Digital health entrepreneurship in Latin America: a systematic review of evidence, challenges, and lessons learned

Objective This systematic review aimed to identify and synthesize the scientific evidence on entrepreneurship in digital health in Latin America. Specifically, it sought to characterize the available evidence, identify the countries and types of digital health entrepreneurship investigated, examine the principal challenges and barriers, and synthesize the conclusions and lessons learned reported in the literature. Methods The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. A systematic search was conducted in Scopus on August 20, 2026, without publication-year restrictions. The search combined terms related to entrepreneurship, digital health, and innovation. Studies addressing entrepreneurial activities or initiatives associated with digital health in Latin America were considered eligible. The geographic scope was determined using the OECD classification of Latin American countries. Two research groups independently conducted the screening process. Evidence was synthesized qualitatively because of substantial heterogeneity in countries, technologies, entrepreneurial initiatives, and study contexts. Results The search identified 417 records, of which 17 remained after applying the geographic criterion. Thirteen full-text articles were retrieved and assessed for eligibility, and 10 studies were included in the final synthesis. Evidence was strongly concentrated in Brazil, with limited representation from other Latin American countries. The studies examined diverse forms of entrepreneurship, including startups, corporate innovation, business models, technological initiatives, and multisectoral collaborations. Major challenges included inadequate infrastructure and connectivity, cybersecurity, interoperability, regulatory barriers, limited financial resources, shortages of skilled personnel, organizational resistance, digital literacy, and user trust. Conclusion Digital health entrepreneurship in Latin America is an emerging and heterogeneous field. Its development requires coordinated technological, organizational, regulatory, financial, and social conditions. Further research should address underrepresented countries and evaluate long-term sustainability, scalability, economic performance, healthcare outcomes, and regulatory determinants.