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Real-world-data enabled assessment
for health regulatory decision-making

REALM Stakeholder Survey: Shaping the Future of Medical Software Innovation

The REALM Project is committed to advancing healthcare innovation through collaboration and cutting-edge technology. By bringing together a diverse group of stakeholders—including regulatory authorities, software developers, healthcare professionals, and policymakers—REALM aims to establish a decentralized and secure evaluation framework for medical software. This ambitious initiative emphasizes the development of AI-powered tools to assess critical factors like bias, privacy, accuracy, legal accountability, and ethics, all while enhancing data-driven decision-making processes.

As part of this journey, we are launching a stakeholder survey to gather valuable insights and feedback from experts like you. This questionnaire is designed to capture your perspectives on the relevance, prioritization, and comprehensiveness of the stakeholders we've identified so far, based on extensive literature review findings.

Your participation is key to ensuring that REALM meets the needs of the healthcare community. The survey takes only 10 minutes to complete, but your input will play a crucial role in shaping the project's future direction. We encourage you to share it with your colleagues, partners, and other interested stakeholders.

Click here to take the survey.

About the REALM Project

The REALM platform is dedicated to providing a comprehensive and easily accessible source of essential medical data for various applications. It adheres to the principles established by DARWIN and aims to simplify the challenging task of locating medical data for innovative solutions and research activities. The platform operates under a multi-procedural framework, offering user-friendly support for developing and implementing applications for post-market utilisation. It utilises cutting-edge practices and technologies for acquiring, storing, processing, and securing medical information, while also providing end-users with limited access medical data to evaluate their algorithms.

Key Objectives of the REALM Project

  • Establish Clinical Software Assessment Guidelines: Develop methods for evaluating software using diverse, multimodal health data.
  • Create a Decentralized Certification Framework: Build a GDPR-compliant health innovation certification system utilizing Blockchain for enhanced transparency and traceability.
  • Enhance Health Data Processing: Implement tools for processing Electronic Health Records (EHR) using Natural Language Processing (NLP) and machine learning for improved data analysis.
  • Develop Ethical AI Tools: Focus on AI tools that evaluate bias, privacy, and ethics within an optimized workflow for health data analysis.
  • Promote Explainable AI: Increase transparency and reduce bias in AI systems, fostering the adoption of machine learning in healthcare.
  • Utilize Synthetic Data & Digital Twins: Apply these technologies to train medical algorithms and assist in decision-making for rare disease scenarios.
  • Standardize Health Data Sharing: Innovate and adopt standards for sharing and assessing medical innovations.
  • Optimize Real-World Data Usage: Improve the selection of parameters for real-world data to enhance post-market medical software surveillance.
  • Share Best Practices Across Europe: Collaborate with EU regulatory bodies to share tools and best practices for medical software evaluation using real-world data.

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