FDA-Approved RPM Devices: What Providers Need to Know

Remote Patient Monitoring (RPM) devices allow healthcare providers to monitor, report, and analyze patients’ health vitals from outside the hospital settings. With real-time monitoring of a patient’s health condition, these devices help clinicians, physicians, and healthcare providers in making proactive clinical decisions and timely interventions. Adhering to the Food and Drug Administration (FDA) compliance is a critical requirement for cellular enabled RPM devices. To avoid discrepancies, manufacturing defects, and other connection problems, there are several compliance laws that need to be followed. Though all remote patient monitoring devices must comply with HIPAA security and compliance standards, not all of them meet the FDA standards.