Standards & Compliance

Versions of the OBIX system are compliant with the Inpatient Modular EHR 2014 Edition and have been certified by ICSA Labs in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.

CCSI is registered with the FDA and the company’s products are FDA listed medical devices.

The OBIX system helps hospitals meet the standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Institute of Child Health and Human Development (NICHD), and operates in compliance with the provisions of the Health Insurance Portability and Accountability ACT (HIPAA).

ICSA

ONC-ACB 2014 Edition v7.1.1

The OBIX System Version 7.1.1 has attained the 2014 Edition Modular Inpatient EHR Certification.*

ICSA

ONC-ACB 2014 Edition v7.2

The OBIX System Version 7.2 has attained the 2014 Edition Modular Inpatient EHR Certification.*

ICSA

ONC-ACB 2014 Edition v7.3

The OBIX System Version 7.3 has attained the 2014 Edition Modular Inpatient EHR Certification.*

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ISO 13485:2003

Clinical Computer Systems, Inc.'s quality management system has been assessed and registered by Intertek Testing Services NA Ltd., a CMDCAS recognized registrar, as conforming to the requirements of ISO 13485:2003.

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ISO 9001:2008

Clinical Computer Systems, Inc.'s quality management system has been assessed and registered by Intertek Testing Services NA Ltd., as conforming to the requirements of ISO 9001:2008.

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Health Canada License

Clinical Computer Systems, Inc. has been licensed in accordance with the Medical Devices Regulations, Section 36, for the OBIX software system.

*There will be no additional costs to Platinum customers for the specified criteria obtained for meaningful use certification on the OBIX system provided the customer owns the associated software modules. Customers with active software support agreements that wish to upgrade their software version certified for meaningful use Stage 2, may be charged for additional software features, software functionality, and/or platform changes if warranted.