New approaches to evaluate digital solutions with clinical value

Evidence required for digital health solutions that claim a clinical benefit and require regulatory approval is complex and differs from the evidence needed for drug therapies

Digital health companies need to cultivate an innovative yet pragmatic evidence generation culture

Leveraging data generation methods such as clinical simulation, observational studies using real-world data, and platform trials will help accelerate the impact of quality digital health solutions

Evaluating digital health solutions with clinical value (healthcaretransformers.com)