How do we approach integrating digital endpoint studies into health technology assessment?

INTRODUCTION: The integration of digital endpoints into Health Technology Assessment (HTA) marks a significant advancement in modern healthcare evaluation, especially in the context of post-pandemic growth in telehealth and remote patient monitoring. AREAS COVERED: Digital endpoints, which are defined by their use of sensor-generated data collected in non-clinical settings, provide a comprehensive, real-time view of patient health. This enhances the precision of HTA by uncovering nuanced aspects of disease burden and improving the evaluation of health technologies. Examples of digital endpoints include smartphone-based diagnostics for cognitive impairment and wearable devices that measure the impact of diseases, such as nocturnal activity in patients with sickle cell disease. Earlier diagnoses, and cost reductions in drug discovery, their integration into HTA faces challenges- data privacy, standardization, and methodological validation. EXPERT OPINION: This paper explores the potential of digital endpoints to revolutionize HTA by enabling more dynamic and patient-centered evaluations, underscoring the need for established frameworks and standards to guide their effective incorporation. Initiatives such as the Digi-HTA process and the Digital Endpoints Ecosystem and Protocols (DEEP) highlight emerging frameworks that could shape the future of digital health assessments, ultimately enhancing healthcare decision-making and policy. Collaborative efforts across healthcare, technology, and regulatory bodies are essential to overcome these barriers.