Patients and Stakeholders' Perspectives Regarding the Privacy, Security, and Confidentiality of Data Collected via Mobile Health Apps in Saudi Arabia: Protocol for a Mixed Method Study.

Background: There is data paucity regarding users' awareness of privacy concerns and the resulting impact on the acceptance of mobile health (mHealth) apps, especially in the Saudi context. Such information is pertinent in addressing users' needs in the Kingdom of Saudi Arabia (KSA).

Objective: This article presents a study protocol for a mixed method study to assess the perspectives of patients and stakeholders regarding the privacy, security, and confidentiality of data collected via mHealth apps in the KSA and the factors affecting the adoption of mHealth apps.

Methods: A mixed method study design will be used. In the quantitative phase, patients and end users of mHealth apps will be randomly recruited from various provinces in Saudi Arabia with a high population of mHealth users. The research instrument will be developed based on the emerging themes and findings from the interview conducted among stakeholders, app developers, health care professionals, and users of mHealth apps (n=25). The survey will focus on (1) how to improve patients' awareness of data security, privacy, and confidentiality; (2) feedback on the current mHealth apps in terms of data security, privacy, and confidentiality; and (3) the features that might improve data security, privacy, and confidentiality of mHealth apps. Meanwhile, specific sections of the questionnaire will focus on patients' awareness, privacy concerns, confidentiality concerns, security concerns, perceived usefulness, perceived ease of use, and behavioral intention. Qualitative data will be analyzed thematically using NVivo version 12. Descriptive statistics, regression analysis, and structural equation modeling will be performed using SPSS and partial least squares structural equation modeling.

Results: The ethical approval for this research has been obtained from the Biomedical and Scientific Research Ethics Committee, University of Warwick, and the Medical Research and Ethics Committee Ministry of Health in the KSA. The qualitative phase is ongoing and 15 participants have been interviewed. The interviews for the remaining 10 participants will be completed by November 25, 2023. Preliminary thematic analysis is still ongoing. Meanwhile, the quantitative phase will commence by December 10, 2023, with 150 participants providing signed and informed consent to participate in the study.

Conclusions: The mixed methods study will elucidate the antecedents of patients' awareness and concerns regarding the privacy, security, and confidentiality of data collected via mHealth apps in the KSA. Furthermore, pertinent findings on the perspectives of stakeholders and health care professionals toward the aforementioned issues will be gleaned. The results will assist policy makers in developing strategies to improve Saudi users'/patients' adoption of mHealth apps and addressing the concerns raised to benefit significantly from these advanced health care modalities.

International Registered Report Identifier (irrid): DERR1-10.2196/54933.