Kapittel 1.3Recommended: Clarify roles relating to the use of AI in the health and care services

Background

Section 6.6 of the final report for the coordination project states the following:

A national AI strategy for safe and effective health and care services will help to:

• clarify tasks, responsibilities and roles for the various stakeholders at the national, regional and local levels, including what constitutes government agency tasks and what must be handled under the auspices of the services.

The Norwegian Directorate of Health has been tasked with drawing up a joint plan, and not an AI strategy, as recommended in the final report. It is equally important to clarify tasks, roles and responsibilities for safe and efficient health and care services.

Current roles

In the National Health and Coordination Plan for 2024-2027, the Government is concerned about ensuring the safe introduction of artificial intelligence within the area of patient treatment. It stresses that the service itself is responsible for quality assurance and validation of solutions, to ensure they are fit for purpose [24].

One valuable tool for ensuring the introduction of safe and effective treatments is health technology assessments (HTAs). From 2024, the Medical Products Agency (DMP) has been given overall responsibility for HTAs of medical products. The DMP is already responsible for the management of regulations concerning medical devices. This also includes medical devices in the form of software and artificial intelligence. In the efforts being made to further develop the New methods national system in the specialist health service, adaptation for the handling of medical devices is one area of focus [25].

The Norwegian Institute of Public Health’s social mission is 1) knowledge: more, better and faster knowledge for health and sustainable services, 2) preparedness: new solutions for protecting life and health, and 3) infrastructure: future health data, laboratories and services [26]. Among other things, the Norwegian Institute of Public Health is responsible for mini-HTAs [27].

The Norwegian Board of Health Supervision’s task is to help improve the safety and quality of services and promote legal rights and trust. Through supervision, the Norwegian Board of Health Supervision is responsible for monitoring compliance with the fundamental requirement incumbent on the health and care services to provide appropriate services and operate responsibly. The requirement to operate responsibly also applies to patient treatment using medical devices in connection with the provision of health and care services, including devices that include AI [28].

The Norwegian Directorate of Health strives to promote health and life skills and acts as a driving force for sustainable, cohesive and equitable health and care services. [The Norwegian Directorate of Health] coordinates the Norwegian health service on a common pathway towards digitalisation [29].

The primary tasks of the regional health authorities are patient treatment, training of health professionals, and research and training of patients and relatives. The regional health authorities have overall responsibility for implementing the national health policy within their region. The regional health authorities are responsible for planning, organising, managing and coordinating the activities of the health authorities they own. The role of the health authorities is to provide high-quality, equitable specialist health services to everyone who needs them, when they need them regardless of their age, gender, residence, financial circumstances or ethnic background, and to facilitate research and teaching [28]

The Norwegian Association of Local and Regional Authorities (KS) is the municipal sector’s interest organisation and development partner, as well as the country’s largest public employer organisation. The development work being carried out by KS is aimed at the municipal sector's need for restructuring, quality improvement and streamlining. KS offers tools and meeting places for municipalities and county councils across a range of disciplines [29].

What is the problem?

Many of the stakeholders in the health sector believe it is unclear what constitutes government agency tasks and what must be handled by the service to ensure the safe and efficient use of AI in the health and care services. It would for example not be efficient if each hospital or GP surgery were to be required to perform the same validations on the same type of AI system, even though certain aspects of the validation process have to be carried out locally. It is unclear what should be done locally, regionally and nationally. It can also be difficult to know whether or not a particular product should be considered a medical device. The processes for carrying out the necessary assessments and approvals are also considered to be inefficient. There is also the question of whether there is anyone who can take overall responsibility for national cooperation - should it be an existing body or should a new one be created?

What do we want to achieve?

It is recommended that an assessment be carried out in early 2025 to determine whether there is a need to initiate a separate measure relating to the clarification of roles, or whether this is already being done through ongoing activities.

The activity should establish a common understanding of roles, clarify the responsibilities of different stakeholders within the health and care sector, and propose changes as and where necessary.

How to do it

The following activities are relevant:

• Clarify the roles through examples, e.g. through the guidance service (section 3.1) or the seminar series (section 4.3).
• A topical issue is effective validation processes: assessing how the validation of an AI product can be carried out effectively from a national perspective. This assessment should include how responsibilities can be distributed between the stakeholders and what needs the various stakeholders have as regards support. This is viewed in the context of the report on the quality assurance of AI in the health and care services (section 4.1) and a possible seminar on validation (section 4.3).

Numerous proposals have been put forward by the sector during the consultation round which could be included in the assessments:

• Establish an approval scheme, e.g. drawing on inspiration from Finland [30]
• Establish an implementation and innovation council for AI in the health services
• The regional health authorities could establish a network between the health trusts to meet the need for competence-sharing and the exchange of experience
• The regional health authorities could draw up an action plan for implementing AI among their own health trusts
• The regional health authorities could establish a dedicated centre of specialist expertise to support efforts to implement AI solutions among the health trusts
• The regional health authorities could work with health trusts to organise and implement targeted continuing education and courses
• The regional health authorities could work with the health trusts to initiate measures to adopt language models to streamline administrative tasks
• Increase regional cooperation between ICT companies across the four regional health authorities concerning the development, implementation and procurement of AI
• Formulate objectives and measures under the auspices of the municipalities, possible cooperation between the municipalities and the regional health authorities

Current collaboration

The Norwegian Directorate of Health, regional health authorities, KS, health and care services, Norwegian Board of Health Supervision, NIPH, DSA and DMP.