Legal and medical aspects regarding data protection in the biobank USMF „Nicolae Testemițanu”
DOI:
https://doi.org/10.52692/1857-0011.2025.2-82.24Keywords:
Biobank, data protection, informed consent, IT security, interoperability, genetic data, Republic of MoldovaAbstract
The paper presents an analysis of the regulatory and technological framework applicable to the protection of personal data in the USMF “Nicolae Testemițanu” biobank. The purpose of the research was to assess the compliance of the digital infrastructure with national and European legislation on data protection, as well as the integration of international standards ISO/IEC 27001 and ISO 20387:2018. The methodology included the analysis of the applicable regulatory framework (Law no. 133/2011, GDPR, the National Law on Biobanks), a case study on the implementation of a Secure Information Registry, and a comparison with best practices promoted by ISBER, BBMRI-ERIC, and the OECD. The results demonstrated the application of advanced data encryption measures, authentication, and strict access control, as well as the use of standardized and withdrawal-enabled informed consent. The implementation of digital solutions contributed to enhancing data security and strengthening the biobank infrastructure as an institutional model of best practices. The main conclusion highlights the maturation of data governance in biomedical research in the Republic of Moldova and the importance of integrating international standards to promote responsible research and the effectiveprotection of individuals’ rights.
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