Background:
Despite the prevalence of central nervous system (CNS) disorders worldwide, there is limited understanding of natural disease course, patients’ own experiences of the illness, the manifestation of its symptoms, and responses to treatment. Assessment of function for many disorders—including Parkinson’s disease, Alzheimer’s disease, mood disorders, and schizophrenia—typically is based on subjective or self-report tests during clinical visits. These provide only snapshots in time, and patients may use extra effort in a doctor’s office, which obscures usual function. The miniaturization and proliferation of devices and mobile technology has led to an explosion of interest in developing tools that provide reliable, high quality, continuous data collection from large patient populations in their natural settings and activities.
The use of devices to advance research and treatment for CNS disorders holds tremendous promise, including enabling major advances in identifying prodromal and subclinical states, but also raises important technological, methodological, ethical, privacy, security, and regulatory issues. For example, there are challenging questions regarding validation of data obtained using device and mobile health technologies. Other important methodological considerations arise with novel approaches for data collection and treatment delivery, such as open source platforms for obtaining and distributing digital biomarker data, behavioral and digital phenotyping, data-driven learning engines, and the use of real-world evidence. There are also questions about who bears responsibility for supporting the cost and infrastructure for data storage and analysis, and how to integrate these data with clinical records. Additionally, while the use of mobile technology for treatment may increase access to care, it also raises ethical issues related to the “digital divide,” informing people about prodromal and sub-clinical states, as well as data-ownership and release.
To help advance the appropriate use of devices and mobile technology to predict, diagnose, monitor, assess adherence, and develop treatments for CNS disorders, the National Academies of Sciences, Engineering, and Medicine’s Forum on Neuroscience and Nervous System Disorders will host a public workshop.
Workshop Objectives:
- Explore innovative approaches to using device and mobile health technology to predict, diagnose, monitor, assess adherence, and develop treatments for CNS disorders, including discussion of methodology, analytical techniques, and the evidence needed to validate the data for use in research and the clinic.
- Share approaches and lessons across efforts to apply device and mobile health technology in different CNS disorders, and identify opportunities for collaboration.
- Discuss regulatory, privacy, ethical, security, and practical issues that specifically arise when using devices for CNS disorders, such as collection, analysis, storage, and use of behavioral information and assuring parity in access to these technologies.