AI regulation and AI compliance

AI compliance - GDPR and the AI Regulation

AI (artificial intelligence) is no longer a technology of the future - it's already an integral part of our everyday lives. From text optimization and data processing to advanced decision-making systems and customer service, AI has become a tool that opens up many new opportunities and challenges. 

But with opportunity comes responsibility. When implementing AI in a company, it's crucial to ensure that the use of the technology is done in a thoughtful and responsible way.

In this article, you can read more about the AI regulation and AI compliance, and what you need to pay special attention to when your company develops and implements AI.


AI compliance

Basically, AI is a technology that can perform tasks that normally require human intelligence.

AI is not a new technology, but it has been developing rapidly in recent years and is now a technology that many companies are either considering using or already using to optimize and streamline all kinds of processes and tasks in the company.

AI is becoming an increasingly important part of both our personal and professional lives. Most people are familiar with ChatGPT and other generative AI models, and many are already using AI for everything from helping to proofread and optimize texts to getting an overview of large amounts of data and supporting business procedures and processes. However, AI can be used for many other purposes and the sky is the limit.

However, depending on what AI is used for, there are a number of compliance issues that are important to be aware of when using AI. When companies develop or use AI, it is, among other things, particularly important to be aware of whether the development, training or use of AI involves the processing of personal data, as the rules of data protection law will then apply.

It is also important to be aware of whether AI is used to make automated decisions that may have consequences for natural persons. It follows from the GDPR that natural persons have the right not to be subject to decisions based solely on automated processing, including profiling, if such a decision produces legal effects concerning or similarly significantly affects the natural person.

The GDPR also means that, as is the case with all other processing activities involving personal data, the company must ensure lawful processing. This means, among other things, that the company must observe the basic principles of, for example, data minimization and transparency, just as the company must also prepare a DPIA before the processing activity begins.

In addition, the new AI regulation (also known as the AI Act) imposes a number of additional AI compliance requirements for companies' use of artificial intelligence. Depending on the purpose of the AI model, companies must, for example, ensure the implementation of a risk management system and the preparation of a "Fundamental Rights Impact Assessment" (FRIA), as well as requirements for the datasets used in the training of the AI model.

The AI Regulation

The AI Regulation governs the development and use of AI and is fundamentally about protecting the safety and rights of individuals.

The AI Regulation came into force on August 1, 2024, and the first parts of the AI Regulation will take effect from February 2, 2025.

The AI Regulation generally categorizes AI models into a number of different risk levels. The categorization is determined by the purpose of using the AI model and includes the following categories:

AI regulation requirements and AI compliance ensure responsible use of AI in your business. Read about the rules and guidelines here.

The prohibited AI models:
Includes, among others, systems that exploit the vulnerabilities of natural persons, perform emotion recognition in workplaces or education and facial recognition in public spaces.
As the use of such AI models would pose a very high and unacceptable risk to natural persons, there are only very few exceptions to this prohibition, including for example in law enforcement.

High-risk AI models:
Includes the use of AI models in biometrics, education, critical infrastructure, employment, employee management, law enforcement, and assessment of life and health insurance conditions.
If a company wishes to use AI models for such purposes, it is important to be aware that it entails a number of obligations and compliance requirements under the AI Regulation, including requirements for training data, implementation of a risk management system, and documentation that it is not the AI model that makes any final decisions in the process.

Regulated AI models:
Includes AI models that are designed to interact with and target natural persons. When using such AI models, it is a requirement that the natural persons with whom the AI model interacts are informed of this, and that the AI model's outputs are clearly marked (e.g. labeling of photos or AI-generated text).

General-purpose AI models:
Includes AI models that are used for general purposes, but still possess certain impact capabilities. These AI models do not have the same impact as the above types of AI models, but there are a number of issues that are important to be aware of, including technical documentation for the AI model, policy for compliance with EU copyright law, cybersecurity and reporting of any incidents.

Non-regulated AI models:
Includes AI models that do not have the ability to influence and are therefore not included in any of the above categories. However, when using these AI models, it is still important to be aware of e.g. drafting policies for use, possible confidentiality issues and intellectual property rights, as well as the use of general purpose AI for "self-development".

The AI Regulation has been finally adopted and the first parts of the regulation will take effect from February 2025. Companies should already now take into account the limitations and AI compliance requirements resulting from the regulation in their work with the development and implementation of AI tools. These requirements and limitations should be taken into account as early as possible in the process to avoid unnecessary use of resources on the development and implementation of AI tools, which in the worst case cannot be deployed without violating the AI Regulation.

Impact assessment (DPIA)

Prior to the implementation of an AI tool that processes personal data, it will often be necessary to carry out a DPIA in order to map the risk picture for the processing activities and conclude whether the Data Protection Authority needs to be consulted before the deployment of the system.

As part of the impact assessment, the company must, among other things, map data flows and identify risks associated with the intended processing of the data and identify the security measures necessary to adapt the identified risks to an acceptable level. If it is not possible to adapt the identified risks, the Danish Data Protection Agency must be consulted on the intended processing activity before the AI tool is put into use.

Legal basis and legitimate purposes

The company must also assess the legal basis on which the personal data can be processed.

In this regard, it is important to note that personal data already collected may not be used for other purposes that are not compatible with the purposes for which it was originally collected.

In addition, it is also necessary to assess how little personal data is necessary to achieve the desired functionality of the AI tool. The company should thus ensure data minimization, anonymization and pseudonymization of personal data to the greatest extent possible.

It is therefore crucial to get an overview of the processing activities that the AI tool entails. This process also helps to ensure that errors and compliance challenges are spotted continuously, just as the process helps to create an overview of special risks and ensure fast response times to any errors or deficiencies.

Sensitive personal data

There is no general prohibition on the use of AI for the processing of sensitive personal data, but it is important to be aware that the legal basis for such processing will often be the consent of the data subjects. This applies, for example, when using biometric data in facial recognition tools for access control.

The Danish Data Protection Agency recently made a decision in a complaint case regarding a fitness center's use of facial recognition, where the Data Protection Agency assessed that the processing activity required consent and also stated that a valid consent to such processing activity also requires that a real alternative is made available, as otherwise the consent cannot be considered voluntary.

In the specific case, the Danish Data Protection Agency assessed that it constituted a real alternative to the processing that users of the fitness center could instead use the center during the manned opening hours or contact a 24-hour support by phone outside the manned opening hours.

Read the full decision on the Danish Data Protection Agency's website

The right not to be subject to decisions based solely on automated decisions

It follows from the GDPR that data subjects have the right not to be subject to decisions based solely on automated decision-making (including profiling) which produces legal effects concerning them or similarly significantly affects them.

For example, if you plan to use AI in recruitment processes, to support managers' handling of performance reviews or to answer customer service inquiries, it's important to ensure that no decisions are made based on AI alone.

Securing this right thus requires, among other things, an assessment of whether the decisions made have legal effect or significantly affect a data subject. In addition, it is a fundamental prerequisite that employees working with such AI-supported processes receive thorough and ongoing training in the use of the AI tool and the limits set by the GDPR.

Information about the processing of personal data

When a company processes personal data as a data controller, the company is also obliged to transparently provide data subjects with information about the processing activities, including the purpose of the use and on what legal basis personal data is processed, as well as whether automated decision-making occurs and, if so, at least meaningful information about the logic involved and the significance and expected consequences such processing may have for the data subjects.

In addition, the requirement for transparency requires that the communication in easily understandable language is targeted at the data subjects, for example, taking into account whether the group of data subjects includes children or vulnerable persons.

Proper compliance with the company's disclosure obligation thus requires in-depth knowledge of how the company uses AI to process personal data.

Penalties for non-compliance with GDPR and AI Regulation

Under the GDPR, the Danish Data Protection Agency has a number of sanction options for companies and authorities that do not comply with the rules of data protection law. For example, the Danish Data Protection Agency can issue orders or issue criticism. In addition, private companies can also be fined up to EUR 20 million or 4% of the total global group turnover, whichever is higher.

Following the same principles, the AI Regulation means that fines of between 2% and 7% of turnover or up to €35 million can be issued if the use of AI models does not comply with the rules of the AI Regulation.

In both the GDPR and the AI Regulation, the amount of the fine depends on a number of factors, including which specific rules have been violated.

CLEMENS advises on AI regulation and AI compliance

At CLEMENS, we follow the development of the AI regulation and AI compliance and data protection rules closely, and we make sure to update regularly with relevant news about developments in the field.

If you have any questions about the article, the GDPR or the AI Act, or how the regulations may affect your business, or if you need help creating an overview of the legalities of developing an AI solution, you are always welcome to reach out to our compliance team

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