue of the Constitution, or of a federal or regional act; b) a natural person, a group of natural persons, a legal person or a group of legal persons determined and controlled in their functioning by an instance in the meaning of a); c) a natural person, a group of natural persons, a legal person or a group of legal persons, when they are entrusted with the execution of a task of public interest by an instance in the meaning of a) or in so far they look after a task of public interest and take decisions that are binding on third parties.” The Dutch Access Act also uses the term “administrative body” (Article 1, a Dutch Access Act).

  39. 39.

    See for example CTB, opinion of 16 April 2012, no. 2012/27 (on an ombuds report of a hospital in the hands of the Belgian Federal Public Service of Health) and CTB, opinion of 13 July 2009, no. 2009/46 (on the reports concerning hand hygiene in hospitals in the possession of the Belgian Federal Public Service of Health). The CTB (Commissie voor Toegang tot Bestuursdocumenten) is an independent advisory federal administrative body in the context of access to government information legislation. See also the Belgian parliamentary documents (known as Parl. St.): Parl. St. Kamer, 1992–1993, no. 1112/1, p. 9.

  40. 40.

    See CTB, opinion of 1 February 2016, no. 2016/18 (on the report to the advising doctor of the health insurance fund). See also Parl. St. Kamer, 1992–1993, no. 1112/1, p. 9.

  41. 41.

    See the collection of decisions as a result of the Dutch Access Act on the website of the NZa (NZa site. https://puc.overheid.nl/nza/. Accessed 7 August 2018).

  42. 42.

    See CTB, opinion of 29 July 2013, no. 2013/30 (on hospital data concerning cardiological interventions).

  43. 43.

    ABRvS 26 February 2001, ECLI:NL:RVS:2001:AN6832. The Raad van State, abbreviated RvS, is the Dutch Council of State.

  44. 44.

    IGJ (2018) Wat maakt IGJ openbaar? www.igj.nl/onderwerpen/openbaarmaking. Accessed 7 August 2018.

  45. 45.

    See for example Article 66d, 2 Act of 16 June 2005, Stb. 2005, no. 649 (the Dutch Care Insurance Act).

  46. 46.

    This information sharing system is known as DIS (“dbc-informatiesysteem”): see NZa (2018) Over DIS. www.opendisdata.nl/dis/over. Accessed 7 August 2018.

  47. 47.

    See VBOB (2018) Annex to the annual report 2016–2017, p. 3. https://www.vlaanderen.be/nl/publicaties/detail/jaarverslag-beroepsinstantie-inzake-de-openbaarheid-van-bestuur. Accessed 7 August 2018. The VBOB (Vlaamse Beroepsinstantie Afdeling Openbaarheid van Bestuur) is the Flemish appeal body in the context of the Flemish access to government information legislation.

  48. 48.

    See Royal Decree of 10 April 2014, BS 28 May 2014; Royal Decree of 28 March 2013, BS 2 April 2013; Royal Decree of 27 April 2007, BS 10 July 2007.

  49. 49.

    In the context of the project known as “VIP” (“Vlaams Indicatorenproject voor Patiënten en Professionals”), which started in 2010, most of the Flemish hospitals voluntarily measure care quality indicators.

  50. 50.

    Opdebeek and De Somer 2017, p. 319.

  51. 51.

    Articles 4–12 versus 2–3 Federal Access Act, Articles 7–27 versus 28–34 Flemish Access Act, Articles 3–7 versus 8–9 Dutch Access Act.

  52. 52.

    Articles 2–9 versus 10 Access Convention.

  53. 53.

    Article 1.2, b Access Convention.

  54. 54.

    Article 1, 2° Federal Access Act and Article 3, 4° Flemish Access Act.

  55. 55.

    Article 1, a Dutch Access Act.

  56. 56.

    Arbitragehof 25 March 1997, no. 17/97. The Arbitragehof is the Constitutional Court of Belgium and is known as Grondwettelijk Hof, abbreviated GwH, since 2007.

  57. 57.

    Article 1, 2° Federal Access Act, Article 3, 4° Flemish Access Act and Article 1, a Dutch Access Act.

  58. 58.

    Parl. St. Kamer, 1992–1993, no. 1112/1, pp. 9–10; Explanatory report to the Dutch Access Act, pp. 22–23. However, it does not apply to information which the government only obtained coincidentally or temporarily (Schram 2008, p. 148).

  59. 59.

    Parl. St. Kamer, 1992–1993, no. 1112/1, p. 22; Schram 2018, p. 307; Schram 2004, pp. 3–34. In this regard, the explanatory report to the Dutch Access Act specifies, the information should also be intended for the government (pp. 22–23).

  60. 60.

    Schram 2018, pp. 165 and 307.

  61. 61.

    RvS 16 January 2015, no. 229.828, cvba Gerhanko; Opdebeek and De Somer 2017, p. 458.

  62. 62.

    VBOB 4 July 2005, no. OVB/2005/22 (preparatory acts); CTB, opinion of 5 May 1998, no. 98/51, 98/63 and 98/65 (internal documents); Opdebeek and De Somer 2017, pp. 457–458.

  63. 63.

    Parl. St. Kamer 1992–1993, no. 1112/1, pp. 11–12; Parl. St. Kamer 1996–1997, no. 871/5, p. 4; Explanatory report to the Flemish Access Act, Parl. St. Vl. Parl. 2002–2003, no. 1732/1, p. 13; Explanatory report to the Dutch Access Act, pp. 22–23; ARRvS 5 March 1982, ECLI:NL:RVS:1982:AM6426 (on audio tapes); RvS 7 April 2011, no. 212.547, cvba Verbruikers Unie Test Aankoop (on statistical data); VBOB 22 November 2004, no. OVB/2004/42 (on an audio recording).

  64. 64.

    Parl. St. Kamer 1996–1997, no. 871/5, p. 4; RvS 16 January 2015, no. 229.828; CTB, opinion of 21 February 2005, no. 2004/103; CTB, opinion of 30 August 2002, no. 2002/79; CTB, opinion of 22 January 1996, no. 96/2 (no governmental duty to draw up new documents); CTB, opinion of 13 October 1995, no. 95/102 (no duty for the government to transform information into statistics).

  65. 65.

    Delvaux 1999, p. 26; Jongen 1995, p. 781.

  66. 66.

    Data merely present in the random access memory (RAM) of a computer is usually volatile.

  67. 67.

    Fonds voor Medische Ongevallen or FMO.

  68. 68.

    Provided legal exceptions or refusal grounds of the legislative framework on access to government information do not apply.

  69. 69.

    Article 20, § 1, limb 1 Flemish Access Act; ARRvS 31 August 1993, ECLI:NL:RVS:1993:AN3429 (The Dutch Access Act entails no translation duty for the Dutch government).

  70. 70.

    Explanatory report to the Dutch Access Act, pp. 22–23; RvS 21 October 2013, no. 225.162, gemeente Schaarbeek; Opdebeek and De Somer 2017, p. 457.

  71. 71.

    Further on in this contribution (Sect. 11.2.4.6), we focus more in detail on the implications of copyright for access to government data.

  72. 72.

    Opdebeek and De Somer 2017, p. 301; Van Eechoud 2008, p. 96.

  73. 73.

    Article 2 Federal Access Act and Article 29 Flemish Access Act.

  74. 74.

    Article 8.1 Dutch Access Act.

  75. 75.

    Article 28, § 2 Flemish Access Act and Article 10 Dutch Access Act.

  76. 76.

    Articles 2 and 4.1 Access Convention, Article 4 Federal Access Act, Article 17, § 2 Flemish Access Act and Article 3 Dutch Access Act.

  77. 77.

    RvS 21 October 2013, no. 225.162, gemeente Schaerbeek.

  78. 78.

    Article 4, limb 2 Federal Access Act and Article 17, § 2 Flemish Access Act.

  79. 79.

    RvS 3 March 2009, no. 191.067, Asselman.

  80. 80.

    Legal persons are excluded (Boes 1996, p. 19).

  81. 81.

    The “harm” criterion is only mentioned in the Federal Access Act.

  82. 82.

    Article 1, 3° Federal Access Act and Article 3, 6° Flemish Access Act.

  83. 83.

    Article 4, limb 2 Federal Access Act.

  84. 84.

    Parl. St. Kamer 1992–1993, no. 1112/13, p. 12; Parl. St. Kamer 1996–1997, no. 871/5, p. 5. The interest is interpreted in a broad sense (on the required interest: Kaiser and Gourdin 2015, pp. 44–58; Opdebeek and De Somer 2017, pp. 564–568).

  85. 85.

    Article 17, § 2 Flemish Access Act.

  86. 86.

    Article 17, § 2 Flemish Access Act.

  87. 87.

    RvS 20 March 2006, no. 156.628; CTB, opinion of 19 February 2001, no. 2001/11.

  88. 88.

    Article 4.3 Access Convention.

  89. 89.

    Article 4.2 Access Convention.

  90. 90.

    Article 5 Federal Access Act and Article 17, § 1 and § 3 Flemish Access Act.

  91. 91.

    I.e. the consultation of the document, information on the document or the provision of a copy.

  92. 92.

    Article 17, § 1 Flemish Access Act.

  93. 93.

    Article 3.2 Dutch Access Act.

  94. 94.

    Article 5.1 Access Convention.

  95. 95.

    Article 5.2 Access Convention.

  96. 96.

    Article 5 Federal Access Act, Article 17, § 3 Flemish Access Act and Article 4 Dutch Access Act. See RvS 8 February 2000, no. 85.178.

  97. 97.

    RvS 24 June 2014, no. 227.809, Verrycken.

  98. 98.

    To the extent reasonably possible.

  99. 99.

    Cf. more infra (Sect. 11.3.4.5).

  100. 100.

    Article 5.4 Access Convention.

  101. 101.

    Article 6, § 5 Federal Access Act.

  102. 102.

    Article 20, § 2 Flemish Access Act.

  103. 103.

    Article 17, § 1, limb 1, 1° Flemish Access Act.

  104. 104.

    Article 17, § 1, limb 1, 2° Flemish Access Act.

  105. 105.

    Article 17, § 1, limb 1, 3° Flemish Access Act.

  106. 106.

    The protection of private life and confidential information can be ground for access refusal in the Federal, Flemish and Dutch Access Act (see further on in this contribution in Sect. 11.2.4.7).

  107. 107.

    Article 4, limb 1 Federal Access Act and Article 7, limb 2 Flemish Access Act.

  108. 108.

    See Article 20, § 1 of the Flemish Access Act; RvS 23 November 2010, no. 209.086, Beuls; VBOB 13 January 2010, no. OVB/2009/172.

  109. 109.

    Article 7 Dutch Access Act.

  110. 110.

    Article 7 Access Convention.

  111. 111.

    Article 12 Federal Access Act, Article 20, § 3 Flemish Access Act and Article 12 Dutch Access Act. For instance, the Belgian municipality of Lier asks 0,10 EUR for a black and white copy and 0,50 EUR for a colour copy. A digital copy is free (www.lier.be/IK_WIL/Ik_wil_aanvragen/Openbaarheid_van_bestuur_aanvraag. Accessed 26 September 2018).

  112. 112.

    Opdebeek and De Somer 2017, p. 456.

  113. 113.

    Article 9, limb 1 and 2 Federal Access Act.

  114. 114.

    See also Jongen 1994, pp. 303–304.

  115. 115.

    See the Dutch Act of 23 September 1912 with regard to copyright, Stb. 1912, no. 308.

  116. 116.

    Van Eechoud 2008, p. 96.

  117. 117.

    Article XI.172, § 2 Belgian Code of Economic Law (the copyright provisions were inserted in the Belgian Code of Economic Law by the Federal Act of 19 April 2014, BS 12 July 2014) and Article 11 Dutch Copyright Act.

  118. 118.

    Van Eechoud 2008, pp. 95–96; Vanhees 1998, p. 22.

  119. 119.

    Opdebeek and De Somer 2017, p. 458.

  120. 120.

    See Article 10 Flemish Access Act; RvS 27 June 2001, no. 97.056, Tassin; RvS 16 January 1998, no. 70.844, Duez; RvS 2 October 1997, no. 68.610, Delwart; RvS 18 June 1997, no. 66.860, Matagne.

  121. 121.

    RvS 3 October 2011, no. 215.506, Baumwald; RvS 29 March 2010, no. 202.459, Sevenhans; RvS 22 June 2006, no. 160.433.

  122. 122.

    Article 3, § 3 Access Convention.

  123. 123.

    Article 10 Dutch Access Act.

  124. 124.

    Article 6, § 1–2 Federal Access Act and Articles 13–14 Flemish Access Act.

  125. 125.

    Article 6, § 3 Federal Access Act and Article 11 Flemish Access Act; RvS 16 January 1998, no. 70.844.

  126. 126.

    Tijs 2012, p. 314.

  127. 127.

    Opdebeek and De Somer 2017, p. 466; Tijs 2012, p. 314.

  128. 128.

    Opdebeek and De Somer 2017, pp. 466–467; Tijs 2012, p. 315.

  129. 129.

    Opdebeek and De Somer 2017, pp. 466–467; Tijs 2012, p. 315.

  130. 130.

    Tijs 2012, p. 315.

  131. 131.

    Schram 2005, pp. 578–586.

  132. 132.

    ECtHR 8 November 2016, no. 18030/11, Magyar Helsinki Bizottsag/Hungary.

  133. 133.

    Voorhoof 2016, p. 5.

  134. 134.

    Article 6, § 1, 1° Federal Access Act and Article 11, 2° Flemish Access Act.

  135. 135.

    Article 6, § 1, 3° Federal Access Act and Article 11, 1° Flemish Access Act.

  136. 136.

    Article 6, § 1, 4° Federal Access Act and Article 11, 1° Flemish Access Act. The Dutch Access Act states in its Article 3.4 the government can ask more details if a request is too vague or imprecise.

  137. 137.

    CTB, opinion of 9 June 1997, no. 97/32 (on the request to access a large quantity of documents: If this is materially almost impossible, the access can be denied or limited to a consultation).

  138. 138.

    VBOB 7 January 2011, no. OVB/2010/295 (on a request to deliver all reports of “B-inspections” of a range of bridges between 2008 and 2010); VBOB 24 December 2008, no. OVB/2008/174 (on the request of large quantities of information from the same city for a column in a local magazine, which hampers the normal functioning of this city); VBOB, 28 July 2005, no. OVB/2005/53 (on the request of more than 10.000 pages).

  139. 139.

    Article 6, § 2, 1° Federal Access Act, Article 13, 2° Flemish Access Act and Article 10.1, d Dutch Access Act; RvS 11 December 2000, no. 85.177; RvS 9 July 1999, no. 81.740.

  140. 140.

    CTB, opinion of 8 July 2002, no. 2002/35.

  141. 141.

    Article 6, § 1, 6° Federal Access Act.

  142. 142.

    Article 14, 1° Flemish Access Act and Article 10.2, (b) Dutch Access Act.

  143. 143.

    RvS 18 June 2002, no. 107.951; RvS 2 October 1997, no. 68.809.

  144. 144.

    Article 6, § 1, 7° Federal Access Act and Article 14, 3° Flemish Access Act.

  145. 145.

    Article 10.1, (c) Dutch Access Act.

  146. 146.

    More in particular, their interest of fair competition is at stake.

  147. 147.

    See Article 458 Belgian Criminal Code, BS 9 June 1867.

  148. 148.

    For instance, there is a duty to report certain communicable diseases.

  149. 149.

    On obligations of secrecy in general: RvS 28 March 2001, no. 94.419; RvS 8 February 2000, no. 85.177.

  150. 150.

    Article 6, § 2 Federal Access Act and Article 13 Flemish Access Act.

  151. 151.

    RvS 10 January 2015, no. 221.961, cvba Verbruikersunie Test Aankoop (on the publicity of data from the annual reports of the ombuds in hospitals).

  152. 152.

    Janssen, K (2009) The EC Legal Framework for the Availability of Public Sector Spatial Data, pp. 108–109. https://lirias2repo.kuleuven.be/bitstream/id/94728/;jsessionid=E986A59479DAE00DAFF2791534E1C4B9. Last accessed 7 August 2018.

  153. 153.

    Its definition can be found in the Belgian and Dutch legislation in Article 2, 4° Federal Re-use Act, Article 2, 3° Flemish Re-use Act and Article 1, b Dutch Re-use Act.

  154. 154.

    Opdebeek and De Somer 2017, p. 480.

  155. 155.

    See recital 9 original PSI Directive.

  156. 156.

    Article 3 PSI Directive.

  157. 157.

    Evaluation report (European Commission) on the Directive 2003/98/EC on the re-use of public sector information, 25 April 2018, SWD (2018).

  158. 158.

    Evaluation report (European Commission) on the Directive 2003/98/EC on the re-use of public sector information, 25 April 2018, SWD (2018), 42; see also PSI Directive Revision Proposal, p. 1.

  159. 159.

    Evaluation report (European Commission) on the Directive 2003/98/EC on the re-use of public sector information, 25 April 2018, SWD (2018), 42; see also PSI Directive Revision Proposal, p. 1.

  160. 160.

    Article 1.2, (c), (ca), (cb) and (cc) PSI Directive.

  161. 161.

    Article 3 PSI Directive.

  162. 162.

    Article 2.1. PSI Directive.

  163. 163.

    Article 2.2 PSI Directive. The Belgian and Dutch definition of “public sector body” can be found in Article 2, 1° Federal Re-use Act, Article 2, 1° Flemish Re-use Act and Article 1, c Dutch Re-use Act.

  164. 164.

    See Directive 2014/23/EU of 26 February 2014 on the award of concession contracts, OJ L 094, 28 March 2014, p. 1; Directive 2014/24/EU of 26 February 2014 on public procurement, OJ L 094, 28 March 2014, p. 56; Directive 2014/25/EU of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors, OJ L 094, 28 March 2014, p. 243.

  165. 165.

    Janssen, 2009, p. 48.

  166. 166.

    Callens et al. 2015, p. 703.

  167. 167.

    See Hoge Raad, 1 June 2007, ECLI:NL:HR:2007:AZ9872 and Court of first instance of Utrecht, 5 December 2012, ECLI:NL:RBUTR:2012:BY5442. De Hoge Raad is the Dutch Supreme Court in the fields of civil, criminal and tax law.

  168. 168.

    Article 1.2, e PSI Directive. See for Belgium and the Netherlands: Article 3, § 2, 7° Federal Re-use Act, Article 2/1, 5° Flemish Re-use Act and Article 2.1, d Dutch Re-use Act. See more infra (in Sect. 11.3.4.6).

  169. 169.

    Article 1.1. PSI Directive. See for Belgium and the Netherlands: Article 3, § 1 Federal Re-use Act, Article 3, limb 1 Flemish Re-use Act and Article 1, d Dutch Re-use Act.

  170. 170.

    Recital 11 of the original PSI Directive.

  171. 171.

    Article 2.3 PSI Directive. See for Belgium and the Netherlands: Article 2, 2° Federal Re-use Act, Article 2, 2° Flemish Re-use Act and Article 1, d Dutch Re-use Act.

  172. 172.

    Proposal (European Commission) for a directive of the European Parliament and of the Council on the re-use and commercial exploitation of public sector documents, 5 June 2002, COM(2002) 207 final, p. 9.

  173. 173.

    We already referred to the definitions of these data categories included in the PSI Directive Revision Proposal in the beginning of this contribution (see Sect. 11.1.3). The proposed modifications regarding these data categories are discussed more in detail further in this contribution (see Sect. 11.3.4.3 et seq.).

  174. 174.

    Article 10 PSI Directive Revision Proposal.

  175. 175.

    PSI Directive Revision Proposal, p. 4.

  176. 176.

    Article 3.1 PSI Directive. See for Belgium and the Netherlands: Article 4 Federal Re-use Act, Article 3 Flemish Re-use Act and Article 3.1 Dutch Re-use Act.

  177. 177.

    Article 3.1 PSI Directive. See for Belgium and the Netherlands: Article 4 Federal Re-use Act, Article 3 Flemish Re-use Act and Article 3.1 Dutch Re-use Act.

  178. 178.

    Article 4 PSI Directive. See for Belgium and the Netherlands: Article 10 Federal Re-use Act, Article 10 Flemish Re-use Act and Article 3 Dutch Re-use Act.

  179. 179.

    See infra for more information on data portals (Sect. 11.3.4.5).

  180. 180.

    It is possible though, the government has imposed some conditions for the re-use of this publicly available information.

  181. 181.

    Article 10, § 1 Federal Re-use Act and Article 10, § 2 Flemish Re-use Act.

  182. 182.

    Article 10, § 2 Flemish Re-use Act.

  183. 183.

    Article 11 Flemish Re-use Act.

  184. 184.

    Article 3.2 Dutch Re-use Act.

  185. 185.

    Article 3.4 Dutch Re-use Act.

  186. 186.

    Articles 4.1 and 4.2 PSI Directive. For Belgium, at the federal level the time limit can be found in a Royal Decree of 29 October 2007 (BS 6 November 2007). According to its Article 3 a request should be investigated within ten working days. Within 20 working days the applicant should be able to re-use the requested information (Article 5). In Flanders, the time limit to process the request is 15 days and for complex requests 30 days (Article 12, § 2 Flemish Re-use Act). When re-use is allowed the information is provided within 30 days after the request (Article 12, § 3 Flemish Re-use Act). In the Netherlands, the time frame is four weeks (Article 4.4 Dutch Re-use Act).

  187. 187.

    Article 5.4 PSI Directive Revision Proposal.

  188. 188.

    Recital 28 and Article 5.4 PSI Directive Revision Proposal.

  189. 189.

    Article 5.5 PSI Directive Revision Proposal.

  190. 190.

    Article 13.2 PSI Directive Revision Proposal.

  191. 191.

    Article 8.1 PSI Directive.

  192. 192.

    Article 8.1 PSI Directive. See for Belgium and the Netherlands: Article 7, § 1–2 Federal Re-use Act, Article 8 Flemish Re-use Act and Article 6.2 Dutch Re-use Act.

  193. 193.

    Article 10.1 PSI Directive.

  194. 194.

    Article 8.2 PSI Directive.

  195. 195.

    Articles 7.2 and 7.3 Federal Re-use Act and Article 8 Flemish Re-use Act.

  196. 196.

    Article 13 PSI Directive Revision Proposal.

  197. 197.

    Article 11.1 PSI Directive. See for Belgium and the Netherlands: Article 20, § 1 Federal Re-use Act, Article 14, § 1 Flemish Re-use Act and Article 7.1 Dutch Re-use Act.

  198. 198.

    Article 11.2 PSI Directive. See for Belgium and the Netherlands: Article 20, § 1 Federal Re-use Act, Article 14, § 2 Flemish Re-use Act and Article 7 Dutch Re-use Act.

  199. 199.

    Article 6.1 PSI Directive. See for Belgium and the Netherlands: Article 8 Federal Re-use Act, Article 7, limb 1 Flemish Re-use Act and Article 9.1 Dutch Re-use Act.

  200. 200.

    Article 7.1 PSI Directive. See for Belgium and the Netherlands: Article 6, § 2 Federal Re-use Act, Article 7/1, limb 1 Flemish Re-use Act and Article 9.4 Dutch Re-use Act.

  201. 201.

    Article 6.3 PSI Directive. See for Belgium and the Netherlands: Article 8, limb 2 and 3 Federal Re-use Act, Article 7, limb 2 and 3 Flemish Re-use Act and Article 9.3 Dutch Re-use Act.

  202. 202.

    Article 7.2 PSI Directive. See for Belgium and the Netherlands: Article 6, § 3 Federal Re-use Act, Article 7/1, limb 2 and 3 Flemish Re-use Act and Article 9.4 Dutch Re-use Act.

  203. 203.

    Article 6.2, a and b PSI Directive. See for Belgium and the Netherlands: Article 8, limb 2 and 3 Federal Re-use Act, Article 7, limb 2 and 3 Flemish Re-use Act and Article 9.3 Dutch Re-use Act.

  204. 204.

    Article 6.1 PSI Directive Revision Proposal; Recital 33 PSI Directive Revision Proposal.

  205. 205.

    Article 6.2 PSI Directive Revision Proposal; Recital 33 PSI Directive Revision Proposal.

  206. 206.

    Article 6.3 PSI Directive Revision Proposal; Recital 33 PSI Directive Revision Proposal.

  207. 207.

    Article 6.5 PSI Directive Revision Proposal.

  208. 208.

    Article 5.1 PSI Directive. See for Belgium and the Netherlands: Article 9, § 1 and 2 Federal Re-use Act, Article 3, limb 3 Flemish Re-use Act and Article 5.1 Dutch Re-use Act.

  209. 209.

    “[W]here possible and appropriate” and “in so far as possible”.

  210. 210.

    Article 5.2 PSI Directive. See for Belgium: Article 9, § 1 Federal Re-use Act and Article 5 Flemish Re-use Act.

  211. 211.

    Article 5.3 PSI Directive. See for Belgium and the Netherlands: Article 9, § 3 Federal Re-use Act, Article 6 Flemish Re-use Act and Article 5.2 Dutch Re-use Act.

  212. 212.

    Article 9 PSI Directive. See also recital 23 of the original PSI Directive.

  213. 213.

    Article 22, § 1 and § 2 Federal Access Act.

  214. 214.

    Article 1.2, a PSI Directive. See for Belgium: Article 3, § 2, 2° Federal Re-use Act and Article 2/1, 1° Flemish Re-use Act.

  215. 215.

    See recital 9 of the original PSI Directive which refers to this as a typical example of “activities falling outside the public task”.

  216. 216.

    Article 1.2, b PSI Directive. See for Belgium and the Netherlands: Article 3, § 2, 3° Federal Re-use Act, Article 2/1, 2° Flemish Re-use Act and Article 2.1, b Dutch Re-use Act.

  217. 217.

    Earlier (see Sect. 11.2.4.6) this contribution mentioned the access to government information legislation also requires consent in case a copy is requested. Mere access however, is possible without consent of the concerned third party.

  218. 218.

    Article 1.2, c, ca and cc PSI Directive. See for Belgium and the Netherlands: Article 3, § 2, 4° and 5° Federal Re-use Act, Article 2/1, 3° Flemish Re-use Act and Article 2.1, a Dutch Re-use Act. Access can be restricted or denied on the grounds of the protection of national or public security, defence, statistical or commercial confidentiality or the protection of personal data. In some cases a particular interest will be needed to obtain access.

  219. 219.

    Article 1.2, e PSI Directive. See for Belgium and the Netherlands: Article 3, § 2, 7° Federal Re-use Act, Article 2/1, 5° Flemish Re-use Act and Article 2.1, d Dutch Re-use Act.

  220. 220.

    Article 1.4 PSI Directive. See for Belgium and the Netherlands: Article 3, § 3 Federal Re-use Act and Article 1, g Dutch Re-use Act.

  221. 221.

    The PSI Directive concept of “government” in a healthcare context was discussed earlier in this contribution (see Sect. 11.3.3).

  222. 222.

    PSI Directive Revision Proposal, p. 10.

  223. 223.

    PSI Directive Revision Proposal, p. 10.

  224. 224.

    Article 10 PSI Directive Revision Proposal.

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  1. Leuven Institute for Healthcare Policy, Kapucijnenvoer 35, 3000, Leuven, Belgium

    Miet Caes

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Caes, M. (2019). Access to and Re-use of Government Data and the Use of Big Data in Healthcare. In: Reins, L. (eds) Regulating New Technologies in Uncertain Times. Information Technology and Law Series, vol 32. T.M.C. Asser Press, The Hague. https://doi.org/10.1007/978-94-6265-279-8_11

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