ENABLING BUILD OF DIGITAL HEALTH APPS AGAINST REGULATORY STANDARDS FOR MEDICAL USE

The Internet of Things has created an explosion of data generating and collecting devices that is transforming all aspects of our lives. Healthcare is no exception, and the opportunity to ensure that whatever data is available can be used to inform the way healthcare is delivered has never been greater. However, the availability of connected clinical data does not necessarily translate into use to inform a clinical decision: any interpretation of this data for a medical purpose falls under strict regulations for software based medical devices, which is designed to protect patient safety, but compliance is currently expensive and complex to achieve. This project demonstrates proof of concept of our software tool kit to enable innovators to harness the potential of connected clinical data, enabling it to be transformed into actionable information to inform clinical decisions. Our platform can be used by many people designing connected apps for specific clinical indications or patient pathway, in a variety of settings, and will guide the inputs and provide the traceability to aid their compliance for regulatory submissions for software classified as a medical device (SaMD), quickly and cost effectively. This will open up new possibilities for service creators to build connected digital health solutions that will be fit for the purpose of enabling remote monitoring and improved self-care; transforming healthcare as we know it.