Over the years, remote patient monitoring (RPM) technology has undergone rapid evolution, transforming from simple patient monitoring systems to sophisticated platforms that enable continuous and real-time data collection. Initially, RPM focused primarily on managing chronic conditions through periodic measurements utilizing off-the-shelf consumer healthcare devices.
With innovations in medical-grade wearable technology and data analytics, RPM has undergone a significant transformation. Today, RPM encompasses a broader range of capabilities, making use of wearable devices and sophisticated analytics to provide comprehensive monitoring and analysis of vital signs. The advancements in RPM offer healthcare professionals a holistic view of patient health and enable personalized care and early intervention.
Over the years, remote patient monitoring (RPM) technology has undergone rapid evolution, transforming from simple patient monitoring systems to sophisticated platforms that enable continuous and real-time data collection. Initially, RPM focused primarily on managing chronic conditions through periodic measurements utilizing off-the-shelf consumer healthcare devices.
With innovations in medical-grade wearable technology and data analytics, RPM has undergone a significant transformation. Today, RPM encompasses a broader range of capabilities, making use of wearable devices and sophisticated analytics to provide comprehensive monitoring and analysis of vital signs. The advancements in RPM offer healthcare professionals a holistic view of patient health and enable personalized care and early intervention.
Recognizing these advancements, FDA has recently issued updated guidance on good clinical practices (GCPs). These revised recommendations aim to modernize the design and conduct of clinical trials while ensuring data integrity and participant protection. Additionally, the FDA recently released other documents that complement these efforts. In May, the agency published draft guidance proposing recommendations for the implementation of decentralized clinical trials (DCTs). They also issued a framework document for digital health technologies (DHTs), offering guidance on how to utilize DHT-derived data in regulatory decision-making for drugs and biological products.