AMC Health has announced that its virtual care and clinical decision support solution has received FDA 510(k) clearance as a Class II software medical device. This marks the company's third FDA clearance and its most comprehensive to date, encompassing both the clinician dashboard and the patient mobile app. The clearance allows for hospital-level, acute-care-at-home use, as well as continuous monitoring via devices like continuous glucose monitors and other wearables.
AI-Driven Risk Prediction
A key component of this clearance is the inclusion of AMC Health's proprietary, machine-learning-based risk prediction algorithms. These algorithms are designed to accurately predict a patient's risk of emergency department visits, hospitalizations, or death, even without intervention. The predictions are based on over 20 years of data from hundreds of millions of real-time patient interactions.
Jon Shankman, AMC Health's Chief Analytics Officer, stated, "Our data science team is doing groundbreaking work with our unprecedented trove of real-time and other data, and this is only the beginning. Gaining this clearance from the FDA is a testament to the high standards to which we hold ourselves and to the meticulous quality of work we deliver to our partners."
Impact on Healthcare
AMC Health's solution aims to reduce costly hospitalizations and readmissions, a key focus area for HEDIS measures. The advanced analytics also encompass precursors to chronic disease status, enabling proactive planning for HEDIS Quality Measures and Risk Adjustment.
By meeting the FDA's standards and maintaining HITRUST certification, AMC Health aims to provide secure and effective virtual care solutions, giving health plans confidence in managing vulnerable populations. AMC Health partners with health plans, health systems, and organizations like the U.S. Department of Veterans Affairs to deliver data-driven solutions.
