[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]

Area of Science:

• Ophthalmology
• Health Informatics
• Data Science

Background:

• The increasing availability of digital health data necessitates robust evaluation methods.
• Real-world data analysis requires careful planning regarding technical, legal, and data protection aspects.
• Experiences from the University Eye Hospital in Munich provide practical insights into establishing such systems.

Purpose of the Study:

• To examine the framework required for developing comprehensive real-world clinical databases.
• To highlight the importance of these databases for future innovations in decision support systems.
• To share practical experiences from a university eye hospital.

Main Methods:

• Review of legal requirements for data privacy and documentation.
• Definition of technical requirements for IT infrastructure and software.
• Conducting a survey among German eye hospitals on digitalization status.
• Outlining necessary staff competencies and training.

Main Results:

• A database of 330,801 patients, including diagnoses, procedures, and diagnostic results, was successfully established and approved.
• Less than half of surveyed German eye hospitals (21/54) have complete electronic documentation.
• Fourteen hospitals remain paper-based, while others use mixed systems.
• Significant variation exists in digitalization levels across German eye hospitals.

Conclusions:

• Comprehensive, well-curated real-world data databases are foundational for advancing clinical decision support.
• The framework detailed in this study addresses critical technical, legal, and operational considerations.
• Future innovations in healthcare will increasingly rely on the availability and quality of real-world clinical data.