The Impact of Regulatory Changes on the Development of Mobile Medical Apps
Mobile applications are being used to perform a wide variety of tasks in day-to-day life, ranging from checking email to controlling your home heating. Application developers have recognized the potential to transform a smart device into a medical device, by using a mobile medical application i.e. a mobile phone or a tablet. When initially conceived these mobile medical applications performed basic functions e.g. BMI calculator, accessing reference material etc.; however, increasing complexity offers clinicians and patients a range of functionality. As this complexity and functionality increases, so too does the potential risk associated with using such an application. Examples include any applications that provide the ability to inflate and deflate blood pressure cuffs, as well as applications that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy. If an unapproved mobile medical application is marketed by a medical device organization, then they face significant penalties such as receiving an FDA warning letter to cease the prohibited activity, fines and possibility of facing a criminal conviction. Regulatory bodies have finalized guidance intended for mobile application developers to establish if their applications are subject to regulatory scrutiny. However, regulatory controls appear contradictory with the approaches taken by mobile application developers who generally work with short development cycles and very little documentation and as such, there is the potential to stifle further improvements due to these regulations. The research presented as part of this paper details how by adopting development techniques, such as agile software development, mobile medical application developers can meet regulatory requirements whilst still fostering innovation.
Digital Object Identifier (DOI): doi.org/10.5281/zenodo.1124381Procedia APA BibTeX Chicago EndNote Harvard JSON MLA RIS XML ISO 690 PDF Downloads 1241
 B. Dolan. (2010). Timeline: The iPhone as medical tool. Available: http://mobihealthnews.com/2580/timeline-the-iphone-as-medical-tool/ (Accessed 03/11/15)
 Research2Guidance, "Fourth annual study on mHealth app publishing," Continua, Research2Guidance2014.
 J. G. Kahn, J. S. Yang, and J. S. Kahn, "‘Mobile’health needs and opportunities in developing countries," Health Affairs, vol. 29, pp. 252-258, 2010.
 A. K. Yetisen, J. L. Martinez-Hurtado, F. da Cruz Vasconcellos, M. C. E. Simsekler, M. S. Akram, and C. R. Lowe, "The regulation of mobile medical applications," Lab on a Chip, vol. 14, pp. 833-840, 2014.
 K. F. B. Payne, H. Wharrad, and K. Watts, "Smartphone and medical related App use among medical students and junior doctors in the United Kingdom (UK): a regional survey," BMC medical informatics and decision making, vol. 12, p. 121, 2012.
 O. I. Franko, "How Helpful Are Mobile Healthcar Apps?" AAOS Now, vol. 7, 2013.
 FDA. (2013, 27/10/15). Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer.
 A. J. Barton, "The regulation of mobile health applications," BMC medicine, vol. 10, p. 46, 2012.
 D. J. Reifer, "How good are agile methods?" Software, IEEE, vol. 19, pp. 16-18, 2002.
 M. McHugh, O. Cawley, F. McCaffery, I. Richardson, and X. Wang, "An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan-Driven Software Development Lifecycles," presented at the Software Engineering in Healthcare (SEHC) workshop at the 35th International Confernence on Software Engineering (ICSE), San Francisco CA, 2013.
 R. Rasmussen, T. Hughes, J. R. Jenks, and J. Skach, "Adopting Agile in an FDA Regulated Environment," presented at the Agile Conference, 2009 AGILE '09 Chicago, IL 2009.
 P. A. Rottier and V. Rodrigues, "Agile Development in a Medical Device Company," presented at the Proceedings of the 11th AGILE Conference. AGILE '08., Toronto, 2008.
 P. T. H. Kim, "FDA and the regulation of medical software," presented at the Sixth Annual IEEE Symposium on Computer-Based Medical Systems, Michigan, 1993.
 FDA, "21 CFR Part 880 Medical Devices; Medical Device Data Systems Final Rule.," Federal Register vol. 76, pp. 8637 - 8649, 2011.
 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, 2004.
 FDA, "Title 21--Food and Drugs Chapter I --Food and Drug Administration Department of Health and Human Services subchapter h--Medical Devices part 820 Quality System Regulation," U.S. Department of Health and Human Services, Maryland2007.
 FDA, "FDA Design Control Guidance for Medical Device Manufacturers," Centre for Devices and Radiological Health, Maryland1997.
 FDAMA §114; 21 USC 352(a). 1997.
 AAMI, "ANSI/AAMI/IEC 62304, Medical device Software - Software life cycle processes," ed. Association for the Advancement of Medical Instrumentation, 2006.
 ISO, "ISO/IEC 14971:2012 Medical devices -- Application of risk management to medical devices," International Organisation for Standards, Geneva, Switzerland 2012.
 ISO, "ISO/IEC 13485:2012 Medical devices -- Quality management systems -- Requirements for regulatory purposes," ed. International Organisation for Standards - Geneva, Switzerland, 2012.
 Guidance for Industry, Third parties annd Food and Drug Administration Staff, Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program, 2012.
 S. Miura, "Industry Viewpoint on software," presented at the 11th Conference of the Global Harmonization Task Force, Washington, 2007.
 ISO, "ISO/IEC 12207 Information technology -- Software life cycle processes," International Organisation for Standards, Geneva, Switzerland1995.
 ISO, "ISO 12207:1995/AMD1:2002 Information technology - Software life cycle processes AMENDMENT 1," International Standards Organisation, Geneva Switzerland2002.
 ISO, "ISO 12207:1995/AMD2:2004 Information technology - Software life cycle processes AMENDMENT 2," International Standards Organisation, Geneva Switzerland2004.
 ISO, "ISO/IEC 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes," ed. International Organisation for Standards - Geneva, Switzerland, 2003.
 ISO, "ISO/IEC 14971:2007 Medical devices -- Application of risk management to medical devices," International Organisation for Standards, Geneva, Switzerland 2007.
 ISO, "ISO/IEC 15288:2008 Systems and software engineering -- System life cycle processes," International Organisation for Standards, Geneva, Switzerland2008.
 European Council, "Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Publication of titles and references of harmonised standards under the directive)," European Council, EU Bookshop2010.
 C. Gerber. (2008). Introduction into IEC 62304 Software life cycle for medical devices. Available: http://www.spiq.com/abs/JF200809IEC62304 SPIQ Rev004.pdf (Accessed 10/10/2015)
 AAMI, "AAMI IEC TIR 80002-1:2009 Medical Device Software - Part 1: Guidance on the Application of ISO 14971 To Medical Device Software," Ed, 2009.
 FDA, "Guidance for Industry and Food and Drug Administration - Mobile Device Applications," Centre for Devices and Radiological Health, Maryland2015.
 FDA, "21 CFR Part 803 Medical Device Reporting," Federal Register vol. 79, pp. 8846-8855, 2014.
 FDA, "21 CFR Part 806 Medical Devices; Reports of Corrections and Removals," Federal Register vol. 8, 2015.
 FDA, "21 CFR Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices," Federal Register vol. 8, 2010.
 P. Bakul, "The Regulatory Perspective: Q&A with FDA's Bakul Patel," Biomedical Instrumentation & Technology, vol. 46, pp. 84-86, 2012.
 F. McCaffery, D. McFall, P. Donnelly, and F. G. Wilkie, "Risk Management Process Improvement for the medical device industry," presented at the Conference on Software Development (SWDC-REK-2005) Iceland, 2005.
 K. Forsberg and H. Mooz, "The Relationship of Systems Engineering to the Project Cycle," presented at the First Annual Symposium of the national Council on Systems Engineering (NCOSE), Chattanooga, Tennessee, 1991.
 W. Royce, "Managing the Development of Large Software Systems," presented at the Proceedings of IEEE WESCON, 1970.
 P. E. Rook, "Controlling software projects," IEEE Software Engineering Journal, vol. 1, p. 7, 1986.
 S. L. Pfleeger and J. M. Atlee, Software Engineering: Theory and Practice. New Jersey: Pearson Higher Education, 2001.
 V. Casey and F. McCaffery, "Med-Trace: Traceability Assessment Method for Medical Device Software Development.," presented at the European Systems & Software Process Improvement and Innovation Conference, (EuroSPI). Roskilde, Denmark, 2011.
 J. Cadle and D. Yeates, Project Management for Information Systems: Pearson Education, 2008.
 N. M. A. Munassar and A. Govardhan, "A Comparison between Five Models of Software Engineering," IJCSI International Journal of Computer Science Issues, vol. 7, pp. 94-101, 2010.
 VersionOne, "8th Annual State of Agile Survey: The State of Agile Development," 2013.
 VersionOne, "7th Annual State of Agile Survey: The State of Agile Development," 2012.
 VersionOne, "6th Annual State of Agile Survey: The State of Agile Development," 2011.
 Beck et al. (2001). The Agile Manifesto. Available: http://agilemanifesto.org/ (Accessed 7/8/2015)
 R. C. Martin, Agile Software Development - Principles, Patterns and Practices. Upper Saddle River, NJ: Prentice Hall, 2003.
 AAMI, "AAMI TIR45:2012 -- Guidance on the use of agile practices in the development of medical device software," Association for the Advancement of Medical Instrumentation, Arlington VA2012.
 D. Vogel, "Agile Methods: Most are not ready for prime time in medical device software design and development," DesignFax Online, vol. 2006, 2006.
 D. Turk, R. France, and B. Rumpe, "Limitations of Agile Software Processes," presented at the Third International Conference on Extreme Programming and flexible processes in Software Engineering (XP2002), Alghero, Sardinia, 2002.
 J. W. Spence, "There has to be a better way!
[software development]," presented at the Proceedings to Agile Conference, 2005. Denver, 2005.
 K. Weyrauch, "What Are We Arguing About? A Framework for Defining Agile in our Organization," presented at the Proceedings of the conference on AGILE 2006, 2006.
 L. Weiguo and F. Xiaomin, "Software Development Practice for FDA-Compliant Medical Devices," presented at the International Joint Conference on Computational Sciences and Optimization, 2009. Sanya, Hainan, 2009.