FDA Launches Pilot to Improve Chronic Disease Management Through Digital Tools
Healthcare IT News
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Contributed by: Kate Gamble
Summary
The FDA has launched the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot (TEMPO) to enhance the management of chronic diseases through the use of digital health technologies. This initiative promotes a risk-based regulatory approach, focusing on improving health outcomes for various conditions, including cardio-kidney-metabolic and behavioral health issues. Collaborating with the CMS Innovation Center, TEMPO aims to facilitate access to integrated healthcare solutions and will involve manufacturers collecting real-world data to evaluate the effectiveness of their tools. This pilot underscores the necessity for regulatory frameworks to evolve alongside digital health innovations, ultimately impacting patient care and outcomes in chronic disease management.
