Challenges in collecting evidence for the safe use of digital health solutions

Abstract

Digital health technologies (DHT) include a wide range of different products used in the health and social care system (applications, software and online platforms), and may be intended for the benefit of the personal care or health and social care system. Since digital interventions have become an integral part of patient care, the need for clinical validation and prescribed regulation of the same within healthcare systems has been imposed. Despite the increasingly rapid efforts in digital transformation of healthcare, it is still a challenge to produce solid evidence for most digital healthcare solutions in a timely and cost-effective manner. For many digital solutions that are currently applied, evidence of the benefits of these tools does not exist or has not been publicly presented. Taking into account the complexity of health systems, cost and duration of traditional approaches for providing evidence of the effectiveness of medical products (which also includes part of digital health applications), it is necessary to work together on methods and tools that are acceptable to innovators and all other stakeholders in the health system, and to provide material and other resources necessary to consider all aspects essential for the effective and safe implementation of digital health technologies.