User or patient/human or person? Development of a practical framework for applying user-centered design to vulnerable populations for digital transformation in healthcare.

Objective: User-centered design (UCD) is essential in developing healthcare technologies that effectively address user needs, particularly in vulnerable populations. Although UCD traditionally emphasizes direct user involvement, challenges arise when individuals face cognitive, emotional, or structural barriers to participation. In medical settings, integrating UCD with inclusive design principles has been crucial to ensuring equitable healthcare solutions. Methods: Based on our expertise and a narrative review, we identified challenges and results in UCD approaches in digital health. Results: The findings reveal key principles for applying UCD in digital health, emphasizing the importance of early user engagement, accessibility, and interdisciplinary collaboration. Studies demonstrate that active involvement of end-users (patients, healthcare providers, and caregivers) through qualitative methods such as interviews, surveys, and usability testing, ideally following iterative design cycles, is critical for designing effective and inclusive digital tools. Accessibility considerations, particularly for vulnerable populations, and integration of digital tools into clinical workflows play an essential role in the process. Conclusion: To address these challenges, we propose a structured UCD framework for "user-patient-human-friendly" digital transformation in healthcare that guides the development of digital health technologies from initial user research to long-term evaluation. The framework provides a roadmap for designing solutions that are adaptable, inclusive, and sustainable, ensuring that healthcare technologies align with the needs of diverse populations.