Analysis of the Regulatory, Legal, and Medical Conditions for the Prescription of Mobile Health Applications in the United States, The European Union, and France

Abstract

Parina Hassanaly,1 Jean Charles Dufour2 1Aix Marseille Université, Inserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Marseille, France; 2Aix Marseille Université, APHM, Inserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Hop Timone, BioSTIC, Biostatistique et Technologies de l'Information et de la Communication, Marseille, FranceCorrespondence: Parina HassanalyAix Marseille Université, Faculté de Médecine, 27 Boulevard Jean Moulin, Marseille, 13005, FranceTel +33 491 324772Email parina.hassanaly@univ-amu.frIntroduction: Mobile health (mHealth) is now considered an important approach to extend traditional health services and to meet the growing medical needs. The prescribability of mHealth applications is a complex problem because it depends on a large number of factors and concerns a wide range of disciplines and actors in the industrial, health, normative, and regulatory domains.Objective: Our study correlated data from the scientific literature with data on regulatory developments in the United States, the European Union, and France with the aim of identifying the conditions for the prescription of mHealth applications.Methods: The search method adopted was the systematic literature review process by Brereton et al. All empirical evidence from the relevant fields of study was gathered and then evaluated to answer our predefined research questions. The WoS and PubMed databases were queried for the period between 1 January 1975 and 30 November 2020. A total of 165 articles (15 with a direct focus and 150 with an indirect focus on mHealth prescribing) were analyzed/cross-referenced. The ScienceDirect database was consulted to complement the collected data when needed. Data published by international and national regulatory bodies were analyzed in light of the scientific data obtained from the WoS, PubMed, and ScienceDirect databases.Results: The International Medical Device Regulators Forum has ensured the international structuring of the regulatory field in collaboration with participating countries. The creation and updating of databases have allowed the tracking of medical device versions/upgrades and incidents. The regulatory organizations of the United States, the European Union, and France are currently consulting healthcare personnel, manufacturers, and patients to establish evaluation criteria for usability and quality of instructions for use that take into consideration patients' level of literacy. These organizations are also providing support to manufacturers who wish to file marketing applications. Marketing, privacy, and cybersecurity measures are evolving with developments in technology and state cooperation policies. The prescription of mHealth applications will gain social acceptance only if consistency and coordination are ensured at all stages of the process: from pre-design, through verification of medical effectiveness, to ethical consideration during data collection and use, and on to marketing.Conclusion: The conditions for mHealth prescribability include the adaptation of international regulation by the different states, the state provision of marketing support, and the evaluation of mHealth applications. For mHealth to gain social acceptance, increased collaboration among physicians, manufacturers, and "information technology stakeholders†is needed. Once this is achieved, MHealth can become the cornerstone of successful health care reform.Keywords: national and international laws and regulations, medical device, evaluation of technologies, mHealth, prescription feasibility