Topic Overview ENVI II

Topic Overview Breda 2021

Committee on Environment, Public Health and Food Safety II (ENVI II)

 Loneliness is being increasingly recognised as a public health concern due to its detrimental effects on individual wellbeing and social cohesion. According to a report conducted by the European Commission Joint Research Centre (JRC) in 2018, 18% of Europeans experience social isolation. In this regard, what steps should the EU take to combat loneliness?.

Chairperson: Beverly Boahene (NL)

By Muhammad Ilyasa from Pexels Stock Photos (taken in 2018)


‘Loneliness has less to do with being alone and much more to do with the experience of feeling unseen’ – quote by Miriam Kirmayer

Loneliness is the feeling of being isolated or distant from other people or society. It is a mental state of feeling alone, empty or unwanted. The people who experience loneliness feel isolated even though they have the desire to have social connections. It is possible that even if they have many social connections, the quality of these relationships is not the desired one.

It is not an uncommon emotion to experience, but feeling this emotion for an extended period of time can cause dangerous after-effects on the mental and physical health. Researchers have found that loneliness and social isolation is as dangerous as smoking and alcohol consumption and more than obesity and physical inactivity. 

The cause for loneliness varies for each individual. We can find loneliness in different age groups, sexualities, genders and nationalities. According to recent studies it has been revealed that young adults are the age group that is most at risk for increases in loneliness. This increase has been exacerbated by the social restrictions imposed during the COVID-19 pandemic, making loneliness be referred to as “the hidden pandemic” or “the double pandemic”. Share of respondents feeling lonely more than half of the time the two weeks preceding the interview

Pre-COVID-19, the European Union (EU) citizens reported in a survey that 12% felt lonely. During the first months of the pandemic the EU citizens felt more lonely resulting in 25% of the citizens. The difference between pre-COVID-19 and the pandemic is 13% in four years. This rise in loneliness is alarming and the rise is not showing any sign of slowing down. The rise of loneliness has, however, been recognized by the EU, which has included it into most of its agendas for upholding mental health.


  • Loneliness is a subjective, unwelcome feeling of lack or loss of companionship, which happens when there is a mismatch between the quantity and quality of the social relationships that we have, and those that we want.
  • Social isolation is a state of complete or near-complete lack of social interaction between an individual and society.
  • Social cohesion is the capacity  of  a  society  to  ensure  the well-being  of  all  its  members  –  minimising  disparities  and  avoiding  marginalisation  –  to  manage differences  and  divisions  and  ensure  the  means  of  achieving  welfare  for  all  members. 
  • Solitude is the act of being alone voluntarily which involves being away from others. With solitude there is a possibility of pleasant and positive feeling in the situation. 


  • European Social Policy Network (ESPN) is a network that provides information, advice, analysis and expertise on social policy issues in the EU. They assist the European Commission by monitoring progress towards the EU social protection and social inclusion agenda set out. They are country teams of independent experts on social policies who are also supported by a team of international experts.
  • The European Commission Joint Research Centre (JRC) is a department of the Commission made to support the Commission and to create scientific advice on EU policy. The JRC is currently researching and creating a framework for Loneliness.
  • Citizens are one of the most important actors in this topic through being directly affected by loneliness. They hold the power to influence the issue through acknowledging their feelings, and seeking support when they need it. 
  • The Member States are responsible for their own legislation on loneliness and applying the policies for loneliness. 


The European Commission has been working on mental health for more than 15 years with different activities impacting different fields of mental health. The European Framework for Action on Mental Health and Wellbeing is a framework for EU-countries to inspect their policies and to exchange experiences in improving policy efficiency and effectiveness. The European Framework for Action on Mental Health and Wellbeing focuses on mental health and mostly on mental disorders, excluding issues like loneliness which is mental health but not a disorder. 

Through programmes like URBACT, which focuses and discusses isolation in cities by involving locals in the issues that are essential to them, or VulnerABLE, aimed to search for ways to improve the living situation of vulnerable and isolated people across Europe, the EU tries to help people suffering from loneliness . Unfortunately VulnerABLE focuses on nine specific areas which they missed that loneliness can happen to anyone in any situation. Also the project runned for two years. URBACT does not focus on making the people’s need for meaningful relationships, but on connecting people. It is already known that people can discuss and be well-engaging individuals, but still feel loneliness.

Currently there is a policy brief about loneliness made by the scientists from the JRC. This policy brief  summarises why loneliness is a problem the EU should focus on, which policy options the EU has and some recommendations on the best policy option. The JRC also announced to be working further on loneliness in the framework. This will include a new EU-wide data collection and a web platform to monitor loneliness. All of these plans will be carried out in 2022, so no current activities are taking place.

Different Member States take different approaches to tackle loneliness. The Mental Health Foundation (MHF) is a charity that is active in the United Kingdom. Their mission is to prevent mental health problems by helping people understand how they can protect, sustain and understand their mental health. The MHF Young leaders Policy group came up with a list of recommendations for policies. The MHF have also found faults in the current government policies. The policies aren’t well known amongst the target group, people suffering from loneliness. They also found out that one of the Government’s tactics to combat loneliness is social prescribing. But because of cutting funding from the  youth services , who are practicing social prescribing, the services and projects are decreasing which means a limited amount of services and projects.

While the recommendations for policies from the MHF are greatly established, it is important to notice that all of the recommendations are focused on young people who attend school. By making policies for certain groups who have access to certain services, the recommendations are excluding people.In the Netherlands, the ‘Reinforced action plan against loneliness’ project was launched in 2014 by the Dutch Ministry of Health, Wellbeing and Sport alongside municipalities. The aim of this project was to create a long-lasting approach to loneliness by identifying signs early on and to discuss the topic of loneliness in society. This project was executed through a partnership on a national and local level. The national partnership consisted of diverse social organisations, businesses and government organisations. On the local level there were alliances formed. The Dutch Health Ministry made a national commitment of €26 million to support the measures concerning loneliness.


Stigma surrounding loneliness constitutes one of the main issues hindering progress. Lonely people are generally perceived as weaker, more passive, less attractive, and less sincere. Affected people do not acknowledge their state, let alone reach out for support. This is partly attributed to the fact that loneliness is not regarded as a ‘real’ issue, with people feeling like it is not important enough to talk about. With this in mind, not wanting to burden others with an issue that could come across as insignificant is a barrier to people talking about their feelings of loneliness.

Many times, loneliness is associated with illnesses or old age, which closely relates to the reluctance of affected individuals when it comes to seeking help. While this is partly true, it is not entirely the case, with its prevalence peaking among young adults as well as the elderly. The lack of recognition of loneliness as a public health issue is very common, therefore people feel like it is not important enough to talk about. 

Moreover, there is a discrepancy among different countries with regards to the prevalence of loneliness. It is less common in adults in northern European countries compared to those in southern Europe. This is highly attributed to the different norms and values of the communities; the minimum acceptable standard of connectedness varies greatly between these areas. Therefore, collectivistic and family-centred countries tend to place community-based and interpersonal relationships at a higher standard, resulting in a higher tendency for people to experience loneliness.


Loneliness and social isolation are much more prevalent than commonly thought, and there is a need to treat them as the critical public health issues that they are. The consequences of loneliness are not only grave for the affected individuals, but affect wider social cohesion. The Covid-19 pandemic exacerbated these issues, especially in young adults. However, through an increased attention on meaningful connections, the pandemic drew more attention to the issue and enhanced social dialogue. At the same time, there is still a huge need for this discussion to be expanded to address the underlying causes of loneliness, the first step of which is addressing the severity of the problem and alleviating the stigma that surrounds it. 

  • How can we ensure that individuals affected by loneliness acknowledge their situation?
  • How can we encourage these individuals to reach out for help, and ensure that those seeking help will receive it?
  • How can we combat stereotypes surrounding loneliness, such as those that associate loneliness with old age, and ensure that people of all ages and backgrounds are a part of the discussion?


Topic Overview ENVI I

Topic Overview Breda 2021

 Committee on Environment, Public Health and Food Safety I (ENVI I)

The animal farming industry is a major contributor to climate change, with the livestock sector being responsible for 81-86% of greenhouse gas emissions. How should the Common Agricultural Policy be adapted to achieve enhanced sustainability in all stages of the food chain, as well as a healthier diet for EU citizens?

Chairperson: Maro Kaisaridi (GR)


The European Union (EU) has the highest demand worldwide on pork and dairy products. It is also its greatest producer and one of the main exporters of poultry meat. More than one third of the EU budget is being invested towards the Common Agricultural Policy (CAP), which is the European program for agriculture aiming to ensure the support of the rural economy, while also promoting more sustainable practices, in the hopes of climate neutral (or even climate positive) agriculture.  

The farming sector is a major contributor to climate change, especially through livestock farming. This is largely due to its sizeable greenhouse gas (GHG) emissions, but also because animal farming contributes to the destruction and depletion of large pieces of land, including rainforests, which are essential for life on earth.

Simultaneously, one of the sectors that are being most affected by climate change is the farming industry. This causes  the production of crops, meat and dairy to be even more difficult, and the farmers to use alternative practices to ensure that there will not be a drop in supply. These alternatives are not always sustainable: for instance, using more fertilisers and more water to fight droughts and other increasingly hostile weather conditions. 

This leads to products being unhealthy to consume, such as meat that is infused with hormones and antibiotics. What is even worse is that the consumer is not always aware of what is actually in their food. 


  • Climate Change is the slow and steady transition of the global climate, through natural and anthropogenic effects. These refer to the rise in the global mean temperature, the ozone hole, weather extremes etc. The past decades, the main cause of climate change has been the emission of greenhouse gases, such as CO2, mainly through agriculture and industry. Farming affects the climate directly through its activities and also indirectly by its land use. Animal farming especially requires extensive use of land, sometimes causing deforestation. Climate change also, in turn, affects the farming industry, having an effect on crop growth because of weather extremes and making animals more prone to disease in warmer weathers.
  • Greenhouse gases (GHG) are gasses such as carbon dioxide (CO2) and hydrofluorocarbons (HFCs) that are causing the greenhouse effect, which then lead to global warming. Most of them naturally exist in the atmosphere, but due to human activity their concentration has rapidly increased these past decades. The main sources of GHGs are industry, agriculture and burning fuels. Not only are the emissions of GHGs stronger, but the forests, the main contributors in removing the atmospheric CO2 and turning it into oxygen, are being cut down due to humans needing more exploitable land.
  • Environmental Sustainability is about producing food and material, without harming the natural resources or making alterations to the land. This ensures that human activity will not contradict nature in any way. Since the lack of respect towards nature leads to climate crisis, living sustainably is crucial. If humanity continues to interfere with nature, vital resources such as water and variety in food are going to be compromised. 


  • The European Commission’s department on Agriculture and Rural Development (AGRI) is responsible for the CAP in all of its aspects. It ensures that the CAP remains dynamic and keeps up with the changing society and economy, by reforming it when needed. Right now, the CAP aims towards safe and affordable food, produced sustainably while respecting animal welfare and supporting the rural economy. It has implemented policies on agriculture and environment, direct payment support and transparency, rural development, organic farming, quality of farming products, trade and promotion, forestry and agricultural market analysis. The CAP was reformed and now also focuses on social and labour rights of workers, greener practices and support of smaller farms. The European Commission’s responsibility is also to assess and approve the plans of each Member State.
  • The Member States are responsible to put the European policies in action, through constructing their own national strategic plans regarding rural matters and following them. By the end of 2021, Member States should have completed and submitted the first draft of their own strategic plan, which will be presented in 2022 and start being implemented by 2023, following the reformed CAP for 2023-2027.
  • The producers are the ones that are directly impacted by the CAP. They are the ones being funded and also the ones that will have to follow regulations to make their work more sustainable. Their goal, which at the end of the day is to make profit, is not always in line with the EU’s environmentally friendly vision and does not always look out for animal well being.
  • The consumers are indirectly affected, since it is their food at stake. Their health is impacted by what they consume and they are also the ones that make the choices that contribute to the demand of each product. Ultimately, the demand is one of the factors that determines the price of products, making more expensive food less accessible.  


Source: Key policy objectives of the new CAP.

The Common Agricultural Policy (CAP) is a European program aiming at supporting  the farmers, via income support, and market and rural measures. That leads to improvement of agricultural productivity, which in turn is going to provide a stable and affordable food supply for consumers. All these, while also ensuring that the farmers are fairly paid and also keeping the environmental aspect in mind. The European Commission gives the Member States the freedom and responsibility to design, implement and evaluate the CAP. Hence, while following the CAP and having in mind the 9 EU-wide objectives1Supporting farm income to enhance food security, increasing market competitiveness, improving farmers’ position in the value chain, contributing to climate change mitigation and adaptation, supporting sustainable development, protecting biodiversity, encouraging young farmers, promoting development and improving the European response to the demand of food., Member States are meant to construct their own national strategic plan regarding rural matters. This provides the benefit of having a more targeted approach and having a plan that does not only support sustainability, but is also fitted to each member’s specific needs. A more eco-friendly initiative is especially noticeable in the new CAP reform for 2023-2027.

The Farm to Fork strategy, which is part of the European Green Deal, is aiming towards a more sustainable food system through various regulations. By 2023, there should be a 50% reduction in agriculturally sourced GHG emissions and in the sale and use of antimicrobials and pesticides for farming. Also,  20% reduction in the use of fertilisers and 25% of the current agricultural land, will be used for organic farming. 

The Biodiversity strategy, also part of the European Green Deal, is a set of commitments and actions aiming to recover Europe’s biodiversity for the benefit of the climate, among others. This is being possible by protecting areas with high climate value and by restoring degraded ecosystems. 

Some measures that are not currently implemented through the CAP, but are proving to provide successful results are the following: 

  • Sweden has been implementing several actions nationwide, one of them being actively trying to change consumer behaviour. It is the country performing best against climate change, with a goal to reach zero net emissions as close as by 2045.
  • There are many individual businesses taking initiative, such as carbon positive farms. This is a revolutionary alternative to traditional farming. 


The CAP does not seem to be effective at combating climate change. There has been no major improvement in agriculturally sourced GHG emissions since 2010, even though more than 100 billion euros (¼ of the CAP budget) were invested towards more environmentally friendly farming practices. There is no polluter pays principle for GHG emissions, which is an effective way to keep pollution under control and is being used in other environmental policies by the European Union. Also, significant amounts of money are being paid to farmers, supporting practices that make the current climate crisis worse.  

The health of the citizens is not always taken into account in the different aspects of the CAP. Although there are measures considering some harmful substances such as sugar or alcohol, there does not seem to be any support towards a more plant based diet. In the current CAP, there is more funding towards wine production than fruit and vegetables for school children. 

The current measures proposed by the CAP are not urgent enough to face climate change on time, since the climate crisis is only getting worse and the introduced changes are only expected to be implemented in the later part of the next decade. So much so that many Member States have already had trouble following the timeline set, and most of them actually expressed complaints about the deadline. 

There are loopholes in certain important sectors, such as water usage. The current CAP does include further restrictions on water usage, but there are no restrictions regarding the location, so areas with plenty of water and drier areas all fall into the same category, with the CAP payments supporting even water-intensive crops. Moreover, strategies such as the Farm to Fork strategy 2 strategy aiming towards a sustainable food system by reducing the use of pesticides, fertilizers, antimicrobials and promoting organic farming and the Biodiversity strategy 3strategy aiming to protect biodiversity in nature. are not legally binding to Member States, so the outcome is clearly dependent on how each country is going to implement the guidelines provided in each national strategic plan.

Since livestock production is one of the main contributors to climate change, reducing animal products in the individuals’ diets is crucial to combat climate change. A mostly plant based diet would have a positive impact on GHG emissions, since animal products provide 37% of consumed protein, while being responsible for approximately 57% of the agricultural GHG emissions. Despite its negative impact for both consumers’ health and the environment, the consumption of meat and dairy does not seem to be significantly decreasing across the EU.

The farmers are feeling the effects of climate change in their everyday life, since their work depends on the climate. Some of them do not think that the new reform will provide the change needed to reverse this issue, while the general public also seems to have both positive and negative opinions. 


All in all, it is apparent the CAP has some flaws preventing it from effectively promoting sustainability and consumers’ health. In fact, although the CAP does include many points that support sustainability, these are often mere suggestions to the Member States that are struggling with following them and not direct instructions or recommendations for the farmers. There are not many suggestions in the CAP for improving the population’s diet, even though there are several studies showing that reducing meat is better for both the individual’s health and the climate. Climate change is a major global issue and agriculture affects it greatly and directly, and therefore constructing a CAP that is adapted to face this challenge is essential.

  • Should the CAP be reformed and actually include regulations that make agriculture climate positive and not just climate neutral, keeping in mind that the demand for food is expected to keep increasing?
  • Should the CAP continue funding animal farms, even if they have a negative impact on the health of the population and the environment?
  • Should the CAP take into account animal welfare while advocating for a more sustainable and healthy farming sector in the EU?
  • How can the CAP promote a more healthy and sustainable diet for European citizens? 


Topic Overview EMPL

Topic Overview Breda 2021

Committee on Employment and Social Affairs (EMPL)

One in three workers worldwide are anxious about the future of their work due to the automation and digitalisation of increasingly complex tasks. How should the EU adequately equip citizens with the skills needed to adapt to the transformation of the job market and what should social welfare models look like in the future?

Chairperson:  Daksh Khanna (NL)


Many citizens of Europe are scared that their jobs will be automated. This fear does not come as a surprise to many, as global technological advancements in the past have already replaced many jobs. 

Research has shown us many sides to both the disadvantages, as well as the advantages of the usage of automation, digital tools and  AI in our future workforce. One type of research argues that the advancement of technology will aid people in their work: health workers for example. The digitalisation of routine tasks would allow this group of workers to spend more time on solving problems, rather than performing small meaningless tasks.

On the other hand we have another group of workers, who will be affected most by the digital future of work: the ‘’medium skilled workers’’, due to their tasks being automatable. These are the workers who work in accounting and administrative work. More examples of vocational working groups who might get replaced are customer service and sales, food services, and building and construction occupations.

The EU promises equal treatment and opportunities, flexible and adaptable employment, fair wages, and a fair work-life balance. But how can we ensure that the workers whose employment life will change, are able to transition to the new labour market, where they might have to sustain themselves by performing tasks on a platform economy? What is certain is that the manner in which the EU will implement policies surrounding the digitalisation of work will greatly impact the outcome of the job market transition in Europe.


  • Vocational Education and Training (VET): responsible for the development of skills people need to be active in the workforce. Through teaching skills, but also reteaching skills, VET helps to lower dropout rates and the transition from school life to the labour market.
  • Digitalisation: the implementation and integration of technology in society and economy.
  • Routine tasks are repeated tasks, occurring at regular intervals. An example of this in the workplace, would be the job of a bank teller, secretary and bookkeepers.
  • Artificial intelligence (AI) is a system set up by humans that can perceive and analyse an environment. It can then respond to certain actions, based on what it learned during its analysis of an environment or situation.
  • Self-employment is a type of employment wherein the worker is not consistently employed by someone, who pays then a periodical wage. Instead, they are ‘’independent contractors’’, who take on jobs as high-skilled workers. Some examples include writing or graphic design.
  • Platform economies are circulations of the work that is based online. This work can be divided into two parts. The first one being platforms for companies to request work, and platforms for people who are offering their services.
  • Social Welfare systems are systems set in place to help citizens who are in need by supporting them with, for example, employment compensation or additional health benefits.


  • CEDEFOP is an organisation that aims to improve the vocational, education and training systems in Europe, by creating effective policies. The creation of CEDEFOP was bolstered by several EU countries who had the same goal in guiding the continent’s labour force. 

It has for instance aided the EU in the validation of the national educational certificates from a country in another country, i.e. attending higher education in Belgium and being able to work in the Netherlands. Through the research it develops, it recognizes the strong and weak points within the European VET systems.

  • The OECD is an international organisation that finds solutions for a broad array of issues; social, economic, etc. OECD aims to work together with governments, policymakers and citizens from all over the world, to create policies that promise equality and opportunity. OECD has 38 member countries, which you can find at the bottom of this page.
  • The World Employment Confederation (WEC) recognises that the world as we know it, is developing fast. Additionally, it sees that we are missing clear regulations to this day, regarding the digitalisation of the future. WEC provides policymakers with recommendations to reach an equal-opportunity workfield, fair working conditions, as well as the changes of social welfare systems.
  • Medium-skilled workers are the workers who will be most impacted by the digitalisation of work in Europe. Whereas the opportunities for lower-skilled workers in the past years grew, such as cleaners, the opportunities for medium-skilled workers have grown less hard, and they are predicted to decrease in the near future.


The European Pillar of Social Rights Action Plan aims to set concrete goals to help turn the European Pillar of Social Rights into reality. The European Pillar of Social rights has several principles, which belong to three groups: ‘’Equal opportunities and access to the labour market’’, ‘’fair working conditions’’, and lastly ‘’social protection and inclusion’’.  These three ambitious targets are to be met before 2030, meaning that by then over 78% of all Europeans aged between 20-64 shall be employed, at least 60% of all adults will be participating in trainings yearly, and the amount of people who are at risk of poverty or social exclusion shall be reduced by 15 million. 

The Dutch Digitalisation Strategy recognises the need for the implementation of the above mentioned principles in the legislation of the Netherlands.  The government of the Netherlands has created this document to serve as an outline when it comes to helping digitalise work, while ensuring the safety of all workers.

The OECD project ‘’going digital’’ aids Member States to make better policies to have a smoother transformation to the future. Their project consists of several phases, and it is now in the phase of experimenting with and creating digital mechanisms to help Member States better understand the way digitalisation in Europe will take place as a whole. 


The fact that many people are scared of their jobs getting taken over by AI or automated systems is quite understandable when we take a look at how much the EU invests in technological development. The opportunities for medium-skilled workers in the past years have grown less in quantity than the opportunities for lower and higher skilled workers. Many models of the future of work in Europe point out that we will experience a transformation to a ‘’platform economy’’. It is therefore important that we can provide adequate training  through national VET systems, as well as prepare the current incoming generation of workers for the digital future of work.

A platform economy entails an online platform, where requests for work are received and accepted. Today’s self-employed workers of such platforms, such as Fiverr and UpWork, can offer physical work ,such as babysitting or cleaning homes, or intellectual work, such as making a code or script for data management or producing logos.

Several big corporations have already made plans to expand their training resources for their current workers, but there are still medium-skilled workers whose skills will not have the same level of demand. It is important for safety nets to be created for these workers to ensure the digital work transformations remain inclusive, sustainable and fair.

The classic set-up for social welfare systems recognises workers whose work is rewarded periodically, whether it be weekly or monthly. For the future, however, this is not ideal. Just as the labour market will evolve in many different ways in the future, so should the social welfare systems in Europe so workers can be supported in a market that is intensely skill-biased. The big challenge we face at the moment is how we can include self-employed workers in our social welfare systems.  As many of them are classified as ‘’independent contractors’’, self-employed workers seldom fall within the national requirements to be included in the social- and health insurance systems.


The start of the digital transformation dates back to as far as the late 1990s and has since taken over the jobs of thousands of employees through the automation of tasks. With robotics and AI systems becoming increasingly sophisticated, it is likely that more jobs will become obsolete  as more tasks become digitalised. Simultaneously, this is generating new jobs positions that require a certain degree of technological and digital knowledge. Hence, one of Europe’s main challenges is the reskilling of the working population and preparing the next generation of workers for the dynamic and changing job market. 

  • Many medium-skilled workers are at risk of losing their jobs, due to their skills being replaced by automation. How can we ensure appropriate reskilling of this group of workers, so they can experience equal working opportunities as other work groups?
  • How can we ensure that self-employed workers have access to the same level of social welfare schemes as traditional workers?


  • What will the future of jobs be like? (2020) video by the World Economic Forum, which talks in a broad view about how the future of work looks like in a digitalised Europe.
  • The big debate about the future of work, explained (2017) video by Vox outlining different perspectives around the issue of the digitalisation of work.
  • The future of work in Europe (2020) article by McKinsey outlining the effects of digitalisation and COVID on the future work in Europe. Please focus solely on section 3: ‘’As Europe’s labor force shrinks, automation will affect occupations and demographic groups unevenly’’.
  • What is platform economy? (2020) a video by BMC Software explaining what platform economy consists of.

Topic Overview AIDA

Topic Overview Breda 2021

Committee on Artificial Intelligence in a Digital Age (AIDA)

Recent  advances  in  AI  systems  in  Medicine  and Healthcare present  extraordinary  opportunities  in many areas of social interest together with significant questions and drawbacks, calling for a close consideration of their implementation. What stance and/or steps should the EU take in the near-future applications of AI in this particular sector?

Chairperson: Nida Abraityte (LT)


Devices entailing Artificial Intelligence (AI) based software become increasingly embedded in healthcare and are poised to transform lives on a remarkable scale: receiving and processing more data helps to make better decisions for both physicians and patients, leading to more beneficial health outcomes. At the same time, access to such private and personal data as health information is a complex and sensitive matter that inevitably poses regulatory gaps and legal uncertainties. If poorly regulated it could erode public trust in AI, infringe privacy and data protection laws and cause discrimination. 

The healthcare sector is already one of the most heavily regulated, from doctors requiring licenses to equipment standards and rigorous clinical trials for new drugs. Therefore, problematic use of health information and bias built into algorithms should be regarded with the same caution,  keeping up with the same standards. Regulation in AI within healthcare will undoubtedly increase legal compliance, but it will also provide much-needed clarity and provide AI developers with the confidence they need to innovate and leverage AI in the healthcare sector to its maximum extent. 


  • Artificial intelligence (AI) is defined as the theory and development of computer systems able to perform tasks normally requiring human intelligence, such as visual perception, speech recognition, decision-making, and translation between languages. AI technologies may potentially optimise the performances of devices in a continuous manner, autonomously, evolving in real time and adapting to its data input.
  • AI in healthcare refers to AI applications that are being used to detect disease, monitor its progression, model pharmacokinetics, optimise  treatment regimens, among other tasks. It is usually based on the processing of vast amounts of biometrical data through deep-learning algorithms.1Deep learning is a type of machine learning and artificial intelligence (AI) that imitates the way humans gain certain types of knowledge. While traditional machine learning algorithms are linear, deep learning algorithms are stacked in a hierarchy of increasing complexity and abstraction.
  • Software as a Medical Device (SaMD) – is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for performing functions without being part of a hardware medical device.


  • Biotech-infotech start ups are public or private entities, led by scientists and engineers  that create AI-based technology. They merge the competences of biotechnologists with data and computer scientists to create a machine-learning based service or product. 
  • Companies and healthcare institutions are the main adopters and beneficiaries of the newest technologies. However, just as producers, the users of the AI products are responsible for ensuring compliance with fundamental values and rights of their patients and clients.
  • National governments are made of decision-makers that determine the conditions based on which the AI startups are being launched and operated in each country, and set the regulations that companies, healthcare institutions and other entities have to comply with in order to adopt AI-based technologies.
  • Citizens, namely patients that may be a subject to  AI services applied in healthcare, have a right to be aware of the extent their data is being used to, stored and what implications the outcomes of health information analysis has on their day-to-day life. They can stir the direction of the field by voting on policies concerning AI and advocating for their rights.
  • The European Commission, in this field, namely the Directorate-General on Communications Network, Content and Technology, proposes new EU laws and policies, monitors their implementation, and sets the framework under which other actors are integrating ethical rules from the very first stages of development to the implementation of AI-operated devices. 


The Commission kicked off its AI rule-making in 2018, with the publication of a European Strategy on AI, which plowed €1.5 billion into research. Then in 2019, the High-Level Expert Group on AI, set out ethical guidelines for trustworthy AI. This was followed in 2020 by the White Paper on AI – a regulatory framework outlining approaches that Europe needs to take to become a global leader in innovation in AI and its applications. In April 2021, the European Commission produced an ARTIFICIAL INTELLIGENCE ACT (AIA), the legal framework on AI, that aims to accelerate and align AI policy priorities and investments across Europe. It should also allow Europe to develop human-centric, sustainable, secure, inclusive and trustworthy AI, while boosting technological development and respecting privacy laws. Healthcare AI applications according to the Proposal of a Regulation harmonizing rules on Artificial Intelligence would generally fall into the high-risk category and would need to fulfill the following criteria to achieve regulatory approval: adequate risk mitigation systems, high quality of the datasets feeding the system, logging of activity to ensure traceability of results, transparency for compliance assessment by authorities, understandability to the user, appropriate human oversight, robustness, security and accuracy.

According to current regulations, companies from within or outside the bloc could be fined up to EUR 30,000,000 or up to 6% of total worldwide annual turnover, for infringements related to non-compliance. To indicate conformity with the proposed regulation before hitting the market, high-risk AI systems would need to obtain a specific CE marking, after performing a conformity assessment procedure by the notified body (designated under the proposed regulation) or the manufacturer himself based on EU declaration of conformity. However, apart from regulating and constraining the EU wants to promote the development and the uptake of AI in healthcare, thus the European Commission is calling for more Research and Development (R&D), including AI “excellence and testing centres”.

To ensure that the regulations can adapt to emerging applications, the proposal would empower the Commission to expand this list of high-risk areas without going through a legislative process. The AIA proposal follows the ordinary legislative procedure and will now be debated in parallel in the European Parliament (EP) and Council well into 2022. AIA will apply to providers of AI systems (e.g. a biotech-infotech startups), as well as users of such AI systems (e.g. clinics providing analysis of biometric data). Moreover, the rules carve out an exception allowing authorities to use the biometric data if they’re fighting serious crime, for example, facial recognition technology from CCTV cameras or genetic databases to find sex offenders. 

The AIA also proposes creating a European Artificial Intelligence Board, comprising one representative per EU country, the EU’s data protection authority, and a European Commission representative. The board will supervise the law’s application and share best practices. 


According to the 2020 survey by McKinsey, less than a half of companies are aware and compliant to the new regulations, which is alarming considering the instances when the uncontrolled AI has gone awry – part of the reason why Europe’s General Data Protection Regulation (GDPR) exists. Thus, technological advancement and active risk mitigation have to be pursued simultaneously. It is argued that to ensure a legal framework that is innovation-friendly, future-proof and resilient to disruption, national competent authorities of the Member States ought to establish AI regulatory sandboxing2“Sandboxes” allow innovators to trial these products, services and business models in a safe space, to confirm their compliance with existing regulation before implementing them within the wider sector. schemes that would facilitate the development and testing of innovative AI systems under strict regulatory oversight before being put into service.

Bias occurs when unrepresentative training data is given to an AI algorithm to help it learn and can have especially detrimental outcomes – skewing data towards a particular group, omitting certain demographic or socio-economic groups. However, at the moment there are no official regulatory guidelines around the data used to train the AI in healthcare. Therefore, it is argued that a far more transparent process is needed, similar to clinical trials, in which manufacturers engage in full and frank disclosure showing the attributes of training data, rather than asking  data to be  “relevant, representative, free of errors and complete”, as mentioned in the act,  because data never represents reality perfectly

Another problem in the field is that salaries in AI have become astronomical elsewhere in recent years making only large firms and not the startups being able to keep talents, thus impeding knowledge transfer and training of new AI researchers in Europe. The challenge for the EU, which is home to only six of the top 100 AI startups worldwide—will be to develop adaptable regulations that facilitate rather than impede positive innovation and the uptake of AI. Policymakers will need to enact appropriate safeguards, without stifling innovation that will enable a myriad of future public benefits.


Even though the EU attempts to catch up with the development of AI, regulations still have some gaps and things to keep in mind moving forward. It is crucial to get everyone, both the producers as well as the users of the AI in healthcare, on board with the most recent regulations. It’s important to consider that different legal frameworks regulating AI and data in healthcare are barriers to the realisation of the potential of AI. MedTech Europe calculated that clearing the barriers could save 400,000 lives a year and free up labor equal to the work time of 500,000 healthcare professionals, therefore getting this out of the way would make the bloc’s maneuvers in the AI field so much more efficient. Although the EU is not home to the largest AI companies worldwide it has a potential to be the leader at setting the standard for a trustworthy AI for the rest of the world as it did with the GDPR. 

  • While upholding our AI creation and applications to the highest standard, how can Europe, apart from investing more money into the sector, promote the development and the up-scaling of AI in the region?
  • How can the EU ensure that Member States share healthcare data to catalyse the development of AI-based healthcare solutions while upholding data protection?
  • How can the EU make sure that by the end of 2022, when the latest regulations will come into force, all of the stakeholders will be aware of and ready to implement the changes in their operations?
  • What should the EC do to ensure more transparency about the data that the AI is being trained on to ensure fairness and absence of discrimination?