{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T20:53:27Z","timestamp":1791665607521,"version":"4.3.4"},"reference-count":118,"publisher":"Cambridge University Press (CUP)","license":[{"start":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T00:00:00Z","timestamp":1791590400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","award":["Grant no. 08540122120004 (project \u2018DECIDE-VerA\u2019)"],"award-info":[{"award-number":["Grant no. 08540122120004 (project \u2018DECIDE-VerA\u2019)"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Law. Med. Ethics"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The European Union Artificial Intelligence (AI) Act was adopted in 2024 to protect public interests from AI-related harms. We aimed to determine whether the AI Act captures the most relevant values of stakeholders (understood as any person potentially affected by the AI system, including, but not limited to, the direct users) related to a high-risk AI Clinical Decision Support System (CDSS) for cardiovascular disease. This system is intended to be implemented in primary care. A secondary analysis was carried out based on empirical data previously generated using ethics and design methodologies that had identified stakeholder values. These values were translated into the Trustworthy AI requirements of the High-Level Expert Group on AI and then contrasted with the AI Act. These requirements do not capture all identified stakeholder values. We describe three groups of untranslatable values and propose three additional complementary requirements. The AI Act mainly supports the requirements of human agency and oversight; transparency; and diversity, nondiscrimination, and fairness; but only partially, limited by its product safety nature. To address this gap, contractual strategies could provide a more legally robust ground for general practitioners to align the AI-CDSS with stakeholders\u2019 values, comply with their duty of care, and promote trustworthy AI-CDSSs.<\/jats:p>","DOI":"10.1017\/jme.2026.10289","type":"journal-article","created":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T20:42:27Z","timestamp":1791664947000},"page":"1-20","source":"Crossref","is-referenced-by-count":0,"title":["Conformity Between Values and EU Legal Requirements Regarding an AI Clinical Decision Support System (AI-CDSS) for Improved Cardiovascular Risk Management (DECIDE)"],"prefix":"10.1017","author":[{"given":"Tycho J.","family":"de Graaf","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/027bh9e22","id-type":"ROR","asserted-by":"publisher"}],"name":"Leiden University Leiden Law School"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andr\u00e9","family":"Krom","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05xvt9f17","id-type":"ROR","asserted-by":"publisher"}],"name":"Leiden University Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Colombo","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02e2c7k09","id-type":"ROR","asserted-by":"publisher"}],"name":"TU Delft"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myrthe L.","family":"van de Pavert","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05xvt9f17","id-type":"ROR","asserted-by":"publisher"}],"name":"Leiden University Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maaike","family":"Harbers","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0481e1q24","id-type":"ROR","asserted-by":"publisher"}],"name":"Rotterdam University of Applied Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7937-9006","authenticated-orcid":false,"given":"Jan H.","family":"van Staalduinen","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/027bh9e22","id-type":"ROR","asserted-by":"publisher"}],"name":"Leiden University Leiden Law School"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ildik\u00f3","family":"Vajda","sequence":"additional","affiliation":[{"name":"Dutch Patients\u2019 Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tijs C.","family":"Portegies","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0481e1q24","id-type":"ROR","asserted-by":"publisher"}],"name":"Rotterdam University of Applied Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels H.","family":"Chavannes","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05xvt9f17","id-type":"ROR","asserted-by":"publisher"}],"name":"Leiden University Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda","family":"Villalobos-Quesada","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05xvt9f17","id-type":"ROR","asserted-by":"publisher"}],"name":"Leiden University Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2026,10,10]]},"reference":[{"key":"S1073110526102897_r56","doi-asserted-by":"crossref","first-page":"81","DOI":"10.54648\/COLA2022005","article-title":"EU Regulation of Artificial Intelligence: Challenges for Patients\u2019 Rights","volume":"59","author":"Van Kolfschooten","year":"2022","journal-title":"Common Market Law Review"},{"key":"S1073110526102897_r52","first-page":"311","volume-title":"Research Handbook on Health, AI and the Law","author":"Minssen","year":"2024"},{"key":"S1073110526102897_r55","unstructured":"55. Artificial Intelligence Board and Medical Device Coordination Group, Interplay between the Medical Devices Regulation (MDR) & in vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)."},{"key":"#cr-split#-S1073110526102897_r57.1","doi-asserted-by":"crossref","unstructured":"57. De Graaf, Tycho and Veldt, Gitta , \"The AI Act and Its Impact on Product Safety, Contracts and Liability,\" European Review of Private Law\/Revue Europ\u00e9enne De Droit Priv\u00e9\/Europ\u00e4ische Zeitschrift F\u00fcr Privatrecht 30, no. 5 (2022): 803-34, https:\/\/doi.org\/10.54648\/erpl2022038","DOI":"10.54648\/ERPL2022038"},{"key":"#cr-split#-S1073110526102897_r57.2","doi-asserted-by":"crossref","unstructured":"Tycho De Graaf, \"Liability for Artificial Intelligence in EU Law,\" in Research Handbook in Data Science and Law, ed. Vanessa Mak, Eric Tjong Tijn Tal, and Anna Berlee (Edward Elgar Publishing 2024), 117-136, https:\/\/doi.org\/10.4337\/9781035316458.00013.","DOI":"10.4337\/9781035316458.00013"},{"key":"S1073110526102897_r19","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.122.027011"},{"key":"S1073110526102897_r91","unstructured":"91. Solaiman and Malik, \u201cRegulating Algorithmic Care in the European Union: Evolving Doctor\u2013Patient Models Through the Artificial Intelligence Act (AI-Act) and the Liability Directives.\u201d"},{"key":"S1073110526102897_r20","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2022.11.005"},{"key":"S1073110526102897_r63","unstructured":"63. For sake of completeness, we note that the patient may also benefit from other mechanisms: requiring the provider to provide evidence to help the patient prove defectiveness (art. 9 PLD) and assuming defectiveness\/causality if the patient faces \u201cexcessive difficulties, in particular due to technical or scientific complexity\u201d in proving such defectiveness\/causality (art. 10 (4) PLD). Those mechanisms are subject to additional requirements, a discussion of which is beyond the scope of this article."},{"key":"S1073110526102897_r8","unstructured":"8. Sutton et al., \u201cAn Overview of Clinical Decision Support Systems: Benefits, Risks, and Strategies for Success.\u201d"},{"key":"S1073110526102897_r107","unstructured":"107. Van Kolfschooten, \u201cThe AI Cycle of Health Inequity and Digital Ageism: Mitigating Biases Through the EU Regulatory Framework on Medical Devices.\u201d"},{"key":"S1073110526102897_r82","unstructured":"82. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI."},{"key":"S1073110526102897_r108","unstructured":"108. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI."},{"key":"S1073110526102897_r10","unstructured":"10. Regulation (EU) 2024\/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300\/2008, (EU) No 167\/2013, (EU) No 168\/2013, (EU) 2018\/858, (EU) 2018\/1139 and (EU) 2019\/2144 and Directives 2014\/90\/EU, (EU) 2016\/797 and (EU) 2020\/1828 (Artificial Intelligence Act), recital 7 and art. 1 para. 1, 2024 O.J. (L1689)."},{"key":"S1073110526102897_r25","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0202344"},{"key":"S1073110526102897_r28","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.32990"},{"key":"S1073110526102897_r71","unstructured":"71. Faber, van Renswouw, and Colombo, \u201cA Tangible Toolkit to Uncover Clinician\u2019s Ethical Values about AI Clinical Decision Support Systems.\u201d"},{"key":"S1073110526102897_r85","doi-asserted-by":"publisher","DOI":"10.1186\/s12911-023-02162-y"},{"key":"S1073110526102897_r60","doi-asserted-by":"publisher","DOI":"10.1515\/9783110260168"},{"key":"S1073110526102897_r94","unstructured":"94. For sake of clarity: the right to explanation only applies to \u201cAnnex III\u201d AI systems, but an AI system which is not an \u201cAnnex III\u201d AI system can still be a high-risk AI system because it is a system currently subject to product safety laws to which an AI component has been added and which is required to undergo a third-party conformity assessment."},{"key":"#cr-split#-S1073110526102897_r40.1","doi-asserted-by":"crossref","unstructured":"40. Niemiec, Emilia et al., \"Legal and Regulatory Challenges in Multi-Country Data-Driven Projects Developing and Validating Medical AI Systems in the EU,\" Expert Review of Medical Devices 22, no. 9 (2025): 925-937, https:\/\/doi.org\/10.1080\/17434440.2025.2531295","DOI":"10.1080\/17434440.2025.2531295"},{"key":"#cr-split#-S1073110526102897_r40.2","unstructured":"Nuno Sousa e Silva, \"The Artificial Intelligence Act: Critical Overview,\" Journal of. Intellectual Property Information Technology. and Electronic Commerce Law 16, no. 1 (2025): 2, https:\/\/www.jipitec.eu\/jipitec\/article\/view\/418"},{"key":"#cr-split#-S1073110526102897_r40.3","doi-asserted-by":"crossref","unstructured":"Kasia S\u00f6derlund, \"High-Risk AI Transparency? On Qualified Transparency Mandates for Oversight Bodies Under the EU AI Act,\" Technology and Regulation (2025): 96-113","DOI":"10.71265\/6bedar76"},{"key":"#cr-split#-S1073110526102897_r40.4","doi-asserted-by":"crossref","unstructured":"Kicky Gerhilde van Leeuwen, Leon Doorn, and Erik Gelderblom, \"The AI Act: Responsibilities and Obligations for Healthcare Professionals and Organizations,\" Diagnostic and Interventional Radiology 32, no. 3 (2025): 273-275, https:\/\/doi.org\/10.4274\/dir.2025.252851.","DOI":"10.4274\/dir.2025.252851"},{"key":"S1073110526102897_r66","unstructured":"66. Hendrikx, Victoria and Smuha, Nathalie , \u201cArtificial Intelligence and interdisciplinarity: An evaluation,\u201d AI Summer School, KU Leuven, February 8, 2023, https:\/\/www.law.kuleuven.be\/ai-summer-school\/blogpost\/Blogposts\/evaluating-interdisciplinarity-in-ai."},{"key":"S1073110526102897_r53","unstructured":"53. Lisa Jansen et al., Organisatievormen in de Nederlandse Huisartsenzorg: Van Solopraktijk Naar Keten (Nivel, 2023), https:\/\/nivel.nl\/sites\/default\/files\/bestanden\/1004531.pdf."},{"key":"S1073110526102897_r64","doi-asserted-by":"publisher","DOI":"10.1016\/j.clsr.2023.105871"},{"key":"S1073110526102897_r1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-020-0221-y"},{"key":"S1073110526102897_r21","doi-asserted-by":"publisher","DOI":"10.1136\/bmjqs-2016-005401"},{"key":"S1073110526102897_r37","unstructured":"37. Artificial Intelligence Board and Medical Device Coordination Group, Interplay between the Medical Devices Regulation (MDR) & in vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA), AIB 2025-1\/MDCG 2025-6 (Artificial Intelligence Board and Medical Device Coordinaton Group, 2025)."},{"key":"S1073110526102897_r38","unstructured":"38. Artificial Intelligence Board and Medical Device Coordination Group, Interplay between the Medical Devices Regulation (MDR) & in vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)."},{"key":"S1073110526102897_r42","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2025-0482"},{"key":"S1073110526102897_r45","article-title":"The AI Act: The Evolution of \u2018trustworthy AI\u2019 From Policy Documents to Mandatory Regulation","author":"Gornet","year":"2024","journal-title":"HAL Open Science"},{"key":"S1073110526102897_r46","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-024-01232-3"},{"key":"S1073110526102897_r70","unstructured":"70. Faber, Ilse , \u201cAn Explorative Study on Enabling Clinicians to Express Ethical Values in the\u00a0Development of a Machine Learning Clinical Decision Support System,\u201d (Master thesis, University of Technology Eindhoven, 2023)."},{"key":"S1073110526102897_r81","unstructured":"81. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, The Assessment List for Trustworthy Artificial Intelligence (ALTAI) for Self Assessment."},{"key":"S1073110526102897_r9","volume-title":"The Impact of Artificial Intelligence on the Doctor-Patient Relationship","author":"Mittelstadt","year":"2021"},{"key":"S1073110526102897_r83","unstructured":"83. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI, p 16."},{"key":"S1073110526102897_r30","unstructured":"30. Ethics By Design and Ethics of Use Approaches for Artificial Intelligence (European Commission, 2021), https:\/\/ec.europa.eu\/info\/funding-tenders\/opportunities\/docs\/2021-2027\/horizon\/guidance\/ethics-by-design-and-ethics-of-use-approaches-for-artificial-intelligence_he_en.pdf; Mittelstadt, The Impact of Artificial Intelligence on the Doctor-Patient Relationship."},{"key":"S1073110526102897_r69","doi-asserted-by":"publisher","DOI":"10.1038\/s42256-019-0088-2"},{"key":"S1073110526102897_r87","doi-asserted-by":"publisher","DOI":"10.1007\/s11023-025-09713-4"},{"key":"S1073110526102897_r22","first-page":"e54264","article-title":"Gender Bias in Diagnosis, Prevention, and Treatment of Cardiovascular Diseases: A Systematic Review","volume":"16","author":"Al Hamid","year":"2024","journal-title":"Cureus"},{"key":"S1073110526102897_r2","volume-title":"Digitalisation of Healthcare: EU Support for Member States Effective Overall, but Difficulties in Using EU Funds","year":"2024"},{"key":"S1073110526102897_r98","unstructured":"98. Van Kolfschooten, \u201cEU Regulation of Artificial Intelligence: Challenges for Patients\u2019 Rights.\u201d"},{"key":"S1073110526102897_r101","unstructured":"101. We have reasons to believe this is relevant for GPs as shown by unpublished data (I.V. personal communications)."},{"key":"S1073110526102897_r27","doi-asserted-by":"publisher","DOI":"10.1016\/j.compbiomed.2016.06.019"},{"key":"S1073110526102897_r79","unstructured":"79. Krom et al., \u201c1e Workshop begeleidingsethiek DECIDE-VerA over een klinisch beslissingsondersteunende systeem (AI-CDSS DECIDE) voor beter cardiovasculair risicomanagement)\u201d; Krom et al., \u201cSlimme computer: Hoe groot is mijn risico op een beroerte of een hartaanval?\u201d"},{"key":"S1073110526102897_r48","doi-asserted-by":"crossref","first-page":"1","DOI":"10.18261\/olr.11.1.2","article-title":"AI Robotics in Healthcare Between the EU Medical Device Regulation and the Artificial Intelligence Act: Gaps and Inconsistencies in the Protection of Patients and Care Recipients","volume":"11","author":"Ebers","year":"2024","journal-title":"Oslo Law Review"},{"key":"S1073110526102897_r12","doi-asserted-by":"publisher","DOI":"10.5040\/9798216401728"},{"key":"S1073110526102897_r34","unstructured":"34. Directive 2006\/42\/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95\/16\/EC, 2006 O.J. (L 157), 24\u201386."},{"key":"S1073110526102897_r35","unstructured":"35. 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, 2017 O.J. (L 117), 1\u2013175."},{"key":"S1073110526102897_r102","unstructured":"102. \u201cUpdated EU AI Model Contractual Clauses,\u201d\u00a0European Commission, March 5, 2025, https:\/\/public-buyers-community.ec.europa.eu\/communities\/procurement-ai\/resources\/updated-eu-ai-model-contractual-clauses."},{"key":"S1073110526102897_r109","doi-asserted-by":"publisher","DOI":"10.2139\/ssrn.4939395"},{"key":"S1073110526102897_r29","unstructured":"29. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI."},{"key":"S1073110526102897_r4","unstructured":"4. European Court of Auditors, Digitalisation of Healthcare."},{"key":"S1073110526102897_r67","doi-asserted-by":"publisher","DOI":"10.3390\/jpm14050443"},{"key":"S1073110526102897_r80","unstructured":"80. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, The Assessment List for Trustworthy Artificial Intelligence (ALTAI) for Self Assessment (European Commission, 2020), https:\/\/data.europa.eu\/doi\/10.2759\/791819."},{"key":"S1073110526102897_r44","first-page":"122","article-title":"AI Legislation, Private International Law and the Protection of Human Rights in the European Union","volume":"11","author":"Malacka","year":"2024","journal-title":"European Studies \u2014 The Review of European Law, Economics and Politics"},{"key":"S1073110526102897_r65","doi-asserted-by":"publisher","DOI":"10.2139\/ssrn.5183304"},{"key":"S1073110526102897_r86","unstructured":"86. Deployment of artificial intelligence in healthcare: Sector-specific challenges and accelerators (Comit\u00e9 Permanent des M\u00e9decins Europ\u00e9ens, 2024), CPME 2024\/073, https:\/\/www.cpme.eu\/api\/documents\/adopted\/2024\/11\/cpme_ad_09112024_073.final.policy.on.deployment.of.ai.in.healthcare.pdf; \u201cWMA Statement on Augmented Intelligence in Medical Care,\u201d World Medical Association, October 26, 2019, https:\/\/www.wma.net\/policies-post\/wma-statement-on-augmented-intelligence-in-medical-care\/; Position Statement: Artificial Intelligence in Healthcare, (Australian Medical Association, 2023), https:\/\/www.ama.com.au\/sites\/default\/files\/2023-08\/Artificial%20Intelligence%20in%20Healthcare%20-%20AMA.pdf; Principles for Artificial Intelligence (AI) and its Application in Healthcare (British Medical Association, 2024), https:\/\/www.bma.org.uk\/media\/njgfbmnn\/bma-principles-for-artificial-intelligence-ai-and-its-application-in-healthcare.pdf."},{"key":"S1073110526102897_r97","doi-asserted-by":"crossref","first-page":"167","DOI":"10.4337\/9781802205657.ch10","volume-title":"Research Handbook on Health, AI and the Law","author":"Cohen","year":"2024"},{"key":"S1073110526102897_r51","unstructured":"51. Regulation (EU) 2023\/988 of the European Parliament and of the Council of 10\u00a0May 2023 on general product safety, May 10, 2023, arts. 2 and 5, 2023 O.J. (L 135)."},{"key":"S1073110526102897_r90","unstructured":"90. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI, p 16."},{"key":"#cr-split#-S1073110526102897_r58.1","unstructured":"58. Traditionally, lawyers have trouble applying laws written for tangible items to software. However, recent developments have shown lawyers overcoming these problems. See cases where a perpetual license is granted in return for payment of a one-time fee (CISG-online 2025), in agency law: Case C410\/19, The Software Incubator Ltd. v Computer Associates (UK) Ltd., ECLI:EU:C:2021:742, and under the Software Directive: Case C128\/11, UsedSoft GMBH v Oracle International Corp., ECLI:EU:C:2012:407. See for Software-as-a-Service (SaaS), i.e., as service which may only be used for the duration of the contract (as long as recurring fees, typically monthly, are paid)"},{"key":"#cr-split#-S1073110526102897_r58.2","unstructured":"the B2C Digital Content and Digital Services Directive (which also applies the conformity requirement to digital services, see Directive (EU) 2019\/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services, May 20, 2019, art. 8 (1) (a) 2019 O.J. (L 136)) and the revised B2C Product Liability Directive (PLD) (which applies regardless of whether software is stored on a device or provided by means of SaaS, see Directive (EU) 2019\/770 rec. 13, 2019 O.J. (L. 136))."},{"key":"S1073110526102897_r104","unstructured":"104. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI, p 18."},{"key":"S1073110526102897_r39","unstructured":"39. Unless it is considered not to pose a significant risk as set out in much detail in Regulation (EU) 2024\/1689, art. 6 para. 3, 2024 O.J. (L1689)."},{"key":"S1073110526102897_r5","unstructured":"5. \u201cAre Your Home and Your Belongings Internet-Connected?,\u201d Eurostat, February 25, 2021, https:\/\/ec.europa.eu\/eurostat\/web\/products-eurostat-news\/-\/ddn-20210225-1."},{"key":"#cr-split#-S1073110526102897_r31.1","unstructured":"31. Regulation (EC) No 765\/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339\/93, 2008 O.J. (L 218) 30-47"},{"key":"#cr-split#-S1073110526102897_r31.2","unstructured":"Decision No 768\/2008\/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, 2008 O.J. (L 218) 82-128."},{"key":"S1073110526102897_r59","doi-asserted-by":"crossref","first-page":"145","DOI":"10.4337\/9781839101939.00019","volume-title":"Research Handbook on Soft Law","author":"Micklitz","year":"2023"},{"key":"S1073110526102897_r3","article-title":"Autonomous Artificial Intelligence for Diabetic Eye Disease Increases Access and Health Equity in Underserved Populations","volume":"196","author":"Huang","year":"2024","journal-title":"NPJ Digital Medicine"},{"key":"S1073110526102897_r11","unstructured":"11. 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, 2017 O.J. (L 117), 1\u2013175."},{"key":"S1073110526102897_r89","unstructured":"89. Minssen et al., \u201cGoverning AI in the European Union: Emerging Infrastructures and Regulatory Ecosystems in Health.\u201d"},{"key":"S1073110526102897_r93","unstructured":"93. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI, p 18."},{"key":"S1073110526102897_r110","doi-asserted-by":"publisher","DOI":"10.1007\/s11023-020-09517-8"},{"key":"S1073110526102897_r23","doi-asserted-by":"publisher","DOI":"10.1038\/nrcardio.2017.154"},{"key":"S1073110526102897_r26","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i2416"},{"key":"S1073110526102897_r75","volume-title":"CHI \u201993: Proceedings of the INTERACT \u201993 and CHI \u201993 Conference on Human Factors in Computing Systems","author":"Nielsen","year":"1993"},{"key":"S1073110526102897_r78","unstructured":"78. Peter-Paul Verbeek and Dani\u00ebl Tijink, Guidance ethics approach (Platform voor de Informatiesamenleving, 2020), https:\/\/ecp.nl\/wp-content\/uploads\/2020\/11\/Guidance-ethics-approach.pdf."},{"key":"S1073110526102897_r105","unstructured":"105. Van Kolfschooten, \u201cEU Regulation of Artificial Intelligence: Challenges for Patients\u2019 Rights.\u201d"},{"key":"S1073110526102897_r62","doi-asserted-by":"crossref","DOI":"10.1038\/s41746-023-00823-w","article-title":"The Proposed EU Directives for AI Liability Leave Worrying Gaps Likely to Impact Medical AI","volume":"6","author":"Duffourc","year":"2023","journal-title":"npj Digital Medicine"},{"key":"S1073110526102897_r13","unstructured":"13. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI, (European Commission, 2019), https:\/\/digital-strategy.ec.europa.eu\/en\/library\/ethics-guidelines-trustworthy-ai."},{"key":"S1073110526102897_r18","doi-asserted-by":"publisher","DOI":"10.1111\/rego.12512"},{"key":"S1073110526102897_r49","doi-asserted-by":"publisher","DOI":"10.1080\/17579961.2025.2469986"},{"key":"S1073110526102897_r32","unstructured":"32. Regulation (EU) 2019\/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004\/42\/EC and Regulations (EC) No 765\/2008 and (EU) No 305\/2011, 2019 O.J. (L 169) 1\u201344."},{"key":"S1073110526102897_r72","first-page":"1","volume-title":"Handbook of Ethics, Values, and Technological Design","author":"Davis","year":"2013"},{"key":"S1073110526102897_r50","unstructured":"50. Regulation (EU) 2024\/1689, art. 3 para. 3, 2024 O.J. (L1689): \u201c\u2018provider\u2019 means a natural or legal person, public authority, agency or other body that develops an AI system \u2026 or that has an AI system \u2026 developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge\u201d. Regulation (EU) 2017\/745, art. 2 para. 30, 2017 O.J. (L 117): \u201c\u2018manufacturer\u2019 means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;\u201d. For the purposes of this article, we assume that the provider in the AI Act is the same entity as the manufacturer in the MDR. Therefore, we will refer only to \u201cproviders\u201d and assume the provider directly sells to the deployer."},{"key":"S1073110526102897_r15","unstructured":"15. European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies (2020\/2012(INL)), 2020 O.J. (C 404)."},{"key":"S1073110526102897_r16","unstructured":"16. See, for example, Regulation (EU) 2024\/1689 recital 1, recital 7 and recital 27, 2024 O.J. (L1689)."},{"key":"#cr-split#-S1073110526102897_r68.1","doi-asserted-by":"crossref","unstructured":"68. Ilse Faber, Loes van Renswouw, and Sara Colombo, \"A Tangible Toolkit to Uncover Clinician's Ethical Values about AI Clinical Decision Support Systems,\" Paper presented at the DRS2024 conference in Boston, Massachusetts, USA, June 23, 2024, https:\/\/doi.org\/10.21606\/drs.2024.862","DOI":"10.21606\/drs.2024.862"},{"key":"#cr-split#-S1073110526102897_r68.2","unstructured":"Andr\u00e9 Krom, Myrthe van de Pavert, and Mar\u00eda Villalobos, \"1e Workshop begeleidingsethiek DECIDE-VerA over een klinisch beslissingsondersteunende systeem (AI-CDSS DECIDE) voor beter cardiovasculair risicomanagement),\" Aanpak Begeldingsethiek, February 13, 2024, https:\/\/begeleidingsethiek.nl\/wp-content\/uploads\/2025\/03\/1e-Workshop-Begeleidingsethiek-DECIDE-VerA-13-feb-2024_DEF.pdf"},{"key":"#cr-split#-S1073110526102897_r68.3","unstructured":"Andr\u00e9 Krom and Mar\u00eda Villalobos-Quesada, \"2de Workshop DECIDE-VerA: Slimme computer: Hoe groot is mijn risico op een beroerte of een hartaanval?,\" Aanpak Begeldingsethiek, July 8, 2024, https:\/\/begeleidingsethiek.nl\/wp-content\/uploads\/2025\/03\/2e-Workshop-Begeleidingsethiek-DECIDE-VerA-8-juli-2024_DEF_revised.pdf."},{"key":"S1073110526102897_r73","doi-asserted-by":"crossref","unstructured":"73. Hartikainen, Maria et al., \u201cHuman-Centered AI Design in Reality: A Study of Developer Companies\u2019 Practices,\u201d presented at NordiCHI Nordic Human-Computer Interaction Conference, Aarhus Denmark, October 8, 2022, https:\/\/doi.org\/10.1145\/3546155.3546677.","DOI":"10.1145\/3546155.3546677"},{"key":"S1073110526102897_r88","unstructured":"88. See e.g., Regulation (EU) 2016\/679 art. 22 \u00b6 1 2026 O.J. (L 119) and Case C-203\/22, CK v Dun & Bradstreet Austria, 2025 ELCI:EU:C:2025:117 (Feb. 27, 2025)."},{"key":"S1073110526102897_r76","doi-asserted-by":"publisher","DOI":"10.1191\/1478088706qp063oa"},{"key":"S1073110526102897_r103","unstructured":"103. Municipality of Amsterdam, \u201cModelbepalingen voor gemeenten voor verantwoord gebruik van Algoritmische toepassingen,\u201d (Gemeente Amsterdam, 2022), https:\/\/openresearch.amsterdam\/en\/pdf\/viewer?file=%2Fimage%2F2022%2F1%2F27%2Fmodelbepalingen_voor_verantwoord_gebruik_van_algoritme_door_de_overheid.pdf."},{"key":"S1073110526102897_r74","first-page":"92","volume-title":"PDC \u201908: Proceedings of the Tenth Anniversary Conference on Participatory Design","author":"Ehn","year":"2008"},{"key":"S1073110526102897_r24","first-page":"e42616","article-title":"Impact of Lifestyle Modifications on Cardiovascular Health: A Narrative Review","volume":"15","author":"Ghodeshwar","year":"2023","journal-title":"Cureus"},{"key":"S1073110526102897_r54","unstructured":"54. DECIDE is not intended to be used by health insurance companies to assess whether to insure a patient or for determining the insurance premium, but by GPs to proactively determine whether a patient has a high enough risk of CVD to justify further analysis and possibly interventions or treatment. Therefore, DECIDE cannot be considered a high-risk AI system listed in Annex III."},{"key":"S1073110526102897_r41","article-title":"The Renewed EU Legal Framework for Medical AI","volume":"15","author":"Palmieri","year":"2024","journal-title":"European Journal of Law and Technology"},{"key":"S1073110526102897_r92","unstructured":"92. See, for example, Regulation (EU) 2024\/1689 recs. 27, 66, 72, 73, 91, and 96 2024 O.J. (L1689)."},{"key":"S1073110526102897_r17","unstructured":"17. Regulation (EU) 2024\/1689 recital 7 2024 O.J. (L1689)."},{"key":"S1073110526102897_r95","doi-asserted-by":"publisher","DOI":"10.2139\/ssrn.4939395"},{"key":"S1073110526102897_r36","unstructured":"36. Regulation (EU) 2024\/1689, 2024 O.J. (L1689)."},{"key":"S1073110526102897_r14","unstructured":"14. Special meeting of the European Council (1 and 2 October 2020) \u2013 Conclusions, Brussels (October 2, 2020), at 6."},{"key":"S1073110526102897_r47","doi-asserted-by":"publisher","DOI":"10.1007\/s00350-025-7094-7"},{"key":"S1073110526102897_r7","doi-asserted-by":"publisher","DOI":"10.3390\/jpm14050443"},{"key":"S1073110526102897_r84","unstructured":"84. Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, Ethics Guidelines for Trustworthy AI; Independent High-Level Expert Group on Artificial Intelligence Set Up by the European Commission, The Assessment List for Trustworthy Artificial Intelligence (ALTAI) for Self Assessment."},{"key":"S1073110526102897_r96","unstructured":"96. Regulation (EU) 2016\/679 art. 22 \u00b6 1 2026 O.J. (L 119) and Case C-203\/22, CK v Dun & Bradstreet Austria, 2025 ELCI:EU:C:2025:117 (Feb. 27, 2025) may apply, but privacy is, as explained, not part of the subject matter discussed in this paper."},{"key":"S1073110526102897_r77","volume-title":"What Things Do","author":"Verbeek","year":"2005"},{"key":"S1073110526102897_r100","first-page":"414","volume-title":"KI-VO: Verordnung \u00fcber K\u00fcnstliche Intelligenz: Kommentar","author":"Martini","year":"2024"},{"key":"S1073110526102897_r106","doi-asserted-by":"publisher","DOI":"10.1093\/jlb\/lsad031"},{"key":"S1073110526102897_r6","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pdig.0000016"},{"key":"S1073110526102897_r33","unstructured":"33. Directive 2009\/48\/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys, 2009 O.J. (L 170) 1\u201337."},{"key":"S1073110526102897_r43","doi-asserted-by":"publisher","DOI":"10.4337\/9781035316496.00031"},{"key":"S1073110526102897_r61","first-page":"92","volume-title":"Research Handbook in Data Science and Law","author":"Graaf","year":"2024"},{"key":"S1073110526102897_r99","doi-asserted-by":"crossref","first-page":"2439","DOI":"10.1093\/eurheartj\/ehab309","article-title":"SCORE2 Risk Prediction Algorithms: New Models to Estimate 10-Year Risk of Cardiovascular Disease in Europe","volume":"42","year":"2021","journal-title":"European Heart Journal"}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110526102897","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T20:42:38Z","timestamp":1791664958000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110526102897\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,10]]},"references-count":118,"alternative-id":["S1073110526102897"],"URL":"https:\/\/doi.org\/10.1017\/jme.2026.10289","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,10]]}}}