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Industry Landscape
The HealthTech RWD industry is rapidly expanding, driven by the increasing demand for data-driven insights in drug development, clinical trials, and patient care. AI/ML integration enhances data quality and analysis, fostering innovation. Partnerships with medical societies are crucial for data access, but data privacy and regulatory compliance remain key challenges and areas of focus for continued growth.
Total Assets Under Management (AUM)
Global Real-World Data Market Size in United States
~$1.8 Billion (2022)
(14.5% CAGR)
- Growth fueled by increasing R&D activities in life sciences.
- Rising demand for value-based healthcare.
- Advancements in data analytics and AI.
Total Addressable Market
2.8 billion USD
Market Growth Stage
Pace of Market Growth
Emerging Technologies
Federated Learning
Federated learning allows multiple parties to collaboratively train a shared AI model without directly exchanging their raw data, enhancing data privacy and security.
Synthetic Data Generation
Synthetic data generation involves creating artificial datasets that mimic the statistical properties of real-world data without containing any actual patient information, addressing privacy concerns and enabling broader data sharing.
Explainable AI (XAI)
Explainable AI focuses on developing AI models whose predictions and decisions can be understood and interpreted by humans, fostering trust and transparency in data-driven healthcare insights.
Impactful Policy Frameworks
21st Century Cures Act (2016) - Information Blocking Rule (2021)
The 21st Century Cures Act's information blocking rule prohibits healthcare providers, IT developers, and health information exchanges from knowingly interfering with the access, exchange, or use of electronic health information (EHI).
This policy mandates greater interoperability and data access, potentially increasing the volume and accessibility of EHR data for RWD companies like Verana Health, while also creating new compliance requirements.
HIPAA Privacy Rule (Updated as of 2013, with ongoing enforcement)
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule sets national standards to protect individuals' medical records and other personal health information, requiring safeguards for covered entities and their business associates.
HIPAA continues to be the foundational regulation governing patient data, directly impacting how Verana Health must de-identify and secure data, influencing their data acquisition and usage strategies.
FDA's Real-World Evidence Program (Ongoing Guidance)
The FDA has been actively issuing guidance on the use of Real-World Evidence (RWE) to support regulatory decision-making for drugs and biological products, including post-market safety studies and supporting approvals for new indications.
This initiative validates the importance of RWD/RWE, increasing the demand for Verana Health's services by life sciences companies seeking to leverage real-world data for regulatory submissions and drug development.
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