EU AI Act and Digital Health

 

The EU AI Act is a groundbreaking legal framework introduced by the European Commission. This Act focuses on the grassroots level of engagement where scenarios from Day-to-Day life and strategic decisions are considered. While the first attempt gives a holistic framework, the industry could witness amendments in due course. This Act addresses the risks associated with artificial intelligence (AI) and positions Europe as a global leader in this field.

 

Let’s Dive in Deep to understand

 

Key Aspects of the EU AI Act:

• Focusing on the specific use of AI, the AI Act aims to provide a clear set of requirements and obligations that AI developers and deployers must follow.
• Along with setting a benchmark on risk-based classification of the use of AI, this Act seeks to reduce administrative and financial burdens on businesses.
• The regulation is part of a broader package of policy measures supporting the development of trustworthy AI, which includes the AI Innovation Package and the Coordinated Plan on AI.

The AI Act is part of a wider package of policy measures to support the development of trustworthy AI, which also includes the AI Innovation Package and the Coordinated Plan on AI. Together, these measures will guarantee the safety and fundamental rights of people and businesses regarding AI and strengthen uptake, investment, and innovation in AI across the EU.

 

The EU AI Act attempts to make a Trustworthy framework where        

• The AI Act ensures that Europeans can trust AI systems by addressing risks and promoting ethical principles.
• While most AI systems are low-risk, certain applications create risks that need mitigation.

The proposed rules:

• Address risks specific to AI applications.
• Prohibit unacceptable AI practices.
• Define a list of high-risk applications.
• Set clear requirements for AI systems in high-risk contexts.
• Impose specific obligations on deployers and providers of high-risk AI applications.
• Require a conformity assessment before deploying AI systems.
• Establish enforcement mechanisms after AI systems are placed on the market.
• Create a governance structure at European and national levels.

 

Similar to EU’s practice on Medical Device Regulations and In-Vitro Diagnostic Regulation [EUMDR, EUIVDR], the EU AI Act [Regulation] classifies AI into different Risk Categories.

 

The EU AI Act defines four levels of risk for AI systems:

 

• Banned: AI systems posing a clear threat to safety, livelihoods, and rights (e.g., social scoring by governments or dangerous voice-assisted toys).
• High Risk: Includes AI technology used in critical infrastructures (e.g., transport) and educational/vocational training (e.g., exam scoring).
• Limited Risk: AI systems with moderate impact.
• Minimal Risk: Most AI systems fall into this category.

 

The AI Act introduces transparency obligations for all general-purpose AI models to enable a better understanding of these models and additional risk management obligations for very capable and impactful models. These additional obligations include self-assessment and mitigation of systemic risks, reporting of serious incidents, conducting test and model evaluations, and cybersecurity requirements.

 

Next steps

• In December 2023, the European Parliament and the Council of the EU reached a political agreement on the AI Act.
• The text is in the process of being formally adopted and translated.
• The AI Act will enter into force 20 days after its publication in the Official Journal, and will be fully applicable 2 years later, with some exceptions: prohibitions will take effect after six months, the governance rules and the obligations for general-purpose AI models become applicable after 12 months and the rules for AI systems - embedded into regulated products - will apply after 36 months.
• To facilitate the transition to the new regulatory framework, the Commission has launched the AI Pact, a voluntary initiative that seeks to support the future implementation and invites AI developers from Europe and beyond to comply with the key obligations of the AI Act ahead of time.

 

The MedTech Industry’s Take on the EU AI Act

 

With the European Parliament’s support to the proposed text of the EU AI Act, MedTech Europe issued a document - Medical technology industry perspective on the final AI Act.

 

MedTech Europe appreciates co-legislators efforts in framing the Act and includes several aspects of challenges posed by this dynamically advancing sector. However, further clarity is still needed to ensure that the AI Act supports European technological innovation and the wider integration of AI within and across European healthcare settings, ensuring timely delivery of trustworthy, safe and effective care and diagnosis for the benefit of patients and healthcare systems.

 

In order to ensure a clear and practical applicability of the AI Act to the medical technology sector, MedTech Europe recommends that the following steps be considered:

 

• European Commission guidelines should be developed swiftly and well before the end of the transition period. They should be developed with active input by stakeholders, including the Medical Device Coordination Group (MDCG).
• Alignment of horizontal AI Act standards under development, with existing vertical standards, including with those for medical technologies.
• Further clarity underpinning a single conformity assessment procedure, let by sectoral processes.
• A clear pathway for clinical and performance evaluation of medical technologies

 

As always, our Regulatory experts are here to provide you with the latest developments in the MedTech space and provide you with end-to-end regulatory support. Since the publication of EUMDR, IVDR, and other similar regulations, innovators and MedTech manufacturers have been trailing in an uncertain market. While everything else sorts itself out, our experts think that manufacturers must do the following and put their ducks in a row:

1. Prepare a robust Quality and Risk Management culture across all operations.
2. Similar to the technical documentation requirements laid out under IVDR and MDR, it will be beneficial for manufacturers to note every change and define the intended use of their AI tools. As for the regulations, ‘if it is not written, it did not happen’, it is better to document everything.
3. The UK MHRA has launched an AI-Airlock which provides a ‘regulatory sandbox’ for developers to test their advanced AI technologies in healthcare. The AI-Airlock will enable innovators to work within the current regulatory system, identify and resolve the evidence gaps, and ensure the safety and performance of their products. [Manufacturers can utilise this feature to safeguard their products and ensure compliance]
4. Cybersecurity could be next in line. Medical Technologies of all types and sizes should focus on getting the proper cybersecurity solutions for their products.

The list of possibilities is very subjective and depends on several aspects of a product. Manufacturers should always seek Expert Regulatory Guidance.

Our team of experts are available to support you and your company with end-to-end bespoke regulatory and quality compliance support.

 

 

Book a FREE 30-minute consultation with our expert by sending an email to mdd@mddltd.com or by submitting a web form – https://med-di-dia.com/contact.php  

 

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