Delphi VitalPoint Home Monitor Manual de usuario Pagina 43

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Legal/Regulatory/
Cyberliability
FDA Clearance/ Listing
(Cleared, Listed (this
category may include
Medical Device Data System
(MDDS)), Pending or None)
FDA Classification (Class I,
Class II, etc.)
HITECH
HIPAA
Security - List HIPAA &
HITECH Act Requirements
Met
List Applicable Regulatory Requirements
Met
Provide a Link to Company's
Cyberliability Policy
List Any Other Legal Requirements
Provide link to Sample
Contract
GrandCare Systems
www.grandcare.com
Listed Class II Yes Yes All are met.
ISO 13485, FM 595123, FDA MDDS, CE 595939,
CMDR part 1 - CMDCAS
Available upon request. Record retention among others. Available upon request.
Guardian eHealth Solutions
www.GeHS.net
Cleared Class II Yes Yes All are met. Medicare and Medicaid Regulations Met Available upon request.
Met all applicable state and federal
guidelines.
Available upon request.
Healthsense, Inc.
www.healthsense.com
None N/A No Yes N/A UL-1069, UL-1637 Available upon request. N/A Available upon request
Honeywell HomMed - Genesis DM
www.hommed.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid Regulations Met
http://www.hommed.com/
privacy-statement/
N/A Available upon request.
Honeywell HomMed - Genesis Touch
www.hommed.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid Regulations Met
http://www.hommed.com/
privacy-statement/
N/A Available upon request.
IDEAL LIFE
www.ideallifeonline.com
Cleared
Class I and
Class II
No Yes HIPAA FDA, CAMDCAS, ISO 13485 N/A N/A Available upon request.
INDEPENDA, INC
www.independa.com
Listed Class I Yes Yes All are met. FDA MDDS Available upon request.
Meets federal record retention
requirements.
Available upon request.
Philips
www.telehealth.philips.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid regulations N/A N/A Available upon request.
SilverSphere - Bios
www.silversphere.com
Cleared Class II Yes Yes All are met.
HIPAA, FCC Certified, IEC60601-1-2, FDA
Class II Cleared, UL 2560 and UL 1069
requirements complant
Availble upon request.
Meets federal record retention
requirements.
Available upon request.
Viterion Health
www.viterion.com
Cleared CLASS II Yes Yes All are met. FDA Class II, Medicare and Medicaid Available upon request.
Meets federal record retention
requirements.
Available upon request.
VRI Telehealth
www.monitoringcare.com
Cleared
Class I/
Class II
Devices VRI
is a device
distributor
and
refurbisher
Yes Yes All are met. Medicare and Medicaid Regulations Met
http://www.monitoringcare.
com/privacy/index.asp
Available upon request. Available upon request.
WoundRounds (Telemedicine Solutions)
www.woundrounds.com
None N/A Yes Yes All are met. HIPAA Privacy Available upon request.
Meets federal record retention
requirements.
Available upon request.
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