Manufacturer Disclosure Statement For Medical Device Security
Data back-up and removable media capabilities. TridentHD 10 RD-04061 Rev 001 18-Dec-2020 Question ID Question See note IEC TR 80001-2-22012 NIST SP 800-53 Rev.
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__ DOC-2 Device Description Mammography System __ DOC-3 Device Model.
Manufacturer disclosure statement for medical device security. Maintaining storing and transmitting ePHI Data back-up and removable media capabilities. Device Model Software Revision Software Release Date VioArchive 27 9152017 Manufacturer Disclosure Statement for Medical Device Security MDS2 DEVICE DESCRIPTION Device Category Document Release Date Clinical information archive 5272015. Maintaining storing and transmitting ePHI.
Consists of the MDS 2 form and instructions for completing it. Manufacturer Disclosure Statement for Medical Device Security MDS2 DEVICE DESCRIPTION Store private data persistently on local media. Can this device display transmit or maintain private data including electronic Protected Health Information ePHI.
Manufacturer Disclosure Statement for Medical Device Security MDS² SECTION 1 Device Category Manufacturer Document ID Document Release Date 4212011 Manufacturer or Representative Contact Information. View all product details. Manufacturer Disclosure Statement for Medical Device Security MDS2 DEVICE DESCRIPTION Device Category Manufacturer Document ID Document Release Date Medical Device Class II Karos Health Incorporated 201505024 2212018 Device Model Software Revision Software Release Date EasyViz 75 2212018 Manufacturer or Representative Contact Information.
4 ISO 270022013 DOC-1 Manufacturer Name Hologic Inc. The sending of this data requires The sending of this data requires an opt-in from the customer. The FilmArray Torch interacts with the reagent pouch to both purify nucleic acids and amplify targeted.
Advanced Workflow Manager AWM 110 RD-04057 Rev 001 18-Dec-2020 Question ID Question See note IEC TR 80001-2-22012 NIST SP 800-53 Rev. The FilmArray Torch is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The intent of the MDS2 is to supply healthcare providers with important information that can assist them in assessing the vulnerability and risks associated with electronic Protected Health Information ePHI1 transmitted or.
Manufacturer Disclosure Statement for Medical Device Security -- MDS2 Hologic Inc. Importexport private data with other systems. Specifically Philips Healthcare is using the Manufacturer Disclosure Statement for Medical Device Security MDS² to provide security information about its products.
Types of private data elements that can be maintained by the device. __ DOC-2 Device Description Advanced Workflow Manager __ DOC-3 Device Model. Manufacturer Disclosure Statement for Medical Device Security -- MDS2 Hologic Inc.
The only requirement is that all users must have the ReadWrite capability otherwise the daily automatic system calibration and image storage will not complete successfully. Manufacturers Disclosure Statement for Medical Device Security MDS 2 Deployment During deployment we verify the installation and configure security controls depending on the network and security requirements of your medical facility. Manufacturer Disclosure Statement for Medical Device Security.
Manufacturer Disclosure Statement for Medical Device Security. The information on the MDS 2 form is not intended and may be inappropriate for other purposes. HIPAA Security Rule the HIMSS Medical Device Security Workgroup has created a standard Manufacturer Disclosure Statement for Medical Device Security MDS2.
The MDS² contains product specific security information related to the capabilities of the devices such as. Standard by American National Standards Institute National Electrical Manufacturers Association 2019. 4 ISO 270022013 DOC-1 Manufacturer Name Hologic Inc.
This device can be connected to a network to provide the following DICOM services according to IHE Integration Profile Scheduled Workflow SWF Modality Image Storage Storage Commitment Patient Based Worklist Query Broad Based Worklist Query Modality. Assists professionals responsible for security-risk assessment in the management of medical device security issues. Specifically we use the Manufacturer Disclosure Statement for Medical Device Security MDS² to provide security information about our products.
Contact manufactuer if there are specific questions about additional security. The FilmArray Torch is an automated in vitro diagnostic IVD device intended for use with FDA cleared or approved IVD FilmArray panels. The MDS² contains product specific security information such as.
Importexport private data with other systems. Manufacturer Disclosure Statement for Medical Device Security -- MDS2 Hologic Inc. Can this device display transmit or maintain private data including electronic Protected Health Information ePHI.
__ DOC-2 Device Description Specimen Radiography System __ DOC-3 Device Model TridentHD 10 __. 4 ISO 270022013 DOC-1 Manufacturer Name Hologic Inc. Within the Windows OS the customer can administer the system as needed from a security standpoint.
Dimensions 111 3Dimensions 22 RD-04060 Rev 001 18-Dec-2020 Question ID Question See note IEC TR 80001-2-22012 NIST SP 800-53 Rev. De-identification is performed on data sent to the manufacturer to improve the product. Device Category Document Release Date Manufacturer Disclosure Statement for Medical Device Security MDS 2 DEVICE DESCRIPTION Store private data persistently on local media.
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