Bridging Gaps in Women’s Heart Health: User-Centered Needs Assessment Informed by Patient and Clinician Interviews (Preprint)

BACKGROUND Women with cardiovascular disease (CVD) remain systematically underserved due to persistent gaps in recognition, diagnosis, and care tailored to sex-specific risks. Digital health tools such as mobile apps and wearables have the potential to address these inequities, but many fail to reflect the distinct needs of women. In a prior review of commercially available tools, we assessed 20 CVD apps and 22 wearables and found that only 25% of apps and 40% of wearables included any sex-specific content, such as hormone cycle tracking and life-stage considerations related to pregnancy or menopause. These findings confirm that current digital tools largely mirror the gender gaps seen in traditional care, reinforcing the need for purpose-built digital solutions to better support women across the CVD continuum. OBJECTIVE This study aimed to define the user requirements for an artificial intelligence (AI)-powered CVD app designed specifically for women. We sought to (1) explore the unmet needs and challenges faced by female patients and their clinicians that current tools fail to address, and (2) identify and prioritize features that would be most valuable and feasible to implement. In addition to user insights, we also considered regulatory and reimbursement perspectives to ensure alignment with real-world integration and future scalability. METHODS We conducted a qualitative study using semi-structured interviews to explore the needs, preferences, and expectations of women living with CVD and their treating. Guided by the Human-Centered Design (HCD) framework, this work focused on the “Define” phase. A total of 20 participants in Switzerland were interviewed, including 11 women with CVD, 7 cardiologists, and 2 experts in regulatory and reimbursement. Participants were recruited through purposive sampling, and interviews were conducted online between April and July 2025. Thematic analysis was used to synthesize the data, highlighting design priorities and contextual factors relevant for developing a patient-centered and system-aware digital health tool. RESULTS The interviews with women living with CVD and cardiologists confirmed the consistent gaps between existing care pathways and the specific needs of female patients. Both groups highlighted the lack of early symptom recognition, insufficient sex-specific guidance, and limited tools tailored to women’s lived experience. While patients prioritized personalized education, emotional support, and features that address hormonal and life-stage-specific risks, clinicians emphasized clinical utility, workload integration, and actionable summaries. Success was defined experientially by patients (e.g., empowerment, reduced anxiety), and operationally by clinicians (e.g., earlier detection, improved adherence). Willingness to pay was moderate among both groups, with patients favoring simplicity and clinicians emphasizing workflow integration and proven clinical utility. CONCLUSIONS These findings highlight the importance of designing a CVD app for women that meaningfully integrates patient empowerment with clinical workflows. A dual-value approach is essential, offering personalized tools that address emotional and lifestyle needs for patients, while supporting clinicians with concise, actionable insights. Early reflections on regulatory and reimbursement considerations suggest that a modular, evidence-based rollout strategy would be key for long-term adoption and scale. These insights will inform the next phase of development that will focus on building and testing a prototype that balances the priorities of patients and healthcare providers. CLINICALTRIAL NA.