Element card for assessment element I0002 in HTA Core Model Application for Screening Technologies 1.0 application

I. Legal aspects

Autonomy of the patient

Is the voluntary participation of patients guaranteed properly?


What kind of informed consent procedure is required by the law/binding rules? The use of screening programs is for symptom free (and probably healthy) people, therefore it must not compromise patient safety. Patients should not be pressured into such programs.

National, international, databases, legal binding guidelines, published laws, related or affected laws


Organisational domain

EU Charter of fundamental rights (2000/C 364/01) Art 3;