FemTech forecast: Policy, regulation, and funding

2024 was a banner year for women’s health. The White House committed $500 million to advance research and innovation in women’s health, which was distributed through the NIH and ARPA-H. Dr. Brittany Barreto published Unlocking Women’s Health, the first book on femtech. California and New York expanded Medicaid coverage to include telehealth services for reproductive health—including abortion care. Menopause entered the national conversation with celebrities like Halle Berry launching educational courses. Companies leveraging AI are popping up right and left. With a changing of the guard from the Biden administration to the Trump administration, here are key considerations on how policy and regulation could impact women’s health technology and innovation in 2025. 

Reproductive health data protection policies 

What’s happening:  

As a response to the 2022 overturning of Roe v. Wade, in 2024 HHS strengthened HIPAA enforcement regarding women’s health data, with new rules that specifically address the protection of reproductive health information in digital health applications. These regulations require enhanced security measures for healthcare apps handling sensitive health data and mandate clear disclosure of data sharing practices. As HIPAA only applies to covered entities and business associates, consumer health apps aren’t required to meet the same standards of data protection. Some states passed their own legislation, like California’s Privacy Rights Act (CPRA) amendment which specifically addresses the protection of reproductive health data in consumer digital platforms. We are likely to see a reduction in access to reproductive healthcare services in 2025 as states continue to pass a plethora of restrictions around abortion, further heightening the need to protect health data.  

 Recommendations for companies: 

• Invest in robust data protection. Given the new HIPAA regulations protecting reproductive health care information, implement stringent data security measures and privacy protocols 

• Prioritize user consent, ensuring that users understand how their health data is used, shared, sold, and stored 

• Establish clear data deletion protocols 

• Conduct regular privacy impact assessments 

• Consider following GDPR to both increase data protection, improve consumer confidence and expand into European markets  

Increased regulation and scrutiny of AI  

What’s happening:  

As artificial intelligence becomes more ingrained in women’s health tech—whether it’s used for breast cancer detection or clinical decision support—regulatory bodies will be taking a closer look. We will likely see more standards set by government, industry and NGOS alike, such as CHAI, to ensure that algorithms used across healthcare are fair, inclusive, and transparent.  

In December 2024, the FDA updated their list of AI/ML enabled medical devices and will likely continue to iterate on how it manages reviewing these products. H.R.6936 – Federal Artificial Intelligence Risk Management Act of 2024 is currently under revision in the House with the intent to require federal agencies to use the Artificial Intelligence Risk Management Framework which lays out suggestions for government procurement of technology with AI, hiring of experts to advise the government on AI, and outline best practices for the use of AI. Additionally, on January 6, 2025, the FDA issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. We can expect to see commentary coming out of every area of government.  

Recommendations for companies: 

• Be prepared for an increase in demand for transparency in how AI algorithms are trained and tested, and where the data comes from  

• Follow regulatory news and plan budgets to adjusting to changes in your product to meet regulatory requirements 

• Regularly consult with legal advisors  

• Proactively implement bias mitigation strategies 

Federal Funding Landscape

What’s happening:  

The Biden administration allocated $500 million for women’s health innovation through 2025, with the NIH’s Office of Research on Women’s Health receiving a 40% budget increase. ARPA-H launched a $100 million initiative focused on women’s health and distributed a sizable amount of those funds to digital health companies. However, the future of these programs face uncertainty under the next Trump administration, given previous cuts to women’s health funding during his first tenure (2017-2021) such as excluding Planned Parenthood from receiving federal funding and cutting over $200 million in teen pregnancy prevention programs. NPR also reported that there are concerns within the NIH about budget cuts in 2025.  

Recommendations for companies: 

• Consider research partnerships with academic institutions that may already have secured multi-year federal grants  

• Become familiar with the grant and investment capital space focused on women’s health companies. A starter list can be found here. 

• Optimize go-to-market strategies if the first iteration of funding came from federal sources and lock in revenue generating clients.  

• Examine SBIR and STTR grants which support small businesses and aren’t subject matter specific 

Telehealth expansion and reproductive rights 

What happening:   

Telemedicine policies and reimbursement practices continue to evolve at both federal and state levels as we move into 2025, with significant implications for women’s and reproductive health services. At the federal level, Congress has extended telehealth flexibilities through March 31, 2025, which have allowed for the expansion of remote prenatal and postpartum care, as well as telehealth consultations for contraception and family planning services. At the state level, telehealth policies for women’s and reproductive health services vary widely. The provision of abortion medication via telemedicine remains a contentious issue, with some states explicitly prohibiting it while others have moved to protect and expand access. Reimbursement policies for these services remain complex and can differ significantly from state to state, with variations in covered services, eligible providers, and reimbursement rates. This patchwork of policies continues to create challenges for providers and patients seeking consistent access to comprehensive reproductive health care via telemedicine. 

Recommendations for companies:  

• Watch for what will happen to telehealth flexibilities after March 2025.  

• Engage with policymakers and industry associations to advocate for the continuation of telehealth flexibilities beyond March 2025, highlighting the benefits for patient access and care quality.   

• Expand cross-state capabilities: Leverage the Interstate Medical Licensure Compact (IMLC) to facilitate cross-state physician licensure, enabling a broader reach for telehealth services across participating states.

There are many unknowns for how the new Trump administration will help or hinder women’s health innovation through funding, policy and regulation, however we have the ability to understand recent events and the administration’s previous priorities. By staying aware of evolving regulations and being agile, companies in the women’s health tech space will be well-positioned to deliver high quality healthcare services and create new innovative solutions.  

Katie D. McMillan, MPH is the CEO of  Well Made Health, LLC, a business strategy consulting firm for health technology companies. She is also a curious researcher and writer focusing on digital health evidence, healthcare innovation, and women’s health. Katie can be reached at katie@wellmadehealth.com or LinkedIn.