Guidelines for Regulating or Rating Mental Health Mobile Applications: A Systematic Review (Preprint)

BACKGROUND Increasing number of mobile applications (apps) have been released to the market to address mental health needs; however, their quality varies. Mental health professionals have been advocating to set up regulating policies or rating guidelines to facilitate users to make informed choice. OBJECTIVE The study aims to map out the landscape and ecosystem of existing regulating policies and rating guidelines concerning mental health apps, streamline core rating criteria, and identify what knowledge and policy gaps exist. METHODS A systematic review was conducted on both English and Chinese literature. Not only academic publication databases but also popular search engines were searched to identify relevant policies or guidelines. Eligible publications were analyzed to identify key stakeholders in the ecosystem of regulating and rating mental health apps, and common approaches and criteria of the regulating or rating. What limitations exist and what improvement should be achieved in order to make good use of mental health apps were then discussed. RESULTS 56 articles were found to meet our inclusion criteria, covering 31 sets of regulating policies, rating protocols, or specific recommendations. Key stakeholders include app developers, governments, app stores, mental health professionals, and individual users. Only very few countries have released specific regulation policies for mental health apps, whereas app stores were almost absent on this matter. Mental health professionals have been advocating to set up rating guidelines but they did not always engage app developers or ordinary users. Regulation approach is to extend existing regulations on medical devices to mental health apps that self-claim for medical use. Quality rating approach is using either a checklist or a scoring scheme to rate mental health apps’ compliance with some criteria. Specific criteria include privacy and data protection, protecting user safety and minimize risks, evidence-based, usability and front-end accessibility, system interoperability, technical stability, cost, and information timeliness. CONCLUSIONS Only very few jurisdictions and professional organizations in the world have released regulating policies or rating guidelines on mental health apps, which can serve as a basis for other policymakers and professional organizations to adapt. The current regulating policies are rather vague with their applicable scope, whereas the current rating guidelines have relatively high requirement with raters’ capability. Future development needs to address the two major limitations. CLINICALTRIAL Nil.