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Artificial Intelligence and Healthcare: Products and Procedures

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Regulating Artificial Intelligence

Abstract

This paper focuses on statutory regulation of learning machines that qualify as medical devices. After a brief case study, the article takes a procedural perspective and presents the main features of the European regulatory framework that applies to medical devices in order to identify the regulatory peculiarities in the use of machine learning. In this context, the Chapter will analyse the immanent risks of machine learning applications as medical devices as well as the role of machine learning in their regulation. The overall finding is that due to its lack of expertise and material equipment the state activates private companies for market access control, which are commissioned with the preventive inspection of medical devices. As a result, security measures adopted by the authority are in principle limited to the period after market-entry. This leads to a structural information deficit for the authority, which has no systematic information about the products on the market. The authority is limited to a challenging overall market observation. This raises the question addressed in the fifth part of the paper: does the law guarantee sufficient instruments for the systematic transfer of knowledge from the risk actors to the authority about the potential risk of medical devices and does this in fact remedy the information deficit of the authority and ensure an effective post market-entry control of learning machines as medical devices?

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Notes

  1. 1.

    De Fauw et al. (2018), p. 1342 et seq.

  2. 2.

    See Wischmeyer, paras 2 et seq.

  3. 3.

    On the reliability of an output of a learning algorithm in the context of search algorithms, see European Court of Justice C-131/12 ‘Google Spain SL/AEPD’ (13 May 2014) margin no. 61 et seq.

  4. 4.

    See in detail Molnár-Gábor, paras 38 et seq.

  5. 5.

    On the term of ‘machine learning’ see Hoffmann-Riem, para 3 and Hermstüwer, para 6.

  6. 6.

    Langkafel (2015), p. 27; Singh (2014), p. 157; Thuemmler (2017), p. 1.

  7. 7.

    Cf. Hadank (2017), p. 811.

  8. 8.

    Neubauer and Uilaky (2004), p. 151; Ostermayer and Kexel (2009), p. 106; Schmitt (2014), p. 26.

  9. 9.

    Trute (2018), p. 1.

  10. 10.

    Ernst (2017), p. 1026; Martini (2017a), p. 1017; Stiemerling (2015), p. 762.

  11. 11.

    Jaumann (1980), p. 7; Kage (2005), pp. 19, 213 et seq.

  12. 12.

    Igl (2018), p. 155; Jäkel (2016), p. 601.

  13. 13.

    Cf. Council Directive 93/42/EEC, former Article 100a EEC.

  14. 14.

    Council resolution of 7 May 1985 on a new approach to technical harmonization and standards (OJ EG No. C 136, p. 1); Braun and Püschel (2014), p. 136; Dieners and Vivekens (2017), p. 20; Tomasini (2015), p. 12 et seq.

  15. 15.

    Part of the European Medical Devices Law is also the Council Directive 98/79/EC concerning in vitro diagnostic medical devices, which shouldn’t be considered in this contribution.

  16. 16.

    Cf. Recital 8 of the Council Directive 93/42/EEC.

  17. 17.

    Cf. Recital 15 of the Council Directive 93/42/EEC.

  18. 18.

    Braun and Püschel (2014), p. 136; a proposal for the establishment of an approval procedure at central level, at least for medical devices of the high-risk group, was made by Roth-Behrendt in the latest legislative reform of EU Medical Devices Law, cf. Heil (2014), p. 16.

  19. 19.

    For further details see below, paras 29 et seq., which describes the control-related process modules.

  20. 20.

    Bieback (2008), p. 214.

  21. 21.

    Cf. Article 16(3) of the Council Directive 93/42/EEC; implemented in detail in national law by Section 15 MPG.

  22. 22.

    Gesetz über Medizinprodukte (Medizinproduktegesetz – MPG) in the version published on 07th August 2002 (BGBl. I p. 3146), last amended by Article 7 of the Act of the 18th July 2017 (BGBl. I p. 2757).

  23. 23.

    For an overview of the historical development of national Medical Devices Law, in particular the implementation of the European directives by the MPG amendments, see Tomasini (2015), pp. 19 et seq.

  24. 24.

    An overview is provided by Webel (2018), p. 852, margin no. 3.

  25. 25.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ EU 2017, No. L 117/1.

  26. 26.

    Cf. Recitals 1, 13 and Annex IX section 4.5. of the MDR.

  27. 27.

    Cf. Article 123(2) of the MDR.

  28. 28.

    Tomasini (2015), p. 18.

  29. 29.

    Irmer (2013), p. 145.

  30. 30.

    The legal qualification of software in the medical scope was simplified by the 4th amendment of the MPG in 2010, cf. Gesetz zur Änderung medizinprodukterechtlicher Vorschriften vom 29. Juli 2009 (BGBl. I p. 2326); Irmer (2013), p. 145.

  31. 31.

    Cf. Section 3 No. 1 MPG, adopted literally from Article 2 of the Council Directive 2007/47/EC; Tomasini (2015), p. 37.

  32. 32.

    Cf. Bill of the Rederal Government, Parliamentary Printing Matter 16/12258, p. 26.

  33. 33.

    See paras 22 et seq., in which the specific risk construction of learning machines is elaborated as a basis for their classification.

  34. 34.

    Cf. Section 3 No. 1 MPG; Tomasini (2015), p. 37; Lücker (2014); pp. 1272 et seq., margin no. 7; Webel (2018), p. 863, margin no. 7 et seq.

  35. 35.

    Kage (2005), p. 42; Lücker (2014); pp. 1272 et seq., margin no. 7; Webel (2018), p. 863, margin no. 7 et seq.

  36. 36.

    Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz—AMG) in the version published on 12th December 2005 (BGBl. I p. 3394), last amended by Article 1 of the Act of the 18th July 2017 (BGBl. I p. 2757).

  37. 37.

    Lücker (2014), pp. 1272 et seq., margin no. 7.

  38. 38.

    Czettritz and Strelow (2017), p. 434; Düwert and Klümper (2013), p. 23; Gassner (2017), p. 25; Hötzel (2018), p. 16; Kage (2005), p. 43; Oen (2009), p. 55; Pramann and Albrecht (2015), p. 132; Sachs (2013), p. 31; Tomasini (2015), p. 37.

  39. 39.

    MEDDEV 2.1/6 (2016), Guidance document concerning the qualification and classification of stand-alone software, p. 4.

  40. 40.

    Cf. Section 3 No. 1 MPG.

  41. 41.

    Irmer (2013), p. 145.

  42. 42.

    Ibid.; Prinz (2017), p. 19.

  43. 43.

    Merten (2004), p. 1212.

  44. 44.

    MEDDEV 2.1/6 (2016), Guidance document concerning the qualification and classification of stand-alone software, p. 18.

  45. 45.

    Sachs (2013), p. 31.

  46. 46.

    Klümper and Vollebregt (2009), p. 100; ensuing Tomasini (2015), p. 43.

  47. 47.

    Courtin (1997), p. 64; Sachs (2013), p. 31; Tomasini (2015), p. 43.

  48. 48.

    Oen (2009), p. 55.

  49. 49.

    Graf (2017a), p. 59; Gassner (2016), p. 111; Hötzel (2018), p. 16; Oen (2009), p. 55; Tomasini (2015), p. 43.

  50. 50.

    Klümper and Vollebregt (2009), p. 100; Tomasini (2015), pp. 43 et seq.

  51. 51.

    Klümper and Vollebregt (2009), p. 100.

  52. 52.

    Tomasini (2015), p. 44.

  53. 53.

    MEDDEV 2.1/6 (2016), Guidance document concerning the qualification and classification of stand-alone software, p. 7; Tomasini (2015), p. 39.

  54. 54.

    Cf. Gesetz zur Änderung medizinprodukterechtlicher Vorschriften vom 29. Juli 2009 (BGBl. I p. 2326).

  55. 55.

    MEDDEV 2.1/6 (2016), Guidance document concerning the qualification and classification of stand-alone software, p. 7; Pramann and Albrecht (2015), p. 132.

  56. 56.

    Tomasini (2015), p. 40; MEDDEV 2.1/6 (2016), Guidance document concerning the qualification and classification of stand-alone software, p. 8.

  57. 57.

    MEDDEV 2.1/6 (2016), Guidance document concerning the qualification and classification of stand-alone software, p. 8.

  58. 58.

    Irmer (2013), p. 145.

  59. 59.

    Cf. Recital 20 of the Council Directive 2007/47/EC.

  60. 60.

    Cf. Bill of the Federal Government, Parliamentary Printing Matter 16/12258, p. 26.

  61. 61.

    Other voices in the literature argue that software cannot be an accessory since the law on the amendment of medical device regulations (4th MPG amendment) came into force. This difference of views has been processed by Tomasini (2015), pp. 46 et seq.; also illustrated by Oen (2009), p. 56; Gassner (2016), p. 111.

  62. 62.

    Cf. Article 1(2)(b) of the Council Directive 93/42/EEC; misleadingly implemented in Section 3 No. 9 MPG.

  63. 63.

    Anhalt et al. (2017), p. 58.

  64. 64.

    Ibid.; similarly Tomasini (2015), p. 45 with reference to Meyer (2011).

  65. 65.

    To this see Tomasini (2015), p. 45.

  66. 66.

    MEDDEV 2.1/6 (2016), Guidance document concerning the qualification and classification of stand-alone software, p. 12; thereafter Tomasini (2015), p. 48.

  67. 67.

    Cf. Article 1(1) of the Council Directive 93/42/EEC.

  68. 68.

    Anhalt et al. (2017), p. 57.

  69. 69.

    Cf. Article 1(1) of the Council Directive 93/42/EEC and the implementation in Section 2(1) MPG.

  70. 70.

    Tomasini (2015), p. 49.

  71. 71.

    Cf. Recital 19 of the Regulation (EU) 2017/745.

  72. 72.

    European Court of Justice C-329/16 ‘Philips France/ Ministre des Affaires sociales et de la Santé’ (7 December 2017), margin no. 36.

  73. 73.

    Ibid.

  74. 74.

    MEDDEV 2.1/6 (2016), Guidance document concerning the qualification and classification of stand-alone software, p. 17 et seq.

  75. 75.

    Anhalt et al. (2017), p. 61.

  76. 76.

    MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 4; Braun and Püschel (2014), p. 136.

  77. 77.

    Jäkel (2016), p. 602; MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 4; Merten (2004), p. 1212.

  78. 78.

    Cf. Article 3 of the Council Directive 93/42/EEC; Braun and Püschel (2014), p. 136.

  79. 79.

    Tomasini (2015), p. 86; for further details on the basic requirements see para 30.

  80. 80.

    Cf. Annex IX of the Council Directive 93/42/EEC.

  81. 81.

    Section 13(1) MPG.

  82. 82.

    Each medical device is classified separately, this also applies to accessories on medical devices, cf. Annex IX, section 2.2 of the Council Directive 93/42/EEC.

  83. 83.

    Anhalt et al. (2017), p. 61.

  84. 84.

    Cf. Annex IX of the Council Directive 93/42/EEC; MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 7.

  85. 85.

    MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 4.

  86. 86.

    If the manufacturer is unsure how to classify his product, he can consult a notified body. In case of a dispute between the manufacturer and the notified body resulting from the application of the classification rules, the matter shall be referred for decision to the relevant Competent Authority to which the notified body is subject, cf. Article 9(2) of the Council Directive 93/42/EEC.

  87. 87.

    Cf. Annex IX, section 2.5 of the Council Directive 93/42/EEC; MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 13.

  88. 88.

    Anhalt et al. (2017), p. 61.

  89. 89.

    MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 37.

  90. 90.

    Anhalt et al. (2017), p. 61; MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 39.

  91. 91.

    Anhalt et al. (2017), p. 61.

  92. 92.

    Ibid.; MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 40.

  93. 93.

    Anhalt et al. (2017), p. 61; MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 47.

  94. 94.

    Anhalt et al. (2017), p. 61.

  95. 95.

    MEDDEV 2.4/1 Rev 9 (2010), Guidance document concerning the classification of medical devices, p. 37.

  96. 96.

    MEDDEV 2.4/1 Rev. 9 (2010), Guidance document concerning the classification of medical devices, p. 38.

  97. 97.

    The BfArM has published a statistical evaluation of the risk reports on software errors in medical devices that were conclusively evaluated between 01st January 2005 and 31th December 2016. Available at: https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Statistik/MP-Statistik/statist-Auswert_Fehlerart_Software.jpg?__blob=poster&v=6.

  98. 98.

    For a description of instances for false negative and false positive errors see Hermstüwer, para 45.

  99. 99.

    Trute (2018), p. 1.

  100. 100.

    Colquhoun (2017), p. 2; van Cauter (1988), p. E786.

  101. 101.

    See in detail Molnár-Gábor, paras 25–28.

  102. 102.

    To the right not to know see Taupitz (1998), p. 591.

  103. 103.

    To risk information in context of informed consent of patients see Molnár-Gábor, paras 34 et seq.

  104. 104.

    Van Cauter (1988), p. E786.

  105. 105.

    Herberger (2018), p. 2827.

  106. 106.

    Ibid.

  107. 107.

    Herberger (2018), pp. 2827 et seq.

  108. 108.

    Everything else would be unsatisfactory in the medical field, so Herberger (2018), p. 2828. On Explainable AI see Rademacher, para 33, Wischmeyer paras 27 et seq.

  109. 109.

    For illustrative examples of qualification and classification of software used in the healthcare environment, see Annex 1 of MEDDEV 2.1/6 (2016), Guidance document concerning the Qualification and Classification of stand alone software, pp. 19 et seq.

  110. 110.

    Scherzberg and Heym (2013), p. 176.

  111. 111.

    Annex IX of the MDD is also referred to by national law in Section 13(1) sentence 2 MPG.

  112. 112.

    Cf. Annex IX, section 2.3 of the Council Directive 93/42/EEC; also Annex VIII section 3.3 of the Regulation (EU) 2017/745; illustratively Tomasini (2015), p. 98.

  113. 113.

    Frankenberger (2017), p. 127.

  114. 114.

    Cf. Annex VIII section 3.3 of the Regulation (EU) 2017/745; Graf (2017a), p. 59.

  115. 115.

    Cf. Annex IX, section 1.4 of the Council Directive 93/42/EEC; also Article 2 of the Regulation (EU) 2017/745.

  116. 116.

    Namely rules 9 to 12 of Annex IX, section 3 of the Council Directive 93/42/EEC.

  117. 117.

    See paras 22 et seq.

  118. 118.

    In accordance with rule 12.

  119. 119.

    For further details on the Essential Requirements see para 30.

  120. 120.

    Cf. Annex XIII of the Council Directive 93/42/EEC; Gassner points out the danger of overregulation, cf. Gassner (2016), p. 112.

  121. 121.

    Cf. Rule 11 in Annex VIII section 6.3 of the Council Regulation (EU) 2017/745.

  122. 122.

    The rule covers for instance hospital beds and patient lifts, cf. Frankenberger (2017), p. 139.

  123. 123.

    See paras 1 et seq.

  124. 124.

    Section 7 MPG refers to Annex I of the MDD.

  125. 125.

    For the basic principles of the New Approach, see Voßkuhle (2002), pp. 310 et seq.; Di Fabio (1996), pp. 1 et seq.; also Merten (2005), pp. 37 et seq., p. 108; similarly Pilniok (2017), p. 6.

  126. 126.

    Kage (2005), p. 248.

  127. 127.

    Cf. Pilniok (2017), p. 11, who describes accredited certification as a model for responding to an erosion of the classic forms of administrative knowledge generation; similarly Dieners and Vivekens (2017), p. 20.

  128. 128.

    Further details on the basic requirements in this para.

  129. 129.

    Di Fabio (1996), p. 69; Dieners and Vivekens (2017), p. 22.

  130. 130.

    Pilniok (2017), p. 12.

  131. 131.

    Ibid.

  132. 132.

    Cf. Annex I, section 17 of the Council Regulation (EU) 2017/745; categorized by Prinz (2017), p. 26.

  133. 133.

    For an overview of the selectable modules depending on the risk class of the device, see Article 11 of the Council Directive 93/42/EEC with reference to the relevant Annexes to the Directive.

  134. 134.

    Scherzberg and Heym (2013), p. 184.

  135. 135.

    Voßkuhle (2002), p. 313; Röhl (2000), pp. 91 et seq.; also Pilniok (2017), p. 12; in contrast, the legal relationship between a notified body and the Accreditation Body is governed by public law, cf. Pilniok (2017), p. 15.

  136. 136.

    Cf. Article 11(10) of the Council Directive 93/42/EEC; also Article 53(4) of the Council Regulation (EU) 2017/745.

  137. 137.

    Voßkuhle (2002), pp. 340 et seq.; Scherzberg and Heym (2013), p. 184.

  138. 138.

    Kage (2005), p. 246.

  139. 139.

    Voßkuhle (2002), p. 331.

  140. 140.

    See Scherzberg and Heym (2013), p. 185.

  141. 141.

    Scherzberg (2002), p. 136; also Stoll (2008); p. 42.

  142. 142.

    Scherzberg and Heym (2013), p. 185.

  143. 143.

    Merten (2005), p. 90.

  144. 144.

    See Martini (2017b), p. 453. In Germany, ‘TÜV’ is the abbreviation for ‘Technischer Überwachungsverein’ and refers to associations that carry out safety checks as a technical testing organization. These are often safety inspections prescribed by law and carried out on a private basis as indirect state administration. The best-known of these is the main inspection for motor vehicles, which is also colloquially called ‘TÜV’.

  145. 145.

    Merten (2005), p. 109; see also Hoffmann-Riem, para 39, on the idea of a public body specifically tasked with monitoring AI applications.

  146. 146.

    Merten (2005), p. 90.

  147. 147.

    In this context, Voßkuhle refers to a process perpetuation, since the element of the final decision is a withdrawal in favour of a continuous control and monitoring obligation, cf. Voßkuhle (2002), p. 345; also Merten (2005), p. 109.

  148. 148.

    Kage (2005), p. 248.

  149. 149.

    Cf. exemplarily Section 15(2) sentence 4 and Section 18(3) No. 2 MPG.

  150. 150.

    Cf. Section 25(1), Section 26(2) sentence 2 and 4 and Section 28(1) MPG.

  151. 151.

    The European legislator maintains this instrument even when the new Regulation on Medical Devices is enacted, cf. Article 45 of the Council Regulation (EU) 2017/745.

  152. 152.

    Merten (2005), p. 110.

  153. 153.

    Cf. Section 26(2) sentence 2 MPG.

  154. 154.

    Merten (2005), p. 111.

  155. 155.

    Ibid.

  156. 156.

    See also below, paras 37 et seq. for further remarks.

  157. 157.

    Merten (2004), p. 1211.

  158. 158.

    Kage (2005), p. 248.

  159. 159.

    Ibid.

  160. 160.

    Laufs (2001), p. 3381; also Kage (2005), p. 248.

  161. 161.

    Di Fabio (1994), p. 347; similarly Kage (2005), p. 248.

  162. 162.

    For further details see Wischmeyer, paras 12 et seq.

  163. 163.

    See also above para 1.

  164. 164.

    Cf. Section 15(2) sentence 4 MPG, which can be systematically assigned to the official monitoring of the activities of the notified bodies, but which, with regard to the range of tasks of the notified bodies, includes conformity assessment of medical devices in compliance with the law.

  165. 165.

    Cf. Section 26(2) sentence 4, (3) MPG.

  166. 166.

    Cf. Section 26(4) sentence 1 MPG.

  167. 167.

    If such a network of system premises exists, an efficient post market-entry control could be conceivable by a continuous, automatic data transfer of the changed premises to the supervising authority. A comparable situation is already known in the field of remote emission monitoring, cf. German (Federal) Constitutional Court 7 C 47/95 (13 February 1997). Solved from questions of the administrative burden and data protection concerns in the health-relevant field, however, considerable constitutional concerns would have to be included in the consideration of a transferability of the model, which would not only affect the manufacturer’s right to exercise an occupation, but also the user’s right to informational self-determination.

  168. 168.

    Tomasini (2015), p. 145; Braun and Püschel (2014), p. 138.

  169. 169.

    Explanation of the rapporteur’s draft of 14th May 2013, 2012/0266(COD), PE510.741v03-00, p. 120; see also Hoffmann-Riem, para 14.

  170. 170.

    Braun and Püschel (2014), p. 139.

  171. 171.

    Cf. Recital 41 of the Council Regulation (EU) 2017/745; Graf (2017b), p. 318.

  172. 172.

    Cf. Article 10(7), Article 27(1) of the Council Regulation (EU) 2017/745.

  173. 173.

    Cf. Article 2 No. 15 and Annex VI Part C section 1 of the Council Regulation (EU) 2017/745.

  174. 174.

    Cf. Article 28(1) of the Council Regulation (EU) 2017/745.

  175. 175.

    Cf. Article 14(2), Article 29(1) of the Council Regulation (EU) 2017/745.

  176. 176.

    Cf. Article 27(7) of the Council Regulation (EU) 2017/745.

  177. 177.

    Cf. Article 92(1) of the Council Regulation (EU) 2017/745.

  178. 178.

    Graf (2017b), p. 318.

  179. 179.

    Cf. Annex VI Part C section 6.5.2 of the Council Regulation (EU) 2017/745.

  180. 180.

    Cf. Annex VI Part C section 6.5.3 of the Council Regulation (EU) 2017/745.

  181. 181.

    Cf. Annex VI Part. C section 5.2 and 5.8 of the Council Regulation (EU) 2017/745.

  182. 182.

    For further details on the inspection competences see above para 35.

  183. 183.

    Cf. Article 93(3)(b) of the Council Regulation (EU) 2017/745; Petersen (2018), p. 105.

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  1. Department of Law, University of Constance, Constance, Germany

    Sarah Jabri

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  1. Faculty of Law, University of Bielefeld, Bielefeld, Germany

    Thomas Wischmeyer

  2. Faculty of Law, University of Hannover, Hannover, Germany

    Timo Rademacher

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Jabri, S. (2020). Artificial Intelligence and Healthcare: Products and Procedures. In: Wischmeyer, T., Rademacher, T. (eds) Regulating Artificial Intelligence. Springer, Cham. https://doi.org/10.1007/978-3-030-32361-5_14

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