Alzheimer’s and mHealth: Regulatory, Privacy and Ethical Considerations

Mobile Health (mHealth) – the provision of health care or wellness services through smartphones or tablets – has the potential to improve health care quality, access, and affordability. mHealth smartphone applications include informational reminders (for example, the names of loved ones or medication schedules) and tracking services designed to minimize the risk of patients’ wandering. These applications, especially applicable to first stage Alzheimer’s patients, might delay patients’ disease progression, improve their quality of life, and empower them and their care-givers. However, people who use these apps may have difficulties providing informed consent, may lose their devices, and might be unaware that their location is being tracked and their data collected. This chapter overviews promises and pitfalls of mHealth, analyzes ethical and legal challenges of mHealth, especially focusing on privacy and security (while recognizing that there are many others) and explains why these general concerns are particularly exacerbated in the case of mHealth apps for Alzheimer’s patients. Existing legislation and regulation of medical devices is generally inapplicable to mHealth apps. Users and app developers currently have little clarity regarding the fragmented legislative and regulatory framework of mHealth. Many of these risks and concerns remain unanswered at the time of this writing. For mHealth in general, and Alzheimer’s patients in particular, more transparency and education, and better design and regulation are needed.