Konstantinos Manikas
ABSTRACT
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.
- M. Anvaari and S. Jansen. Evaluating architectural openness in mobile software platforms. In Proceedings of the Fourth European Conference on Software Architecture: Companion Volume, ECSA '10, pages 85--92, New York, NY, USA, 2010. ACM. Google Scholar
Digital Library
- Apple App Store. Health & fitness - app store downloads on itunes. https://itunes.apple.com/us/genre/ios-health-fitness/, Accessed 2013-11-25, 2013.Google Scholar
- Australian Government Department of Health and Ageing - Therapeutic Goods Administration. Australian medical devices guidance document number 35 -- device - medicine boundary products, 2005.Google Scholar
- Council of the European Union. COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities, 2014.Google Scholar
- European Commission. What process does a medical device have to follow to be placed on the market? http://ec.europa.eu/health/medical-devices/faq/market_en.htm, 2014.Google Scholar
- Happtique. Registry statement. http://www.happtique.com/app-certification/registry-statement/, 2014.Google Scholar
- A. Holzer and J. Ondrus. Mobile application market: a developer's perspective. Telematics and Informatics, 28(1):22--31, 2011. Google ScholarDigital Library
- S. Hyrynsalmi, T. Mäkilä, A. Järvi, A. Suominen, M. Seppänen, and T. Knuutila. App store, marketplace, play! an analysis of multi-homing in mobile software ecosystems. In Proceedings of the International Workshop on Software Ecosystems, page 59, 2012.Google Scholar
- S. Hyrynsalmi, A. Suominen, T. Mäkilä, A. Järvi, and T. Knuutila. Revenue models of application developers in android market ecosystem. In Software Business, pages 209--222. Springer, 2012.Google Scholar
- A. Idu, T. van de Zande, and S. Jansen. Multi-homing in the apple ecosystem: why and how developers target multiple apple app stores. In Proceedings of the International Conference on Management of Emergent Digital EcoSystems, pages 122--128. ACM, 2011. Google ScholarDigital Library
- iMedical Apps. After happtique's recent setback, is there a future for app certification? http://mobihealthnews.com/28165/happtique-suspends-mobile-health-app-certification-program/, 2014.Google Scholar
- S. Jansen and E. Bloemendal. Defining app stores: The role of curated marketplaces in software ecosystems. In Software Business. From Physical Products to Software Services and Solutions, pages 195--206. Springer, 2013.Google Scholar
- Mobile Helath News. Happtique suspends mobile health app certification program. http://mobihealthnews.com/28165/happtique-suspends-mobile-health-app-certification-program/, 2014.Google Scholar
- NHS choices health apps library. Review Process. http://apps.nhs.uk/review-process/, Accessed 2014-06-10, 2014.Google Scholar
- G. G. Parker and M. W. Van Alstyne. Two-sided network effects: A theory of information product design. Management Science, 51(10):1494--1504, 2005. Google ScholarDigital Library
- J.-C. Rochet and J. Tirole. Platform competition in two-sided markets. Journal of the European Economic Association, 1(4):990--1029, 2003.Google ScholarCross Ref
- C. Shapiro and H. Varian. Information Rules: A Strategic Guid. Harvard Business Press, 1998. Google ScholarDigital Library
- Steering Committee on the Usability, Security, and Privacy of Computer Systems, Computer Science and Telecommunications Board, Division on Engineering and Physical Sciences, National Research Council. Toward Better Usability, Security, and Privacy of Information Technology: Report of a Workshop. National Academies Press, 2010.Google Scholar
- The National Patient Safety Agency. Healthcare risk assessment made easy, 2007.Google Scholar
- The Washington Post. FDA approves iPhone, iPad app for docs. http://voices.washingtonpost.com/checkup/2011/02/fda_oks_iphones_ipads_for_radi.html, Accessed 2014-06-10, 2014.Google Scholar
- U.S. Department of Health and Human Services -- Food and Drug Administration. Mobile medical applications -- guidance for industry and food and drug administration staff. http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf, Accessed 2014-06-10, 2013.Google Scholar
- U.S. Department of Health and Human Services -- Food and Drug Administration. Medical Device Reporting for Manufacturers. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094529.htm, Accessed 2014-06-10, 2014.Google Scholar
- U.S. Department of Health and Human Services -- Food and Drug Administration. Quality System (QS) Regulation/Medical Device Good Manufacturing Practices. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm, Accessed 2014-06-10, 2014.Google Scholar
- R. Xia, M. Rost, and L. E. Holmquist. Business models in the mobile ecosystem. In Mobile Business and 2010 Ninth Global Mobility Roundtable (ICMB-GMR), 2010 Ninth International Conference on, pages 1--8. IEEE, 2010. Google ScholarDigital Library
Index Terms
- Governance Mechanisms for Healthcare Apps
Recommendations
App store governance: Implications, limitations, and regulatory responses
AbstractEvents such as the riot at the United States Capitol and tightening constraints on the Russian public sphere have highlighted the socio-political significance of app store governance. This is dominated by Apple and Google as operators ...
Highlights- App store governance is an important, understudied aspect of digital governance.
Comments