Background
Background
Section 6.2 of the final report for the coordination project states the following recommendation:
- that cross-agency regulatory guidance continues, with improvements and developments in certain areas.
- that the Norwegian Directorate of Health has primary responsibility for the guidance service from 2024 onwards, with contributions from the Medical Products Agency and the Norwegian Board of Health Supervision, in accordance with their respective administrative responsibilities.
Status
Cross-agency regulatory guidance continues [33].
The purpose of the cross-agency guidance service is to provide targeted guidance on artificial intelligence for projects or environments that require assistance with regard to legal issues relating to a number of regulatory areas. The service aims to develop expertise and regulatory understanding both in the sector and among government agencies. This is useful specialist expertise which can help keep the sector moving forward as regards the safe introduction of AI and clarify existing regulations, propose regulatory changes and contribute to the introduction of new EU regulations. The guidance service has so far received a number of applications for guidance in 2024, and has found that there is increasing interest and need for this type of guidance.
The Norwegian Directorate of Health has primary responsibility for the guidance service from 2024 onwards, with contributions from the Medical Products Agency and the Norwegian Board of Health Supervision, in accordance with their respective administrative responsibilities. The Norwegian Radiation and Nuclear Safety Authority also wish to participate in the guidance service going forward.
It is the needs within the sector that guide the guidance service. As these needs vary and the various stakeholders have differing levels of expertise, the guidance service must be flexible as regards how guidance is offered and what cases are considered. There is a need to be able to scale the service both up and down.
If the need increases and becomes clearer, consideration should be given to expanding the service into a regulatory sandbox and whether other agencies and areas should be included in the service.
Plan going forward
- Receive applications for and offer regulatory guidance
- Update and produce new articles on the cross-agency information page on AI, including sharing relevant clarifications and answers to legal questions from the guidance service
- Continue to market the guidance service.
- Consider further areas for development of the guidance service
- Include the Norwegian Radiation and Nuclear Safety Authority in the guidance service
- Consider establishing a network for lawyers working with AI
Who is responsible?
The Norwegian Directorate of Health
Who collaborates?
The Medical Products Agency and the Norwegian Board of Health Supervision contribute upon request. The Norwegian Radiation and Nuclear Safety Authority (DSA) wishes to be included in the work.