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.[1]  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”[2] in 2022 and the Biden Administration making women’s health a stated priority.  International governments also are increasingly focusing on women’s health issues.[3]  This post outlines five reasons digital solutions for women+ health should be a front-burner digital health focus in 2023.

  1. 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+.[4]  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.
  2. 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.”[5]  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.[6]  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.[7] 
  3. 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.[8]  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.[9]  Professionals have stated they plan to use this technology to “address data bias regarding breast health and imaging.”[10]  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.
  4. 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.[11]  These innovations are consistent with trends in regulation and enforcement.  Even prior to Dobbs, the FTC[12] and state attorneys general[13] 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.”[14]  The FTC[15] and HHS[16] 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.”[17]  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.[18]
  5. 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.


[1] https://www.law.com/thelegalintelligencer/2022/10/08/femtech-what-to-watch-for-womens-wellness/.

[2] https://www.fda.gov/media/155461/download.

[3] See, e.g., https://www.gov.uk/government/publications/our-vision-for-the-womens-health-strategy-for-england.

[4] Id.

[5] https://www.liebertpub.com/doi/10.1089/whr.2021.0083.

[6] https://www.sciencedirect.com/science/article/pii/S1551714422000441?via%3Dihub; see also https://www.washingtonpost.com/health/2022/06/27/underrepresentation-women-clinical-trials/.

[7] https://www.mobihealthnews.com/news/clinical-trials-have-historic-gender-gap-tech-could-help.

[8] 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.

[9] https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220080.pdf.

[10] Id.

[11] https://www.cnn.com/2022/07/08/tech/period-tracking-apps-data-privacy/index.html.

[12] https://www.ftc.gov/news-events/news/press-releases/2021/01/developer-popular-womens-fertility-tracking-app-settles-ftc-allegations-it-misled-consumers-about.

[13] https://oag.ca.gov/news/press-releases/attorney-general-becerra-announces-landmark-settlement-against-glow-inc-%E2%80%93.

[14] https://www.govinfo.gov/content/pkg/FR-2022-07-13/pdf/2022-15138.pdf.

[15] https://www.ftc.gov/business-guidance/blog/2022/07/location-health-and-other-sensitive-information-ftc-committed-fully-enforcing-law-against-illegal.

[16] https://www.hhs.gov/about/news/2022/06/29/hhs-issues-guidance-to-protect-patient-privacy-in-wake-of-supreme-court-decision-on-roe.html.

[17] Id.

[18] https://lawfilesext.leg.wa.gov/biennium/2023-24/Pdf/Bills/House%20Bills/1155.pdf?q=20230109060119.

Photo of Olivia Dworkin Olivia Dworkin

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance.

With a focus on cutting-edge…

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance.

With a focus on cutting-edge medical technologies and digital health products and services, Olivia regularly helps new and established companies navigate a variety of state and federal regulatory, legislative, and compliance matters throughout the total product lifecycle. She has experience counseling clients on the development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical applications, general wellness products, medical device data systems, administrative support software, and products that incorporate artificial intelligence, machine learning, and other emerging technologies.

Olivia also assists clients in advocating for legislative and regulatory policies that will support innovation and the safe deployment of digital health tools, including by drafting comments on proposed legislation, frameworks, whitepapers, and guidance documents. Olivia keeps close to the evolving regulatory landscape and is a frequent contributor to Covington’s Digital Health blog. Her work also has been featured in the Journal of Robotics, Artificial Intelligence & Law, Law360, and the Michigan Journal of Law and Mobility.

Prior to joining Covington, Olivia was a fellow at the University of Michigan Veterans Legal Clinic, where she gained valuable experience as the lead attorney successfully representing clients at case evaluations, mediations, and motion hearings. At Michigan Law, Olivia served as Online Editor of the Michigan Journal of Gender and Law, president of the Trial Advocacy Society, and president of the Michigan Law Mock Trial Team. She excelled in national mock trial competitions, earning two Medals for Excellence in Advocacy from the American College of Trial Lawyers and being selected as one of the top sixteen advocates in the country for an elite, invitation-only mock trial tournament.

Photo of Kristin Davenport Kristin Davenport

Kristin Davenport advises medical device companies regarding premarket strategies and pathways, the premarket submission process, advertising and promotion, compliance and enforcement matters, and import/export issues.

She has extensive experience with 510(k) premarket notifications, de novo petitions, premarket approval applications, investigational device exemptions, device…

Kristin Davenport advises medical device companies regarding premarket strategies and pathways, the premarket submission process, advertising and promotion, compliance and enforcement matters, and import/export issues.

She has extensive experience with 510(k) premarket notifications, de novo petitions, premarket approval applications, investigational device exemptions, device modifications, 513(g) Requests for Information, MDR reporting, device recalls, and Part 806 reports.

Kristin regularly prepares 513(g) Requests for Information to obtain FDA’s views regarding the classification and applicable regulatory requirements for novel devices, such as mobile medical applications. She develops successful premarket strategies for clients, and frequently participates in pre-submission meetings with CDRH. Kristin navigates issues that arise during the premarket review process, and has successfully represented device companies in administrative appeals.

She also assists and represents clients in compliance and enforcement proceedings, including responding to FDA Form 483s and Warning Letters.

Kristin advises on jurisdictional questions and assists clients with combination product issues, including submitting Requests for Designation to the Office of Combination Products.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences law. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

Sarah regularly advises on:

  • obligations under the EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulation, including associated transition issues, and UK-specific considerations caused by Brexit;
  • medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • borderline classification determinations for software medical devices;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah is also Graduate Recruitment Partner for Covington’s London office.

Photo of Libbie Canter Libbie Canter

Libbie Canter represents a wide variety of multinational companies on privacy, cyber security, and technology transaction issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports…

Libbie Canter represents a wide variety of multinational companies on privacy, cyber security, and technology transaction issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports clients on their efforts to launch new products and services involving emerging technologies, and she has assisted dozens of clients with their efforts to prepare for and comply with federal and state privacy laws, including the California Consumer Privacy Act and California Privacy Rights Act.

Libbie represents clients across industries, but she also has deep expertise in advising clients in highly-regulated sectors, including financial services and digital health companies. She counsels these companies — and their technology and advertising partners — on how to address legacy regulatory issues and the cutting edge issues that have emerged with industry innovations and data collaborations.

As part of her practice, she also regularly represents clients in strategic transactions involving personal data and cybersecurity risk. She advises companies from all sectors on compliance with laws governing the handling of health-related data. Libbie is recognized as an Up and Coming lawyer in Chambers USA, Privacy & Data Security: Healthcare. Chambers USA notes, Libbie is “incredibly sharp and really thorough. She can do the nitty-gritty, in-the-weeds legal work incredibly well but she also can think of a bigger-picture business context and help to think through practical solutions.”

Photo of Olivia Vega Olivia Vega

Olivia Vega provides strategic advice to global companies on a broad range of privacy, health care, and technology issues, including in technology transactions, mergers and acquisitions, and regulatory compliance. Within her practice, Olivia counsels clients on navigating the complex web of federal and…

Olivia Vega provides strategic advice to global companies on a broad range of privacy, health care, and technology issues, including in technology transactions, mergers and acquisitions, and regulatory compliance. Within her practice, Olivia counsels clients on navigating the complex web of federal and state privacy and data security laws and regulations, including on topics such as HIPAA, California’s Confidentiality of Medical Information Act, and the California Consumer Privacy Act. In addition, Olivia maintains an active pro bono practice.