Monitoring Female Fertility Through 'Femtech': The Need for a Whole-System Approach to Regulation

Area of Science:

• Digital health
• Women's health technology
• Regulatory science

Background:

• The femtech market, focusing on women's health and wellness technologies, is rapidly expanding.
• Current regulatory frameworks may not adequately address the unique challenges posed by femtech.
• Ambiguity in femtech regulation risks users relying on unproven technologies.

Purpose of the Study:

• To identify regulatory gaps in the femtech market.
• To analyze the impact of femtech on existing regulatory mechanisms.
• To propose a feminist-informed, comprehensive regulatory approach for femtech.

Main Methods:

• Literature review of digital health, femtech, and regulatory frameworks.
• Analysis of regulatory sensitivity to feminist perspectives on health and technology.
• Conceptual framework development for a multidimensional regulatory approach.

Main Results:

• Existing regulatory structures are insufficient for the complexities of femtech.
• Current regulations lack sensitivity to feminist viewpoints on women's health technologies.
• Femtech's expansion highlights a critical unmet need for specialized regulatory oversight.

Conclusions:

• Femtech requires a distinct regulatory strategy that prioritizes user safety and efficacy.
• A multidimensional, whole-system regulatory approach is necessary.
• Integrating feminist perspectives into regulation is crucial for protecting femtech users.