BACKGROUND: It is very difficult to find a consensus that will be accepted by most players when creating health care legislation. The Czech electronic prescription system was launched in 2011 and new functions were introduced in 2018. To ensure that these functions will not conflict with any other existing law, a process modeling tool based on the patent "Method and system for automated requirements modeling" was used successfully in the Czech Republic for the first time. OBJECTIVE: The aim of this project was to develop another successful application of process modeling to add COVID-19 vaccination records to the existing electronic prescription system. METHODS: The method employed was based on the mathematical theory of hierarchical state diagrams and process models. In the first step, sketches that record the results of informal discussions, interviews, meetings, and workshops were prepared. Subsequently, the architecture containing the main participants and their high-level interactions was drafted. Finally, detailed process diagrams were drawn. Each semiresult was discussed with all involved team members and stakeholders to incorporate all comments. By repeating this procedure, individual topics were gradually resolved and the areas of discussion were narrowed down until reaching complete agreement. RESULTS: This method proved to be faster, clearer, and significantly simpler than other methods. Owing to the use of graphic tools and symbols, the risk of errors, inaccuracies, and misunderstandings was significantly reduced. The outcome was used as an annex to the bill in the legislative process. One of the main benefits of this approach is gaining a higher level of understanding for all parties involved (ie, legislators, the medical community, patient organizations, and information technology professionals). The process architecture model in a form of a graphic scheme has proven to be a valuable communication platform and facilitated negotiation between stakeholders. Moreover, this model helped to avoid several inconsistencies that appeared during workshops and discussions. Our method worked successfully even when participants were from different knowledge areas. CONCLUSIONS: The vaccination record process model was drafted in 3 weeks and it took a total of 2 months to pass the bill. In comparison, the initial introduction of the electronic prescription system using conventional legislative methods took over 1 year, involving immediate creation of a text with legislative intent, followed by paragraph-by-section wording of the legislation that was commented on directly. These steps are repeated over and over, as any change in any part of the text has to be checked and rechecked within the entire document. Compared with conventional methods, we have shown that using our method for the process of modification of legislation related to such a complex issue as the integration of COVID-19 vaccination into an electronic prescription model significantly simplifies the preparation of a legislative standard.

Department of Anesthesiology and Intensive Care General Teaching Hospital Praha Czech Republic

Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University Prague Kladno Czech Republic

Institute of Pathological Physiology 1st Faculty of Medicine Charles University Prague Praha Czech Republic

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