It is argued that usability engineering should be a formative, safety-critical discipline integrated throughout the product lifecycle, including aftermarket deployment, and not merely a compliance task.
Abstract
Abstract Regulated healthcare settings continue to face gaps between established HCI methodology, user-centered design principles, and everyday clinical practice. Although standards and regulatory frameworks mandate usability engineering, their integration into regulated clinical settings often remains inconsistent, compliance-driven, and detached from real-world workflows. To better understand and address this disconnect, we report insights from applied work in clinical studies, hospital collaborations, and industry partnerships. Our aim is to identify methodological and organizational challenges in assessing digital health technologies and discuss potential strategies to mitigate them. While usability evaluations are typically conducted in accordance with international standards, our observations reveal systemic problems: hospital stakeholders are rarely involved in early design stages, procurement decisions are frequently made without structured user testing, and patients are often excluded from technology selection processes. We argue that usability engineering should be a formative, safety-critical discipline integrated throughout the product lifecycle, including aftermarket deployment, and not merely a compliance task. Drawing on case study reflections and practitioner experience, we articulate actionable lessons and practical strategies for integrating usability engineering more effectively into regulated healthcare environments. By bridging methodological, regulatory, and organizational divides, the paper contributes to guidance for aligning human-centered design with the needs of complex healthcare systems.
Evaluating usability in healthcare remains a challenge due to the absence of clear guidelines and standardized HCI/UX frameworks tailored for pre- and post-deployment evaluation. Clinical practice relies predominantly on generic questionnaires that fail to capture domain-specific challenges in technology use. Existing approaches often overlook the complex interplay among hardware reliability, user interaction, and technology acceptance in clinical settings, which limits the identification of design flaws, hinders user adoption, and reduces the effectiveness of healthcare technologies. The objective of my PhD research is to develop an evidence-based guidance system that synthesizes usability metrics and evaluation methods from HCI literature and informed by a mixed-method approach to empower clinical specialists with knowledge and resources to conduct rigorous, contextually grounded evaluations. By bridging disciplinary silos between HCI and clinical research, this work addresses a pivotal need in healthcare technology evaluation and contributes to improved adoption, safety, and efficacy of digital health interventions.
Highlights What are the main findings? Clinical pathways can support healthcare reliability when designed as sociotechnical interventions informed by human factors engineering and systems principles rather than solely as standardization tools. Integrating human factors, workflow design, cognitive support, and organizational learning into pathway development provides a framework for safer, more adaptive, and more reliable care delivery. What are the implications of the main findings? Healthcare organizations should approach clinical pathways as dynamic operational systems that support clinician performance, reduce variability, and strengthen patient safety across complex care environments. Applying human factors principles to pathway design may improve implementation success, clinician engagement, and sustainability of quality improvement initiatives in modern healthcare systems. Abstract Background/Objectives: Healthcare delivery systems are inherently complex, and efforts to improve quality and safety often fail to achieve sustained, system-wide impact because of misalignment between work system design, care processes, and clinical practice. This article presents a practical, theory-informed framework that integrates human factors and systems thinking to guide the design and implementation of clinical pathways for reliable care delivery and system-level transformation. Methods: A conceptual framework was developed through synthesis of literature from human factors engineering, sociotechnical systems theory, and healthcare quality improvement. The framework organizes healthcare delivery into three interconnected domains—the work system, care processes, and outcomes—while positioning clinical pathways as the operational mechanism linking system design to care execution. Pediatric immunization was used as an illustrative case example. Results: The framework illustrates how misalignment in system design may contribute to variability in care processes and outcomes. Clinical pathways integrated into routine workflows and supported by human factors strategies—including decision-support heuristics, workflow simulation, and structured debriefing—may promote more reliable care delivery. Sustained implementation across teams and clinical settings is expected to reduce missed opportunities, improve consistency of care, and support progression toward system-level transformation. Conclusions: Clinical pathways can serve as practical tools for translating system design principles into reliable healthcare delivery when implemented using human factors and systems-based approaches. This framework provides healthcare leaders and quality improvement teams with a structured approach for designing, implementing, and scaling pathways to support safer, more reliable, and more consistent care delivery.
Designing effective clinical documentation systems requires understanding clinical work. While HCI has produced numerous ethnographic studies of documentation practices, we lack a systematic overview of their design implications. This study contextualizes the field by analyzing methods and environments in existing research. We manually screened all ACM proceedings of CHI and CSCW full papers since their founding, identifying 318 articles involving clinicians and a subset of 52 papers that used ethnography to derive design implications for documentation. Our analysis shows that research remains concentrated in US-based emergency and internal medicine. Methodologically, the field has transitioned from "long-haul" residencies to shorter studies supplemented by formal or informal interviews. This work establishes a foundation to evaluate how design implications diverge across specialties, evolve alongside policy pushes or technological developments, and translate across healthcare systems.
Anastasiya Zakreuskaya, Helena Bøjer Djernæs, F. Nunes et al.· Information Hiding· 0 citations
The design of smart-building digital ecosystems presents challenges when multiple interfaces must serve users with distinct roles, expertise levels, and operational contexts. Rather than focusing solely on the identification of performance deficiencies, this study adopts an interpretive approach aimed at generating real-use-based insights for the design of multi-interface systems. Three interfaces of a smart-building software ecosystem were evaluated: the End-User App, the Management Software, and the Worker App. A heuristic evaluation based on Nielsen’s ten usability heuristics and ISO 9241-110 principles was combined with a usability study involving eight participants who performed representative tasks under a think-aloud protocol. Sessions were recorded and analyzed through thematic analysis. The integration of these two methods reveals a coherent and mutually reinforcing picture: heuristic violations identified prior to testing, including insufficient system feedback, inconsistent iconography, and poor information architecture, were consistently confirmed by user behavior and verbalizations. The Worker App demonstrated strong task-oriented usability, while the End-User App was generally accessible but exhibited specific interaction gaps. The Management Software presented the steepest learning curve among the three interfaces. Cross-cutting themes point to ecosystem-level design opportunities. The study contributes evidence-based recommendations framed as a practical resource for iterative interface improvement, and illustrates how combined heuristic and usability evaluation constitutes a methodologically robust approach to the human-centered assessment of complex multi-interface systems.
Rosana Alexandre, Filipe Moreira, André Cardoso et al.· AHFE International· 0 citations
The evaluation of healthcare technologies utilizing standardized usability questionnaires has grown exponentially, reflecting the increasing importance of user-centered design in eHealth. However, the application of these instruments remains fragmented across clinical specialties and target populations.
This scoping review synthesizes 26 years of literature to examine how standardized usability questionnaires are applied across distinct use cases, healthcare specialties, and target populations to identify current methodological gaps.
A search in MEDLINE/PubMed was conducted for articles published between 1999 and June 2025. Studies employing standardized usability questionnaires for evaluating healthcare technologies were included. Data regarding publication year, the specific usability instrument employed, target population, healthcare specialty, and application domain were extracted and analyzed descriptively.
The search yielded 1,342 peer-reviewed articles. The publication volume showed a substantial upward trend, peaking in 2024 with 256 studies. The System Usability Scale (SUS) was the dominant instrument utilized in 92.8 percent of the publications. The Post-Study System Usability Questionnaire (PSSUQ) was the second-most common instrument applied in 6.0 percent of studies. Internal Medicine and Public Health were the most prominent clinical fields. Mobile Apps and Web Tools constituted the most frequently targeted systems, accounting for 41.4 percent. Patients and healthcare professionals represented the primary user groups.
While publication volumes have surged, the field relies heavily on the SUS, limiting the ability to extract diagnostic insights. To ensure that future healthcare technologies are specifically optimized for complex clinical environments, researchers must mature beyond global satisfaction scores and strategically adopt established, comprehensive tools like the PSSUQ.
Matthias Fabian Berger, Thomas Augustin, Lars-Peter Kamolz et al.· Frontiers in Digital Health· 0 citations
A scoping review of XAI applications in telemedicine is presented, examining 20 studies published between 2022 and 2026 to characterise the methods used, their evaluation approaches, and gaps between technical explainability and clinical usability.
