Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the technology is relatively new, however, the regulatory environment is still evolving as regulators scramble to keep pace with innovation.
Health providers are increasingly deploying SaMDs to facilitate patients’ pain management, arrhythmia management, and blood glucose monitoring. Some applications require daily use by the patient — sometimes multiple times a day — while remaining compliant with good clinical practice. The potential advantages include fewer office visits, increased frequency of patient metrics, and real-time alerts if readings from the software suggest a risk to the patient. On the other hand, the use of SaMD may result in less face-to-face contact with patients, with potential ramifications for clinical trial operations and long-term care.