The rapid rise of the femtech industry has introduced innovative tools that help women track menstrual cycles, manage fertility, and even detect diseases like cancer through AI-powered diagnostics. However, these advancements come with significant regulatory and ethical challenges, particularly around data privacy, algorithmic bias, and the lack of comprehensive legal oversight. Sara Gerke, a health law scholar and bioethicist at the Cancer Center at Illinois (CCIL), is leading efforts to address these concerns. Gerke’s recently published paper in The BMJ, co-authored with Sara Raza, Eric Bressman, and Carmel Shachar, examines the legal and ethical gaps in how femtech products are regulated. A key issue she highlights is that most direct-to-consumer women’s health apps are not covered by the U.S. Health Insurance Portability and Accountability Act (HIPAA), leaving sensitive personal data—such as information about menstruation, sexual activity, and fertility—vulnerable to misuse. Unlike in Europe, where the General Data Protection Regulation offers stronger protections, the U.S. lacks a unified framework for safeguarding health data collected by non-traditional health providers. “Many women trust these apps with deeply personal information, but they often don’t realize their data may be shared or sold without clear consent,” Gerke said. “This is especially troubling when the data is so intimate and private.” Another major concern is bias in AI systems used in femtech. If AI models are trained on datasets that lack diversity—such as images of lighter skin tones in skin cancer detection tools—they may perform poorly for underrepresented groups. This can lead to missed diagnoses or inaccurate results, potentially worsening existing health disparities. Gerke emphasizes the importance of integrating ethics and legal considerations from the earliest stages of development. “We need to practice ethics by design,” she said. “We must ask the right questions before deploying these tools, not after problems arise.” She also points to emerging challenges in AI-assisted medical procedures, such as surgery and colonoscopy, where questions about liability remain unresolved. If an AI system provides a flawed recommendation and a clinician acts on it, determining responsibility is complicated by the absence of established legal precedents. At CCIL, Gerke organizes interdisciplinary conferences to bring together developers, clinicians, ethicists, and legal experts. Her goal is to foster collaboration early in the innovation process to build safer, more equitable AI tools. She plans to host the next major conference at the University of Illinois Urbana-Champaign in spring 2027. “Stakeholders often work in silos,” Gerke said. “But real progress comes when we engage everyone—from the start—so we can build trust, ensure fairness, and protect patients.”