CoActiv Medical Regulatory Information
|IHE Integration Statement||Date: June 10 2011|
|Vendor: CoActiv, LLC||Product Name: EXAM-PACS||Version: V2.01|
|This product implements all transactions required in the IHE Technical Framework to support the IHE Integration Profiles, Actors and Options listed below:|
|Integration Profiles Implemented||Actors Implemented||Options Implemented|
|Basic Image Review (BIR)||Image Manager/Image Archive||None|
|Scheduled Workflow (SWF)||Image Manager/Image Archive||None|
|Consistent Presentation of Images (CPI)||Image Manager/Image Archive||N/A|
|Access to Radiology Information (ARI)||Image Manager/Image Archive||N/A|
|Key Image Note (KIN)||Image Manager/Image Archive||N/A|
|Nuclear Medicine Image (NMI)||Image Manager/Image Archive||None|
|Mammography Image (MAMMO)||Image Manager/Image Archive||None|
|Portable Data for Imaging (PDI)||Portable Media Creator||None|
|Portable Media Importer||N/A|
|Patient Information Reconciliation (PIR)||Image Manager/Image Archive||None|
|Radiation Exposure Monitoring (REM)||Image Manager/Image Archive||None|
|Displayable Reports (DRPT)||Report Reader||N/A|
|Internet address for vendor's IHE information||http://coactiv.com/regulatory|
|Links to Standards Conformance Statements for the Implementation:|
|Links to general information on IHE:|
|In North America: www.ihe.net||In Europe: www.ihe-europe.net||In Japan: www.jira-net.or.jp/ihe-j|
Furthermore, CoActiv EXAM-PACS is FDA 510(k) listed and meets complete conformance with DICOM 3.0 Standards for the creation, movement, storage and retrieval of diagnostic radiological images and exams.
An example of some of the tools and procedures that CoActiv provides to its HIPAA covered client include the following:
- Access and usage logs of all image creation, use, distribution and storage.
- Separate User Login IDs, Passwords and User Rights and Privileges.
- Total client control over user accounts and access. CoActiv strongly encourages clients to safeguard this information and prohibit the use of shared passwords.
- Hierarchical User Access Rights & Privileges based on a strict need-to-know and right-to-know classification. Only patient medical treatment concerns can over-ride User Privilege classifications.
- Ability to limit access to specific patient images and information to Users based on both User Class as well as Individual Rights & Privileges within the system.
- Ability to limit access to patient’s images and information to only those physicians, practice medical staff and administrative staff with a legal and/or medical right to such images and information.
- All access to PACS images and information across the Internet is via Department of Defense 256-bit encryption and is limited to authorized Users only with appropriate User IDs and Passwords and all users are exposed to appropriate HIPAA warnings and are required to acknowledge such warnings before being allowed access to patient images or other patient information.
- Ability for the imaging entity to require varying levels of access information to different classes of remote users.
- Ability to organize and structure image and information archives into specific entity, practice or departmental groupings.
- Automated redundant backup of all patient image and related information on secure HIPAA audited on-line multiple remote archive sites as well as on the imaging center site. If requested, images and information may also be copied to archival removable electronic media for storage in offsite secure vaults.
- Archive redundancy includes: redundant hard drives; redundant RAID arrays; redundant servers with redundant power supplies, redundant cooling fans and redundant network interface cards; redundant archive centers with redundant Internet connections and redundant power sources, residing on divergent power grids and Internet peering points.
- All exams, images and information reside on: 1. Local Redundant On-Line RAID equipped Exam Server; 2. Remote Archive Site #1 with On-Line Redundant RAID devices; 3. Remote Archive Site #2 with On-Line Redundant RAID devices.
- Biometric Access Control to primary archive center.
- Ability to produce “anonymized” exam copies for teaching or clinical review purposes.
- Automatic Log-off of any and all unattended workstations and servers with PACS access.
- Ability for authorized Users of the PACS to manually enter PACS orders and patient demographic information in the event of HIS/RIS failure.
- CoActiv also can automatically populate all connected modalities with patient exam orders and demographic via a self contained DICOM Modality Worklist in the event of a HIS/RIS failure.
- Department of Defense 256-bit encryption of all transmitted images and exams to and from Secure Socket Level Internet based access devices.
- Use of secure client server technology to eliminate less secure “browser based” remote access protocols.
- CoActiv supplied user training in proper HIPAA compliant practices and procedures when accessing and handling all patient related images and information in the PACS system.
- Classes in HIPAA practices and procedures are also made available on an as requested basis for any and all members of the entity PACS community, including physicians, medical staff, administrative staff, support staff and off-site PACS users such as referring and consulting physicians and their practice staff.
- CoActiv employees are required to execute appropriate confidentiality agreements and adhere to all HIPAA privacy guidelines.
To receive more detailed or specific information regarding CoActiv Medical HIPAA practices, procedures or policies please contact us at email@example.com or in writing to: CoActiv, LLC, Department of Regulatory Control, 900 Ethan Allen Highway, Ridgefield, CT 06877, or by phone at: 877-COACTIV (262-2848).
Information regarding CoActiv FDA and DICOM regulatory compliance is also available elsewhere on this website.
Additional Information regarding HIPAA may be found at the following Internet locations:
US Dept of Health and Human Services – www.hhs.gov/hipaa/
US Office of Civil Rights (OCR) – www.hhs.gov/ocr/privacy
American College of Radiology – www.acr.org
AHIMA – www.ahima.org/topics/psc
HIMSS – www.himss.org
|Device Listing Database|
|Proprietary Device Name:||EXAM-PACS|
|Common/Generic Device Name:||PICTURE, ARCHIVE, AND COMMUNICATION SYSTEM|
|Classification Name:||SYSTEM, IMAGE PROCESSING, RADIOLOGICAL|
|Registered Establishment Name:||COACTIV MEDICAL BUSINESS SOLUTIONS|
|Date of Listing:||09/11/04|