How can we change behavior to bolster biosecurity? A scoping review and recommendations.

Genetic data are a special category of personal data based on structural sharing with an intrinsic accompanying predictive attitude. Typically, genetic data have interpersonal value, since genetic information transcend the sphere of the person who has undergone the test and are also capable of involving the members of the so-called “genetic family” to which the former belongs. The potentialities of access and the relatedness of access to specific genetic information are one the most relevant aspects to be discussed in informed consent process. According to the Italian Code of Medical Ethics (), for example, the physician must maintain secrecy about everything he or she knows by reason of his or her professional activity. In Italy, genetic investigations are performed by physician only with the written consent of the person concerned, who is the only recipient of the relevant information. About that, there are some differences among the countries, such as in the United States of America, where genetic tests can be ordered by other healthcare providers, like nurses and genetic counselors. The processing of “genetic,” “biometric” and “health-related” data () requires prior information process (given in a written form and mediated using understandable and simple language, possibly even considering the patients’ level of education) on the characteristics of the processing data and patient’s rights. “Genetic test” is defined as the analysis for clinical purposes of a specific gene or its product or function or other parts of DNA or a chromosome (). Tests for clinical purposes are usually divided into: (a) diagnostic testing: to make a diagnosis or confirm a clinical suspicion in an affected individual; (b) presymptomatic testing: to detect or rule out the presence of a pathogenic variant associated with a genetic disease that may develop in an unaffected individual; (c) predictive or susceptibility testing: to assess an individual’s greater or lesser susceptibility to develop multifactorial diseases. The use of cancer-related genetic and genomic testing (CGT) for the prevention, diagnosis, and treatment of cancer is expected to revolutionize cancer care, leading to an era of precision medicine (). Genetic counseling and germline testing for pathogenic variants in known cancer susceptibility genes is an important component of preventive medicine (), guides timing and nature of therapeutics, and it’s useful as a starting point for “cascade” testing, in which blood relatives are tested for a known genetic mutation (). Moreover, the next-generation sequencing (NGS) techniques, used to interrogate and analyze the cancer genome, have the promise of personalizing treatment for patients with cancer (; ). Indeed, NGS brought new insight into the biology of head and neck squamous cell carcinoma (HNSCC) and revealed its’ high genetic complexity. It is estimated that in the next decades, precise genetic profiling of pathogenic variant in tumors as well as a wide range of targeted anti-tumor drugs will become available (). Some ethical and medical-legal questions specifically raised by predictive medicine concern how to inform the patient, the extension of information, the relative obligation to inform, and who the recipients of the information are. The purpose of this paper is to provide an up-to-date overview of the state of the art on information management regarding genetic data, privacy protection, current legal standards, and ethical/ethical rules to be observed, especially in the European area where GDPR provisions apply (). This study was conducted using an interdisciplinary approach, integrating bioethical, medico-legal, and legal perspectives, with the objective of analysing the communication of genetic test results in clinical settings across Europe, with a specific focus on the Italian context. All documents addressing communication procedures for genetic results in clinical settings, combined with legal texts or judicial proceedings, were considered eligible for inclusion. Both international and national materials were included, encompassing scientific literature, jurisprudential sources, policy documents, clinical guidelines, European Regulations, Italian statutory law, the General Data Protection Regulation (GDPR), and international Ethical Declarations. These documents were identified through targeted searches on official institutional websites and publicly accessible internet search engines. No time limit was applied to the document search, which includes all documents up to 2025. To verify the “state of the art” in scientific literature, PubMed was consulted using the following terms: genetic [Title/Abstract] AND communication [Title/Abstract]. Only articles in English and Italian were included. Sources were selected based on their direct relevance to the clinical, ethical, and legal dimensions of genetic test communication. Two reviewers conducted the search separately, achieving the same results. Retrieved