Different approaches to regulate digital health applications in seven European countries

Abstract

Abstract Background Demographic ageing, shortages in health workforce and increased use of digital tools in daily life kindle decision makers’ interest to utilize digital health applications (DHA). While there are several reviews that provide an overview across remuneration frameworks, no synthesis between additional regulatory aspects and frequency of remuneration approval has been conducted. Methods European countries with either strong status in digital health in general or regulation for health apps in particular were chosen for analysis (BE, DK, DE, EE, EN, FR, NL). Country specific information was collected from scientific and grey literature, legal and stakeholder webpages. Semi-structured interviews were conducted with country experts via video call or e-mail and analyzed using Mayring’s structured, qualitative content analysis. Preliminary results We find three approaches concerning DHT-definitions: For BE, DE, FR, specific regulations define national remuneration requirements. EN and NL define only minimum requirements while decentralized payors make financing decisions. DK and EE fit DHTs into existing financing schemes. Among countries with a national financing framework, DE achieved the largest number of approvals, followed by FR, while BE has not yet issued a (lasting) financing approval. Evaluation requirements focus on clinical and economic outcomes, largely ignoring non-clinical improvements for patients. Conclusions The German regulation stands out with a peculiar definition that might help clarify evaluation criteria, increase the number of financing approvals but also empower patients while reducing the role of health workforce in their application. BE and NL regulations necessitate involvement of health workers, thus addressing structurally different applications. Key messages • Drawing lessons for DHT regulations across countries needs to address differences in national definitions and evaluation criteria. • A standardization system for DHT may help to speed utilization of effective tools and clarify evaluation requirements.