Integrating Patient Perspectives Into the Digital Health Technology Readiness Framework: Delphi Study.

Background: Digital health technologies-including mobile applications, telemedicine platforms, artificial intelligence, and eHealth tools-are transforming health care delivery by enhancing access, personalization, and efficiency. However, traditional technology readiness levels (TRLs), while widely used to assess technological maturity, do not explicitly account for patient involvement-an essential factor in usability, acceptability, and real-world effectiveness. Objective: This study aimed to integrate patient perspectives into the TRLs framework, specifically tailoring it for applications in digital health innovations. By developing a patient-centered dimension using a Delphi methodology, this study provides actionable insights to enhance usability, acceptance, and real-world effectiveness of digital health technologies such as mHealth apps, telemedicine platforms, and eHealth solutions. Methods: A Delphi methodology was applied, involving 24 Spanish-speaking experts from diverse disciplines, including patient advocacy, clinical care, public health, ethics, and digital health engineering. Experts evaluated patient involvement statements across 10 TRL stages using a 6-point Likert scale. Consensus was defined a priori as ≥75% agreement and a mean score of ≥4.5. The Delphi process included 2 iterative rounds, allowing for refinement of the content despite initial consensus. Results: The Delphi process finally included 2 rounds, achieving a final 83.3% participation rate (20 of 24 experts). In round 1, all 10 TRL statements reached the predefined consensus threshold, with median scores ranging from 5.0 to 6.0 (83.3% to 100%) and mean scores from 4.70 (TRL2, 78.3%) to 5.25 (TRL5, 87.5%). While consensus was achieved, the presence of variability and qualitative feedback-particularly in early-stage TRLs such as TRL2 (Idea)-motivated a second round for refinement. In round 2, revised statements incorporating expert feedback were re-evaluated. Agreement increased across all TRLs, with mean scores ranging from 5.00 (TRL2, 83.3%) to 5.65 (TRL5, 94.2%). In total, 4 TRLs (TRL3, TRL4, TRL5, and TRL10) received a median of 6.0, indicating a unanimous strong agreement. Key refinements included more precise patient roles in usability testing, co-creation, clinical protocol design, and implementation monitoring. The framework also integrates patient-reported experience measures and patient-reported outcome measures in TRLs 5, 7, and 8. Conclusions: The PULSO-Tech-Clinic (Patient Participation, User/Usability, Literacy, System, and Observatory) Model is the first framework to systematically embed patient perspectives within the TRLs. Although consensus was achieved in the first round, a second round allowed for methodological rigor and optimization of clarity and inclusivity. This validated model enhances alignment with real-world patient needs and supports the design, evaluation, and adoption of patient-centered digital health technologies. Further research should evaluate its adaptability in diverse health care systems.