Regulatory standards and guidance for the use of health applications for self-management in Africa: scoping review protocol

Introduction: Despite health applications becoming ubiquitous and with enormous potential to facilitate self-management, regulatory challenges such as poor application quality, breach of data privacy and limited interoperability have impeded their full adoption. While many countries now have digital health-related policies/strategies, there is also a need for regulatory standards and guidance that address key regulatory challenges associated with the use of health applications. Currently, it is unclear the status of countries in Africa regarding regulatory standards and guidance that address the use of health applications. This protocol describes the process of conducting a scoping review which aims to investigate the extent to which regulatory standards and guidance address the use of health applications for self-management within the WHO African Region countries. Methods: The review will follow the methodological framework for conducting a scoping study by Arksey and O’Malley (2005), and the updated methodological guidance for conducting a Joanna Briggs Institute (JBI) scoping review. Given that regulatory standards and guidance are unlikely to be available in scientific databases, we will search Scopus, Google, OpenGrey, WHO Regional Office for Africa Library (AFROLIB), African Index Medicus (AIM), websites of WHO, ITU and Ministries of Health, repositories for digital health policies. We will also search the reference lists of included documents, and contact key stakeholders in the region. Results will be reported using descriptive qualitative content analysis based on the review objectives. The policy analysis framework by Walt and Gilson (1994) will be used to organise findings. A summary of the key findings will be presented using tables, charts and maps. Ethics and dissemination: The collection of primary data is not anticipated in this study and hence ethical approval will not be required. The review will be published in a peer-reviewed journal while key findings will be shared with relevant organisations and/or presented at conferences

Assessment of clinical information quality in digital health technologies: an international eDelphi study

Background: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs. Objective: This study explored clinicians’ perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework. Methods: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions. Results: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity. Conclusions: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care