Integrating Digital Solutions for Chronic Disease Management

摘要

The digital health market is projected to top $142 Billion worldwide by the end of 2019 and reach $206 Billion by 2020,1 based on technologies that span the spectrum from lifestyle apps on a smart phone to medical devices that measure our glucose or take an instantaneous EKG. The integration and strong potential of these technologies have steadily increased, first in the clinical setting, as mobile electronic data collection solutions secure a foothold in clinical research organizations (CRO) to dramatically simplify and lower per-patient cost, and by positively impacting the accuracy and control of patient data acquisition and management. The industry is moving toward patient engagement, whether it is via support groups collaborating to improve their own disease management, or through software apps designed to help you become healthier and live a better life. Lifestyle software and smart devices leverage mobility and the wireless connectivity inherent in Internet of Things (loT) devices. Genetic characterization services, such as 23andMe, now allow patients to proactively drive their own healthcare regimes. Laboratory developed test (LDT) services provide patients and healthcare organizations with benchmarks and metrics indicating where a patient sits in the continuum of their health, with data that can be used to drive lifestyle choices from alimentation to pre-emptive elective surgery. The FDA's guidance on Software as a Medical Device (SaMD) is one of several guidances that provide the framework for utilizing these technologies.