Submissions to Ireland’s public consultation process on the implementation of the EU Artificial Intelligence (AI) Act are due next week.

The Act has particular ramifications for the healthcare sector, where certain AI-powered systems such as medical devices, patient triage and clinical decision support systems are deemed high risk.

The AI Act is expected to be published later this month, coming into force 20 days thereafter. This will mark the beginning of a phased implementation process to put the various rules and obligations of the AI Act into practice.

The legislation is the first-ever legal framework on AI globally and aims to provide AI developers and deployers with clear requirements and obligations regarding specific uses of AI.

At the same time, the regulation seeks to reduce administrative and financial burdens for business, in particular small and medium-sized enterprises (SMEs).

A further key objective of the Act is to ensure that the EU remains competitive for AI investment and innovation. The regulations are 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.

The proposed rules will address risks specifically created by AI applications, determine a list of high-risk applications, and prohibit AI practices that pose unacceptable risks. The legislation also defines specific obligations for deployers and providers of high-risk AI applications, which includes those in the healthcare sector.

A conformity assessment will be required before a given AI system is put into service or placed on the market.

The framework defines four levels of risk for AI systems – minimal, limited, high and unacceptable. Specific compliance requirements are set according to the risk categorisation, including bans on AI applications deemed unethical or harmful, and detailed requirements for high-risk AI applications to manage potential threats effectively.

Additionally, it provides transparency guidelines for AI technologies designated to have limited risk.

Member States are required to provide for the supervision and enforcement of the Act at national level, including the designation of at least one national notifying authority, and one or more market surveillance authorities within 12 months after the legislation is enforced.

Member States will not have discretion in relation to the interpretation of the provisions applying to AI systems or to the providers or deployers of such systems.

The Department of Enterprise, Trade and Employment is leading the national implementation of the Act. The Department is currently assessing, in conjunction with other government departments and public authorities, alternative possible approaches to national implementation to determine the optimal national structure for efficient and effective enforcement of the provisions of the Act.

The department is seeking submissions from interested parties. In particular, contributions are invited on the following four topics:

• What considerations should the government have regard to when devising the configuration of national competent authorities for implementation?
• Are there potential synergies between the implementation of AI Act and the implementation of other EU Regulations applying to digital markets, services, and infrastructure?
• How can Ireland’s implementation of the AI Act bolster the country’s position as a leading digital economy, increasing investment and accelerating innovation in AI? What would excellence in AI regulation look like?
• How can Ireland’s implementation of the AI Act drive support and accelerate progress building public trust in AI, leveraging AI for economic and societal benefit, and enablers for AI, while meeting our regulatory obligations?

Contributors are asked to provide rationale and explanations to support the points in their submissions, along with any evidence or references.

Submissions should be sent by email to ConsAIregulation@enterprise.gov.ie. The deadline for receipt of submissions is 5pm on Tuesday, 16 July 2024.