|
Abstract: Over the past decade, mental health applications (apps) have surged in popularity. While some of these apps may be beneficial, as a category, they present three major challenges: privacy and security, safety and efficacy, and integration into the traditional model of care. While there are legislative and regulatory efforts that aim to address these challenges at the U.S. federal and state level and through international standards, these challenges persist. To better understand the mental health app governance landscape, especially as it relates to these three challenges in the United States, we examined all U.S. federal and state legislative and regulatory efforts related to mental health apps and four international standard-setting body's mental health app-related standards, the IEEE, ISO/IEC, ITU, and ETSI (as of April 2023). Our findings revealed that the governance landscape studied predominantly addresses the privacy and security challenge, particularly around consumer data, whereas the other two challenges are almost entirely forgotten. As these apps' popularity continues surging, more and more health care professionals will encounter patients who use and rely on these apps for their mental health care. Consumers will unknowingly download and use mental health apps that may or may not have been tested, based on scientific evidence or follow international standards. To address consumer and health care professionals' inability to distinguish between properly tested, evidence-based, and rule compliant apps from those that are not, we recommend a suite of interrelated soft law proposals: (1) to develop and implement a code of conduct that captures and addresses each of the three mental health app governance challenges; (2) to create a corresponding certification program and certification mark to demonstrate compliance with this standard; (3) to develop a label or ranking site so that consumers and providers can easily discern the evidence supporting an app; and (4) to include all certified mental health apps on an online public registry. This certification mark or label can be added to mental health apps' home screens or app store information pages and possibly be required for app store listing. It would signal to consumers and health care professionals that the certified app has addressed the major mental health app governance challenges, particularly that it was rigorously tested against its target population.
|