By Mark Chillingworth

March 14, 2024

Digital experts called on the European Union to be consistent. As the EU AI Act gains Parliamentary approval and the forthcoming European Health Date Space moves closer to reality, a community of digital and health-tech leaders demand that European politicians create innovation opportunities and citizen protection through the deployment of legislation that is harmonious across all 27 member states. 

Technology is dominating the EU agenda; the AI Act follows hard on the heels of the Digital Markets Act and the Transatlantic Digital Cooperation forum to ensure the US and Europe collaborate on technology policy, and the European Health Data Space (EHDS) could boost health tech innovation. 

The EU describe the AI Act as: 

The world's first comprehensive AI law. It aims to address risks to health, safety and fundamental rights. The regulation also protects democracy, rule of law and the environment.

The AI Act covers public and private organizations within and beyond the EU (if their AI systems are placed within the Union and its market, or if the use of the AI impacts the citizens of the EU). Free and open-source AI models are exempt from most of the obligations set out in the law. The law is needed, the EU says, because: 

While most AI systems will pose low to no risk, certain AI systems create risks that need to be addressed to avoid undesirable outcomes.

For example, the opacity of many algorithms may create uncertainty and hamper the effective enforcement of the existing legislation on safety and fundamental rights. Responding to these challenges, legislative action was needed to ensure a well-functioning internal market for AI systems where both benefits and risks are adequately addressed.

Be consistent 

Responding to demands from speakers and moderators at the Masters of Digital 2024 event in Brussels, Dragos Tudorache, EU Parliament Member and Rapporteur for the AI Act, said he expects the new law to lower the cost of compliance for businesses in Europe, especially for small and medium enterprises (SME), which dominate the European economy: 

We have learned from the mistakes from the past. So there are measures in this text, such as special provision for research and development, small and medium-sized enterprises and governance to make sure that you can achieve certainty of compliance through self-assessment rather than needing lawyers.

Tudorache says these are lessons from the implementation of GDPR: 

You have to have a legal understanding to be GDPR compliant, so you have to knock on the door of a lawyer. There is a body of AI that will grow regulation free and if you are developing in one of the areas that is regulated, you will be able to achieve compliance with the minimum cost possible and this will be key to how the AI office achieves its role.

A European AI Office is being set up, in what can be seen as one of those lessons from GDPR; this will centralize AI expertise and be within the European Commission and its Directorate-General for Communications Networks, Content and Technology (CNECT), which is essentially the civil service of the EU. Roberto Viola, Director General of CNECT, said the AI Office will be in place when the act becomes law in mid-2025 and ready to work with the global technology industry. 

Tudorache is confident that these actions will ensure the AI Act is beneficial to digital leaders and citizens: 

The AI Act will not be a barrier; on the contrary, it will create the necessary predictability for the market.

The hard work will be for the member states, both in terms of ensuring consistent implementation and demonstrating the benefits of AI and a centralized AI policy. As the European digital law makers discussed their plans at the conference, farmers were blockading roads in protest about EU environmental policies and the free market status of the EU, whilst the people of the Netherlands and Portugal have voted in fractious hard right parties to their national governments. The EU will be watching these trends with rising nervousness and aware that the same trend led to a fractious right-wing government in the UK that became the first nation to leave the economic superpower. Tudorache said: 

Governments understand that they need to be AI platform states and then reinvent the social contract with their citizens.

State Secretary for Digitalization in Austria Florian Tursky is one of those leaders charged with that task and said: 

The most challenging part of my role is to explain to the public why we need digitalization.

Tursky said governments need to work with the technology industry to ensure there is good awareness of positive case studies, such a knee injury image database developed in Austria with a global hyperscaler that has benefited its residents: 

This helps people in their daily lives, so that digital and AI will make people more healthy.

New laws must also promote increased collaboration in Europe to ensure the continent can compete. According to the event speakers, there are good foundations for this already. Dr Uwe Heckert, Head of Enterprise Informatics, Europe at Philips, the medical devices maker said: 

Collaboration is really the key. The Cancer Image Europe project is a good example. This has created a uniform platform for data exchanges, and it is showing that data privacy is secure, and we need more of these examples.

From the research community, Loredana Simulescu, director of the Biomedical Alliance in Europe, added: 

Look at Horizon Europe, we have wonderful outcomes from that, so we have cases that show we can have a good implementation.

She added that these projects provide the data that will remove unwanted bias in AI. The Commission's Executive Vice President for An Economy that Works for People, Valdis Dombrovskis, said this means creating a level playing field across Europe and one that ensures that innovative companies are able to scale-up in Europe. He admitted Europe is good at start-ups but less good at scaling those into major businesses: 

The single market is our largest economic asset, and in many cases, it is not really working, especially for digital.

This analysis is something Julie Linn Teigland, EMEIA Area Managing Partner at business advisors EY agrees with: 

Europe has three of the five Cs: Competence (skills), collaboration, capital, and it needs consistency and confidence.

Healthy partnerships

Since the summer of 2021, the US and the EU have shared a forum from which to direct relations between the two trading giants on technology. The US-EU Trade and Technology Council seeks to establish new global trade standards for emerging technology, promote democratic values online and explore US/EU collaboration on research and development. But in this year of major elections and the possibility of Donald Trump being returned to the White House, it was inevitable that European leaders were asked about the future of this forum. Valdis Dombrovskis said: 

The key for success is a political will on both sides, then we will move forward. We need to partner with reliable partners around the world, especially like minded partners.

The economic minister went on to stress that the EU is targeting risks in critical technologies such as AI, semiconductors, quantum computing and biotechnology and analyzing the impact of economic growth in regions other than the EU. He said: 

The EU works on economic openness, and we are an economic superpower with the largest set of trade agreements…we have the right regulatory framework in place, so it is clear that we have much more active industrial policies than we used to have.

He championed aims for 20% of EU chip demand to be met by internal production and said the EU's raw materials strategy was ambitious, though he questioned some of the assumptions it is based on, and reminded digital leaders that just 10% of the raw materials needed for digitization and clean energy can be sourced within the EU. 

Since May 2022, the EU has been working towards a European Health Data Space (EHDS), a set of common rules, standards, practices and infrastructure to increase trust and innovation in healthcare. Just like its cousin, the AI Act, digital leaders demand that the EU ensures consistency in the implementation of the EHDS. Heckert at Philips said: 

The barrier we see is interoperability, with many hospitals having over 400 applications and they are not talking with each other, let alone the hospital talking to pharmacies, patients or insurance providers. So there are lots of interoperability questions coming up. The solution could be the EHDS, but it has to be implemented the right way.

Simulescu of the Biomedical Alliance in Europe agreed: 

We need clarity on the connections with other policies such as the AI Act, and clinical trial regulations. We need to really understand the interlinkage between these regulations in order to help researchers.

My take

Good regulation creates good business, but as the experts speaking in Brussels point out, good regulations, like technology, relies on good and consistent implementation. Well-thought-out and applied laws create a platform for companies and citizens. Digital leaders will watch the EU's regulated AI agenda with interest.