Kapittel 4.5Recommended: Developing health technology assessments

Background

Section 6.2 of the final report for the coordination project states the following recommendation:

• that health technology assessments (HTA) are further developed to be adapted to assessments of AI systems [58]

Problem to be solved

Assessing whether a new health technology which uses artificial intelligence is safe, secure, ethical and cost-effective is important. Health technology assessments that we are accustomed to today are not well adapted to medical devices which use AI. AI systems are data-driven, which means that biases propagate rapidly and broadly. Generative models are difficult to test and validate. Many AI systems are likely to be launched on the market, and carrying out a health technology assessment (HTA) on every product would require considerable capacity. It will therefore be necessary to assess whether health technology assessments should be carried out at an overarching level or on specific types of AI systems, e.g. products in a particular area such as digital pathology.

Status

Many decisions will be made locally, and mini-health technology assessments may be relevant. Norwegian Institute of Public Health  (NIPH) is responsible for mini-health technology assessments. A mini-health technology assessment is a scaled-down form of the national health technology assessments and is adapted for use by both hospitals and municipalities. The Norwegian Institute of Public Health’s website contains guidance and a national database of all completed and started mini-health technology assessments, in addition to a contact person for third-party mini-health technology assessments [59]. Mini-health technology assessments can be published and re-used.

Work of relevance to health technology assessments involving the use of AI systems is underway:

• The Medical Products Agency (DMP) is leading a working group which will submit a report to the Decision Forum on a framework and criteria for medical devices in New methods (Nye metoder). The working group includes the medical directors and representatives of hospital procurement. The report will be presented in 2024. It will be appropriate to wait until this work has been completed before considering whether any specific aspects of AI need to be taken into account. 
• How the systems for prioritisation will be further developed in line with advances in medical technology will probably be addressed in the next priority report, which will be launched in early 2025 [60]

Plan going forward

• Once the report on a framework and criteria for medical devices has been completed (scheduled for the end of 2024): follow up on any input and measures.
• Once the priority report has been completed: carry out the same assessment as above.

Current collaboration

The regional health authorities, the Medical Products Agency, NIPH and the Norwegian Directorate of Health.