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THE GOLD STANDARD OF SECURITY


Smile’s Certifications and What They Mean For You

At Smile Digital Health, we balance data transformation, collaboration, and innovation—through the HL7® FHIR® open framework—with the intentional rigor of quality assurance, proven security standards, and certifications. The certifications below are awarded to companies who have proven discipline in the end-to-end product design and development process and ongoing management. 

THE CERTICATIONS AND WHAT THEY MEAN

Smile Digital Health has obtained various certifications and attestations (listed below) as part of our dedication to maintaining the highest standards of privacy and security. Our suite of certifications demonstrates a commitment to compliance, enabling your organization to focus on innovation and your business needs, while we handle the complexities of data security.

Choose Smile and rest assured that your regulatory needs—current and evolving—are met with confidence.

SMILE'S CERTIFICATIONS

HITRUST r2 Certification

The gold standard in healthcare IT, HITRUST r2 certifies compliance with HIPAA and other regulations. Smile’s HITRUST certification ensures mature privacy and security practices, including 350+ audited controls. In April 2023, Smile received the HITRUST Award for Maintaining the Highest Information Security and Privacy Standards.

For our payer and provider customers, HITRUST is the broadest, widest and deepest set of requirements. Having completed our HITRUST r2 certification, we were audited for over 350 different controls, which your organization inherits as part of our solution and service suite.

Smile Digital Health is also a part of the Global Healthcare Compliance Scale Program with partners like HITRUST and Microsoft Azure. This enables the simplification of regulatory compliance in order to accelerate solution adoption and value, without compromising security.

SOC 2 - Type II

This certification attests to Smile’s robust internal controls over security, availability, confidentiality, and more. Unlike one-time audits, SOC 2®- Type II validates processes over time, rather than a snapshot of data, ensuring continuous protection of customer data.

Since this certification involves extensive validation of testing recovery plans, vulnerability scanning, access management and audits, it allows Smile to keep privacy and security at the core of all processes.

ISO/IEC 27001:2013

ISO 27001 sets the global benchmark for information security. This certification is awarded to companies who have successfully completed an independent audit of their information security management system. Smile’s certification reflects a proactive, continuous risk-based approach to safeguarding sensitive data and meeting interoperability demands in a secure environment.

ISO/IEC 27018:2019

Focused on cloud data protection and consent management, ISO 27018 ensures the safeguarding of PII (Personally Identifiable Information). Smile integrates these controls, guaranteeing transparency and regulatory compliance. The ISO/IEC 27018 certification is a code of practice that focuses on cloud data protection and consent management. An add-on to ISO 27001, ISO 27018 establishes controls, objectives, and guidelines to implement measures and protect PII (Personally Identifiable Information). Smile integrates these controls into all processes end-to-end, guaranteeing transparency and regulatory compliance.

ISO 13485:2016 ISO 13485 is an internationally recognized standard that demonstrates commitment to the design, safety, quality and installation of medical devices. It is a rigorous certification that ensures secure, high-quality, and reproducible solutions that evolve alongside FHIR regulations.
ONC Health IT Certification Program, G(10) The (g)(10) (and related criteria) mandates the use of HL7® FHIR as the standard to support the ONC and CMS interoperability and compliance strategies. Through this certification, Smile’s product suite is functionally compliant with all US Federal regulations, which reduces administrative costs and burdens associated with compliance for your organization.
Drummond Certification

Smile is the first company to achieve the Drummond Certification for CMS-compliant FHIR APIs, ensuring seamless data sharing and improved care coordination for payers and patients.

The certification validates Smile’s platform as fully compliant with the HL7 U.S. Drug Formulary FHIR Implementation Guide referenced in the Patient Access API requirements of the CMS Final Rule. 

HOW SMILE'S SECURITY HELPS YOUR ORGANIZATION

Partnering with Smile reduces your organization’s administrative and compliance burdens, allowing you to focus on your business innovations.

Smile’s trusted, secure products and services make achieving gold-standard security and regulatory compliance effortless. You can also use Smile’s certifications as a benchmark to evaluate your vendors and ensure alignment with rigorous security standards.

Benefits Include

- Comprehensive, un-duplicated compliance efforts.

- Robust protocols for access, consent, data portability, and quality and auditing.

- Enhanced trust through adherence to gold-standard certifications.

- Effortless data ingestion from third party vendors and SMART on FHIR apps to enable expanded clinical insights.

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