Regulatory & Legal
Novarad Corporation provides its customers with the highest quality products and services by complying with all regulatory requirements and adhering to the high standards of our quality management system.
ISO 13485 Registered Quality Management System, Certificate Number: MDSAP 712843ISO 13485 Registered Quality Management System, Certificate Number: FM 508586
ISO 27001 Registered Information Security Management System, Certificate Number: IS 634314
EU Quality Management System according to Regulation (EU) 2017/745, Annex IX Chapter I and III, Certificate Number: MDR 720744
- Meaningful Use
Meaningful Use CertificationsNovaRIS v. 7.5.3 – ONC-ATCB 2011/2012EHR 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
Substantial Equivalence has been determined by the FDA and accordingly, NovaPACS and OpenSight are cleared for marketing in the USA.FDA 510(k): K171754FDA 510(k): K172418
Canadian Class 2 Medical Device License #72644
NovaPACS and Nova RIS 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).
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.
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.
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 with an 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.
Novarad Corporation (“Novarad”) values the privacy of those who provide private personal information to the Company. This policy summarizes what personally identifiable information we may collect, and how we might use this information. This policy also describes other important topics relating to information privacy. Novarad has voluntarily certified that it complies with the EU-U.S. Privacy Shield Framework and the Swiss – U.S. Privacy Shield Framework as set forth by the U.S. Department of Commerce for adequate privacy protection and embraces the requirements of the of EU General Data Protection Regulations. Novarad is committed to the protection of natural persons in relation to the processing of personal data as outlined in the GDPR.
1. Information Collection
EXTERNAL INFORMATION SOURCES (Customer Inquiries) Novarad only will collect personally identifiable information (such as name, title, company name, address, telephone number, or e-mail address) that is voluntarily provided through our website or email correspondence. We will collect general information (such as the type of browser used, the files requested, and the domain name and country which requests information) to improve our website and better meet customer needs.
2. Use of Information
Before we collect any personally identifiable information, we will provide an explanation for the possible use of the data. The information supplied will be used by Novarad to respond to inquiries, supply requested information on Novarad products and services, or track orders placed with Novarad . Authorized third parties may be utilized by Novarad to collect, track, and process such information. If you have submitted personal information to Novarad electronically and would like it removed or modified, please contact us. We will use reasonable efforts to comply with your request. Any marketing communications sent by Novarad Corporate have an automatic opt-out link at the bottom of each communication. You may elect to remove yourself from further informational communications by selecting and confirming this link.
EU-U.S. Privacy Shield Framework and the Swiss – U.S. Privacy Shield Framework Novarad complies with the EU-U.S. Privacy Shield Framework and the Swiss – U.S. Privacy Shield Framework as set forth by the U.S. Department of Commerce through self-assessment. We make every effort to ensure privacy and encourage you to contact us at any time if you feel we are not in compliance with the EU-U.S. Privacy Shield Framework and the Swiss – U.S. Privacy Shield Framework as set forth by the U.S. Department of Commerce. In the event we are unable to resolve an issue regarding our compliance, we will contact the appropriate Data Protection Authorities to expeditiously resolve the complaint. Please see EU-US Privacy Shield Framework and the Swiss – U.S. Privacy Shield Framework for additional information.
4. GDPR (EU General Data Protection Regulation)
We’re meeting the new requirements for how we process EU personal data. We embrace these changes, and our policy updates reflect the transparency that this new law requires. Please see GDPR for additional information.
Any individual has the right to opt-out of email communication from us at any time. Each email sent by Novarad contains a link that allows the individual to permanently opt-out of receiving emails from Novarad.
6. Do Not Track
“Do not track” refers to how Internet web browsers may request that a web application turn off tracking through the use of an HTTP header. Tracking may be disabled by any user through the use of the browser’s built-in cookie handling mechanism. Cookies are typically stored on your computer or device when a website is visited and may contain information such as site preferences or login status. This cookie is used to help determine use of the site. The cookie itself does not contain any personally identifiable information.
8. Internal Information Sources (Employee Data)
Novarad does not request or gather any information regarding political opinions, religion, philosophy, union membership, or sexual preferences. To the extent Novarad maintains information on an individual’s medical health or ethnicity (as legally required of U.S. employees and US applicants for employment), consistent with this policy, Novarad will not disclose such information to third parties.
Novarad is committed to protecting personal information from loss, misuse, disclosure, alteration, unauthorized access and destruction. Novarad takes all reasonable precautions to safeguard the confidentiality of personally identifiable information.
10. Updating or Correcting Information
Any employee wishing to review or update their personal information can do so by contacting their local Human Resources Department.
11. Other Important Information
Please note that this Policy does not govern the collection and use of information by companies that Novarad does not control, nor by individuals not employed or managed by us.
We reserve the right to make changes to this Policy at any given time. If you want to make sure that you are up to date with the latest changes, we advise you reach out to firstname.lastname@example.org. If at any point in time Novarad decides to make use of any personally identifiable information on file, in a manner that is vastly different from that which was stated when this information was initially collected, the user or users shall promptly be notified by email. Users at any time shall have the option as to whether to permit the use of their information in this separate manner.
This Policy applies to Novarad, and it governs any and all data collection and usage by us. Through the use of Novarad, you are therefore consenting to the data collection procedures expressed in this Policy.
12. How to Contact Us
Mailing Address: P.O. Box 859, Provo, Utah 84603-0859