Building trust in healthcare data: Real-world interoperability with AWS HealthLake and DataArt

As healthcare regulations push for greater interoperability and the adoption of artificial intelligence (AI), they are under pressure to modernize data infrastructure not just in theory, but in practice. The challenge is not just technical, but also regulatory, operational, and strategic. At the center of this shift is the need to transform disconnected clinical, claims, and observational data into structured formats that can support real-time exchange and intelligent analysis.

From standards to solutions: DataArt’s approach to health data modernization

DataArt, an HAQM Web Services (AWS) Advanced Consulting and Healthcare Competency Partner, helps clients respond to the regulatory and operational pressures outlined in the previous section. We turn complex data modernization challenges into clear, standards-driven solutions built on AWS HealthLake, a fully managed, HIPAA-eligible FHIR storage, transactional, and analytics service.

DataArt supports healthcare payors, providers, and life sciences organizations by engineering cloud-based architectures grounded in healthcare interoperability standards. With a long-standing collaboration in healthcare, DataArt has worked with AWS to bring HealthLake into real-world enterprise contexts. Our teams combine deep technical expertise with domain knowledge, but what makes our approach distinct is the ability to engage globally distributed engineering teams who understand the infrastructure and the intricacies of healthcare data standards like Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) or Electronic Data Interchange (EDI) format by American National Standards Institute’s Accredited Standards X12. From implementing components in alignment with the European Health Data Space (EHDS) in Europe to aligning with the Centers for Medicare & Medicaid Services (CMS) interoperability rules in the US, we support clients in building compliant and operationally resilient systems.

Most organizations stop at technical implementation. DataArt goes further, bringing strategic guidance, standard fluency, and deep healthcare experience. DataArt stands out due to its:

• Proven track record delivering HL7/FHIR solutions in both EU and US regulatory frameworks
• Engineering-driven approach grounded in real project delivery, not theory
• Purpose-built accelerators to shorten timelines and reduce complexity

DataArt operates globally, with a strong presence in the EU market and offices in Germany, the UK, and Switzerland among others. This geographic reach enables the DataArt team to develop a deep understanding of regional compliance nuances—so that they are equipped to support health systems within the European regulatory landscape.

DataArt offers AWS-based healthcare accelerators to help clients implement critical healthcare use cases and align with global standards more efficiently. These include the FHIR accelerator, which simplifies resource templating and validation for use cases such as patient data exchange (PDex), clinical data exchange (CDex), and prior authorization support (PAS). DataArt also offers an EHDS accelerator with preconfigured application programming interfaces (APIs) aligned with EU-specific standards such as European Electronic Health Record Exchange Format (EEHRxF) profiles, Shared Assurance Conformity Knowledge Library (SHACKL) validation, and Applicability Statement 4 (AS4) messaging support.

Challenge #1: Enabling real-world evidence in hybrid clinical trials

One example of DataArt’s work in the space is the project for a biopharma sponsor working with a contract research organization and academic partners. The goal was to integrate real-world data connected via the Trusted Exchange Framework and Common Agreement (TEFCA), a US regulatory initiative to enable secure, nationwide health information exchange. While TEFCA and EHDS operate in different regulatory contexts, they share core goals such as promoting interoperability, safeguarding data integrity, and enabling the secondary use of data for public benefit. The capabilities DataArt implemented in this project are equally relevant for supporting similar EHDS-aligned use cases in the European Union.

Solution

To support the data needs of the hybrid clinical trial, DataArt implemented FHIR-native architecture using AWS. The solution ingested structured and unstructured data from multiple sources, including electronic health records (EHRs), insurance claims, and research registries. With the help of HAQM Comprehend Medical, key clinical entities were extracted from free-text notes and automatically mapped to the FHIR data model. The data was stored securely in HAQM Simple Storage Service (HAQM S3), while HAQM Athena enabled researchers and analysts to run on-demand queries across the data lake. This architecture established a consistent, standards-based framework for real-time access to trial-relevant data.

Use cases and results

This architecture enabled two critical research capabilities. First, the use of synthetic control arms allowed the project team to reduce the sample size for a Phase II clinical trial by 30 percent. By leveraging historical and real-world data (RWD), the sponsor could construct valid control comparisons without enrolling a separate patient cohort. Second, the environment supported faster post-market surveillance. By unifying signals across EHRs, claims data, and registry inputs, potential safety issues were detected six months earlier than with previous systems.

Challenge #2: Preparing for CMS-0057-F with a modular data architecture

One of the largest US healthcare payors struggled with its aging infrastructure to meet the CMS-0057-F regulation, which mandates interoperability through APIs by 2026. The client’s environment was fragmented, with multiple isolated data sources and reliance on nightly extract, transform, and load (ETL) batches.

The business objective was clear: move toward real-time, standards-based data exchange that complies with the HL7 Da Vinci framework.

Solution

DataArt designed and implemented a modular data architecture centered on AWS HealthLake to convert structured and unstructured health data into the FHIR R4 standard. HAQM Comprehend Medical was used to extract clinical information from free-text notes and documentation. AWS Lambda and HAQM API Gateway were applied to manage real-time data flows and facilitate API-based integration. For storage and analytics, HAQM S3 and HAQM Athena enabled secure storage and on-demand querying of patient data.

This solution supported three key use cases defined by the HL7 Da Vinci Project:

• PDex provides payors and providers with standardized clinical and claims data access.
• CDex supports retrieving clinical information necessary for treatment and care coordination.
• PAS automates prior authorization workflows by mapping traditional X12 transactions to modern FHIR-based APIs.

Results

By modernizing the payor’s data infrastructure, the organization achieved a 50 percent reduction in prior authorization turnaround times. Automating clinical documentation processes, including the use of coverage requirements discovery (CRD) and document templates and rules (DTR), led to a 40 percent decrease in administrative burden. Furthermore, the move from nightly batch ETL processing to near real-time data exchange enabled faster and more reliable access to information. This transformation resulted in full technical compliance with the CMS Prior Authorization API requirements and laid the groundwork for future scalability.

Alignment with EHDS and TEFCA

DataArt’s experience spans European initiatives like the EHDS regulation and US-centric frameworks such as the TEFCA. While each operates within its own regulatory context, both aim to improve interoperability, data quality, and the secondary use of health data.

Enabling alignment with the European Union standards

• eDelivery-compliant messaging and access point development
• Compliance with Service Metadata Locator (SML)/Service Metadata Publisher (SMP) protocols and national validation engines
• AWS-based reference architectures for regulated environments

Enabling alignment with the United States standards

• Integration with Qualified Health Information Networks (QHINs) and TEFCA-aligned networks
• Modernization from Clinical Document Architecture (CDA) to FHIR R4
• Interoperability with X12, US Core, and Representational State Transfer (RESTful) FHIR APIs

Conclusion

Along with technical infrastructure, healthcare organization need guidance, assurance, and practical experience to navigate changing regulations. AWS HealthLake provides the foundation, and the real impact comes from how the data is structured, exposed, and governed.

DataArt’s work has shown that the right mix of cloud services, healthcare data standards, and engineering discipline can achieve measurable improvements in:

• Time-to-compliance
• Data readiness for artificial intelligence (AI) and analytics
• Operational efficiency
• Patient care outcomes

In the context of EHDS, AWS HealthLake’s ability to normalize data to FHIR R4 is especially valuable. EHDS aims to facilitate cross-border health data exchange and secondary use of data for research, policymaking and innovation. AWS HealthLake supports this vision by offering scalable ingestion, semantic mapping, and analytics-ready data pipelines. These components are foundational for national and transnational health systems.

Next Steps

If you’re working towards EHDS implementation, exploring real-world data in clinical trials or preparing for CMS mandates, the technology exists. The difference is in how you apply it.

Let’s talk about the future of healthcare and discuss how we can help you transform your operations!