Η ευκαιρία ανάπτυξης ενός Θεματικού Μηχανισμού Ανοικτών Δεδομένων Φαρμάκου στη χώρα μας: Ανάλυση της εταιρείας re:for:med για την άμεση αξιοποίηση των μεγάλων δεδομένων φαρμάκου (www.reformed.gr)

Abstract

The article refers to a recent study (completed in September 2021), conducted by re:for:med, a consulting services company in the health sector. This study sponsored by the Panhellenic Association of Pharmaceutical Industries (PEF) and funded by the Greek pharmaceutical company ELPEN. It comprises the first comprehensive study in terms of strategic planning and immediate integration of a Digital Gateway dealing with the systemic exploitation of medicinal drug big data that are constantly reposited in the databases of many of the national digital health services such as national e-prescription, e-dispensation, and e-reimbursement services, Hospital Information Systems and National Organization for Medicines’ ERP. According to the authors, the basic principle is the fact that this type of digital data represents a "public good" that must follow a systematic exploitation by the State, for the benefit of society, the health ecosystem, and the Greek National Health System (G-NHS). Publicly available Medicinal Drug Open Data is a timeless request of the research and academic community and not only, to strengthen both Open-Research and Open-Innovation. Additionally, modern global e-Governance trends manifest the value of open data as a catalytic ingredient for business innovation (e.g., start-ups digital companies), and smart digital product and service delivery. According to the study, the implementation of such a domain-oriented mechanism will be beneficial for both health professionals and patients in terms of quality and security of treatments, but additionally facilitates pharmaceutical innovation and development, and the establishment of a rational National Drug Policy and Budget definition. The study covers the most essential aspects for the methodical and systematic exploitation of these data (both in terms of legal, organizational, semantic, and technical maturity) in the form of a modern "Collaborative Network", that will be fully expanded between every involved stakeholder, hosting the appropriate interoperability and procedural integration. Furthermore, the study is focused on the appropriate data governance structure, in the form of a concrete Data Management Maturity Model (DMMM), as a mandatory key element for sustainable integration of a dedicated mechanism. The study also performs an in-depth analysis according to the final form of delivered open data templates, categories, necessary access and security policies, the solution for financial autonomy of the mechanism, the frame of its institutional shielding, and its mandatory compliance with the General Data Protection Regulation (GDPR). In the aspect of an Open Data Gateway development acceleration, and facilitation of its fast adoption scheme by the Greek State, the study specifies the compliance of the mechanism, with critical strategic guidelines of economic growth and digital reform of Greece. Finally, the study analyses the most critical international best practices in the field of open data management and public deliverance, concluding to the most suitable approach model for the immediate implementation of the first operating phase of the suggested gateway model, for a quick-win approach.