Kapittel 3.2 Initiated: Prepare for future regulations

Section 9.5 of the report entitled “Tilgang til data til KI" (Access to data for AI) from the coordination project for AI sets out the following recommendation:

• monitor work relating to the AI Act in the EU.
  The government agencies should monitor the development and process of implementing the AI Act within the EU, and disseminate consequences and opportunities for the health and care sector. This will lead to greater understanding and offer better opportunities to exert an influence regarding the regulation of AI and health data in the EU.

Status

The regulations are constantly evolving, and EU regulations such as the AI Act, the AI Liability Act, the European Health Data Space (EHDS), the Health Technology Assessment Regulation (HTAR) and the Data Governance Act (DGA) are of particular interest to the AI work. For sector-wide regulations such as the AI Act, there should be closer cooperation between the national bodies within the field of health and relevant agencies such as the Agency for Public and Financial Management and the Norwegian Digitalisation Agency concerning impact analysis and interpretation of the regulations within the sector concerned.

The re-use committee has submitted its report on the re-use of public data. In NOU 2024: 14, the committee proposes new legislation to make it easier for businesses, researchers, the press, civil society and others to find and use public data to create new products, services and solutions [34].

To ensure that AI can be used in a controlled, safe and secure manner, careful consideration must be given to the consequences of impending EU regulations that will impact the field. In connection with the introduction and implementation of new regulations, it will also be relevant to assess whether there is a need for further national regulation of the development and use of artificial intelligence in the health and care services. The AI Act is a horizontal regulation, so cross-agency cooperation is important. 

The EU’s AI Act was finalised and approved by the European Commission on 21 May 2024 [35]. The Norwegian Agency for Public and Financial Management (DFØ) has been tasked with assessing Norway’s administrative structure under the AI Act. New laws and regulations are likely to result in more stakeholders, both within and outside the health and care sector, being given new responsibilities and thus new roles. Through the AI Act, the EU will establish new bodies that we in Norway will have to relate to, and Norway will be obliged to establish new functions as a result of the new legal regulations.

The leadership forum SKATE (Steering and Coordination of Services in E-Government) [36] has set up a working group for cooperation regarding EU policies and regulations in the field of digitalisation, in which the Norwegian Directorate of Health is participating.

Plan going forward

• Boost competence relating to new regulations, internally within the Norwegian Directorate of Health, across government agencies, for the health and care sector and cross-sectorally, e.g. in presentations, etc. on the AI Act. 
• Use the cross-agency information page on AI to inform the sector about the AI Act and its consequences
• Prepare guidance on the AI Act
• Establish and communicate an understanding of which laws and regulations will come into force in Norway and when. Among other things, this includes clarifying how the AI Act and the regulations regarding medical devices should be viewed in context, such as understanding the risks and documentation requirements in the two certification processes.

Who is responsible?

The Norwegian Directorate of Health

Who collaborates?

The Norwegian Digitalisation Agency, the Norwegian Data Protection Authority, the Norwegian Board of Health Supervision and the Medical Products Agency as and when necessary.