Defining legislation for electronic prescription systems (EPS) is inherently challenging due to conflicting interests and requirements. The study aimed to develop a comprehensive EPS within the Czech healthcare framework, integrating legislative, process, and technical aspects to ensure security, user acceptability, and compliance with health regulations. A process modeling tool based on hierarchical state machines was employed to create a detailed process architecture for the EPS. Key participants, scenarios, and state transitions were identified and incorporated into a process model using the Craft.CASE based on the BORM methodology. The final process architecture model facilitated interdisciplinary communication and consensus-building among stakeholders, including healthcare professionals, IT specialists, and legislators. The model served as a foundation for the legislative framework and was included in the explanatory memorandum for the draft amendment to the Pharmaceuticals Act. The use of hierarchical state machines and process modeling tools in developing healthcare legislation effectively reduced misunderstandings and ensured precise implementation. This method can be applied to other complex legislative and system design projects, enhancing stakeholder communication and project success.

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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