Health protection is non-negotiable in the AI Act negotiations

A health-centric approach to the Artificial Intelligence (AI) Act is essential for the protection of health and fundamental rights of European citizens, write Hannah van Kolfschooten and Janneke van Oirschot. 

The European Commission’s proposal for an Artificial Intelligence (AI) Act has been the topic of a heated debate since its publication in April 2021. Civil society organisations believe the proposal falls short on fundamental rights protection, industry is worried it will stifle innovation, and governments fear consequences for national security. We critique the AI Act for neglecting the risks health AI pose to patients’ health and fundamental rights.

The 3,000 amendments to the Act tabled by political groups in the European Parliament say a lot about how controversial regulation of AI really is. This summer, the Parliament’s co-rapporteurs start the negotiation process with compromise amendments. Our message to MEPs, who will need to vote on the amendments is the following: Make health non-negotiable. A health-centric approach to the AI Act is essential for the protection of health and fundamental rights of European citizens, in particular the rights to access to healthcare, non-discrimination and privacy.  

AI is the simulation of human intelligence by machines. AI systems are software-based technologies that use certain data-driven approaches to solve specific problems. What all AI systems have in common, is that they recognise patterns in enormous amounts of data.

AI in the health sector is not like AI in any other sector and deserves special consideration because (1) people’s health is at stake, (2) people are in a vulnerable position when in need of healthcare, (3) the collection of health data has dramatically increased in recent times and (4) health data is historically littered with bias. Because of these characteristics, health AI faces unique risks that need to be specifically addressed in the AI Act. 

Take disease outbreak surveillance as an example. Many people with flu-like symptoms use Google for self-diagnosis. AI can use this data to monitor and predict the spread of infectious diseases. This can be useful for public health officials to make decisions about infectious disease control and how to distribute care resources.

But how accurate are these AI systems when the model is based on subjective user data? Limited regulation of the quality of health AI will lead to distrust in public health and healthcare, breeding hesitancy in access to healthcare. What is more, increased use and sharing of health data threatens privacy and data protection rights.

Another example is the use of AI for medical diagnostics. AI can be used to identify skin cancer in images of skin lesions, after being trained on the basis of thousands of images of “healthy” and cancerous skin lesions. But what happens when image datasets were non-representative, incomplete or of low-quality?

Biases in the training data can lead to discrimination and individual injury or even death. Especially racial bias may lead to incorrect diagnoses and deepen existing socio-economic inequality, something that is not taken into account in current regulation on medical technology. Additionally, lack of transparency and explainability threatens patients’ rights to information and informed consent to medical treatment.

These are just a couple of illustrations of the risks of AI usage for health, one of the most popular sectors for AI deployment in the European Union. Yet, the AI Act does not specifically address health AI and does not provide solutions for its key risks. It can’t be stressed enough that health must be prioritised when MEPs negotiate their amendments over the coming months, with some tabled amendments that deserve particular support. 

Foremost, given its extensive risk, important AI uses in health and healthcare should be marked as high-risk, which will ensure more stringent regulatory requirements. 

Second, high-risk AI should undergo a fundamental rights impact assessment, which takes into account risks to human health. Also technical documentation of health AI should include an assessment of its risks for health, safety and fundamental rights. 

Finally, AI systems that disadvantage groups based on health status should be prohibited completely. 

Similarly, we call on MEPs to strongly oppose amendments that remove health AI from the current list of ‘high-risk AI uses’ or add extra requirements for AI systems to be marked high-risk. 

It’s high time to take on a health-centric approach to the AI Act. It’s worth reiterating: health protection is non-negotiable in the AI Act negotiations. 

By Hannah van Kolfschooten and Janneke van Oirschot – originally posted on EURACTIV. Please cite as: Hannah van Kolfschooten & Janneke van Oirschot, ‘Health protection is non-negotiable in the AI Act negotiations’, 18 August 2022, EURACTIV, available at: <>

EU Regulation of Artificial Intelligence: Challenges for Patients’ Rights

In order to create a well-functioning internal market for Artificial Intelligence (AI) systems, the European Commission recently proposed the Artificial Intelligence Act. However, this legislative proposal pays limited attention to the health-specific risks the use of AI poses to patients’ rights. This article outlines that fundamental rights impacts associated with AI such as discrimination, diminished privacy and opaque decision-making are exacerbated in the context of health and may threaten the protection of foundational values and core patients’ rights. However, while the EU is facilitating and promoting the use and availability of AI in the health sector in Europe via the Digital Single Market, it is unclear whether it can provide the concomitant patients’ rights protection. This article theorizes the Europeanization of health AI by exploring legal challenges through a patients’ rights lens in order to determine if the European regulatory approach for AI provides for sufficient protection to patients’ rights.

In 2021, the European Commission proposed the Artificial Intelligence Act. In her recent article for Common Market Law Review, Hannah van Kolfschooten expresses concerns about this legislative proposal with regard to patients’ rights. The aim of the proposed act is to create a well-functioning internal market for Artificial Intelligence (AI) systems. However, Van Kolfschooten argues that limited attention is paid to the health-specific risks the use of AI poses to patients’ rights. She states that fundamental rights violations associated with AI are exacerbated in the context of health and may threaten the protection of patients’ rights. While the EU is facilitating and promoting the use and availability of AI in the European health sectors, it remains unclear whether it is simultaneously able to protect patients’ rights against the risks that the use of AI poses.

Please cite as: Hannah Van Kolfschooten, ‘EU regulation of artificial intelligence: Challenges for patients’ rights’, (2022), 59, Common Market Law Review, Issue 1, pp. 81-112.

How the Parliament’s AIDA Report Misdiagnoses the Risks and Benefits of Health AI

In November 2021, the European Parliament’s Special Committee on AI in a Digital Age (AIDA Committee) put forward its draft report on artificial intelligence (AI) in a digital age. The report advocates for a very permissive approach to the regulation of AI to stimulate innovation and foster the competitiveness of the EU. With this, however, it understates the possible risks specific to the development and use of AI in the context of health and lacks actual solutions to translate potential into action. We identified five shortcomings and hereby appeal to the regulator to address them.

Jorge Félix Cardoso, M.D., M.A. is a Parliamentary Assistant at the European Parliament

Hannah van Kolfschooten, LL.M. is a PhD Researcher at Law Centre for Health and Life, University of Amsterdam.

Diogo Nogueira Leite, M.Sc. is a PhD Researcher in Health Data Science at the Center for Health Technology and Services Research, University of Porto.

Tjaša Petročnik is a PhD Researcher at TILT/TILEC, Tilburg University

Henrique Vasconcelos, M.D.

The authors write in their personal capacity.

Health is broader than healthcare

When talking about AI in or for health, we are not only talking about a cancer diagnosis or the personalisation of therapeutics in the clinic; the scope of health provision is expanding from formal healthcare systems into our smart devices, actively involving (pre-)patients and consumers. Think about increasingly AI-driven fitness apps, symptom checkers, disease management tools and so on, which have the potential to widen access to health-enhancing resources by cutting conventional healthcare ‘gatekeepers’ out of the equation.

These tools are, however, in the report seen as mere means to relieve pressure on healthcare systems, even though they might affect the health attitudes and behaviours of users or even result in serious harm if not performing optimally. Additionally, as health data is scarce and desirable, we can expect such consumer-facing AI tools to progressively act as an avenue to obtain such data. Misuse might result in privacy violations, civil rights discrimination based on health records, or health inequality increases. AI regulation should thus take into account that AI-based health practices are also taking place outside formal healthcare settings and properly address this.

Exaggerated benefits of health AI

Without a doubt, AI applications in clinical practice and health research show significant promise. Yet, reading the AIDA report, one may get the impression that AI is widely and successfully used in clinical settings. Although the fight against COVID-19 has indeed accelerated research of new technologies in health, this has (so far) produced few robust, generalisable results. While some AI algorithms may perform with high accuracy on paper, even comparable to human specialists, they might not perform as well in real-world clinical practice. The expectations for AI in health appear inflated as the promised transformative events have for now mostly been confined to lab-controlled environments. Furthermore, the AIDA report seems to falsely equate more diagnoses with improved clinical outcomes. However, that is not always the case – overdiagnosis might even result in more harm than good. Ultimately, implementing AI technologies in health contexts requires accurate algorithms and investments in care infrastructure, professionals, and resources.

Underdiagnosis of the risks for both individuals and society

While the benefits of AI appear over-diagnosed, the AIDA report seems to downplay the risks. It correctly acknowledges some of them, in particular, harms to individuals’ wellbeing due to, for instance, misdiagnosis and related liability issues. But, by focusing on individual risks, the report overlooks broader societal risks and harms of AI. Unlike ‘human’ medical errors, mistakes of AI systems can have a much larger impact: technical system errors in AI could lead to mass patient injuries because of widespread use. Additionally, AI might perform better on sub-populations that are better studied or better represented in the training datasets, reflecting existing societal biases. For example, when AI is used to aid health professionals in diagnosing skin cancers, the system frequently uses freely available image databases that often do not include images of people of colour. As a result, these systems may lead to people of colour’s underdiagnosis. This would not only directly harm the health of individual members of (already) marginalised groups; it could also deepen the (existing) socio-economic inequalities in terms of access to health and health outcomes. It thus seems that the report disregards these societal implications in favour of potential economic benefits.

Patients are not mere data points; they are humans with fundamental rights

The risks of AI in health go well beyond health risks. AI runs on data, but data is not just an input; it is “collected by people, from people and for people”. Data subjects and those affected by AI are human beings with fundamental rights like dignity, non-discrimination and privacy. For instance, the report does not touch upon the black-box nature of many AI systems; a lack of understanding of how AI reaches its conclusion makes it difficult for clinicians to explain and for patients to understand AI’s advice, which can impair existing health practices of information provision and informed consent as an integral part of the right to health. Moreover, those seeking care are in a specific situation of vulnerability due to asymmetry in information and risk aversion. Therefore, the EU’s approach to AI in health should not only ensure health-specific fundamental rights are protected in the design, deployment, and usage of AI in health tools but also to address citizens’ willingness to provide and curate health data and ways to govern it appropriately.

Development of AI in health requires a specific approach

Developing health solutions is different from conventional product development because it touches upon people’s bodies and lives in a way no other industry does. Introducing AI in health amplifies the need for multidisciplinary teams that bring together insights from (bio)medicine, data science, behavioural sciences, and ethics and law. By lacking identification of this heterogeneity, namely through the recognition of the need for sector-specific regulation, the report fails to address the needs of patients, practitioners, and also developers and industry.

The AIDA report should therefore acknowledge the special nature of AI in the context of health and call for the proper regulation of the risks to patients or consumers as affected individuals and society. After all, health is everyone’s concern, and the algorithms have already entered doctor’s offices and our living rooms. Let’s ensure that they are really here to make us healthier.

This blog was first published on Euractiv on 24 January 2022.