Current Regulation of Mobile Mental Health Applications

摘要

In recent years, the availability of software that is targeted toward the general public and designed to assist in the diagnosis and treatment of mental illness or to promote general mental health has expanded greatly. Regulation of more traditional health care providers and health care-associated devices is well established by statute, regulatory guidelines, and common law precedents. Applications (apps), in contrast, pose a novel regulatory challenge. This review examines the current regulatory guidelines for psychiatric mobile mental health apps, as well as the current state of case law in the psychiatric mobile mental health realm. Society has a long-standing tradition of regulating those who claim to diagnose and treat mental health conditions, as well as the products, such as drugs and devices, used in diagnosis and treatment. Mobile health software that is targeted toward lay people, however, is a recent development that currently faces much less regulatory oversight. Modern computer hardware and software have been available for a relatively short time, and their capabilities will only continue to expand. Society is now faced with questions about whether, and how, to regulate the novel services that these software programs provide. Any regulation of emerging software must promote safety while allowing for innovation. In this review, we consider what currently constitutes the regulated diagnosis or treatment of mental illness, as applied to popular mobile health software. In the United States, medical boards, psychology boards, nursing boards, and other similar regulatory bodies are assigned the task of licensing and overseeing clinicians. The goal of these boards is to protect the public by ensuring that the care licensees provide meets minimal standards of quality. To diagnose or treat medical conditions without the approval of such a board is generally considered the practice of medicine without a license. Doing so can result in criminal and civil penalties. In addition to maintaining appropriate licensure, clinicians must be aware of a body of federal law that has been written to regulate the medical profession, such as the Health Insurance Portability and Accountability Act (HIPAA)sup 1 /sup and the laws and regulations associated with the Drug Enforcement Administration (DEA). Clinicians also must be aware of state laws that regulate many facets of health care provision. Finally, clinicians should have some awareness of the judicial rulings that have established common law precedents for the practice of medicine in their area. In short, the practice of psychiatry and other mental health disciplines is highly regulated at both the federal and state levels. In recent years, expansions in technology have introduced computer software that is intended to assist in the diagnosis or treatment of mental illness or to provide coaching or other services to individuals who are in mental distress. There is reason to believe that some patients will benefit from working with computer programs to augment the effectiveness of more traditional treatment programs. There is also reason to believe that, in some instances, patients could derive benefit from working with computer programs without the involvement of a licensed practitioner. The development of software that can diagnose and treat mental illness carries significant and obvious appeal for patients and society. A person who is trained to conduct psychotherapy, for instance, can provide attention and individualized treatment to only a relatively small number of patients at any given time. Those patients must make themselves available at a particular time and, usually, at a particular location. Between sessions, the clinician is available in only a limited fashion, for instance by phone or pager. The clinician must also charge a fee that is sufficient to provide an appropriate income for his level of education and training. A computer program, in contrast, can overcome many of the barriers to traditional treatment. Once the software has been written, a computer application (app) can be installed and run on an unlimited number of devices simultaneously. A computer program can be run at a time and place of the user's choosing. Economies of scale also make it possible for a computer program to provide treatment at a low per-user cost. The potential for developing scalable technologies that can autonomously provide benefit to an unlimited number of patients at low cost is alluring. Although technology offers new benefits, these must be balanced against new risks. The most obvious risk is that the treatment that is provided will be ineffective, or even harmful. This could occur when users self-select treatment that is inappropriate for their condition, for instance when an individual with undiagnosed hypothyroidism or schizophrenia attempts a course of treatment that is targeted toward major depressive disorder. It could also occur when the trea