Clinical Validation of Digital Healthcare Solutions: State of the Art, Challenges and Opportunities

Abstract

Digital health technologies (DHTs) at the intersection of health, medical informatics, and business aim to enhance patient care through personalised digital approaches. Ensuring the efficacy and reliability of these innovations demands rigorous clinical validation. A PubMed literature review (January 2006 to July 2023) identified 1250 papers, highlighting growing academic interest. A focused narrative review (January 2018 to July 2023) delved into challenges, highlighting issues such as diverse regulatory landscapes, adoption issues in complex healthcare systems, and a plethora of evaluation frameworks lacking pragmatic guidance. Existing frameworks often omit crucial criteria, neglect empirical evidence, and clinical effectiveness is rarely included as a criterion for DHT quality. The paper underscores the urgency of addressing challenges in accreditation, adoption, business models, and integration to safeguard the quality, efficacy, and safety of DHTs. A pivotal illustration of collaborative efforts to address these challenges is exemplified by the Digital Health Validation Center, dedicated to generating clinical evidence of innovative healthcare technologies and facilitating seamless technology transfer. In conclusion, it is necessary to harmonise evaluation approaches and frameworks, improve regulatory clarity, and commit to collaboration to integrate rigorous clinical validation and empirical evidence throughout the DHT life cycle.

Keywords: adoption challenges; clinical validation; digital health technologies; eHealth; empirical evidence; evaluation frameworks; healthcare digitalisation; innovation; patient care; technology transfer.

Figure 1

Study selection flow diagram. The figure illustrates the process by which articles were selected for inclusion in the study.

Figure 2

Results of the bibliometric analysis showing (a) the evolution of published papers indexed in PubMed by quartile and (b) the frequency of papers by scope.

Figure 3

Results of the visual analysis showing (a) the map of the frequency of papers by countries worldwide and (b) the word cloud of the more prominent keywords among all papers analysed.

Figure 4

Structure of the Digital Health Validation Center involving various entities, coordinated by the Scientific Coordinating Committee composed of a multidisciplinary team specialised in digital health and research methodology.

Figure 5

Graphic showing an adapted version of a Guidance and Impact Tracking System (GAITS) healthcare innovation cycle for a digital medicine solution at an early stage at risk due to excessive focus on technology and poor attention to aspects of the clinical domain. Purple: level 1–2, Initial idea and Co-Design; Blue: Proof of concept; Orange: Clinical validation. The Digital Health Validation Center provides support in 4 areas of DHT: Technology, regulation, market and clinical. The services offered includes co-creation and design for initial stages of maturity; proof-of-concept of DHT for initial tastes, and clinical validation through clinical trials including a larger number of participants and specific clinical endpoints.