Standards & Compliance

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).

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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.

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Costs and Limitations

OBIX versions 7.1.1, 7.2, and 7.3 are compliant with the Modular EHR (Inpatient) 2014 Edition, and have been certified by Drummond Group in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification criteria does not represent an endorsement by the U.S. Department of Health and Human Services.

OBIX version 7.1.1 was certified on August 28, 2017. Certification number: 14.04.04.1250.OBIX.71.1.0.170828

OBIX version 7.2 was certified on August 28, 2017. Certification number: 14.04.04.1250.OBIX.72.1.0.170828

OBIX version 7.3 was certified on August 28, 2017. Certification number: 14.04.04.1250.OBIX.73.1.0.170828

Certification criteria for all three versions include: 170.314(a)(4), 170.314(a)(9), 170.314(a)(11), 170.314(a)(17), 170.314(d)(1),
170.314(d)(2), 170.314(d)(3), 170.314(d)(5), 170.314(d)(6), 170.314(d)(8), 170.314(g)(1), 170.314(g)(4)

No Clinical Quality Measures were tested, and no additional software was used.

Customers must purchase the relevant Notes and Forms modules to enable the following certified EHR functionality:
Triage Form - 170.314(a)(4), Admit Form - 170.314(a)(9), 170.314(a)(11), 170.314(a)(17), Triage and Admit Form - 170.314(g)(1)

The OBIX software licensing and annual support agreement includes all software required for the remainder of the certified
EHR functionality.

There are no known limitations that a user may encounter in using the Certified Health IT's capabilities.