Mobile Mental Health: Navigating New Rules and Regulations for Digital Tools
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.
KeywordsmHealth Legal Informed consent Smartphone
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
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