Women's Health at a Turning Point: What the Federal Policy & Regulatory Outlook Means for the FemTech Industry

As federal policy priorities shift, companies in the FemTech and broader women's health space face a rapidly evolving legislative and regulatory landscape — one that is creating significant market opportunities alongside new compliance considerations. Recent developments, including executive actions affecting in vitro fertilization (IVF) and fertility benefits, updated guidance from the US Food and Drug Administration (FDA) on digital health and artificial intelligence (AI) applications, and CMS initiatives supporting wearable technologies, are reshaping the operational environment for health innovation companies.

Join ML Strategies and Mintz for a practical discussion of the federal policy developments driving change across the women's health ecosystem and what they mean for your market access strategy and compliance posture.

Discussion topics include:

• Federal policy developments creating new opportunities for companies in FemTech and digital health, including the impact of recent executive orders on IVF and employer-sponsored fertility benefits
• FDA oversight of digital health technologies, AI, wearables, and software applications in women's health, including possible device classifications and regulatory pathways
• Federal Trade Commission enforcement trends and HIPAA privacy considerations for digital health companies and platforms
• Market access strategies and the investment landscape for women's health innovation