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Artificial Intelligence in Healthcare: Doctors, Patients and Liabilities

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Regulating Artificial Intelligence

Abstract

AI is increasingly finding its way into medical research and everyday healthcare. However, the clear benefits offered to patients are accompanied not only by general limitations typical of the application of AI systems but also by challenges that specifically characterize the operationalization of the concepts of disease and health. Traditionally, these challenges have been dealt with in the physician-patient relationship in both medical ethics and civil law. The potential for incorrect decisions (and the question of who is responsible for such decisions) in cases where AI is used in a medical context calls for a differentiated implementation of medical ethical principles and a graduated model of liability law. Nevertheless, on closer examination of both fields covering relevant obligations towards patients and users against the backdrop of current medical use cases of AI, it seems that despite a certain level of differentiation in the assignment of responsibilities through rules on liability, those affected, in the end, are generally left to deal with any AI-specific risks and damages on their own. The role played by the physician in all this remains unclear. Taking into account the physician-patient relationship as a contractual obligation in a broad sense can assist in clarifying physicians’ roles and determining their duties in a sustainable and patient-friendly manner when applying AI-based medical systems. This can contribute to reinforcing their established ethical and legal status in the context of AI applications.

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Notes

  1. 1.

    Cf. only the Elsevier journal Artificial Intelligence in Medicine, https://www.journals.elsevier.com/artificial-intelligence-in-medicine.

  2. 2.

    Cf. Ranschaert et al. (2019), which focuses on radiology but with universal findings related to general imaging.

  3. 3.

    Haenssle et al. (2018).

  4. 4.

    Albu and Stanciu (2015).

  5. 5.

    The Economist (2018).

  6. 6.

    Aftergood (2018).

  7. 7.

    Cf. the definition of health in the WHO Constitution. See also Committee on Economic, Social and Cultural Rights, General Comment No.14 - The Right to the Highest Attainable Standard of Health (Article 12) [UN Doc E/C.12/2000/4, [2001] ESCOR Supp 2, 128], para 4.

  8. 8.

    Lanzerath and Honnefelder (2000), pp. 51 et seq.; Eckart (2013), p. 300.

  9. 9.

    Parks (2010), pp. 100–120; Loder and Nicholas (2018).

  10. 10.

    Biegel and Kurose (2016).

  11. 11.

    Sackett et al. (1996).

  12. 12.

    Ebers (2017), p. 95.

  13. 13.

    Ebers (2017), p. 107.

  14. 14.

    Katzenmeier (2016), § 823, recital 366.

  15. 15.

    For this general division and evaluation, also subsequently, cf. Schneider (2010), p. 11 (with further references).

  16. 16.

    Steffen (1995), p. 190; Dressler (2010), p. 380.

  17. 17.

    Dressler (2010), p. 380.

  18. 18.

    Laufs (1999), p. 626.

  19. 19.

    Brüggemeier (1999), p. 63.

  20. 20.

    Hart (1998), p. 13.

  21. 21.

    Wischmeyer (2018), p. 1.

  22. 22.

    Eckart (2013), p. 324.

  23. 23.

    Janda (2013), p. 123; Kluth (2008), p. 39; Maclean (2009), p. 93.

  24. 24.

    Jones (1999), p. 129. The Hippocratic Oath is the earliest expression of medical ethics and already emphasizes a crucial principle, that of non-maleficence, which has been preserved in theories of modern medical ethics (paras 17 and 24).

  25. 25.

    Molnár-Gábor (2017), p. 111 et seq., with further references. Emanuel and Emanuel (2012), p. 107; Schöne-Seifert (2007), pp. 88 et seq.

  26. 26.

    The paternalistic model is the original Hippocratic model, in which the physician’s duty of care is largely decisive. The task of the physician to promote the well-being of the patient has priority over the will of the patient and also extends to future sensitivities. Boyd (2006), p. 31.

  27. 27.

    On the contrary, the informative doctor-patient model states that the patient themselves decides on medical measures. The physician must convey the medical facts to the patient in an appropriate form to enable this, and the personal values or convictions of the physician may play no role. The contractual model, on the other hand, represents the interaction between physician and patient as a service in which the current will of the patient plays a leading role in the physician’s actions. The will has priority over the patient’s well-being even if the will is obviously not beneficial according to medical standards. The difference between the informative and contractual models is that in the former the doctor knows the personal values of the patient, while in the latter these are jointly determined. Emanuel and Emanuel (2012), p. 56.

  28. 28.

    Maclean (2009), p. 129 et seq.; Elwyn et al. (2012), p. 1361.

  29. 29.

    Thiele (2013), pp. 560 et seq.

  30. 30.

    Schöne-Seifert (2007), p. 44.

  31. 31.

    Taupitz (2002), p. 132.

  32. 32.

    Beauchamp and Childress (2013).

  33. 33.

    Cf. Düwell (2008), p. 95.

  34. 34.

    Spranger (2010), pp. 18 et seq.

  35. 35.

    Marckmann et al. (2012), pp. 32 et seq.

  36. 36.

    Marckmann et al. (2012), p. 33.

  37. 37.

    Beauchamp and Childress (2013), pp. 101 et seq.

  38. 38.

    Schöne-Seifert (2007), p. 32.

  39. 39.

    Marckmann et al. (2012), pp. 35 et seq.

  40. 40.

    Wiesing (2005), pp. 77 et seq.

  41. 41.

    Beauchamp and Childress (2013), p. 405.

  42. 42.

    Beauchamp and Childress (2013), pp. 403 et seq.

  43. 43.

    Clouser and Gert (1990), pp. 222 et seq.

  44. 44.

    Wiesing (2005), p. 82.

  45. 45.

    Cf. Nuffield Council on Bioethics (2018).

  46. 46.

    Sharkey and Sharkey (2012), p. 5.

  47. 47.

    Mittelstadt (2017).

  48. 48.

    Sharkey and Sharkey (2012).

  49. 49.

    Wallach and Allen (2008).

  50. 50.

    Wachter (2015), p. 4, cited in: Nuffield (2018), p. 4.

  51. 51.

    Yuste et al. (2017), p. 6, cited in: Nuffield (2018), p. 6.

  52. 52.

    Future Advocacy (2018), p. 30.

  53. 53.

    Nuffield (2018), p. 5.

  54. 54.

    Future advocacy (2018), p. 35.

  55. 55.

    House of Lords (2018), pp. 41 et seq.; Future advocacy (2018), p. 39.

  56. 56.

    Future advocacy (2018), p. 40; Nuffield (2018), pp. 5 et seq.; House of Lords (2018), p. 55, No. 164.

  57. 57.

    Nuffield (2018), p. 6.

  58. 58.

    Jansen (2003), p. 37. In Germany, the ethical and legal principles of the medical profession are defined in the (Model) Professional Code. It serves the medical associations as a model for their professional codes of conduct, in order that the development of professional law be as uniform as possible throughout Germany. The professional code of conduct of the respective medical association regulates the rights and duties applicable to individual physicians vis-à-vis patients, professional colleagues and their medical association. This code of conduct is a statutory law issued by the medical association on the basis of the Medical Profession and Chamber Act of the respective federal state. The medical associations are responsible for ensuring that doctors observe their professional duties, dealing with complaints about doctors and checking whether their conduct is in accordance with professional law. In the event of violations, they can appeal to the professional court. Cf. http://www.bundesaerztekammer.de/weitere-sprachen/english/german-medical-association/ (accessed 06 January 2019). Altogether, elaborating on the relationship between physicians’ duties based on principles of general medical ethics, professional law and medical malpractice law would go beyond the scope of this chapter, and so we will simply cite Eberhard Schmidt [translation by the author]: ‘Ethics of professional conduct are not isolated from the law, they have a constant, universal effect on the legal relationship between the physician and the patient. What professional ethics require from the physician, the law also largely assumes as a legal duty. Far more than in other social relations of human beings, the ethical and the legal merge in the medical profession.” Schmidt (1957), p. 2; German Federal Constitutional Court 2 BvR 878/74 ‘medical liability’ (25 July 1979) para 106 et seq. Regarding the relationship between medical standards, guidelines and directives, cf. Greiner (2018), § 839, recital 21.

  59. 59.

    It is generally accepted that the treatment contract is not classified as a contract for work (“Werkvertrag”) but as a service contract (“Dienstvertrag”) in accordance with § 611 BGB. This has not been affected by the special regulation of the treatment contract in the BGB since the Patient Rights Act came into force on 26 February 2013, and the subtitle ‘Treatment Contract” has been included in the BGB, which deals with the medical treatment contract and the rights and obligations within the framework of treatment. Spickhoff (2018a, b), § 630a BGB, recital 5, § 630b BGB, recital 1.

  60. 60.

    See §§ 280, 630a et seq. of the German Civil Code (BGB).

  61. 61.

    § 280 para. 1 BGB states the following: If the obligor breaches a duty arising from the obligation, the obligee may demand damages for the damage caused thereby. This does not apply if the obligor is not responsible for the breach of duty.

  62. 62.

    § 823 para. 1 BGB states: A person who unlawfully violates the life, body, health, etc. of another person is obliged to make compensation for the resulting damage. In German tort law, it is necessary to show a breach of one of the norms of the BGB and, contrary for instance to French civil law (Art. 1382 French Civil Code), it is not possible to bring a claim solely based on negligence. If there has been a breach of one of the norms, then there is unlawfulness prima facie, but this can be justified via a defense as in English law, van Dam (2014), p. 80.

  63. 63.

    Dierks (2018).

  64. 64.

    Cf., however, regarding elective treatments Laufs (2015), Chapter I, recital 29. German Federal Court of Justice VI ZR 202/79 (10 March 1981); German Federal Court of Justice VI ZR 247/78 (18 March 1980).

  65. 65.

    § 630 e and § 630 h BGB. Critically re: double regulation Spickhoff (2018a, b), § 630c BGB, recital 11.

  66. 66.

    Laufs (2002), p. 121. In German law, this arises from the general right to personality as provided for in Art. 2 (1) and Art. 1 (1) of the German Basic Law. German Federal Constitutional Court 2 BvR 878/74 ‘medical liability’ (25 July 1979) para 109 et seq.; German Federal Administrative Court 3 C 19.15 (2 March 2017). According to established case law, medically indicated treatment of diagnostic and therapeutic nature carried out to the standard of a specialist (Facharztstandard) also constitutes bodily harm (Körperverletzung) if the patient’s consent has not been obtained. German Federal Court of Justice VI ZR 313/03 (15 March 2005); German Federal Court of Justice VI ZR 37/79 (22 April 1980).

  67. 67.

    Gehrlein (2018), pp. 100 et seq.

  68. 68.

    Quaas (2018), § 14, recital 1-135.

  69. 69.

    German Federal Court of Justice VI ZR 131/02 (25 March 2003) para 18. Gehrlein (2018), pp. 101 et seq.

  70. 70.

    German Federal Court of Justice VI ZR 65/88 (14 February 1989).

  71. 71.

    German Federal Court of Justice VI ZR 232/90 (12 March 1991).

  72. 72.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 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.

  73. 73.

    German Federal Court of Justice VI ZR 83/89 (12 December 1989); German Federal Court of Justice VI ZR 323/04 (13 June 2006). In various areas there is disagreement in the literature about the physician’s duty within the framework of informed consent to inform patients about established alternative treatment methods as well as those that are still being tested. Blechschmitt (2016), pp. 79 et seq.; in case of a new method: id., pp. 85 et seq.

  74. 74.

    As is also derived by Droste (2018), p. 112.

  75. 75.

    Hager (2017), § 823, recital 18.

  76. 76.

    German Federal Court of Justice VI ZR 201/75 (15 March 1977) para 11 et seq.; German Federal Court of Justice VI ZR 213/76 (14 March 1978).

  77. 77.

    Cf. § 630a BGB.

  78. 78.

    BR-Drucks. 312/12, p. 26.

  79. 79.

    Gehrlein (2018), p. 33, recital 1. Cf. footnotes 63 and 64.

  80. 80.

    Taupitz (2011), p. 387.

  81. 81.

    Gehrlein (2018), p. 34, recital 3.

  82. 82.

    German Federal Court of Justice VI ZR 238/86 (22 September 1987) para 12 et seq.; German Federal Court of Justice VI ZR 132/88 (6 December 1988) para 6; German Federal Court of Justice VI ZR 323/04 (13 June 2006) para 6; German Federal Court of Justice VI ZR 35/06 (22 May 2007) para 12 et seq.

  83. 83.

    Dierks (2018). It is necessary to distinguish between locked closed-loop AI applications and continuous learning closed-loop AI applications.

  84. 84.

    The Act on Medical Devices of 2nd August 1994 (Federal Law Gazette I, p. 1963), in the version of 7th August 2002 (Federal Law Gazette I, p. 3146), last amended by Article 12 of the Act of 24th July 2010 (Federal Law Gazette I, p. 983). § 4 MPG is also a protective law within the meaning of § 823 Abs. 2 BGB, Edelhäuser (2014), § 6 MPG, recital 29a.

  85. 85.

    Droste (2018), pp. 112–113.

  86. 86.

    Medical Device Operator Ordinance, from the version published 21st August 2002 (BGBl. I p. 3396), last amended by Article 9 of the Ordinance of 29th November 2018 (BGBl. I p. 2034).

  87. 87.

    One solution advocated to avoid liability risks is a contractual agreement between the physician and the manufacturer, whereby the manufacturer is obliged to maintain and repair the intelligent medical device. Wagner (2018), § 6, recital 7. Regarding further obligations of the manufacturer in this context cf. Droste (2018), p. 113.

  88. 88.

    BR-Drucks. 312/12, pp. 40, 44.

  89. 89.

    § 286 Code of Civil Procedure as promulgated on 5 December 2005 (Bundesgesetzblatt (BGBl., Federal Law Gazette) I page 3202; 2006 I page 431; 2007 I page 1781), last amended by Article 1 of the Act dated 10 October 2013 (Federal Law Gazette I page 3786).

  90. 90.

    Schreiber (2019), § 630h BGB, recitals 10 et seq. German Federal Court of Justice VI ZR 325/98 (8 February 2000); German Federal Court of Justice VI ZR 389/90 (26 November 1991); German Federal Court of Justice VI ZR 21/85 (24 June 1986).

  91. 91.

    Gehrlein (2018), p. 88, recital 86.

  92. 92.

    German Federal Court of Justice VI ZR 158/06 (20 March 2007).

  93. 93.

    Gehrlein (2018), p. 42, recital 13.

  94. 94.

    Gehrlein (2018), p. 91, Rn. 90.

  95. 95.

    Droste (2018), p. 113.

  96. 96.

    Spindler (2018), § 823 BGB, recital 1018.

  97. 97.

    According to § 630f BGB, and records need to be kept, not just as an aide-memoire, Scholz (2018), recital 1.

  98. 98.

    Compare §§ 823 et seq. BGB for tortious liability and § 1 (1) sentence 1 Product Liability Act (ProdHaftG) for product liability law, Product Liability Act of 15 December 1989 (BGBl. I p. 2198), last amended by Article 5 of the Act of 17 July 2017 (BGBl. I p. 2421). Regarding this summary, compare Droste (2018), p. 110; Backmann (2012), p. 37, with further references.

  99. 99.

    Foerste (2012), § 24 recital 4. § 3 ProdHaftG.

  100. 100.

    Oechsler (2013), § 3, recital 13.

  101. 101.

    Rolland (1990), part I, recital 39.

  102. 102.

    Cf. § 1 (2) no. 2 ProdHaftG.

  103. 103.

    Cf. § 1 (2) no. 5 ProdHaftG.

  104. 104.

    Droste (2018), p. 112.

  105. 105.

    Heil and Sandrock (2017), § 23, recitals 30 et seq; Meyer (2018), p. 237.

  106. 106.

    Cf. Spindler (2015), p. 776; Ortner and Daubenbüchel (2016), p. 2918; Keßler (2017), p. 589; Denga (2018), p. 69.

  107. 107.

    Droste (2018), p. 114; Zech (2019), p. 214.

  108. 108.

    Cf. § 311 (1) BGB.

  109. 109.

    Mansel (2011), § 241, recital 1.

  110. 110.

    Mansel (2011), § 241, recitals 9, 10.

  111. 111.

    Mansel (2011), § 241, recitals 9, 10.

  112. 112.

    Grüneberg (2011), § 24, recital 6.

  113. 113.

    According to § 630c BGB.

  114. 114.

    Cf. also Buchholtz, paras 14 et seq., on the application of law as a necessarily social act.

  115. 115.

    Rössler (2011), p. 226.

  116. 116.

    Taupitz (2002), p. 132.

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Acknowledgement

FMG acknowledges funding by the Volkswagen Foundation.

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  1. Heidelberg Academy of Sciences and Humanities, BioQuant Center, Heidelberg, Germany

    Fruzsina Molnár-Gábor

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  1. Fruzsina Molnár-Gábor
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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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Molnár-Gábor, F. (2020). Artificial Intelligence in Healthcare: Doctors, Patients and Liabilities. In: Wischmeyer, T., Rademacher, T. (eds) Regulating Artificial Intelligence. Springer, Cham. https://doi.org/10.1007/978-3-030-32361-5_15

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