Regulatory Protocols and Legal Mandates for Genetic Counseling and Informed Consent
In Italy, genetic testing is strictly regulated by the Ministry of Health and the Italian Data Protection Authority (Garante per la protezione dei dati personali). A defining feature of the Italian legal framework is the mandatory requirement for Genetic Counseling.
By law, all clinical genetic tests must be preceded by a pre-test consultation and followed by a post-test consultation. This protocol is designed to ensure the patient fully understands the medical, psychological, and familial implications of the results.
The General Authorization for the Processing of Genetic Data provides a robust privacy framework. It treats genetic information with a unique status, requiring specific informed consent that is distinct from general medical consent. These documents must clearly state how the samples will be stored, whether they can be used for future research, and how incidental findings (secondary results unrelated to the primary diagnostic question) will be managed. In 2026, the transition to digital…


