Safe and Ethical AI (SEA) Platform Network · Linking Artificial Intelligence Principles (LAIP)

IDAIS-Venice

Principle: IDAIS-Venice, Sept 5, 2024

Published by IDAIS (International Dialogues on AI Safety)

Related Principles

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

2 Promote human well being, human safety and the public interest

AI technologies should not harm people. They should satisfy regulatory requirements for safety, accuracy and efficacy before deployment, and measures should be in place to ensure quality control and quality improvement. Thus, funders, developers and users have a continuous duty to measure and monitor the performance of AI algorithms to ensure that AI technologies work as designed and to assess whether they have any detrimental impact on individual patients or groups. Preventing harm requires that use of AI technologies does not result in any mental or physical harm. AI technologies that provide a diagnosis or warning that an individual cannot address because of lack of appropriate, accessible or affordable health care should be carefully managed and balanced against any “duty to warn” that might arise from incidental and other findings, and appropriate safeguards should be in place to protect individuals from stigmatization or discrimination due to their health status.

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

3 Ensure transparency, explainability and intelligibility

AI should be intelligible or understandable to developers, users and regulators. Two broad approaches to ensuring intelligibility are improving the transparency and explainability of AI technology. Transparency requires that sufficient information (described below) be published or documented before the design and deployment of an AI technology. Such information should facilitate meaningful public consultation and debate on how the AI technology is designed and how it should be used. Such information should continue to be published and documented regularly and in a timely manner after an AI technology is approved for use. Transparency will improve system quality and protect patient and public health safety. For instance, system evaluators require transparency in order to identify errors, and government regulators rely on transparency to conduct proper, effective oversight. It must be possible to audit an AI technology, including if something goes wrong. Transparency should include accurate information about the assumptions and limitations of the technology, operating protocols, the properties of the data (including methods of data collection, processing and labelling) and development of the algorithmic model. AI technologies should be explainable to the extent possible and according to the capacity of those to whom the explanation is directed. Data protection laws already create specific obligations of explainability for automated decision making. Those who might request or require an explanation should be well informed, and the educational information must be tailored to each population, including, for example, marginalized populations. Many AI technologies are complex, and the complexity might frustrate both the explainer and the person receiving the explanation. There is a possible trade off between full explainability of an algorithm (at the cost of accuracy) and improved accuracy (at the cost of explainability). All algorithms should be tested rigorously in the settings in which the technology will be used in order to ensure that it meets standards of safety and efficacy. The examination and validation should include the assumptions, operational protocols, data properties and output decisions of the AI technology. Tests and evaluations should be regular, transparent and of sufficient breadth to cover differences in the performance of the algorithm according to race, ethnicity, gender, age and other relevant human characteristics. There should be robust, independent oversight of such tests and evaluation to ensure that they are conducted safely and effectively. Health care institutions, health systems and public health agencies should regularly publish information about how decisions have been made for adoption of an AI technology and how the technology will be evaluated periodically, its uses, its known limitations and the role of decision making, which can facilitate external auditing and oversight.

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

5 Ensure inclusiveness and equity

Inclusiveness requires that AI used in health care is designed to encourage the widest possible appropriate, equitable use and access, irrespective of age, gender, income, ability or other characteristics. Institutions (e.g. companies, regulatory agencies, health systems) should hire employees from diverse backgrounds, cultures and disciplines to develop, monitor and deploy AI. AI technologies should be designed by and evaluated with the active participation of those who are required to use the system or will be affected by it, including providers and patients, and such participants should be sufficiently diverse. Participation can also be improved by adopting open source software or making source codes publicly available. AI technology – like any other technology – should be shared as widely as possible. AI technologies should be available not only in HIC and for use in contexts and for needs that apply to high income settings but they should also be adaptable to the types of devices, telecommunications infrastructure and data transfer capacity in LMIC. AI developers and vendors should also consider the diversity of languages, ability and forms of communication around the world to avoid barriers to use. Industry and governments should strive to ensure that the “digital divide” within and between countries is not widened and ensure equitable access to novel AI technologies. AI technologies should not be biased. Bias is a threat to inclusiveness and equity because it represents a departure, often arbitrary, from equal treatment. For example, a system designed to diagnose cancerous skin lesions that is trained with data on one skin colour may not generate accurate results for patients with a different skin colour, increasing the risk to their health. Unintended biases that may emerge with AI should be avoided or identified and mitigated. AI developers should be aware of the possible biases in their design, implementation and use and the potential harm that biases can cause to individuals and society. These parties also have a duty to address potential bias and avoid introducing or exacerbating health care disparities, including when testing or deploying new AI technologies in vulnerable populations. AI developers should ensure that AI data, and especially training data, do not include sampling bias and are therefore accurate, complete and diverse. If a particular racial or ethnic minority (or other group) is underrepresented in a dataset, oversampling of that group relative to its population size may be necessary to ensure that an AI technology achieves the same quality of results in that population as in better represented groups. AI technologies should minimize inevitable power disparities between providers and patients or between companies that create and deploy AI technologies and those that use or rely on them. Public sector agencies should have control over the data collectedby private health care providers, and their shared responsibilities should be defined and respected. Everyone – patients, health care providers and health care systems – should be able to benefit from an AI technology and not just the technology providers. AI technologies should be accompanied by means to provide patients with knowledge and skills to better understand their health status and to communicate effectively with health care providers. Future health literacy should include an element of information technology literacy. The effects of use of AI technologies must be monitored and evaluated, including disproportionate effects on specific groups of people when they mirror or exacerbate existing forms of bias and discrimination. Special provision should be made to protect the rights and welfare of vulnerable persons, with mechanisms for redress if such bias and discrimination emerges or is alleged.

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