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Compliance

Regulatory Compliance

Certificates

ISO 13485 Registered Quality Management System under CMDCAS

Certificate Number: FM 508586

ISO 27001 Registered Information Security Management System

Certificate Number: IS 634314

CE 0086

NovaPACS is CE marked as a Class IIa medical device according to 93/42/EEC-Medical Device Directive Certificate Number: 584245

Meaningful Use

Meaningful Use Certifications

NovaRIS v. 7.5.3 – ONC-ATCB 2011/2012

EHR Certified Technology for Hospitals – Certificate #CC-1112-100046-1 (July 6, 2012)

EHR Certified Technology for Eligible Providers – Certificate #CC-1112-100046-2 (July 6, 2012)

This EHR Module is ONC-ATCB 2011/2012 compliant and has been tested and certified by, the Certification Commission for Health Information Technology (CCHIT®), an ONC-ATCB, 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 or guarantee the receipt of incentive payments.

United States

FDA 510(k): K160371

Substantial Equivalence has been determined by the FDA and accordingly, NovaPACS is cleared for marketing in the USA.

Canada

Canadian Class 2 Medical Device License #72644

IHE

Conformance with IHE is a top priority in the development of Novarad’s clinical planning solution. Our IHE Integration Statements specify capabilities in terms of the key concepts of IHE: Actors and Integration Profiles. The Statement describes the intended conformance of NovaPACS with the IHE Technical Framework.

HIPAA

NovaPACS and NovaRIS help users and system integrators to meet the privacy and security standards set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

DICOM

NovaPACS is a self-contained, networked computer system used for routing and archiving diagnostic medical images. The system conforms to the DICOM standard to allow the sharing of medical information with other digital imaging systems.

ICD-10

Since January 2014, over 1.5 years ahead of the deadline, the Novarad Corporation has provided support for the new ICD-10 code sets used to report medical diagnoses and inpatient procedures in compliance with CMS. Novarad remains committed to supporting both ICD-9 and ICD-10 until ICD-9 becomes irrelevant. If a coder enters an ICD code beginning with a numeric character, then Novarad software assumes the user is entering an ICD-9 code. Likewise, if a coder enters a code starting within alpha character, then our software assumes the user is entering an ICD-10 code. This way, Novarad customers have the flexibility to choose their preference and timeline for compliance.