Smile Digital Health

Smile Digital Health provides FHIR-native health data infrastructure and interoperability solutions for healthcare organizations worldwide. Founded in 2016, the company launched its first commercial release of Smile CDR (clinical data repository) and has since expanded to serve over 160 implementations globally. The founding team includes James Agnew, maintainer of the HAPI FHIR open-source project, positioning the company as a leader in HL7 FHIR standards development.

The company's core offering is the Smile Health Data Platform, which transforms legacy healthcare data into standardized FHIR resources. Their platform handles nearly 2 billion resources daily and processes over 255,000 transactions per second across on-premises, cloud, and hybrid environments. Smile also offers a Clinical Quality Intelligence Suite and CMS Suite designed to help organizations meet regulatory compliance requirements while modernizing their data infrastructure.

Smile Digital Health maintains leadership positions in 31+ HL7 working groups and holds multiple security certifications including HITRUST r2, ISO 27001, ISO 27018, ISO 13485, and SOC 2 Type II. The company was the first to earn Drummond Group Certification for end-to-end interoperability, demonstrating their technical depth in healthcare data standards.

Consider Smile Digital Health when your organization needs proven, enterprise-scale FHIR infrastructure with comprehensive CMS compliance capabilities. Their combination of open-source standards leadership and commercial platform maturity makes them particularly valuable for organizations building long-term data modernization strategies rather than addressing immediate tactical needs.

Expect a technically sophisticated engagement with options ranging from consulting guidance to fully managed services. Their 160+ implementations and mega-volume performance metrics indicate they can handle complex, high-transaction environments that would challenge less mature platforms.

Smile Digital Health serves exclusively healthcare with 100% focus on health data interoperability and compliance. Their solutions specifically address CMS mandates for payers including prior authorization (CMS-9115-F) and patient access requirements (CMS-0057-F). The company works across healthcare verticals including payers, providers, health information exchanges, and research organizations.

Their healthcare-specific certifications include ONC 2015 Edition Cures, HITRUST r2, and ISO 13485 for medical device quality management. The platform is built specifically for healthcare data standards including FHIR, HL7 v2, and CQL (Clinical Quality Language) for clinical decision support.

Large payers and health systems with annual revenues exceeding $500 million facing CMS interoperability mandates and seeking comprehensive FHIR infrastructure. Organizations that have outgrown point solutions and need enterprise-grade data platforms capable of handling hundreds of thousands of transactions per second. Health information exchanges coordinating data across multiple provider networks who require proven scalability and standards compliance.