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Need for the Development of a Specific Regulatory Framework for Evaluation of Mobile Health Apps in Peru: Systematic Search on App Stores and Content Analysis.

ABSTRACT: BACKGROUND:In Peru, there is an increase in the creation of mobile health (mHealth) apps; however, this situation could present problems related to the quality of information these apps share, data security and privacy, usability, and effectiveness, as there is no specific local regulation about their creation and use. OBJECTIVE:The objective of this study was to review mHealth apps created, uploaded, or used in Peru, and perform an analysis of the national regulatory framework that could be applied to evaluate whether there is a need to develop and implement a specific regulation to these apps. METHODS:A total of 3 reviews were performed. First, we reviewed information about Peruvian mHealth apps created up to May 2019 from scientific publications, news, government communications, and virtual stores, and evaluated their purpose, creator, and the available evidence of their usability and effectiveness. The second review was carried out by taking a sample of the 10 most commonly used mHealth apps in Peru (regardless of the country of creation), to evaluate the information they collect and classify them according to the possible risks that they could present in terms of security and privacy. In addition, we evaluated whether they refer to or endorse the information they provided. Finally, in the third review, we searched for Peruvian standards related to electronic health (eHealth) that involve information technology that can be applied to regulate these apps. RESULTS:A total of 66 apps meeting our inclusion criteria were identified; of these, 47% (n=31) belonged to government agencies and 47% (n=31) were designed for administrative purposes (private and government agencies). There was no evidence about the usability or effectiveness of any of these apps. Concerning the 10 most commonly used mHealth apps in Peru, about the half of them gathered user information that could be leaked, changed, or lost, thus posing a great harm to their users or to their related patients. In addition, 6/10 (60%) of these apps did not mention the source of the information they provided. Among the Peruvian norms, the Law on the Protection of Personal Data, Law on Medical Devices, and administrative directives on standards and criteria for health information systems have some regulations that could be applied to these apps; however, these do not fully cover all aspects concerning the evaluation of security and privacy of data, quality of provided information, and evidence of an app's usability and effectiveness. CONCLUSIONS:Because many Peruvian mHealth apps have issues related to security and privacy of data, quality of information provided, and lack of available evidence of their usability and effectiveness, there is an urgent need to develop a regulatory framework based on existing medical device and health information system norms in order to promote the evaluation and regulation of all the aforesaid aspects, including the creation of a national repository for these apps that describes all these characteristics.

SUBMITTER: Rojas Mezarina L

PROVIDER: S-EPMC7382017 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Need for the Development of a Specific Regulatory Framework for Evaluation of Mobile Health Apps in Peru: Systematic Search on App Stores and Content Analysis.

Rojas Mezarina Leonardo L Silva-Valencia Javier J Escobar-Agreda Stefan S Espinoza Herrera Daniel Hector DH Egoavil Miguel S MS Maceda Kuljich Mirko M Inga-Berrospi Fiorella F Ronceros Sergio S Ronceros Sergio S

JMIR mHealth and uHealth 20200710 7

<h4>Background</h4>In Peru, there is an increase in the creation of mobile health (mHealth) apps; however, this situation could present problems related to the quality of information these apps share, data security and privacy, usability, and effectiveness, as there is no specific local regulation about their creation and use.<h4>Objective</h4>The objective of this study was to review mHealth apps created, uploaded, or used in Peru, and perform an analysis of the national regulatory framework th ...[more]

PMID: 32352926

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Project description:BackgroundUsing a mobile app for self-management could make it easier for patients to get insight into their blood pressure patterns. However, little is known about the availability, quality, and features of mobile apps targeting blood pressure.ObjectiveThe goal of the research was to determine the availability, functionality, and quality of mobile apps that could be used for blood pressure monitoring purposes.MethodsA systematic app search was performed based on the standards for systematic reviews. We searched the Dutch official app stores for Android and iOS platforms using predefined keywords and included all English and Dutch mobile apps targeting blood pressure. Two independent assessors determined eligibility and quality of the apps using the 5-point Mobile App Rating Scale (MARS). Quality scores of the apps with and without 17 a priori selected characteristics were compared using independent sample t tests.ResultsA total of 184 apps (104 Android, 80 iOS) met the inclusion criteria. The mean overall MARS score was 2.63 (95% CI 2.55-2.71) for Android and 2.64 (95% CI 2.56-2.71) for iOS. The apps Bloeddruk (4.1) and AMICOMED BP (3.6) had the highest quality scores on the Android and iOS platforms, respectively. Of the app characteristics recorded, only pricing, in-app advertisements, and local data storage were not associated with the quality scores. In only 3.8% (7/184) of the apps, involvement of medical experts in its development was mentioned, whereas none of the apps was formally evaluated with results published in a peer-reviewed journal.ConclusionsThis study provides an overview of the best apps currently available in the app stores and important key features for self-management that can be used by health care providers and patients with hypertension to identify a suitable app targeting blood pressure monitoring. However, the majority of the apps targeting blood pressure monitoring were of poor quality. Therefore, it is important to involve medical experts in the developmental stage of health-related mobile apps to improve the quality of these apps.

Project description:BackgroundThe wide use of mobile health apps has created new possibilities in social anxiety education and treatment. However, the content and quality of social anxiety apps have been quite unclear, which makes it difficult for people to choose appropriate apps to use on smartphones and tablets.ObjectiveThis study aims to identify the psychoeducational social anxiety apps in the two most popular Australian app stores, report the descriptive and technical information provided in apps exclusively for social anxiety, evaluate app quality, and identify whether any apps would be appropriate for people with social anxiety or others who know someone with social anxiety.MethodsThis systematic stepwise app search was guided by the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) standards and entailed searching for, identifying, and selecting apps in the Australian Apple App and Google Play Stores; downloading, using, and reviewing the identified apps; reporting technical and descriptive information in the app stores, an online app warehouse, and individual apps; evaluating app quality; and deciding whether to recommend the use of the apps.ResultsIn the app stores, 1043 apps were identified that contained the keywords social anxiety, social phobia, or shyness in their names or descriptions. Of these, 1.15% (12/1043) were evaluated (3 iOS apps and 9 Android apps). At the time of evaluation, the apps were compatible with smartphones and tablet devices; 9 were free to download from the app stores, whereas 3 were priced between US $2.95 (Aus $3.99) and US $3.69 (Aus $5.00). Among the evaluated apps, 3 were intended for treatment purposes, 3 provided supportive resources, 1 was intended for self-assessment, and the remaining 5 were designed for multiple purposes. At the time of downloading, app store ratings were available for 5 apps. The overall app quality was acceptable according to the Mobile App Rating Scale (MARS). On the basis of the MARS app quality rating subscale (sections A-D), the apps functioned well in performance, ease of use, navigation, and gestural design. However, app quality was less favorable when rated using the MARS app subjective quality subscale (section E).ConclusionsThe psychoeducational social anxiety apps evaluated in our study may benefit people with social anxiety, health professionals, and other community members. However, given that none of the apps appeared to contain empirical information or were shown to clinically reduce social anxiety (or aid in managing social anxiety), we cannot recommend their use. App accessibility could be improved by developing apps that are free and available for a wider range of operating systems, both between and within countries and regions. Information communication and technology professionals should collaborate with academics, mental health clinicians, and end users (ie, co-design) to develop current, evidence-based apps.

Project description:BackgroundPhysical inactivity is a major contributor to the development and persistence of chronic diseases. Mobile health apps that foster physical activity have the potential to assist in behavior change. However, the quality of the mobile health apps available in app stores is hard to assess for making informed decisions by end users and health care providers.ObjectiveThis study aimed at systematically reviewing and analyzing the content and quality of physical activity apps available in the 2 major app stores (Google Play and App Store) by using the German version of the Mobile App Rating Scale (MARS-G). Moreover, the privacy and security measures were assessed.MethodsA web crawler was used to systematically search for apps promoting physical activity in the Google Play store and App Store. Two independent raters used the MARS-G to assess app quality. Further, app characteristics, content and functions, and privacy and security measures were assessed. The correlation between user star ratings and MARS was calculated. Exploratory regression analysis was conducted to determine relevant predictors for the overall quality of physical activity apps.ResultsOf the 2231 identified apps, 312 met the inclusion criteria. The results indicated that the overall quality was moderate (mean 3.60 [SD 0.59], range 1-4.75). The scores of the subscales, that is, information (mean 3.24 [SD 0.56], range 1.17-4.4), engagement (mean 3.19 [SD 0.82], range 1.2-5), aesthetics (mean 3.65 [SD 0.79], range 1-5), and functionality (mean 4.35 [SD 0.58], range 1.88-5) were obtained. An efficacy study could not be identified for any of the included apps. The features of data security and privacy were mainly not applied. Average user ratings showed significant small correlations with the MARS ratings (r=0.22, 95% CI 0.08-0.35; P<.001). The amount of content and number of functions were predictive of the overall quality of these physical activity apps, whereas app store and price were not.ConclusionsApps for physical activity showed a broad range of quality ratings, with moderate overall quality ratings. Given the present privacy, security, and evidence concerns inherent to most rated apps, their medical use is questionable. There is a need for open-source databases of expert quality ratings to foster informed health care decisions by users and health care providers.

Project description:BackgroundThe number of mobile health (mHealth) apps released for musculoskeletal (MSK) injury treatment and self-management with home exercise programs (HEPs) has risen rapidly in recent years as digital health interventions are explored and researched in more detail. As this number grows, it is becoming increasingly difficult for users to navigate the market and select the most appropriate app for their use case. It is also unclear what features the developers of these apps are harnessing to support patient self-management and how they fit into clinical care pathways.ObjectiveThe objective of this study was to scope the current market of mHealth apps for MSK rehabilitation and to report on their features, claims, evidence base, and functionalities.MethodsA cross-sectional study of apps for MSK rehabilitation was performed across the iTunes App Store and Google Play Store. Four search terms were used, namely, physiotherapy rehabilitation, physical therapy rehabilitation, rehabilitation exercise, and therapeutic exercise to identify apps, which were then cross-referenced against set selection criteria by 4 reviewers. Each reviewer, where possible, downloaded the app and accessed supplementary literature available on the product to assist in data extraction.ResultsA total of 1322 apps were identified. After applying the inclusion and exclusion criteria and removing duplicates, 144 apps were included in the study. Over half (n=81, 56.3%) of the included apps had been released within the past 3 years. Three quarters (n=107, 74.3%) of the apps made no reference to evidence supporting the design or efficacy of the app, with only 11.1% (n=16) providing direct citations to research. Most of the apps did utilize exercise pictures (n=138, 95.8%) or videos (n=97, 67.4%); however, comparatively few harnessed additional features to encourage engagement and support self-management, such as an adherence log (n=66, 45.8%), communication portal (n=32, 22.2%), patient-reported outcome capture (n=36, 25%), or direct feedback (n=57, 39.6%). Of note and concern, many of these apps prescribed generic exercises (n=93, 64.6%) in the absence of individualized input to the user, with few providing specific patient education (n=43, 34%) and safety advice or disclaimers (n=38, 26.4%).ConclusionsThe cohort of apps included in this study contained a large heterogeneity of features, so it is difficult for users to identify the most appropriate or effective app. Many apps are missing the opportunity to offer key features that could promote exercise adherence and encourage self-management in MSK rehabilitation. Furthermore, very few developers currently offering products on the market are providing evidence to support the design and efficacy of their technologies.

Project description:BackgroundWomen are increasingly turning to mobile health platforms to receive health information and support in pregnancy, yet the content of these platforms vary. Although there is great potential to influence health behaviors, little research has assessed the quality of these platforms or their ability to change behavior. In recent years, validated tools to assess app quality have become available.ObjectiveTo identify and assess the quality and ongoing popularity of the top 10 freely available pregnancy apps in Australia using validated tools.MethodsA systematic search on app stores to identify apps was performed. A Google Play search used subject terms pregnancy, parenting, and childbirth; the iTunes search used alternative categories medical and health and fitness. The top 250 apps from each store were cross-referenced, and the top 100 found in both Google Play and iTunes were screened for eligibility. Apps that provided health information or advice for pregnancy were included. Excluded apps focused on nonhealth information (eg, baby names). The top 10 pregnancy apps were assessed using the Mobile App Rating Scale (MARS). A comparative analysis was conducted at 2 time points over 2 years to assess the ongoing popularity of the apps. The MARS score was compared to the download and star rating data collected from iTunes and Google Play in 2017 and 2019. Health behaviors including breastfeeding, healthy pregnancy weight, and maternal awareness of fetal movements were reviewed for apparent impact on the user's knowledge, attitudes, and behavior change intentions using the MARS perceived impact section and the Coventry, Aberdeen, and London-Refined (CALO-RE) taxonomy.ResultsA total of 2052 free apps were screened for eligibility, 1397 were excluded, and 655 were reviewed and scored. The top 10 apps were selected using download numbers and star ratings. All 10 apps were suboptimal in quality, practicality, and functionality. It was not possible to identify a primary purpose for all apps, and there was overlap in purpose for many. The mean overall MARS app quality score across all 10 apps was 3.01 (range 1.97-4.40) in 2017 and 3.40 (range 2.27-4.44) in 2019. A minority of apps scored well for perceived impact on health behavior using the MARS tool. Using the CALO-RE 40 item taxonomy, the number of behavior change techniques used was low. The mean number of behavior change techniques for breastfeeding was 5 (range 2-11), for pregnancy weight was 4 (range 2-12), and for maternal awareness of fetal movements was 5 (range 2-8).ConclusionsThis review provides valuable information to clinicians and consumers about the quality of apps currently available for pregnancy in Australia. Consideration is needed regarding the regulation of information and the potential opportunity to incorporate behavior change techniques to improve maternal and fetal outcomes.

Project description:BACKGROUND:Mobile mental health apps have become ubiquitous tools to assist people in managing symptoms of anxiety and depression. However, due to the lack of research and expert input that has accompanied the development of most apps, concerns have been raised by clinicians, researchers, and government authorities about their efficacy. OBJECTIVE:This review aimed to estimate the proportion of mental health apps offering comprehensive therapeutic treatments for anxiety and/or depression available in the app stores that have been developed using evidence-based frameworks. It also aimed to estimate the proportions of specific frameworks being used in an effort to understand which frameworks are having the most influence on app developers in this area. METHODS:A systematic review of the Apple App Store and Google Play store was performed to identify apps offering comprehensive therapeutic interventions that targeted anxiety and/or depression. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist was adapted to guide this approach. RESULTS:Of the 293 apps shortlisted as offering a therapeutic treatment for anxiety and/or depression, 162 (55.3%) mentioned an evidence-based framework in their app store descriptions. Of the 293 apps, 88 (30.0%) claimed to use cognitive behavioral therapy techniques, 46 (15.7%) claimed to use mindfulness, 27 (9.2%) claimed to use positive psychology, 10 (3.4%) claimed to use dialectical behavior therapy, 5 (1.7%) claimed to use acceptance and commitment therapy, and 20 (6.8%) claimed to use other techniques. Of the 162 apps that claimed to use a theoretical framework, only 10 (6.2%) had published evidence for their efficacy. CONCLUSIONS:The current proportion of apps developed using evidence-based frameworks is unacceptably low, and those without tested frameworks may be ineffective, or worse, pose a risk of harm to users. Future research should establish what other factors work in conjunction with evidence-based frameworks to produce efficacious mental health apps.

Project description:BACKGROUND:The large number of available cancer apps and their impact on the population necessitates a transparent, objective, and comprehensive evaluation by app experts, health care professionals, and users. To date, there have been no analyses or classifications of apps for patients with genitourinary cancers, which are among the most prevalent types of cancer. OBJECTIVE:The objective of our study was to analyze the quality of apps for patients diagnosed with genitourinary cancers using the Mobile Application Rating Scale (MARS) and identify high-quality apps. METHODS:We performed an observational cross-sectional descriptive study of all smartphone apps for patients diagnosed with genitourinary cancers available on iOS and Android platforms. In July 2019, we searched for all available apps for patients with genitourinary cancers (bladder, prostate, cervical, uterine, endometrial, kidney, testicular, and vulvar) or their caregivers. Apps were downloaded and evaluated, and the general characteristics were entered into a database. The evaluation was performed by 2 independent researchers using the MARS questionnaire, which rates 23 evaluation criteria clustered in 5 domains (Engagement, Functionality, Esthetics, Information, and Subjective Quality) on a scale from 1 to 5. RESULTS:In total, 46 apps were analyzed. Of these, 31 (67%) were available on Android, 6 (13%) on iOS, and 9 (20%) on both platforms. The apps were free in 89% of cases (41/46), and 61% (28/46) had been updated in the previous year. The apps were intended for prostate cancer in 30% of cases (14/46) and cervical cancer in 17% (8/46). The apps were mainly informative (63%, 29/46), preventive (24%, 11/46), and diagnostic (13%, 6/46). Only 7/46 apps (15%) were developed by health care organizations. The mean MARS score for the overall quality of the 46 apps was 2.98 (SD 0.77), with a maximum of 4.63 and a minimum of 1.95. Functionality scores were quite similar for most of the apps, with the greatest differences in Engagement and Esthetics, which showed acceptable scores in one-third of the apps. The 5 apps with the highest MARS score were the following: "Bladder cancer manager," "Kidney cancer manager," "My prostate cancer manager," "Target Ovarian Cancer Symptoms Diary," and "My Cancer Coach." We observed statistically significant differences in the MARS score between the operating systems and the developer types (P<.001 and P=.01, respectively), but not for cost (P=.62). CONCLUSIONS:MARS is a helpful methodology to decide which apps can be prescribed to patients and to identify which features should be addressed to improve these tools. Most of the apps designed for patients with genitourinary cancers only try to provide data about the disease, without coherent interactivity. The participation of health professionals in the development of these apps is low; nevertheless, we observed that both the participation of health professionals and regular updates were correlated with quality.

Project description:BackgroundWomen consult information in mobile apps (apps) during pregnancy, and even obstetrics specialists highlight that pregnancy is the ideal moment for the use of apps as consultation sources. However, the high number of apps designed for pregnancy requires a careful assessment to determine their suitability before recommendation.ObjectiveThe aim of this study is to identify the apps available in Spanish that can be recommended based on their content, behavior change techniques (BCTs), and quality as a complementary tool during pregnancy.MethodsA systematic search on app stores to identify apps was performed in the Apple App Store and Google Play with the subject term "pregnancy." The apps meeting the following criteria were chosen: pregnancy-related content, free, and available in Spanish. An app was excluded if it was classified as a game or entertainment and thus lacking an educational or health aim and if it did not target the population under study. The selected apps were downloaded, and their quality was assessed using the Mobile Application Rating Scale (MARS), with the BCTs included evaluated using the BCT taxonomy version 1 and its content.ResultsA total of 457 apps were identified, 25 of which were downloaded for assessment (5.6%). The median for objective and subjective quality was 2.94 (IQR 2.71-3.46) and 1.75 (IQR 1.25-2.25), respectively. Regarding content, the median of topics included in the apps was 23 (IQR 16-23), with weight gain, nutrition, fetal development, and physical activity being the most common. The median number of BCTs was 12 (IQR 0.5-3.5). The most frequently identified BCTs in the apps were "Self-Monitoring of Outcomes," followed by "Goal Behavior" and "Instructions." Statistically significant correlations were observed between objective quality and content (ρ=0.624; P=.001), subjective quality and content (ρ=0.638; P=.001), objective quality and BCTs (ρ=0.672; P<.001), subjective quality and BCTs (ρ=0.623; P<.001), and BCTs and content (ρ=0.580; P=.002).ConclusionsThe results of this study suggest that only a small percentage of free pregnancy apps available in Spanish should be recommended. The apps with the best MARS scores were those that addressed a higher number of topics and included a higher number of BCTs. Those with the best content and quality, and a higher number of BCTs included could be recommended by health professionals.

Project description:BackgroundPatients suffering from inflammatory bowel disease (IBD) frequently need long-term medical treatment. Mobile apps promise to complement and improve IBD management, but so far there has been no scientific analysis of their quality.ObjectiveThis study evaluated the quality of German mobile apps targeting IBD patients and physicians treating IBD patients using the Mobile Application Rating Scale (MARS).MethodsThe German Apple App Store and Google Play Store were systematically searched to identify German IBD mobile apps for patient and physician use. MARS was used by 6 physicians (3 using Android smartphones and 3 using iPhones) to independently assess app quality. Apps were randomly assigned so that the 4 apps with the most downloads were rated by all raters and the remaining apps were rated by 1 Android and 1 iOS user.ResultsIn total, we identified 1764 apps in the Apple App Store and Google Play Store. After removing apps that were not related to IBD (n=1386) or not available in German (n=317), 61 apps remained. After removing duplicates (n=3) and apps for congresses (n=7), journals (n=4), and clinical studies (n=6), as well as excluding apps that were available in only 1 of the 2 app stores (n=20) and apps that could only be used with an additional device (n=7), we included a total of 14 apps. The app "CED Dokumentation und Tipps" had the highest overall median MARS score at 4.11/5. On the whole, the median MARS scores of the 14 apps ranged between 2.38/5 and 4.11/5. As there was no significant difference between iPhone and Android raters, we used the Wilcoxon comparison test to calculate P values.ConclusionsThe MARS ratings showed that the quality of German IBD apps varied. We also discovered a discrepancy between app store ratings and MARS ratings, highlighting the difficulty of assessing perceived app quality. Despite promising results from international studies, there is little evidence for the clinical benefits of German IBD apps. Clinical studies and patient inclusion in the app development process are needed to effectively implement mobile apps in routine care.

Dataset Information

Need for the Development of a Specific Regulatory Framework for Evaluation of Mobile Health Apps in Peru: Systematic Search on App Stores and Content Analysis.

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Need for the Development of a Specific Regulatory Framework for Evaluation of Mobile Health Apps in Peru: Systematic Search on App Stores and Content Analysis.

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