Ethical considerations of digital therapeutics for mental health

This chapter provides an overview of the ethical issues that arise when healthcare practitioners (HCPs) prescribe or recommend digital therapeutics, in particular for treating mental health and addiction issues. We show that the lack of adequate clinical validation and regulatory frameworks for digital therapeutics leaves HCPs with particularly high responsibility. We group ethical issues into those affecting patients directly, those arising for society, and HCPs’ new roles and responsibilities. We identify privacy, transparency, autonomy, lack of clinical validation, fairness, and equality, as well as HCP's changing responsibilities and roles as major ethical issues. We illustrate why these issues matter for patients and society, discuss how and where they occur in practice and provide suggestions on what HCPs can practically do about these issues. We argue that HCPs have high overall responsibility and should pay special attention to ethical issues when recommending digital therapeutics or using them with their patients.