Pilot Study of Digital Health Technologies for Managing Low Back Pain: Digital Therapeutics Value Assessment in South Korea

OBJECTIVES: The Digital Therapeutic (DTx) Evaluation Toolkit was established by the Digital Therapeutics Alliance (DTA) to provide a common language and process for decision-makers and DTx manufacturers to jointly use through DTx product evaluation and implementation processes. This study aims to present the operationalization and piloting of the value framework in the South Korea DTx ecosystem.

METHODS: This work was carried out collaboratively with a variety of stakeholders. Three sequential phases were undertaken: (1) Quick validation of the evaluation framework on the local market and implementation, (2) piloting of the evaluation criteria through applying the framework on low back pain digital technologies, (3) validation of the result on the value evaluation, where usefulness and implementation aspects of the framework were assessed.

RESULTS: The advisory board of Digital therapeutics conducted the framework's operationalization. They highlighted the need to improve ambiguous distinct among criteria, and the potential for added complexity. The value framework was applied in a technical document on low back pain management digital technology. The result showed that the ‘Clinical Impact’ was the highest priority criteria, while the ‘DTx Product Technical Consideration’ was the lowest. This is consistent with the view that it is difficult to clearly describe and verify the process of cognitive behavioral therapy interventions and the implementation of AI algorithms in technologies used for therapeutic interventions.

CONCLUSIONS: This study has shown that different technologies can have diverse priorities for consideration, reflecting the need to consider technology-specific importance when assessing value evaluation.