Experts Debate Data Access with Regulator: FHIR Standard and Secondary Use Challenges

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The discussion at the Telemed Forum focused on expanding access to anonymized personal medical data and implementing FHIR as a unified structural standard. While developers anticipate market growth and economic benefits, officials from the Ministry of Health (Minszdrav) insisted that existing restrictions are necessary for protecting information security. Another key area was evaluating AI-based technologies. Minszdrav stated that merely installing servers would increase physician workload; effective implementation requires evaluation based on five metrics: medical personnel training, regulatory framework, control system, regional technical maturity of the electronic health record system, and process transformation within medical organizations. Regarding data usage challenges, a lack of legal basis for secondary processing (e.g., research) was highlighted. Experts criticized the current restriction that limits data handling unless a specific purpose is defined, suggesting the need for modern standards and tools like 'data intermediaries,' similar to those in Israel or the Netherlands. The regulator countered these concerns by framing them through an information security lens, arguing against the concept of a 'universal cloud.' Instead, they stressed that data utilization must be based on clearly defined and limited objectives. The focus should shift from opening a door to correctly formulating the research question and identifying necessary data sets.