Certified Operations
KaVo operates according to the following international standards and directives. Our quality assurance complies with these certificate standards, and with the laws and requirements in the United States, Europe, Canada, Japan, China and Brazil. Our products are approved and registered globally. The testing and monitoring of our products is always performed adhering to the standards. Our business operations are monitored and audited by authorities and facilities for healthcare product technology around the world.
Certificates | Company | Valid Until (yyyy.mm.dd) |
---|---|---|
MDR (EU) 2017/745 Annex IX Chapter I+III | KaVo Dental GmbH | 2026-09-28 |
EN ISO 13485:2016 + AC:2018 + A11:2021 | KaVo Dental GmbH | 2027-09-28 |
ISO 13485:2016 MDSAP | KaVo Dental GmbH | 2027-12-01 |
HIPAA Statements
Statements | Company |
---|---|
DEXIS™ HIPAA Statement | DEXIS™ |
Dental Imaging Technologies Corporation | Dental Imaging Technologies Corporation |
The Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) require the Department of Health and Human Services to establish national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data.
HIPAA requires that dental facilities safeguard patient privacy and create a protocol to safeguard sensitive information. To help with compliance, DEXIS offers the following information on our software:
- DEXIS gives you the option of showing only one patient on-screen at any given time.
- Always back up your DEXIS data. We provide DEXsafe™, a module that allows you to backup all or a part of your data in one step. We recommend a removable hard disk drive device. Should you need to recover this data, our Technical Support team can offer assistance.
- When using scanned signatures in DEXwrite, always use a security code. You can change the security code by rescanning the signature.
- DEXIS X-ray images contain security information. Altered sensor-captured images lose the “Original DEXray by DEXIS” security banner.
- DEXIS software does not allow email of DEXIS images (DEXIS format) with the viewer (DEXview) that opens them.
For more information on these items, refer to the DEXIS Manual.
As the owner of a DEXIS Digital X-ray System, you’ll need to file a HIPAA Business Associate Agreement with DEXIS, LLC if a DEXIS staff member will come in contact with your DEXIS data. Please download the document below, complete it, and submit either by e-mail or fax as instructed in the document. We will add our signature and send it back to you.
Additional Information:
Please contact NEAFastAttach for information on electronic transfer through DEXclaim: www.nea-fast.com
For complete HIPAA rules, visit the Department of Health and Human Services website: www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.html