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Regulatory Affairs

IHE-RO

Integrated with MOSAIQ radiation oncology is the MOSAIQ image-enabled electronic medical record (EMR), which supports the entire cancer care team by uniting diverse systems and devices. The ‘Integrating the Healthcare Environment for Radiation Oncology’ (IHE-RO) initiative seeks to improve the practice of radiation oncology through a standardized exchange of information. Working through the IHE-RO, Elekta Software leads the way in promoting open systems standards, leveling the interoperability playing field and affording vendors greater latitude to focus on maximizing efficiency and achieving high patient throughput.

HIPAA

Elekta Software stands side-by-side with you to ensure that you maintain an even higher level of quality care after the Health Insurance Portability and Accountability Act (HIPAA) unfolds and makes its mark on the healthcare world. Elekta Software’s HIPAA Implementation Team is busy keeping pace with developments by analyzing released and proposed regulations and guidance, attending and contributing to user/industry meetings, and reviewing relevant publications.

Read general HIPAA information, read about Elekta Software's HIPAA efforts, view Elekta Software compliance statements, and access helpful HIPAA links.

Regulatory Information

ISO, EN, and CE Markings, United States: Food and Drug Administration (FDA) information, FDA Pre-Market Notification information, European Community: CE Marking (MDD) information, Canada: Health Canada information, Australia: Therapeutic Goods Administration (TGA) information, Elekta Software Regulatory Affairs Contact.

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