Element card for assessment element F0006 in HTA Core Model Application for Screening Technologies 1.0 application

F. Ethical analysis

Autonomy

Can the technology entail special challenges/risk that the patient/person needs to be informed of?

Core

Is the common professional practice of discussing the technology with patients enough, or is special care needed with this technology? Should the patient be explicitly informed, for example, that false positive results may lead unnecessary further investigations and treatments with serious harms? Screening programmes to be used for early identification of life-threatening situations may have life-threatening side effects (e.g. treatment is invasive surgery with risk of death). Technology used to get exact diagnostic information for those screening positive may have unexpected severe side-effects (e.g. miscarriage due to amniocentesis).

Literature search. Expert opinion. Registers

Critical
Complete

Safety

Miller 2004