Governance Mechanisms for Healthcare Apps

The introduction of the `app store' concept has challenged the way software is distributed and marketed: developers have easier access to customers, while customers have easy access to innovative applications. Apps today are increasingly focusing on more \"mission-critical\" areas like healthcare with the Apple AppStore counting more than 40,000 apps under the category \"health & fitness\". This rapid development of healthcare apps increases the necessity of governance as, currently, healthcare apps are not thoroughly governed. The U.S. Food and Drug Administration and the European Commission only have policies for apps that are medical devices. In this paper, we approach the problem of how to govern healthcare and medical apps by addressing the risks the use of these apps pose, while at the same time inviting for development of new apps. To do so we (i) analyze four cases of healthcare app governance/regulation, (ii) propose the analysis of the app governance from three perspectives: aim, impact, and revenues, (iii) apply the proposed analysis in the app of the healthcare domain, and (iv) identify the governing actors and propose governance policies.