title: Mobile Mental Health: Navigating New Rules and Regulations for Digital Tools.
abstract: Mobile health (mHealth) apps are becoming much more widely available. As more patients learn about and download apps, clinicians are sure to face more questions about the role these apps can play in treatment. Clinicians thus need to familiarize themselves with the clinical and legal risks that apps may introduce. Regulatory rules and organizations that oversee the safety and efficacy of mHealth apps are currently fragmentary in nature and clinicians should pay special attention to categories of apps which are currently exempt from significant regulation. Uniform HIPAA protection does not apply to personal health data that are shared with apps in many contexts which creates a number of clinically relevant privacy and security concerns. Clinicians should also consider several relatively novel potential adverse clinical outcomes and liability concerns that may be relevant to specific categories of apps, including apps that target (i) medication adherence, (ii) collection of self-reported data, (iii) collection of passive data, and (iv) generation of treatment recommendations for psychotherapeutic and behavioral interventions. Considering these potential pitfalls (and disclosing them to patients as a part of obtaining informed consent) is necessary as clinicians consider incorporating apps into treatment.
authors.affiliation: University of California, San Francisco, 401 Parnassus Avenue Box PLP-0984, San Francisco, CA, 94143-0984, USA. james.armontrout@ucsf.edu.
authors.forename: James
authors.initials: J
authors.lastname: Armontrout
authors.affiliation: Beth Israel Deaconess Medical Center, 330 Brookline Ave E/Rabb 2, Boston, MA, 02115, USA.|Massachusetts Mental Health Center, Boston, USA.
authors.forename: John
authors.initials: J
authors.lastname: Torous
authors.affiliation: Mirick O'Connell Attorneys at Law, Boston, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Fisher
authors.affiliation: Beth Israel Deaconess Medical Center, 330 Brookline Ave E/Rabb 2, Boston, MA, 02115, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Drogin
authors.affiliation: Beth Israel Deaconess Medical Center, 330 Brookline Ave E/Rabb 2, Boston, MA, 02115, USA.|Massachusetts Mental Health Center, Boston, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gutheil
mesh_terms: D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D001523:Mental Disorders / Q000628:therapy*; D063731:Mobile Applications / Q000331:legislation & jurisprudence*; D018907:Privacy; D017216:Telemedicine / Q000331:legislation & jurisprudence* / Q000379:methods*; D014481:United States
keywords: Informed consent; Legal; Smartphone; mHealth