The conversation about health has traditionally excluded women, but two recent frameworks—the Nordic Charter for Women’s Health 2040 (the “Charter”) and the [American] National Strategy to Close the Women’s Health Gap (the “National Strategy”)—offer a nontraditional response.[i] They position women’s health as the basis for economic resilience, showing that placing women’s health in a silo has real economic repercussions widening the gap between male and female health. Per the Charter, closing the gap would yield $30-50 billion annually in Nordic productivity, healthcare savings, and innovation.[ii] In July 2026, the Charter’s American counterpart called Congress to action to commit $20 billion over ten years to close the health gap.[iii] While neither framework holds the force of law, each functions as a course correction with a strong blueprint for women’s health lawmakers. Namely, the Charter provides a legal mechanism that the United States could adopt: a regulatory sandbox for FemTech. If authorized by Congress, a federal regulatory sandbox could fall under FDA and FTC supervision to put privacy protections in place.
The need for a regulatory sandbox at the federal level would cover FemTech devices that fall outside of existing regimes—such as menstrual trackers and fertility applications. In recent years FemTech has brought a data-driven spotlight to women’s health, and how women spend 25% more of their lives in poorer health than men.[iv] With a projected value of $35 billion by 2032 and AI as a central intervention, FemTech sits at the nexus of healthcare, technology, and economic growth.[v] However, this centrality invites unresolved legal questions that concern data privacy under HIPAA, device regulation under FDA wellness policies, and clinical evidence standards set by the NIH Revitalization Act of 1993.[vi] The Charter’s answer is to implement a “regulatory sandbox” in which FemTech startups would test digital health products without having to navigate each Nordic country’s regulations.[vii]
In fact, the EU AI Act has already moved in this direction by requiring each Member State to establish an AI regulatory sandbox at the national level. While the United States does not yet have a federal equivalent, the National Strategy’s proposition for a $1 billion investment in regulatory coordination and modernization could lay the groundwork for federal coordination to address the uncertainty created by a patchwork of state laws.[viii] In the absence of federal regulations like that of the EU, FemTech companies in the U.S. are faced with unique challenges to protect data privacy in products like wearables and menstrual trackers, as well as limited market reach.[ix] While HIPAA does not extend to data collected by consumer apps, the EU has strengthened its data privacy laws via the GDPR, which replaced a directive whose uneven implementation across Member states caused legal and, subsequently, market uncertainty.[x] A sandbox approach, however, would counter patchwork inconsistency and give developers a more defined path to market. It may subsequently offer regulators real-world evidence on which to base broad legislation. For FemTech investors, the National Strategy is the framework that could provide the U.S. with consistent rules that reduce distortion of competition—providing greater stability and predictability to invest in women’s health technologies.
Though developed independently across the ocean, the Nordic Charter and the National Strategy have a shared vision in which women’s health fuels economic and technological growth. They present a classic “soft law” structure, holding adaptive guidelines that could translate into binding solutions.[xi] Home to some of the happiest countries on earth, the Nordic region offers the Charter as yet another health model worth reviewing.[xii] For the U.S., the question is whether Congress will supply legislation, such as federal protective privacy standards that would stabilize the FemTech market, and turn vision into law.
Preetica Pooni is a staff member of Fordham International Law Journal Volume L.
[i] See Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, 58 Fed. Reg. 39,406 (July 22, 1993); Jeanette Kæsler Mortensen & Julia Persson, The Nordic Charter for Women’s Health 2040 (2d ed. 2026), https://womenshealth2040.org/charter [hereinafter “Nordic Charter”]; Soc’y for Women’s Health Rsch. et al., National Strategy to Close the Women’s Health Gap (2026), https://swhr.org/wp-content/uploads/2026/07/National-Strategy_Full-Document.pdf [hereinafter “National Strategy”].
[ii] Nordic Charter, supra note i, at § 1.3.
[iii] National Strategy, supra note i, at 1.
[iv] Women’s Health in Numbers, World Econ. F., https://www.weforum.org/stories/health-and-healthcare-systems/womens-health-in-numbers.
[v] Nordic Charter, supra note i at 15
[vi] See 21 U.S.C. § 360j(o)(1)(B); NIH Revitalization Act of 1993, Pub. L. No. 103-43, § 131, 107 Stat. 122 (amended at 42 U.S.C. § 289a-2); 45 C.F.R. §§ 160.102(a), 160.103 (2025); U.S. Food & Drug Admin., General Wellness: Policy for Low Risk Devices (2026), https://www.fda.gov/media/90652/download.
[vii] Nordic Charter, supra note i at 43.
[viii] See National Strategy, supra note i at 2–3; Ariella Dreyfus et al., Femtech: Navigating Legal and Regulatory Risk, Barnea (September 8, 2026), https://barlaw.co.il/femtech-navigating-legal-and-regulatory-risk.
[ix] See Sara Raza et al., Effective Regulation of Technology in Women’s Health and Healthcare, 391 bmj 1, (2025) https://pmc.ncbi.nlm.nih.gov/articles/PMC12516473/.
[x] 45 C.F.R. § 164.500(a) (2025); See Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation), Recitals 9, 13, 2016 O.J. (L. 119) 1 (EU) [hereinafter “GDPR”].
[xi] Eur. Ctr. for Const. & Hum. Rts., Hard Law/Soft Law, https://www.ecchr.eu/en/glossary/hard-law-soft-law.§
[xii] See Nicholas Kristof, What We Should Learn From Nordic Happiness, N.Y. Times (July 4, 2026), https://www.nytimes.com/2026/07/04/opinion/norway-nordic-social-democracy; Frank Martela et al., The Nordic Exceptionalism: What Explains Why the Nordic Countries Are Constantly Among the Happiest in the World, in World Happiness Report 2020 https://www.worldhappiness.report/ed/2020/the-nordic-exceptionalism-what-explains-why-the-nordic-countries-are-constantly-among-the-happiest-in-the-world.
This is a student blog post and in no way represents the views of the Fordham International Law Journal.