Aetion® Generate Expands with Replicate, Protect, and Enhance

Purpose-Built Solutions to Secure, Scale, and Strengthen Real-World Data Utility

Meeting the Demands of Modern Evidence Generation

Healthcare and life sciences organizations face growing pressure to produce real-world evidence (RWE) that is faster, more representative, regulatory-grade, and decision-ready. Yet most still encounter significant barriers to working with real-world data (RWD) at scale.

Data privacy regulations are tightening globally. Frameworks such as GDPR, HIPAA, Quebec’s Law 25, and the forthcoming European Health Data Space (EHDS) Regulation redefine how health data is accessed, shared, and applied—particularly across borders. At the same time, fragmented datasets, underrepresentation of key populations, and manual de-identification workflows continue to limit the value of RWD, delaying insights and increasing compliance risk.

To overcome these challenges, organizations need purpose-built tools that enable them to:

• Securely access and share sensitive data: Facilitate compliant, cross-functional collaboration without compromising patient privacy or data integrity.
• Streamline compliance across jurisdictions: Automate risk management and align with evolving global privacy frameworks to reduce legal and operational complexity.
• Enhance dataset completeness and representation: Fill critical data gaps and ensure the inclusion of diverse populations to improve the quality and generalizability of real-world evidence.

Inside the Aetion Generate Suite: Protect, Replicate, and Enhance

To meet these needs, Aetion has expanded its Aetion® Generate suite with three distinct, interoperable modules. Protect, Replicate, and Enhance—designed in direct response to the evolving challenges of RWD utility.

It started with a privacy problem. De-identification was the necessary first step—but traditional, manual approaches were slow, inconsistent, and difficult to scale. That’s why Aetion built Protect—to automate risk scoring and apply privacy-preserving transformations aligned with global regulations.

However, de-identification alone wasn’t enough. On certain datasets, it removed too many important fields or couldn’t be applied at all. So Replicate was introduced to generate synthetic, statistically accurate data—enabling secure data sharing without compromising analytical integrity.

Once the team realized the power of synthetic data generation, the next step became clear: use generative models to go beyond replication and Enhance datasets—specifically to simulate underrepresented populations, predict clinical outcomes, and improve representativeness. Enhance helps fill critical data gaps in cases where real-world datasets are too sparse, unbalanced, or demographically skewed to support robust, generalizable evidence. 

Together, these tools form a scalable, regulatory-grade framework that unlocks the full value of RWD while addressing privacy, completeness, and compliance at every stage of the evidence generation lifecycle.

How Aetion Generate Solves Real-World Data Challenges

As RWD becomes indispensable for drug development, regulatory submissions, market access, and value-based care organizations are under increasing pressure to turn complex datasets into decision-ready, compliant evidence—quickly and at scale.

Aetion Generate delivers this value by solving for the three core forces reshaping RWD strategy:

1. Heightened Regulatory Oversight

Global privacy frameworks—including GDPR, HIPAA, Law 25, and EHDS—now require structured, jurisdiction-specific risk management and audit-ready compliance. Protect operationalizes this through automated de-identification workflows that include global Risk Assessment and HIPAA-compliant Expert Determination, conducted on both the de-identified data and its associated transformations. These privacy-preserving workflows help organizations maintain regulatory readiness and enable secure, cross-border collaboration.

2. Operational Inefficiencies

Traditional de-identification and data-sharing workflows are manual, resource-intensive, and slow—often extending project timelines by months. Protect and Replicate automate these processes, reduce friction, and enable faster access to high-utility data for internal and external collaboration.

3. Incomplete and Underrepresented Data

Many RWD assets lack adequate representation of diverse demographics or disease states, limiting generalizability and slowing regulatory acceptance. Enhance addresses this gap through virtual patient modeling and synthetic augmentation, helping simulate outcomes for rare or underrepresented populations and supporting health equity.

Capabilities and Use Cases of Aetion® Generate Solutions

Product Deep Dive

Aetion® Generate: Protect

Automated Risk Assessment and De-identification to Streamline Compliance and Enable Scale

Manual de-identification processes are often slow, inconsistent, and dependent on third-party vendors—resulting in delays and variability in re-identification risk assessments or expert determinations (particularly in the U.S.). Generate: Protect automates this workflow using Aetion’s patent-pending risk estimator, delivering rapid, defensible risk assessments and privacy-preserving data transformations. The result: scalable compliance aligned with global privacy standards.

Key Features:

• Jurisdiction-Specific Compliance: Automated risk scoring supports global regulatory alignment with global privacy frameworks (e.g., GDPR, HIPAA, Law 25, EHDS)
• Privacy-Preserving Data Transformation: Removes, generalizes, or obfuscates direct and quasi-identifiers using statistically defensible techniques—reducing re-identification risk while preserving analytical utility
• Audit-Ready Outputs: Structured documentation and transformation logs enable defensible compliance reviews and streamline regulatory submissions
• Scalable Deployment: Enables large-scale data access across use cases and geographies without compromising privacy, data quality, or legal defensibility

Example in Practice: Accelerating HIPAA-Compliant Insights at Scale Through Automated De-Identification

A top U.S. retail corporation and its affiliated pharmacy network needed to unlock insights from a massive health dataset—while ensuring HIPAA compliance and managing re-identification risk. Using Aetion’s software-based risk assessment and de-identification solution, Protect, the company processed a cohort of over 3 million records in under 24 hours. This enabled the development of new data products and long-term cost savings through reduced manual compliance workflows while ensuring ongoing adherence to evolving privacy requirements.

Aetion® Generate: Replicate

GenAI-Powered Synthetic Data for Secure Collaboration and Scalable Exploration

When de-identification removes too much useful information or is infeasible, synthetic data fills the gap. Replicate empowers teams to generate privacy-compliant datasets that mirror the statistical structure of real-world data—without including any real patient-level data.

Key Benefits:

• Built-in Privacy Protection: Reduces re-identification risk for secure data sharing
• Preserved Analytical Integrity: Maintains statistical fidelity for early research
• Faster Time-to-Insight: Avoids privacy delays to enable quick exploration

Example in Practice: Enabling Responsible Access to Clinical Trial Data with Privacy-Preserving Transformation

A multinational life sciences company needed to accelerate access to clinical trial data for internal research, secondary use, and statistical software validation while meeting participants' privacy expectations and global compliance requirements. Using Aetion Generate: Replicate, the company created synthetic datasets that mimicked the structure and statistical properties of the original trial data. This enabled secure sharing across internal teams and external partners, supporting data science initiatives and accelerating innovation.

Aetion® Generate: Enhance

Virtual Patient Modeling to Augment Data and Expand Evidence Impact

When datasets lack depth—whether due to rare diseases, pediatric populations, or limited diversity—Enhance uses generative models to simulate virtual cohorts and predict clinical outcomes. This strengthens the completeness and generalizability of evidence.

Strategic Benefits:

• Modeling for Data-Limited Populations: Simulate outcomes to support health equity
• Trial Simulation and Scenario Analysis: Inform trial design and payer strategy
• Data Augmentation: Strengthen evidence for HTA, regulatory, and clinical use cases

Example in Practice: Virtual Patient Modeling to Augment Data and Expand Evidence Impact

In a recent validation study conducted by Aetion scientists—including Lucy Mosquera, synthetic data augmentation was applied to strengthen underpowered control arms in oncology clinical trials. Researchers compared synthetic augmentation techniques—such as Bayesian networks and sequential decision trees—with traditional methods like propensity score weighting and bootstrap sampling. The study found that when bias in the external control data was moderate, synthetic augmentation consistently reduced variance while maintaining acceptable levels of bias—providing more stable and reliable estimates of treatment outcomes.

Business and Regulatory Impact of Aetion® Generate Solutions

A Scalable, Regulatory-Grade Framework for Evidence Generation

Replicate, Protect, and Enhance reflect Aetion’s commitment to delivering scalable, scientifically validated, and compliance-ready solutions for real-world evidence. Fully integrated into the Aetion® Generate platform, each solution is supported by expert implementation, regulatory guidance, and training—ensuring a seamless path from deployment to measurable impact.

Make Your Data Work Harder. Scale Smarter.

Aetion® Generate equips organizations to move faster, reduce risk, and produce high-quality evidence with confidence. Whether your priority is secure data sharing, regulatory-grade submissions that meet data robustness requirements, or augmenting datasets for broader impact, Replicate, Protect, and Enhance provide the infrastructure to support your goals—at scale.

Contact us to explore how Aetion Generate can streamline your operations, strengthen compliance, and drive meaningful outcomes through real-world data.