Element card for assessment element F0010 in HTA Core Model Application for Screening Technologies 1.0 application

F. Ethical analysis

Beneficence/nonmaleficence

What are the benefits and harms for patients, and what is the balance between the benefits and harms when implementing and when not implementing the technology? Who will balance the risks and benefits in practice and how?

Core

The decision to implement a technology requires careful decision on the balance between benefit and harm, cost-effectiveness, reallocation of resources etc. When this decision has been made on the system level, the decision on individual patient level rests on both the professional who offers the technology and the patient who autonomously accepts to participate at every possible step. The individual decision has to be based on objective information on possible benefit and risks. Risks are only justified to the extent they are needed to create benefits. If not proven otherwise, the individual patient is generally to be seen as the best judge of risks and benefits for her/himself.

Literature search. Expert opinion. Stakeholder hearing

Critical
Partial

Safety.and Effectiveness

Autti-Rämö 2007