Pryv has joined the RealWorld4Clinic project which creates a device connected by artificial intelligence (AI) to enhance patient care. Pryv eHealth backend ensures privacy-by-design development and compliant real-world patient data collection, usage and sharing.
From reactive to proactive heart health: Inspired by consumer wearable devices, RealWorld4Clinic, set about creating a wearable that could collect data suitable for drug approval trials and guide interventions in heart failure management.
Heart failure is responsible for five per cent of emergency hospital stays and two per cent of national health expenditure within Europe. Furthermore, COVID-19 pandemic has represented a clinical challenge in patients with heart failure. It’s widely accepted that real-world data is vital for diagnosing heart failure early. Yet, clinical research and heart failure management still buy in data, limiting the predictive power of clinical trials.
By diagnosing heart failure aggravation from 30 days before an emergency event occurs, RealWorld4Clinic will halve the number of days patients spend in a hospital, while reducing hospital costs.
RealWorld4Clinic will achieve its ambitions through the market launch of SentinHealth‘s MyHeartSentinel – a coin-sized medical device anchored to the fundus of the stomach in immediate proximity to the heart and the lungs or, optionally, implanted subcutaneously in the chest area. Equipped with multiple sensors MyHeartSentinel shall acquire a wide array of real-world cardio-respiratory health data. Via SentinHealth’s gateway and regulated through Pryv eHealth data privacy-preserving patient’s data management backend will be deployed on a cloud infrastructure.
In addition to co-creating the wearable MyHeartSentinel product, EIT Health will help resolve the ethical, legal and social issues involved with buying and using AI to maximise heart health data.
In clinical research, AI-powered analytics shall reveal information on the real-world safety and tolerability of an investigational medicinal product or device. This is forecasted to add value to the decision making of pharma on the continuation of its clinical development. In outpatient cardiology, AI-powered analytics shall reveal real-world information on the pre-symptomatic progression of heart failure. This is forecasted to prevent heart failure decompensation while reducing the number of outpatient visits and days spent in the hospital.
About RealWorld4Clinic: RealWorld4Clinic is a new pan-European project aiming at bringing real-world data to pivotal clinical research and outpatient cardiology care. The EU-funded project is part of the innovation portfolio curated by the EIT Health knowledge and innovation community.
MyHeartSentinel is just the beginning. Supported by EIT Health, the RealWorld4Clinic consortium is committed to transforming the standard of care from reactive to proactive heart health management. By diagnosing heart failure aggravation from 30 days before an emergency event occurs, RealWorld4Clinic will halve the number of days patients spend in a hospital, while reducing hospital costs.
RealWorld4Clinic is part of the innovation project portfolio curated by EIT Health. EIT Health is funded by the European Institute of Innovation and Technology (EIT), a body of the European Union
About Pryv: Pryv developed personal and health data lifecycle middleware (e-Health backend) for empowering developers create compliant and scalable health data-driven products. Our purpose-built middleware helps organizations manage personal and patients data from creation to use, sharing and disposal. We accelerate time to market, cut IT development costs and speed up connectivity to all data sources. Pryv addresses the enhanced citizen’s right under GDPR and turns privacy compliance into a competitive advantage. For more information, please visit www.pryv.com