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Quality Factors for Mobile Medical Apps _________________________________________________________________________________________________________________Proceedings of the Central European Conference on Information and Intelligent Systems 229 Quality Factors for Mobile Medical Apps Nadica Hrgarek Lechner Vjeran Strahonja MED-EL Elektromedizinische Geräte GmbH Faculty of Organization and Informatics Fürstenweg 77, 6020 Innsbruck, Austria Pavlinska 2, 42000 Varaždin, Croatia [email protected] [email protected] Abstract. The increased use of mobile phones, less in healthcare. According to a report from the smartphones, tablets, and connected wearable devices business consulting firm Grand Review Research, Inc. has fostered the development of mobile medical (2016), the global connected health and wellness applications (apps) in the last few years. Mobile devices market is expected to reach USD 612.0 billion medical apps are developed to extend or replace some by 2024. existing applications that run on a desktop or laptop The results of the sixth annual study on mobile computer, or on a remote server. health app publishing done by research2guidance If mobile apps are used, for example, to diagnose, (2016) are based on 2,600 plus respondents who mitigate, treat, cure, or prevent human diseases, participated in the online survey. As displayed in Fig. patient safety is at potential risk if the apps do not 1, remote monitoring, diagnostic, and medical function as intended. Therefore, such apps need to be condition management apps are the top three mHealth cleared, approved, or otherwise regulated in order to app types offering the highest market potential in the protect public health. next five years. In 2016, 32% of total respondents There are many papers that have been published predicted remote monitoring apps as the app category about the quality attributes of mobile apps. Less is that offers the highest market potential for mobile known about quality factors of mobile medical apps. health apps in five years’ time. In this paper we provide key definitions and examples 60% of regulated mobile medical apps, and identify factors 53% that influence the quality of mobile medical apps. 50% 38% 40% 35% 32%32% 32% 31% 31%30% 29% 29%28% Keywords. quality attributes, quality factors, medical 30% 26% 22% 22% device software, mHealth, mobile medical apps 20% 10% 0% Remote Remote Diagnostic apps Medical Patient health 1 Introduction monitoring apps consultation condition record apps apps management apps Consumer demand for wearable medical devices and 2014 2015 2016 personal monitoring devices continues to rise. The results of research2guidance’s (2015) annual study with 5,009 respondents indicate that 85% of mobile Figure 1. mHealth app types offering the highest health practitioners rate smartphones as a primary market potential in the next 5 years target device. Fox & Duggan (2012) summarized the (research2guidance, 2014-2016) results of a survey of 3,014 adults living in the United States. They found that 52% of smartphone owners Typical users of mobile medical apps are health use their devices to get health information and 19% of care providers and patients. Although mobile devices them have at least one health app on their phone (e.g., and apps provide many benefits for healthcare exercise, fitness, heart rate monitoring, diet, calorie professionals such as convenience, better clinical counter, weight apps, etc.). decision-making, improved accuracy, increased According to Business Insider (“Internet of Things efficiency, and enhanced productivity (Ventola, in healthcare: Information technology in health”, 2014), there are still some challenges that need to be 2016), 646 million IoT (Internet of Things) devices addressed. The following are some of challenges (not including wearable devices such as fitness facing users using mobile medical apps: concerns trackers) will be used for healthcare by 2020. The related to false claims in app stores, concerns about Deloitte Center for Health Solutions (2016) identified app quality, safety, security, privacy, availability, and biosensors in wearables and medical devices as one of training. Aungst et al. (2014) emphasized that ten innovations that will most likely achieve more for clinicians seeking to identify mobile medical applications for use in their individual practice should _________________________________________________________________________________________________________________ 28th CECIIS, September 27-29, 2017, Varaždin, Croatia _________________________________________________________________________________________________________________230 Proceedings of the Central European Conference on Information and Intelligent Systems use a combination of app stores, published literature, and no installation through app stores is required. web-based resources, and personal review to ensure However, they have limited access to the device safe and appropriate use. Hanrahan et al. (2014) hardware and features. identified the following criteria for evaluating mobile 3. Hybrid apps: “apps that consist of different Web medical applications in clinical practice: usefulness, technologies such as HTML or JavaScript” (Knott, accuracy, authority, objectivity, timeliness, 2015, p. 20). Hybrid mobile apps are built using a functionality, design, security, and value. hybrid development framework such as Ionic, Mobile Angular UI, Sencha Touch, Intel® XDK, Titanium® SDK, or PhoneGap. 2 Key Definitions According to the FDA (2015), a mobile medical app is a mobile app that meets the definition of a This chapter provides definitions of the key terms device as defined by the Federal Food, Drug, and used in this paper. Cosmetic Act (FD&C Act) and either is intended to The World Health Organization (2011, p. 6) be used as an accessory to a regulated medical device, defines mHealth as “medical and public health or to transform a mobile platform into a regulated practice supported by mobile devices, such as mobile medical device. The Medicines & Healthcare products phones, patient monitoring devices, personal digital Regulatory Agency (MHRA) (2014) considers some assistants (PDAs), and other wireless devices”. apps, which are used on smartphones and computers, The United States Food and Drug Administration as a medical device in their own right if they have a (FDA, 2015, p. 7) defines mobile platforms as medical purpose. “commercial off-the-shelf (COTS) computing According to the FDA (2015, p. 9), a mobile platforms, with or without wireless connectivity, that medical app manufacturer is “any person or entity that are handled in nature”. Examples of such platforms manufactures mobile medical apps in accordance with include smartphones, tablet computers, smartwatches, the definitions of manufacturer in 21 CFR Parts 803, laptops, convertibles, etc. 806, 807 and 820”. It does not include persons who The FDA’s final guidance on mobile medical apps exclusively distribute mobile medical apps without (2015) defines a mobile application or mobile app as a engaging in manufacturing functions (e.g., owners software application that can be executed on a mobile and operators of mobile app stores like Google Play, platform with or without wireless connectivity, or a iTunes App store, Windows Phone Store, BlackBerry web-based software application that is tailored to a World) (FDA, 2015). mobile platform but is executed on a server. Mobile The FDA (2016) defines general wellness apps can be grouped into three categories: products as products that are intended for only general 1. Native apps: developed using a specific wellness use, and present a low risk to the safety of programming language (Knott, 2015). For users and other persons. Such products may include example, Java/Kotlin/C#/Python/C/C++ for exercise equipment, audio recordings, video games, Android apps, Objective-C/Swift for iOS apps, software products, etc. (FDA, 2016). and C# for Windows Phone apps. They are usually The IEC 82304-1 (2016) standard defines health distributed through app stores, run directly on a software as software intended to be used specifically mobile device, have full access to the device for managing, maintaining or improving the health of hardware and features, and can store data offline. individual persons, or the delivery of care. The latest smartphones could be considered a mini computer having a number of sensors and other features (e.g., cameras, microphones, Bluetooth, 3 Regulations of Mobile Medical Bluetooth Low Energy (BLE), GPS, NFC, Wi-Fi, pedometer, heart rate monitor, magnetometer, Apps barometer, air humidity sensor, fingerprint sensor, proximity sensor, temperature sensor, sensor Using a risk-based approach to regulation of mobile detecting harmful radiation, touchscreen, speakers, medical apps, the FDA released in July 2011 draft push notifications, e-mail, storage, etc.). guidance for developers of mobile medical apps. The Smartphones can be also used with adapters. For FDA’s initiative aimed to indicate which mobile example, using low cost smartphone adapters medical apps fall under medical device regulatory invented by Myung, et al. (2014), a smartphone requirements. An updated guidance document issued can capture high-quality images of the front and in 2013 was superseded by a final guidance (FDA, back of the eye. 2015) issued in February 2015. According to the final 2. Web apps: websites usually hosted on the Web guidance, mobile apps may fall into one of three servers and accessed through the mobile device’s categories: 1) mobile apps that
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