· Human oversight and determination

35. Member States should ensure that it is always possible to attribute ethical and legal responsibility for any stage of the life cycle of AI systems, as well as in cases of remedy related to AI systems, to physical persons or to existing legal entities. Human oversight refers thus not only to individual human oversight, but to inclusive public oversight, as appropriate. 36. It may be the case that sometimes humans would choose to rely on AI systems for reasons of efficacy, but the decision to cede control in limited contexts remains that of humans, as humans can resort to AI systems in decision making and acting, but an AI system can never replace ultimate human responsibility and accountability. As a rule, life and death decisions should not be ceded to AI systems.
Principle: The Recommendation on the Ethics of Artificial Intelligence, Nov 24, 2021

Published by The United Nations Educational, Scientific and Cultural Organization (UNESCO)

Related Principles

I. Human agency and oversight

AI systems should support individuals in making better, more informed choices in accordance with their goals. They should act as enablers to a flourishing and equitable society by supporting human agency and fundamental rights, and not decrease, limit or misguide human autonomy. The overall wellbeing of the user should be central to the system's functionality. Human oversight helps ensuring that an AI system does not undermine human autonomy or causes other adverse effects. Depending on the specific AI based system and its application area, the appropriate degrees of control measures, including the adaptability, accuracy and explainability of AI based systems, should be ensured. Oversight may be achieved through governance mechanisms such as ensuring a human in the loop, human on the loop, or human in command approach. It must be ensured that public authorities have the ability to exercise their oversight powers in line with their mandates. All other things being equal, the less oversight a human can exercise over an AI system, the more extensive testing and stricter governance is required.

Published by European Commission in Key requirements for trustworthy AI, Apr 8, 2019

· Proportionality and Do No Harm

25. It should be recognized that AI technologies do not necessarily, per se, ensure human and environmental and ecosystem flourishing. Furthermore, none of the processes related to the AI system life cycle shall exceed what is necessary to achieve legitimate aims or objectives and should be appropriate to the context. In the event of possible occurrence of any harm to human beings, human rights and fundamental freedoms, communities and society at large or the environment and ecosystems, the implementation of procedures for risk assessment and the adoption of measures in order to preclude the occurrence of such harm should be ensured. 26. The choice to use AI systems and which AI method to use should be justified in the following ways: (a) the AI method chosen should be appropriate and proportional to achieve a given legitimate aim; (b) the AI method chosen should not infringe upon the foundational values captured in this document, in particular, its use must not violate or abuse human rights; and (c) the AI method should be appropriate to the context and should be based on rigorous scientific foundations. In scenarios where decisions are understood to have an impact that is irreversible or difficult to reverse or may involve life and death decisions, final human determination should apply. In particular, AI systems should not be used for social scoring or mass surveillance purposes.

Published by The United Nations Educational, Scientific and Cultural Organization (UNESCO) in The Recommendation on the Ethics of Artificial Intelligence, Nov 24, 2021

· Transparency and explainability

37. The transparency and explainability of AI systems are often essential preconditions to ensure the respect, protection and promotion of human rights, fundamental freedoms and ethical principles. Transparency is necessary for relevant national and international liability regimes to work effectively. A lack of transparency could also undermine the possibility of effectively challenging decisions based on outcomes produced by AI systems and may thereby infringe the right to a fair trial and effective remedy, and limits the areas in which these systems can be legally used. 38. While efforts need to be made to increase transparency and explainability of AI systems, including those with extra territorial impact, throughout their life cycle to support democratic governance, the level of transparency and explainability should always be appropriate to the context and impact, as there may be a need to balance between transparency and explainability and other principles such as privacy, safety and security. People should be fully informed when a decision is informed by or is made on the basis of AI algorithms, including when it affects their safety or human rights, and in those circumstances should have the opportunity to request explanatory information from the relevant AI actor or public sector institutions. In addition, individuals should be able to access the reasons for a decision affecting their rights and freedoms, and have the option of making submissions to a designated staff member of the private sector company or public sector institution able to review and correct the decision. AI actors should inform users when a product or service is provided directly or with the assistance of AI systems in a proper and timely manner. 39. From a socio technical lens, greater transparency contributes to more peaceful, just, democratic and inclusive societies. It allows for public scrutiny that can decrease corruption and discrimination, and can also help detect and prevent negative impacts on human rights. Transparency aims at providing appropriate information to the respective addressees to enable their understanding and foster trust. Specific to the AI system, transparency can enable people to understand how each stage of an AI system is put in place, appropriate to the context and sensitivity of the AI system. It may also include insight into factors that affect a specific prediction or decision, and whether or not appropriate assurances (such as safety or fairness measures) are in place. In cases of serious threats of adverse human rights impacts, transparency may also require the sharing of code or datasets. 40. Explainability refers to making intelligible and providing insight into the outcome of AI systems. The explainability of AI systems also refers to the understandability of the input, output and the functioning of each algorithmic building block and how it contributes to the outcome of the systems. Thus, explainability is closely related to transparency, as outcomes and ub processes leading to outcomes should aim to be understandable and traceable, appropriate to the context. AI actors should commit to ensuring that the algorithms developed are explainable. In the case of AI applications that impact the end user in a way that is not temporary, easily reversible or otherwise low risk, it should be ensured that the meaningful explanation is provided with any decision that resulted in the action taken in order for the outcome to be considered transparent. 41. Transparency and explainability relate closely to adequate responsibility and accountability measures, as well as to the trustworthiness of AI systems.

Published by The United Nations Educational, Scientific and Cultural Organization (UNESCO) in The Recommendation on the Ethics of Artificial Intelligence, Nov 24, 2021

1 Protect autonomy

Adoption of AI can lead to situations in which decision making could be or is in fact transferred to machines. The principle of autonomy requires that any extension of machine autonomy not undermine human autonomy. In the context of health care, this means that humans should remain in full control of health care systems and medical decisions. AI systems should be designed demonstrably and systematically to conform to the principles and human rights with which they cohere; more specifically, they should be designed to assist humans, whether they be medical providers or patients, in making informed decisions. Human oversight may depend on the risks associated with an AI system but should always be meaningful and should thus include effective, transparent monitoring of human values and moral considerations. In practice, this could include deciding whether to use an AI system for a particular health care decision, to vary the level of human discretion and decision making and to develop AI technologies that can rank decisions when appropriate (as opposed to a single decision). These practicescan ensure a clinician can override decisions made by AI systems and that machine autonomy can be restricted and made “intrinsically reversible”. Respect for autonomy also entails the related duties to protect privacy and confidentiality and to ensure informed, valid consent by adopting appropriate legal frameworks for data protection. These should be fully supported and enforced by governments and respected by companies and their system designers, programmers, database creators and others. AI technologies should not be used for experimentation or manipulation of humans in a health care system without valid informed consent. The use of machine learning algorithms in diagnosis, prognosis and treatment plans should be incorporated into the process for informed and valid consent. Essential services should not be circumscribed or denied if an individual withholds consent and that additional incentives or inducements should not be offered by either a government or private parties to individuals who do provide consent. Data protection laws are one means of safeguarding individual rights and place obligations on data controllers and data processors. Such laws are necessary to protect privacy and the confidentiality of patient data and to establish patients’ control over their data. Construed broadly, data protection laws should also make it easy for people to access their own health data and to move or share those data as they like. Because machine learning requires large amounts of data – big data – these laws are increasingly important.

Published by World Health Organization (WHO) in Key ethical principles for use of artificial intelligence for health, Jun 28, 2021

4 Foster responsibility and accountability

Humans require clear, transparent specification of the tasks that systems can perform and the conditions under which they can achieve the desired level of performance; this helps to ensure that health care providers can use an AI technology responsibly. Although AI technologies perform specific tasks, it is the responsibility of human stakeholders to ensure that they can perform those tasks and that they are used under appropriate conditions. Responsibility can be assured by application of “human warranty”, which implies evaluation by patients and clinicians in the development and deployment of AI technologies. In human warranty, regulatory principles are applied upstream and downstream of the algorithm by establishing points of human supervision. The critical points of supervision are identified by discussions among professionals, patients and designers. The goal is to ensure that the algorithm remains on a machine learning development path that is medically effective, can be interrogated and is ethically responsible; it involves active partnership with patients and the public, such as meaningful public consultation and debate (101). Ultimately, such work should be validated by regulatory agencies or other supervisory authorities. When something does go wrong in application of an AI technology, there should be accountability. Appropriate mechanisms should be adopted to ensure questioning by and redress for individuals and groups adversely affected by algorithmically informed decisions. This should include access to prompt, effective remedies and redress from governments and companies that deploy AI technologies for health care. Redress should include compensation, rehabilitation, restitution, sanctions where necessary and a guarantee of non repetition. The use of AI technologies in medicine requires attribution of responsibility within complex systems in which responsibility is distributed among numerous agents. When medical decisions by AI technologies harm individuals, responsibility and accountability processes should clearly identify the relative roles of manufacturers and clinical users in the harm. This is an evolving challenge and remains unsettled in the laws of most countries. Institutions have not only legal liability but also a duty to assume responsibility for decisions made by the algorithms they use, even if it is not feasible to explain in detail how the algorithms produce their results. To avoid diffusion of responsibility, in which “everybody’s problem becomes nobody’s responsibility”, a faultless responsibility model (“collective responsibility”), in which all the agents involved in the development and deployment of an AI technology are held responsible, can encourage all actors to act with integrity and minimize harm. In such a model, the actual intentions of each agent (or actor) or their ability to control an outcome are not considered.

Published by World Health Organization (WHO) in Key ethical principles for use of artificial intelligence for health, Jun 28, 2021