56 Chapter 2 or efficacy. There are no specific rules or regulations in the submission guidelines for the app stores, which is an important issue.57,58 When scientific evidence is needed to safeguard the efficacy, quality and safety of apps to be in clinical settings, and with the medical device regulations in place, the public should at least be able to discern apps that are built and proofed reliable from those that are not before they are downloaded and granted permission from the user. App stores are encouraged to change their submission guidelines for apps that act as a medical device. Healthcare apps which are used to monitor, guide, diagnose, or treat patients must be regarded as a medical device and thereby have to comply to medical device regulations (FDA or MDR).8,9 The regulations have strict requirements for the (technical)development, validation and quality surveillance of the app, and the manufacture itself. Even with legislation in place, HCP’s or manufacturers may be unaware of the importance of such legislation, which may impede the quality and safety of apps. Although apps evaluated in a clinical study do not have to fully comply to the regulations, it is worthwhile to note that only one author has mentioned the regulations.39 It is unclear if other apps would be allowed under the medical device regulations. However, it is not guaranteed that the app will lead to valid outcomes if they have met the regulations.7,10 Therefore, well-designed scientific research validating apps are needed. As with researching medical devices or drugs, conducting research with healthcare apps is time-and cost-consuming. The role of app manufacturers with commercial interests and eagerness of the public to use apps are potential hazards. It is essential that an expert HCP is involved in the development and validation of healthcare apps. Not only to safeguard content, but also to ensure that apps are well researched and vetted before they become accepted in clinical practice. Although the development process of the apps identified in this review has been rarely or obscurely described, the involvement of HCP is presumed. HCP’s are mostly not involved in unvalidated apps which are available in the app stores, resulting in a potential higher risk.51 Moreover, apps that collect and/or process medical data must comply with data privacy regulations.59,60 Specific standards needs to be followed, but not all app manufacturers are familiar with them.61 Most of the included apps collect or process patient data (25/29), however, only three have mentioned privacy measures.30,48,50 This does not have to imply that these apps do not comply with data privacy regulations as the development process was generally obscurely described. Since the use of apps in healthcare has grown rapidly, hospitals and health insurers are increasingly demanding that apps are adequately validated before deployment in clinical care. However, they struggle with the minimum required proof of evidence. Conventionally, a RCT is the golden standard, and is especially applicable for high-risk apps which are classified as medical devices. But there are also other methods to validate apps of which mixed methods studies are an excellent example.62 It is important that all evaluations are
RkJQdWJsaXNoZXIy MTk4NDMw