Women’s health is no longer a narrow policy category on the margins of federal attention, and the consequences for the FemTech industry are significant.
FemTech now spans menstrual health, fertility, pregnancy and postpartum care, pelvic and sexual health, menopause, contraception, and conditions that affect women differently or disproportionately.
Apps, wearables, connected devices, and digital platforms are moving health data and clinical decisions closer to users, while simultaneously raising new questions about protecting sensitive reproductive data.
The industry intersects directly with federal executive action and congressional work, making it impossible for founders, investors, and health systems to treat Washington as a distant concern.
Fertility policy offers the clearest early signal of where federal activity may shape the broader FemTech market first, with executive action already setting a visible precedent.
In February 2025, the President signed Executive Order 14216, directing the Domestic Policy Council to recommend ways to expand access to in vitro fertilisation and reduce out-of-pocket costs within 90 days.
In October 2025, the administration announced a most-favoured-nation pricing agreement with EMD Serono for common IVF medications, with reported discounts of up to 84 percent off list prices for drugs including Gonal-f, Ovidrel, and Cetrotide.
The Department of Labor has also proposed a new excepted benefit category allowing employers to offer standalone fertility benefits outside a group health plan, including a capped contribution model reportedly set at $2,150 for 2025.
Congressional responses have been mixed, with Senator Katie Britt publicly supporting the executive order while Senators Patty Murray and Tammy Duckworth have argued it does not go far enough without legislation requiring insurance coverage.
The American Society for Reproductive Medicine has published its own analysis noting open questions about how the excepted-benefit proposal will be implemented and what it will mean for equitable access.
For companies building fertility tracking, cycle prediction, or fertility-benefits navigation tools, lower drug costs and a new employer benefits pathway both have the potential to expand the addressable population for these products.
Many of the issues most important to FemTech’s long-term growth remain with Congress, where IVF and fertility-benefit bills have drawn bipartisan sponsors but none has passed both chambers.
The Senate HELP Committee’s work on 340B reform and congressional interest in FDA digital health authorities, rooted in the 21st Century Cures Act, will directly affect how FemTech products are reviewed and reimbursed.
Data privacy represents the industry’s largest unresolved regulatory risk, as most consumer-facing fertility and cycle-tracking apps are not subject to HIPAA because they are not covered entities or business associates under the law.
That gap has already led to enforcement activity, including the widely cited $200,000 penalty against the Premom app for sharing fertility data with Google and Chinese analytics firms.
Although HIPAA updates finalized in April 2024 added new protections for reproductive health information held by covered entities, those safeguards do not reach most consumer-facing apps.
Companies that treat privacy architecture and data minimisation as core design principles rather than compliance afterthoughts will be better positioned across administrations, particularly if Congress or the Department of Health and Human Services moves to close the HIPAA gap.
Federal policy is no longer a backdrop for women’s health innovation but is becoming one of the forces that will define how the FemTech market grows across fertility, menopause, maternal mental health, contraception, and diagnostics.
Companies that engage early with regulators and lawmakers can help shape the rules taking shape at HHS, the Department of Labor, the FDA, and the FTC, turning policy into a genuine competitive advantage.