From a smartphone microphone that can support an Alzheimer’s diagnosis to a wearable device that helps predict stroke, digital devices are poised to play a transformative role in the ability of healthcare stakeholders to collect key “endpoints”: criteria used by care providers to assess health and disease.

By capturing patient-generated health data right where patients live and work via wearables, apps, and sensors, digital health technologies (DHTs) are fostering earlier diagnoses, amassing information on treatment effectiveness and safety in the real world, and enabling providers to track disease progression and clinical burden outside of traditional settings.

However, gender bias in DHTs is a known issue that limits their optimal use for women. To address this, the Food and Drug Administration has indicated diversity and representation requirements will be a focus of future regulations. Separately, FDA’s Center for Devices and Radiological Health issued the Health of Women Strategic Plan in 2022, outlining the goals of a “modern program to explore the unique issues related to the performance of medical devices in women, not only in the reproductive health space, but across a woman’s lifetime.”

Last November, the White House unveiled a new initiative designed to spur research and innovation in women’s health. The program aims to establish priorities to guide federal research investments, improve coordination among agencies, engage scientific communities, develop public-private partnerships, and form recommendations to address health disparities affecting women.

This push comes at a time when just “3% of the U.S. commercial digital health venture capital funding since 2011 has focused on women’s health,” even though women have been identified as 75% more likely to use digital tools than men, providing a wide-open space for greater growth in the “femtech industry.”

Read Exponent’s perspective on “Engineering Approaches to Understand and Treat Women’s Health” in the National Academy of Engineering Journal


Realizing the benefits of digital health technologies for women

Important developments in DHTs are on the horizon that could have significant impacts on the health of women and other underrepresented and underserved populations, including real-time tracking of biosensor data that enables users to track their health status; integration with smart devices that allows users to easily access and share data with their healthcare providers for evidence-based treatment decisions; or the use of machine learning and predictive analytics to document user patterns and trends that could lead to identifying demographic-specific triggers at the population level and generating recommendations for lifestyle adjustments or early medical interventions at the individual level.

For women, these digital solutions could support healthcare services such as:

  1. Real-time tracking for varying levels of an endpoint throughout the menstrual cycle
  2. Communications with OB-GYN or other healthcare practitioners around triggers or patterns that may deviate from symptom presentation in males
  3. Collecting real-world evidence around peri-menopausal symptoms for instance that are unique for each individual without the fear of being dismissed

Identifying and mitigating bias in the use of DHTs can help pharmaceutical companies, device manufacturers, and other tech and life science companies create more effective products and therapeutic interventions to ultimately improve public health outcomes for women. Below, we explore four questions for developing inclusive digital health solutions by identifying requirements and endpoints that are specific to women’s experiences and needs as users, patients, and clinical research participants.