Compliance | Novarad

Compliance

Regulatory Compliance

Novarad Corporation provides its customers with the highest quality products and services. Novarad management is committed to maintaining the quality management system and complying with all regulatory requirements.
Certificates
ISO 13485 Registered Quality Management System under CMDCASCertificate 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 CertificationsNovaRIS 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

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

FDA 510(k): K171754

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.
Privacy Policy
Novarad Corporation 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 Corporation 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.
Information Collection
EXTERNAL INFORMATION SOURCES (Customer Inquiries)
Novarad Corporation 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 web site or e-mail 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 Web site and better meet customer needs.
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 Corporation to respond to inquiries, supply requested information on Novarad Corporation products and services, or track orders placed with Novarad Corporation. Authorized third parties may be utilized by Novarad Corporation to collect, track and process such information. If you have submitted personal information to Novarad Corporation 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.
Compliance
EU-U.S. Privacy Shield Framework and the Swiss – U.S. Privacy Shield Framework
Novarad Corporation 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.
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.
Opt-Out
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.
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. eTrigue DemandCenter does not make use of this 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.
Requests
Privacy and Privacy Policy requests and inquiries may be made to privacy@Novarad.com
INTERNAL INFORMATION SOURCES (Employee Data)
Novarad Corporation is the sole owner of the information collected from its employees and applicants for employment. Novarad Corporation will not sell or share this information with third parties in ways different from what is disclosed in this privacy policy statement. Novarad Corporation only collects personal data that is relevant and necessary to legitimate human resources and business functions. Personal information collected by Novarad Corporation from employees and applicants for employment is maintained at its corporate offices. Among other things, Novarad Corporation collects and maintains personal information on current and former employees for legitimate corporate business purposes, such as processing payroll, collecting resumes to fill vacant positions, and maintaining accurate benefits records.
Novarad Corporation does not request or gather any information regarding political opinions, religion, philosophy, union membership, or sexual preferences. To the extent Novarad Corporation 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 Corporation will not disclose such information to third parties.
Security
Novarad Corporation is committed to protecting personal information from loss, misuse, disclosure, alteration, unauthorized access and destruction. Novarad Corporation takes all reasonable precautions to safeguard the confidentiality of personally identifiable information.
Updating or Correcting Information
Any employee wishing to review or update their personal information can do so by contacting their local Human Resources Department.
Other Important Information
The Novarad Corporation Web site may contain links to other sites. We do not endorse or otherwise accept responsibility for the content or privacy policies of those sites. Additionally, some of our Web pages may contain “cookies,” which are data that may be sent to your Web browser and stored on your computer. This allows our server to “recognize” you when you visit our Web site in the future and enables you to view protected content without requiring an additional login, password, or re-registration. Most Web browsers can be configured to not accept cookies, or to notify you if a cookie is sent to you. If you prefer to not accept a cookie upon registration, you will be required to register each time you request access to protected content on our web site.