Preventing Medication Mismanagement in People Living with Dementia through Automated Medication Dispensing with Facial Recognition and Video Observation - Globally, over 47 million individuals are living with dementia, with new incidence of 7.7 million annually. Medication mismanagement is one of the most common and concerning risk factors in people with dementia (PwD), as it leads to undertreatment of disease, emergency department visits, hospital admissions/readmissions, and serious adverse events. In the U.S. an estimated 3 million older adults are admitted to nursing homes due to drug-related adherence problems with annual cost exceeding $14 billion. The challenge is complex medication management requires moderate executive functioning. However, as cognitive function declines, PwD can no longer perform such Instrumental Activities of Daily Living (IADLs) safely, effectively, and independently. While the goal is to keep older adults at home as long as possible, caregivers are not available 24/7 & costs of external care are often prohibitive. The HiDO platform will solve these market challenges by automating medication administration for PwD to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization and facilitate the ability for PwD to age in place. While still premarket, HiDO is being designed and validated as an automated, AI driven medication dispensing and direct observation platform to optimize adherence. The innovative device integrates medication dispensing, dose administration time, medication synchronization, and a pair of front-facing video cameras to validate the right medications, the right route, right time, right dosage to the right patient (5R’s). The cameras record every dose using facial recognition & provide real-time medication consumption recordings for medical review if needed by monitoring the time a patient interacts with the device. Through cloud connectivity, providers & caregivers have access to video observation logs, dose administration time, adherence trends, & longitudinal adherence through the platform’s dashboard. Patients & caregivers can easily setup complex medication protocols in minutes using a smartphone app. The device then alerts patients and dispenses up to 7 different types of meds simultaneously, with up to 40 doses each. The fully commercialized HiDO platform will integrate the full feature suite above. However, to demonstrate feasibility, Phase I will target an in-clinic usability study, platform enhancements & novel AI to confirm ingestion, and remote pilot study to document independent usability & adherence in PwD. An existing prototype HiDO platform, which already integrates facial recognition AI, will be leveraged as a base technology to increase likelihood of project success. First, using the existing prototype we will complete an in-clinic usability study to validate use cases and product features in the target population. The existing platform will then be enhanced with machine vision AI to confirm medication ingestion, as well as updates to address challenges found in early usability. Once the enhanced platform has been technically verified, it will be deployed in a remote field usability study with PwD and caregivers.