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Industry Landscape

The Real-World Data (RWD) and Data-as-a-Service (DaaS) industry is experiencing robust growth, driven by increasing demand for privacy-compliant, AI-ready data across life sciences, healthcare, and other data-intensive sectors. Technological advancements in de-identification and AI are enhancing data utility and accessibility, while regulatory pressures continue to shape compliance standards. The market is competitive, with a focus on data quality, longitudinal access, and specialized curation.

Industries:
Real-World DataDe-identificationAI-Ready DataData as a ServiceHealthcare Data

Total Assets Under Management (AUM)

Real-World Data Market Size in United States

~Approximately 1.8 billion USD in 2023

(15.0% CAGR)

- Growth driven by increased adoption in pharmaceutical and medical device companies.

- Rising need for RWD in clinical trials and post-market surveillance.

- Expansion into new therapeutic areas and geographic regions.

Total Addressable Market

2.1 billion USD

Market Growth Stage

Low
Medium
High

Pace of Market Growth

Accelerating
Deaccelerating

Emerging Technologies

Generative AI for Synthetic Data

Generative AI can create highly realistic, de-identified synthetic datasets that mimic real-world data distributions without containing any actual patient information, addressing privacy concerns directly.

Federated Learning

Federated learning enables collaborative AI model training across decentralized data sources without centralizing raw data, enhancing privacy and data security.

Differential Privacy

Differential Privacy provides a mathematically rigorous framework for quantifying and guaranteeing the privacy of individuals in a dataset, even when releasing aggregate statistics or models built on that data.

Impactful Policy Frameworks

HIPAA Privacy Rule (ongoing enforcement and potential updates)

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule sets national standards to protect individuals' medical records and other protected health information (PHI) by establishing patient rights and responsibilities for covered entities regarding the use and disclosure of PHI.

Strict adherence to HIPAA-compliant de-identification processes is crucial for OneMedNet, ensuring their RWD solutions remain legally sound for healthcare clients in the US.

21st Century Cures Act (2016) - Information Blocking Rule

The 21st Century Cures Act, signed into law in 2016, includes provisions to promote interoperability and prevent information blocking by healthcare providers and IT developers, aiming to increase patient access to their health information.

This rule encourages greater data liquidity, potentially increasing the availability of real-world data for platforms like OneMedNet, while also emphasizing secure and compliant data sharing.

California Privacy Rights Act (CPRA) (2020, fully effective 2023)

The California Privacy Rights Act (CPRA), a ballot initiative passed in 2020 and fully effective January 1, 2023, amended and expanded the California Consumer Privacy Act (CCPA), granting consumers more control over their personal information and establishing the California Privacy Protection Agency (CPPA).

The CPRA strengthens data privacy regulations in a key US market, requiring OneMedNet to ensure its de-identification and data handling practices meet stringent standards for data sourced from or affecting California residents.

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