In search of a few good apps.

mHealth apps are mobile device applications intended to improve health outcomes, deliver health care services, or enable health research.1 The number of apps has increased substantially, and more than 40 000 health, fitness, and medical apps currently are available on the market.2 Because apps can be used to inexpensively promote wellness and manage chronic diseases, their appeal has increased with health reform and the increasing focus on value. The bewildering diversity of apps available has made it difficult for clinicians and the public to discern which apps are the safest or most effective. The US Food and Drug Administration (FDA) has paid close attention to mHealth apps, because it has regulatory authority over their safety. The agency recently clarified that mHealth apps acting as medical devices or as accessories to medical devices will require FDA approval, whereas apps that provide users with the ability to log life events, retrieve medical content, or communicate with clinicians or health centers will not be regulated under its jurisdiction.3 For example, an app that tracks glucose levels and suggests insulin dosages would be regulated, whereas an app that tracks a patient’s weight and makes general suggestions about exercise would not. In general, apps that provide precise treatment recommendations and diagnostic information will receive more regulatory attention. Although the FDA has focused on safety, it has largely left the review and certification of apps to the marketplace. The currently available reviews of mHealth apps have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security. Although evidencebased reviews are not extensively available for mHealth apps, they are available for other categories of health information technology software. For instance, KLAS has successfully made a business out of producing report cards on the quality of health information technology vendors and enterprise software packages, presumably simplifying the lives of hospital leaders.4 This model has worked for enterprise software because users of expensive software are seemingly willing to fund unbiased reviews. However, this approach appears unlikely to work for mHealth apps because users of free and inexpensive apps are less financially invested in their decisions than hospitals. Furthermore, certification may be problematic in mHealth because certification companies ordinarily aim to generate revenues by charging the app developers they are evaluating—an inherent conflict of interest. Thus, there is a need for alternative models for app review and certification that are sustainable and free of conflict of interest. However, given the sheer number of mHealth apps, it is unlikely that all will ever be meaningfully reviewed by a single organization. As a start, an organization could feasibly review the quality of the most widely used and clinically useful mHealth apps. Furthermore, guidelines could be established to help developers build highquality apps and to serve as a basis for app review. The guidelines might include a broad range of categories, such as safety, accuracy, and security. By telegraphing these guidelines, as well as standardized approaches to achieving them, the organization will be able to influence mHealth app developers early in their planning process, enabling them to build their apps with these principles and a review process in mind. App review organizations would likely need to include in their reviews a certification process to ensure that apps do not pose potential harm to their users or have significant security and privacy vulnerabilities. Certification entities in other industries are successfully protecting people from harm. For instance, the Health On the Net Foundation, a nonprofit, nongovernmental organization, plays an active role in evaluating the quality of online medical content and provides websites a certification that assures both consumers and clinicians of the accuracy of the medical content.5 Similarly, Underwriters Laboratories is a well-respected for-profit entity that provides meaningful but optional information that consumers can use to evaluate the safety of electronic devices. In mHealth, the startup Happtique began certifying the operability, privacy, security, and content of apps but ultimately suspended its operations after a developer discovered that 2 certif ied apps handled data insecurely.6 The attention that Happtique received suggests that many people consider the security of mHealth apps to be important and want them to be evaluated rigorously. From these cases, it appears that both nonprofit and for-profit certification are viable means of improving the quality of low-cost and free consumer products and services and that there is demand for mHealth apps to be certified. The Office of the National Coordinator for Health Information Technology (ONC) could help support the development of mHealth app guidelines and eventually commission app certification entities, as it is now doing for electronic health records (EHRs). Another important role for app review organizations is illuminating the effectiveness of mHealth apps. Although more rigorous evaluations are needed across all mHealth, many apps share components (eg, reminders, logging, pedometer). Evidence for these common features might be cited in app reviews. For example, because countless apps use smartphone-based accelerometers as makeshift pedometers, it would be helpful to highlight that evidence suggests that pedometerbased walking interventions are associated with an average weight loss of 0.05 kg per week.7 Greater focus on outcomes may shift the focus of app developVIEWPOINT