Innovative digital solutions intended to address health issues typically experienced by women have been an area of increased focus. Ranging from reproductive-related mobile applications to AI-enabled breast cancer screening devices, digital solutions for women+ health show promise to serve an enormous market with medical needs that have often failed to get the level of attention that women deserve. Experts estimate that the women+ health market could skyrocket in worth in the coming years — potentially reaching $475 billion by 2027. And women’s health in general has gained attention at the federal level, with FDA’s Center for Devices and Radiological Health sharing a “Health of Women Program Strategic Plan” in 2022 and the Biden Administration making women’s health a stated priority. International governments also are increasingly focusing on women’s health issues. This post outlines five reasons digital solutions for women+ health should be a front-burner digital health focus in 2023.
- The growing women+ health sector is normalizing the conversation around women’s health, leading to much-needed innovation in key areas. Research suggests that people sometimes shy away from discussing health topics historically labeled as “taboo” — such as reproductive health, pregnancy loss, female sexual health and pleasure, period health, infertility, postnatal depression, incontinence, pelvic floor dysfunction, breastfeeding, and menopause. Even well-intentioned healthcare providers are sometimes insufficiently informed to create and offer effective solutions and support for women+. The recent attention to digital solutions for women+ health serves to change these dynamics — challenging and dispelling existing taboos, stigmas, and practices surrounding women’s health. Digital solutions for women+ health can also help address social stigma and legal hurdles for the delivery of care, for example with telemedicine consultations on sexual health, abortions and menopause. Innovators in the women+ health space aim to put women’s needs and voices at the core of products and services, thus empowering women to prioritize and openly discuss their health and wellness. Increased and improved knowledge of women’s health issues, as well as growing access to women’s health data through digital offerings, will accelerate innovation in this area.
- Digital solutions for women+ health are advancing health equity among gender and racial lines. History has shown disparities in both health access and outcomes among gender and racial lines, particularly for women of color. Indeed, a recent literature review found that females “remain broadly under-represented in the medical literature, sex and gender are poorly reported and inadequately analyzed in research, and misogynistic perceptions continue to permeate the narrative.” Additionally, a 2022 study demonstrated that while women make up 50.8% of the U.S. population, only 41.2% of clinical trial participants from 2016-2019 were female. This is particularly concerning considering that the percentage of women affected by the diseases and disorders at issue in the clinical studies ranged from 49-60%. For example, 60% of people with psychiatric disorders are women, but just 42% of participants in trials for psychiatric drugs were female. The explosive growth of digital solutions in the women+ health arena is already helping to drive attention to these gaps in medical research and will be critical to addressing these issues — facilitating clinical trial participation from a broader scope of women and the generation of women-forward data sets.
- The expanding range of digital solutions for women+ health is creating opportunities for better and more cost effective health outcomes. A variety of digital solutions for women+ health are on the market already, including menstrual period and symptom trackers, digital therapeutics for sexual wellness, fitness apps for pregnant and postpartum women, pelvic floor trainers, wearable technology for menopause support, digital contraceptives that enable women+ to track fertility and predict ovulation windows, innovative breast pumps, AI-enabled breast cancer screening software, and more. As an example, in 2018 FDA permitted marketing of the first direct-to-consumer app as a method of contraception to prevent pregnancies, with another app to follow in 2021. More recently in late 2022, FDA cleared a device that uses AI and machine learning to flag areas on mammograms that are suggestive of the presence of at least one suspicious finding to categorize exams and allow for prioritization. Professionals have stated they plan to use this technology to “address data bias regarding breast health and imaging.” Similar products are making their way to the international market. With healthcare costs a constant area of focus, some digital health solutions may offer a less expensive and more accessible option, and the breadth of solutions makes clear that innovators are thinking about ways to both address historically unmet medical needs, while also delivering solutions in cost effective ways.
- The women+ health sector is innovating to address the need to protect women’s privacy. In the aftermath of the Supreme Court’s Dobbs decision, the privacy of women’s health information has never been more important. Many digital solutions for women+ health are on the cutting edge of deploying privacy-by-design strategies to minimize the collection and retention of identifiable health and location information. Last summer, many period tracking and fertility solutions announced innovations to better protect women’s privacy. These innovations are consistent with trends in regulation and enforcement. Even prior to Dobbs, the FTC and state attorneys general have focused some of their enforcement activity on digital solutions for women+ health. However, the Dobbs decision has accelerated that interest, as illustrated by President Biden’s Executive Order Protecting Access to Reproductive Health Care Services, which directs federal agencies to take various steps to protect consumer privacy in response to “this health crisis.” The FTC and HHS subsequently issued guidance on what is required by the pre-existing regulatory frameworks and reaffirmed the particular sensitivity of reproductive health data, and HHS Secretary Xavier Becerra has indicated that this area is an “enforcement priority.” State legislatures have also taken an increased interest in the privacy of women’s reproductive health and have proposed legislation to protect health data. For example, Washington’s state legislature introduced a bill that would prevent sharing of certain women’s health data — including reproductive health data — without a consumer’s consent.
- Digital solutions for women+ health will lead to more sex-specific data. The physiology of a woman’s body is different than that of a man’s. For example, women have unique presentations for serious conditions such as stroke and diabetes, but to date medical research and therapies have typically failed to take into account sex. Additionally, as noted above, women have been underrepresented in clinical trials. Changing clinical trial recruitment to recruit a higher percentage of women is a long-term challenge. But digital solutions for women+ health could help solve some of the imbalance by collecting valuable data and creating communities of users for recruitment. For example, real world data sets, such as those coming from wearables, could be used to develop sex-specific insights, and those insights could be used for sex-based protocols that could customize digital care responses.
In short, as digital solutions for women+ health continue to expand, the opportunities to serve unmet needs for women’s health, improve medical research, and deliver better, cost efficient care increases. Of course, the rise of these solutions also implicates a host of regulatory considerations, such as how companies will ensure privacy of women’s health data and whether certain digital solutions for women+ health will be considered medical devices subject to regulatory oversight in the U.S. and elsewhere. As women+ health solutions continue to grow, we expect federal and international guidance to develop as well — including advancements on CDRH’s Health of Women Program Strategic Plan. Navigating those developments will be key to realizing those opportunities.
 See, e.g., https://www.gov.uk/government/publications/our-vision-for-the-womens-health-strategy-for-england.
 https://www.sciencedirect.com/science/article/pii/S1551714422000441?via%3Dihub; see also https://www.washingtonpost.com/health/2022/06/27/underrepresentation-women-clinical-trials/.
 https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-direct-consumer-app-contraceptive-use-prevent-pregnancy; https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193330.pdf.