Novel informatic platform for the standard unification of donors, offspring and patients records: institutional registry requirements in the reproductive biomedicine regulations compliance.

The Donor ART (DART), recently promulgated by italian institution, has posed several incumbent questions to the Artificial Reproductive Techniques (ART) world. Besides the critical social and ethical aspects, a crucial issue is the engagement of a centralised “Donors-offspring Registry” which introduces new stringent criteria up on the treatments of the sensitive data of donors, newborns and patients. Such registry will have to comply with applicable italian laws (Legge 40/04, Dlg.191/07 and Dlg.16/10, the so called “Patto per la Salute 2014-2016) and the european Tissue Directive (2006/17/CE, Ed. 2004). Moreover, recent Guide Lines were introduced by the italian Conferenza Stato Regioni in the 4/9/2014 which officially refer to the creation of dedicated “donors-offspring” registry for the fecundation of donated gametes issuance. Lastly, the entire model will have to comply with a preliminar check of the Privacy Authority (Dlg196/03). In order to fulfill the mandatory requisites related to anonymisation, traceability, protection of biomedical data and creating an informatic “platform design” capable of an heuristical objective discrimination and control of donors’s phenotypes, we coupled cryptology and Artificial Intelligence (AI) techniques to design and propose an adequate software architecture of such launching registry. At the time of our study, no official standard was unified to this purpose nor scientific works oriented on DART Registry specification are available yet, therefore, we worked on a novel central IT repository conception capable of accomplishing all the essential compliancies with law and regulation. Our aim is to describe technical and functional features of an informatic data-banking model for the DART and design a working prototype which is indispensable to its realisation. We also candidate an entity-relational structure of the database at a systemic level of abstraction under the upcoming technological paradigm of the Cloud Computing and Big Data technologies. This vision was demonstrated to be particularely suitable for the ART with gamete donation because of its peculiar features such as security multi-layers control, segregation of accountability, central algoritm for control logics and others. More in general, we theorised a biomedical semantic informational storage implementation as a possible reference model for the unification under an institutional nationwide mandatory standard for the DART. This paper is intended for a divulgative description of the forthcoming software technology scenario which will impat on the reproductive biomedice and it can not be dodged; in the close future embriologists and physicians belonging to the ART professionals community should become acquainted with insight and notions pertaining informatic tools and computation logics as a daily practise of their ART expertise. We also provide system IT administrators and programmers who works for ART Centers, with essential technical informatic hints of the software design and infrastructure of the platform model.