Digital health has moved beyond early pilot projects and into partial real-world use .AI tools now support clinical workflows. Hospitals provide acute care at home. Digital therapeutics have shown clinical value. Decentralized tools Decentralized tools are being used in clinical trials, mostly in hybrid designs,and national networks exchange health records at scale.
However, adoption does not guarantee commercial success. Generative AI lacks a clear regulatory path. Digital therapeutics struggle to secure insurance coverage. Hospital-at-home programs built on remote patient monitoring can lose money despite improving patient outcomes. Decentralized trials remain concentrated in low-risk studies. Health data networks still struggle to write information back into clinical systems.
This report examines these five areas using evidence from regulatory decisions, clinical studies, patents, company announcements, funding rounds, acquisitions, and health system deployments.
295
AI and machine-learning medical devices cleared by the FDA in 2025.
50%
of remote-monitoring alerts were filtered by a centralized virtual operations center before reaching frontline staff.Â
1 Billion+
documents exchanged through the national TEFCA health data network.
What’s Inside the Report?
AI-Native Clinical Decision Support :See where AI is producing measurable results in sepsis detection, medical documentation, and speed gains in radiology. The report also examines FDA review routes, legal liability, product recalls, EHR competition, and the regulatory gap facing generative AI tools.
Digital Therapeutics :Understand why clinically tested products still struggle to gain coverage. Compare prescription-based models with enterprise contracts and examine the approaches taken by Pear Therapeutics, Akili, DarioHealth, Omada Health, Novo Nordisk, Sanofi, and Takeda.
Continuous Remote Patient Monitoring : Review the clinical and financial performance of hospital-at-home programs. Explore wearable accuracy, alert fatigue, payer restrictions, program shutdowns, and why centralized care teams may be more valuable than adding more sensors.
Decentralized Clinical Trials and Health Data Infrastructure :Examine how ICH E6(R3), FDA guidance, trial software platforms, TEFCA, FHIR, cloud services, and patient identity systems are shaping digital trials and connected care. See where technical access has improved and where workflow integration remains limited.
These findings help healthcare companies decide where to invest, pilot, partner, acquire, monitor, or wait. The report separates working deployments from early claims and identifies opportunities where regulatory routes exist but commercial services remain limited.
