JMIR Publications

ABSTRACT

Background:

Digital health technology (DHT) has the potential to revolutionize the healthcare industry by reducing costs and improving the quality of care in a sector that faces significant challenges. However, the healthcare industry is complex, involving numerous stakeholders, and subject to extensive regulation. Within the European Union, medical device regulations impose stringent requirements on various ventures. Concurrently, new reimbursement pathways are also being developed for DHTs. In this dynamic context, establishing a sustainable and innovative business model around DHTs is fundamental for their successful commercialization. However, there is a notable lack of structured understanding regarding the overarching business models within the digital health sector.

Objective:

This study aims to address this gap and identify key elements and configurations of business models for DHTs in the European Union, thereby establishing a structured understanding of the archetypical business models in use.

Methods:

The study was conducted in two phases. First, a business model taxonomy for DHTs was developed based on a systematic literature review, the analysis of 169 European real-world business models, and qualitative evaluation through 13 expert interviews. Subsequently, a two-step cluster analysis was conducted to identify business model archetypes.

Results:

The developed taxonomy of DHT business models revealed 11 central dimensions organized into 4 meta-dimensions. Additionally, 6 archetypes of DHT business models were identified: Administration and Communication Supporter (A1), Insurer-to-Consumer Digital Therapeutics and Care (A2), Diagnostic and Treatment Enabler (A3), Professional Monitoring Platforms (A4), Clinical Research and Solution Accelerators (A5), Direct-to-Consumer Wellness and Lifestyle (A6).

Conclusions:

The findings highlight the critical elements constituting business models in the DHT domain, emphasizing the significant impact of medical device regulations and revenue models, which often involve reimbursement from stakeholders such as health insurers. Three drivers contributing to DHT business model innovation were identified: targeting patients and private individuals directly, using artificial intelligence as an enabler, and DHT-specific reimbursement pathways. The study also uncovered surprising business model patterns, including shifts between regulated medical devices and unregulated research applications, as well as wellness and lifestyle solutions. This research enriches the understanding of business models in digital health, offering valuable insights for researchers and digital health entrepreneurs.