Digital diagnostics, biomarkers and therapeutics in an evolving healthcare system: From promise to practice.

Health care is shifting towards a digital-guided system, integrating digital diagnostics, biomarkers and therapeutics in many care pathways. However, despite rapid technological advancement and preliminary adoption accelerated by the COVID-19 pandemic, a significant implementation gap persists. This narrative review explores the causes of this gap, highlighting several examples from early development to final implementation. These show that technical validation alone is insufficient. Success depends on alignment with clinical need, robust external validation, patient empowerment and sustainable funding models. Furthermore, other systemic barriers include data privacy concerns and lack of transparency by commercial companies. To improve adoption and translate promise to practice, more international alignment of regulations and international collaboration is needed. Lessons must be learned from promising initiatives that did not reach clinical care, as much as from their successful counterparts. Ultimately, a comprehensive redesign of healthcare will be undertaken, with digital diagnostics and therapeutics both embedded as critical components rather than add-ons. This demands a multi-stakeholder effort involving governments, regulatory bodies, insurance providers, industry, research funders, hospital leadership, clinicians and, most importantly, patients.