Modern healthcare is increasingly powered by data — but much of that data was never designed to reflect half the population. When the data is incomplete or unbalanced, even the most sophisticated tools can struggle to deliver accurate, actionable insights.
For decades, modern medicine and product development have been built around a narrower definition of the “average patient.” The consequences are well documented.
Cardiovascular disease is the leading cause of death for women in the United States, affecting nearly 44% of women over age 20, yet many historical datasets and diagnostic tools were not designed with women’s full symptom patterns in mind. Women spend roughly a quarter more years of their lives in poor health than men and experience adverse reactions to medications about twice as often. In a review of more than 700 cardiovascular trials, only about 38% of participants were women.
Those are not inevitable gaps; they are performance gaps. When algorithms are trained on datasets that underrepresent women, it becomes harder to calibrate thresholds, validate models and ensure devices behave consistently across the full population. As more care is mediated through software and sensors, these gaps become a core innovation challenge.
There is growing recognition that better outcomes require more representative data and more rigorous validation frameworks. This is why the Consumer Technology Association (CTA) recently introduced the first women’s health standard for the consumer technology industry, the first of its kind developed by an American National Standards Institute (ANSI) accredited association. It provides developers with a practical framework to design, test and validate digital health technologies with these considerations built in from the outset.
The new standard was created in collaboration with industry and translates complex issues into concrete guidance. It encourages developers to account for physiological factors in product design and to structure validation and testing so participant populations better reflect the people who rely on these tools. It also establishes stronger expectations for how data should be collected, managed and used so algorithms are trained and validated on datasets that more fully capture women’s health experiences across life stages and conditions.
Importantly, the standard is not limited to reproductive health. It addresses cardiovascular disease, metabolic health, autoimmune disorders and other conditions where differences in physiology and usage patterns can influence how technologies collect data, set thresholds and generate insights.
The effort reflects a broader shift in digital health. As AI and connected devices become more embedded in care delivery, expectations around performance, safety and data quality are rising. For companies, that means less tolerance for one-size-fits-all design assumptions — and greater pressure to demonstrate that tools work reliably across real-world populations.
Innovation in women’s health technology is sometimes misunderstood as a matter of aesthetics or branding. In reality, it is about improving input data, refining performance criteria and ensuring design assumptions align with biological reality and real-world usage. When those fundamentals are in place, products are more accurate, more trustworthy and more likely to be adopted by clinicians and consumers alike.
There is also a clear market dimension. In the United States, women make roughly 80% of healthcare decisions for their families. They are often the ones choosing which devices to purchase, which apps to use and which tools to continue using over time. Technologies designed and validated with those users in mind are more usable, more trusted and more effective.
Digital health is entering a phase where differentiation will increasingly come from real-world performance and trust, not just feature lists. By aligning around a clearer framework for women’s health technologies, the industry can move faster, reduce costly redesigns and deliver products that work better for more people from day one.
For digital health to work at scale, it must be built on data and performance standards that reflect the full population. Incorporating women’s health considerations into those foundations is essential to unlocking the next generation of inclusive, evidence-based health technologies.
Author bio:
Kinsey Fabrizio is president and incoming CEO of the Consumer Technology Association (CTA), which represents more than 1300 consumer technology companies and owns and produces CES — the most powerful tech event in the world.
Photo: asnidamarwani, Getty Images
