Regulatory framework for artificial intelligence in Bulgaria and its significance for hospital pharmacy

Abstract

The adoption of artificial intelligence (AI) in clinical pharmacy is increasingly discussed in terms of clinical benefit, yet its practical feasibility depends equally on the regulatory framework surrounding it. Since 1 August 2024, Regulation (EU) 2024/1689 (the AI Act) has been in force across the European Union – the first horizontal legal act governing the development and use of AI systems based on their level of risk. As a Member State, Bulgaria is directly bound by the Regulation, yet the national institutional framework around it remains under construction: as of mid-2026, the country still lacks a finally designated market surveillance authority for high-risk AI systems, and the national AI bill submitted in October 2025 has not yet been adopted. This article maps the European and Bulgarian regulatory landscape for AI, with emphasis on the sectoral authorities responsible for healthcare, and translates the resulting obligations into practical implications for the hospital pharmacist – from the classification of medication-safety systems as medical device software to requirements for human oversight, documentation and accountability. Key barriers to implementation in the Bulgarian hospital context are discussed, along with guidance for proactive risk management pending completion of the national framework. The key takeaway is that compliance should not be deferred until the national framework is complete: the classification of medication-safety systems and the obligations of the hospital pharmacist already follow directly from the European regulation in force, irrespective of the national delay.