Digital Health

The new year has brought notable changes on the regulatory front for life science companies seeking to expand their portfolio of digital health products. In January 2026, the U.S. Food & Drug Administration (FDA) published updated guidance documents addressing two broad product categories: (1) low-risk digital health devices for general wellness use; and (2) clinical decision support (CDS) software.

A transformative shift is underway in the life sciences sector, particularly regarding digital health products. Increasingly, life science companies are moving beyond developing medical technology solely for healthcare providers. Their focus now includes developing, marketing, and selling digital products directly to patients as consumers. Diagnostic tools such as self-administered glucose monitors, wearable electrocardiograms, and other self-administered tests, monitors, and therapies are increasingly common.

At my last doctor’s appointment, I learned how to use my smartwatch to perform an electrocardiogram (ECG) to test for atrial fibrillation. Naturally, I found myself checking my ECG multiple times a day, curious about the fluctuations in my heart rate. Did I have cause for concern? Fortunately, my watch consistently reported no evidence of atrial fibrillation, while also issuing a clear disclaimer that it could not detect signs of a heart attack.

Digital health technology is experiencing a period of unprecedented growth and innovation. The global digital health market is projected to expand from $309B in 2023 to $1,019B by 2032 with a Compound Annual Growth Rate (CAGR) of 12%. Europe is reportedly the largest market, while Asia Pacific is the fastest-growing region. Although many factors contribute to this significant market growth, advancements in robotics, artificial intelligence, and remote monitoring devices stand out as primary driving forces.