Element card for assessment element F0004 in HTA Core Model Application for Pharmaceuticals (2.0) application

F. Ethical analysis


Does the implementation or use of the technology affect the patient´s capability and possibility to exercise autonomy?


Many technologies can alter a person´s self-determination. The technology may interfere with patients’ right to autonomy directly or indirectly by influencing/subtracting the decisional capacity. However, patients have in most cases a right to autonomy, i.e. right to be self-governing agents. This means both the right to decide (not to) use/participate, and the right to receive relevant information. Drugs for sedation and surgical treatment of severely ill patients are examples where patient autonomy may be reduced.

Technology may require users/patients to behave in a certain way (e.g. dietary restrictions for fecal blood test). In order to be able to decide autonomously, the user/receiver of the technology should understand all alternative treatments or different therapeutic paths following test results. They should be able to make informed consent at every step.

The practical challenge with treatment technologies is that in order to be fully autonomous, the patient should understand not just direct risks of the treatment, but also all alternatives if side effects take place and how these can affect the living quality or choices (eg car driving, nutrition).

Literature search. Expert opinion. Stakeholder hearing



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