Twenty years ago, Frank Westermann was diagnosed with type‑1 diabetes and quickly realised that managing the condition meant making dozens of life‑or‑death decisions every day. The emergence of smartphones gave him a way to collect and analyse the data that underpin those decisions. In 2012 he co‑founded mySugr, an app that helps people with diabetes manage their condition more easily. Headquartered in Vienna, mySugr grew from four founders to more than thirty people and accumulated roughly 800,000 users, 55 % in the United States and 40 % in Europe. The team even opened an office in San Diego to be closer to its U.S. community.
Westermann’s experience illustrates Europe’s promise and its shortcomings in digital health. Europe’s regulatory framework for medical devices is relatively permissive, so it is often easier to bring a new product to market than in the United States. However, the cultural climate is markedly different. Investors and doctors on the continent tend to focus on risks and data‑security concerns instead of potential benefits. Raising a ten‑to‑twenty‑million‑dollar round from European venture capitalists is much harder than from their Californian counterparts. Clinicians in Austria and Germany, for example, often see digital tools as threats to patient safety or their own livelihoods and have little incentive to learn how the technologies work.
Another obstacle is fragmentation. Whereas the U.S. Food and Drug Administration provides a single set of guidelines for the entire country, health care in Europe is governed by dozens of national systems. Germany alone has more than a hundred statutory insurers and a handful of private payers. A company wishing to roll out a digital service across the continent must navigate myriad reimbursement rules and procurement processes, while American start‑ups can concentrate on a single, large market. The U.S. also benefits from proximity to Silicon Valley and other technology clusters and still leads in innovations such as continuous glucose monitoring.
Europe’s problem is not regulation. It is an attitude. If Europe wants to be a global champion in health innovation, policy‑makers, physicians and investors have to prioritise digital transformation. A unified health authority would simplify compliance and reimbursement. More importantly, a mindset shift is required. European societies need to embrace the notion that digital tools can relieve overstretched health systems, empower clinicians and improve patients’ quality of life. Until that happens, promising companies will continue to leave for markets that value their work.