Legal

This catalogue contains the legal norms that inspired the questions in the PIO Model on Health. It also lists texts of other types that contain recommendations regarding the ethical use of AI in the field of Health.

1. Preliminary analysis of the use of the system

Article

Model PIO question

Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Law
8 9 11
1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.6 1.1.7 1.1.8 1.1.9
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Appli-cation of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine [Ovie-do Convention]
5 10
1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.7 1.1.8 1.1.9
Directive 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for damage caused by defective products
7
1.1.2 1.1.4 1.1.6 1.1.7 1.1.9
Statute of Autonomy of Catalonia
23.3
1.1.5
Law 41/2002, of November 14, 2002, basic law regulating patient autonomy and rights and obligations regarding information and documentation clinical
2 4 5
1.1.2 1.1.5
Regulation 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance [Data Governance Act]
21
1.1.3
Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [RegulationGeneral Data Protection]
13
1.1.3
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
10 29 32 63 83 110
1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.6 1.1.7 1.1.8
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
10 26 29 59 78 102 103
1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.6 1.1.7 1.1.8
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
10 11 12 13 14 17 50 53 55
1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.6 1.1.7 1.1.8 1.1.9
Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, the Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies
4
1.1.5
Royal Decree 192/2023, of 21 March, which regulates health care products
5 21
1.1.1 1.1.2 1.1.4 1.1.5 1.1.6 1.1.7
ICO's AI and data protection risk toolkit d’ICO
1.1.2 1.1.3 1.1.7
GSMA's AI ethics assessment
1.1.1 1.1.4 1.1.5
Assessment list for Trustworthy artificial Intelligence (ALTAI) for self assessment
1.1.1 1.1.4 1.1.5 1.1.6 1.1.7 1.1.9
Ethics and governance of artificial intelligence for health (WHO)
1.1.4 1.1.5
Generative AI and medical ethics: the state of play (Zohny, Mann, et al)
1.1.5
The ethics of AI in health care: A mapping review (Morleya, Machadoa, et al.)
1.1.3
Transparency of AI in Healthcare as a Multilayered System of Accountabilities: Between Legal Require-ments and Technical Limitations, (Anastasia Kiseleva et al.)
1.1.6 1.1.7 1.1.8

2. Interpretability of the system and information to the patient

Article

Model PIO question

Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Law
8 20
1.2.1 1.2.2 1.2.3
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Appli-cation of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine [Ovie-do Convention]
5
1.2.1 1.2.2 1.2.3
Statute of Autonomy of Catalonia
23.3
1.2.2 1.2.3
Law 41/2002, of November 14, basic regulation of patient autonomy and rights and obligations in matters of information and clinical documentation, relating to the right to information. healthcare
2 4
1.2.2
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices 2017/745 del Parlament Europeu i del Consell, de 5 d'abril de 2017 sobre els productes sanitaris
10 63
1.2.2 1.2.3
Regulation 2017/746 of 5 April 2017, on in vitro diagnostic medical devices
10 59
1.2.2 1.2.3
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
12 13 16 53 95
1.2.1 1.2.2 1.2.3
Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, the Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies
4
1.2.2
Royal Decree 192/2023, of 21 March, which regulates health care products
5
1.2.2 1.2.3
AIEIG's An interdisciplinary framework to operationalise AI ethics
1.2.1
Assessment list for Trustworthy artificial Intelli-gence (ALTAI) for self assessment
1.2.1

3. Explicability of the system

Article

Model PIO question

Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Law
8 9 12 18
1.3.2 1.3.3 1.3.4 1.3.5 1.3.6 1.3.8 1.3.7
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine [Ovie-do Convention]
7
1.3.1 1.3.3 1.3.4 1.3.5 1.3.7
Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [General Data Protection Regulation]
8
1.3.8
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
10 19 20 25-34 32 52
1.3.1 1.3.4 1.3.5 1.3.6 1.3.7
Regulation 2017/746 of 5 April 2017, on in vitro diagnostic medical devices
10 17 18 22-30 29 48
1.3.1 1.3.4 1.3.5 1.3.6 1.3.7
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
9 10 12 13 14 15 17 43 53 95
1.3.1 1.3.2 1.3.3 1.3.4 1.3.5 1.3.6 1.3.8 1.3.7
Royal Decree 192/2023, of 21 March, which regulates health care products
5 21
1.3.1 1.3.4 1.3.5 1.3.6 1.3.7
GSMA's AI ethics assessment
1.3.1 1.3.2 1.3.3
Assessment list for Trustworthy artificial Intelligence (ALTAI) for self assessment
1.3.1 1.3.2 1.3.3 1.3.5 1.3.8
The ethics of AI in health care: A mapping review (Morleya, Machadoa, et al.)
1.3.6

2. Risk management

Article

Model PIO question

Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Lawmarc del Consell d'Europa sobre in-tel·ligència artificial i drets humans, democràcia i estat de dret
8 12 16
3.2.1 3.2.2 3.2.3 3.2.4 3.2.5
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the application of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine [Oviedo Convention]
4 5
3.2.2 3.2.3 3.2.5
Directive 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for damage caused by defective products
7
3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6
Law 41/2002, of November 14, 2002, basic law regu-lating patient autonomy and rights and obligations regarding clinical information and documentation
10
3.2.5
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
10 32 62
3.2.2 3.2.3 3.2.5
Regulation 2017/746 of 5 April 2017, on in vitro diagnostic medical devices
10 29 58
3.2.2 3.2.3 3.2.5
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
9 14 15 17 27 55 72 95
3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6
Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, the Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies
3.b) 4
3.2.2 3.2.5
Royal Decree 192/2023, of 21 March, which regulates health care products
5
3.2.2 3.2.3 3.2.5
Ethics and governance of artificial intelligence for health (WHO)
3.2.6
FUTURE-AI (Karim Lekadir, Alejandro F Frangi, et al.)
3.2.3 3.2.5
Holding AI to Account: Challenges for the Delivery of Trustworthy AI in Healthcare, de Rob Procter, Peter Tolmie, i Mark Rouncefield
3.2.3 3.2.4
Report on impact assessments of Fundamental Rights in relation to the Digital Services Law of AN and ECNL
3.2.1
The ethics of AI in health care: A mapping review (Morleya, Machadoa, et al.)
3.2.1
The medical algorithmic audit (Liu, Glocker, et al.)
3.2.3 3.2.4

1. Control

Article

Model PIO question

Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Law
8 9 12 16 20
4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7 4.1.8 4.1.9 4.1.10 4.1.11 4.1.12
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine [Oviedo Convention]
4
4.1.1 4.1.2 4.1.5 4.1.7
Directive 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for damage caused by defective products
7
4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7 4.1.11 4.1.12
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
10 32 62 86
4.1.1 4.1.4 4.1.6 4.1.9 4.1.12
Regulation 2017/746 of 5 April 2017 on in vitro diagnostic medical devices
10 29 58
4.1.1 4.1.4 4.1.6 4.1.9 4.1.12
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
9 14 17 55 72 95
4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7 4.1.8 4.1.9 4.1.11 4.1.12
Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, the Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies
3.f)
4.1.1
Royal Decree 192/2023, of 21 March, which regulates health care products
5 8
4.1.1 4.1.4 4.1.6 4.1.9 4.1.10 4.1.12
GSMA's AI ethics assessment
4.1.3
ACLUS's Algotrithmic Equity Toolkit
4.1.3
Artificial Intelligence, Responsibility Attribution, and a Relational Justification of Explainability de Coeckelbergh
4.1.1 4.1.2 4.1.7
Assessment list for Trustworthy artificial Intelli-gence (ALTAI) for self assessment
4.1.3 4.1.5 4.1.12
Ethics and governance of artificial intelligence for health (WHO)
4.1.8 4.1.9 4.1.10 4.1.11 4.1.12
FUTURE-AI (Karim Lekadir, Alejandro F Frangi, et al.)
4.1.4 4.1.6 4.1.9
The ethics of AI in health care: A mapping review (Morleya, Machadoa, et al.)
4.1.6
The four dimensions of contestable AI diagnostics - A patient-centric approach to explainable AI, Artificial Intelligence in Medicine (Thomas Ploug i Søren Holm)
4.1.8 4.1.9
The medical algorithmic audit (Liu, Glocker, et al.)
4.1.1 4.1.2 4.1.7 4.1.11 4.1.12

3. Protection figures and repair measures

Article

Model PIO question

Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Law
9 16
4.3.1 4.3.2 4.3.3
Law 33/2011, of 4 October, General of Public Health (Law 33/2011, of October 4, General of Public Health)
5
4.3.1
Law 14/1986, of 25 April, General of Health
10.12
4.3.1
Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [Regu-lationGeneral Data Protection ]
24-31
4.3.4
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
10 19 20 51 52
4.3.2 4.3.3 4.3.4 4.3.5
Regulation 2017/746 of 5 April 2017 on in vitro diagnostic medical devices
10 17 18 47 48
4.3.2 4.3.3 4.3.4 4.3.5
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
6 11 13 17 27 43 51
4.3.2 4.3.4 4.3.6
Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, the Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies
9
4.3.2 4.3.3
Royal Decree 192/2023, of 21 March, which regulates health care products
21 32
4.3.2 4.3.3 4.3.4
ICO's AI and data protection risk toolkit
4.3.4
Assessment list for Trustworthy artificial Intelli-gence (ALTAI) for self assessment
4.3.4
Ethics and governance of artificial intelligence for health (WHO)
4.3.2 4.3.3
Ethics guidelines for trustworthy AI (Comissió Europea)
4.3.2 4.3.3
Guide for the Application of the European Regulation on AI in Health developed (Fundació TIC Salut Social)
4.3.6

1. Privacy protection

Article

Model PIO question

Spanish Constitution
18
5.1.1 5.1.2 5.1.3 5.1.4 5.1.6 5.1.5
Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Law
11
5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine [Oviedo Convention]
10
5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6
Statute of Autonomy of Catalonia
31
5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6
Law 14/1986, of 25 April, General of Health
10.3
5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6
Law 33/2011, of 4 October, General of Public Health (Law 33/2011, of October 4, General of Public Health)
7
5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6
Law 41/2002, of November 14, 2002, basic law regu-lating patient autonomy and rights and obligations regarding clinical information and documentation
7
5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6
Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [General Data Protection Regulation]
32
5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
110
5.1.1 5.1.2 5.1.4
Regulation 2017/746 of 5 April 2017, on in vitro diagnostic medical devices
102 103
5.1.1 5.1.2 5.1.4
Regulation 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance [Data Governance Act]
5 21
5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
5.1.1 5.1.2 5.1.3 5.1.5 5.1.6
OHCHR's A Human Rights-Based Approach To Data
5.1.5 5.1.6
ICO's AI and data protection risk toolkit
5.1.5 5.1.6
GSMA's AI ethics assessment
5.1.1 5.1.2 5.1.3
AIEIG's An interdisciplinary framework to operationalise AI ethics
5.1.1 5.1.2 5.1.3
Assessment list for Trustworthy artificial Intelligence (ALTAI) for self assessment
5.1.1 5.1.2
Ethical Challenges and Solutions of Generative AI: An Interdisciplinary Perspective (Al-kfairy, Mustafa, et al)
5.1.3
Generative AI and medical ethics: the state of play (Zohny, Mann, et al)
5.1.4

2. Data governance

Article

Model PIO question

Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Law
11 12
5.2.1 5.2.3
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine [Oviedo Convention]
10
5.2.1
Directive 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for damage caused by defective products
7
5.2.1
Law 41/2002, of November 14, 2002, basic law regu-lating patient autonomy and rights and obligations regarding clinical information and documentation
16
5.2.1 5.2.2
Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [General Data Protection Regulation]
24-31
5.2.3
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
32
5.2.3
Regulation 2017/746 of 5 April 2017 on in vitro diagnostic medical devices
29
5.2.1
Regulation 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance [Data Governance Act]
20
5.2.1 5.2.2 5.2.3
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
10
5.2.3
Royal Decree 192/2023, of 21 March, which regulates health care products
5.2.3
ACNUDH's A Human Rights-Based Approach To Data
5.2.1 5.2.2
Assessment list for Trustworthy artificial Intelli-gence (ALTAI) for self assessment
5.2.3
Generative AI and medical ethics: the state of play (Zohny, Mann, et al)
5.2.3

1. Contestable systems and patient's point of view

Article

Model PIO question

Framework Convention of the Council of Europe on Artificial Intelligence and Human Rights, Democracy and the Rule of Law
7 9 11
6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6 6.1.7 6.1.8
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine [Oviedo Convention]
4 5 10
6.1.1 6.1.2 6.1.3 6.1.7 6.1.8
Law 41/2002, of November 14, 2002, basic law regulating patient autonomy and rights and obligations regarding clinical information and documentation
2 3 4 8
6.1.8
Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data [General Data Protection Regulation]
21
6.1.1 6.1.4 6.1.6
Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
10
6.1.1 6.1.4 6.1.6
Regulation 2017/746 of 5 April 2017, on in vitro diagnostic medical devices
10
6.1.1 6.1.3 6.1.4 6.1.6 6.1.7 6.1.8
Regulation 2024/1689 of the Parliament and of the Council on artificial intelligence [AI Act]
13
6.1.1 6.1.4 6.1.6
Royal Decree 192/2023, of 21 March, which regulates health care products
6.1.7
GSMA's AI ethics assessment
6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6
Artificial Intelligence, Responsibility Attribution, and a Relational Justification of Explainability de Coeckelbergh
6.1.7 6.1.8
Assessment list for Trustworthy artificial Intelligence (ALTAI) for self assessment
6.1.8
The ethics of AI in health care: A mapping review (Morleya, Machadoa, et al.)
6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6

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