Delphi VitalPoint Home Monitor Manual de usuario Pagina 43

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Legal/Regulatory/
Cyberliability
FDA Approval (Approved,
Cleared, Pending, Listed
(this category may include
Medical Device Data System
(MDDS)) 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
Tunstall - Contact Center Services/IVR
americas.tunstall.com/Contact-Center
None N/A N/A Yes
Available
upon
request.
Available upon request Available upon request N/A Available upon request
Tunstall - Telehealth
americas.tunstall.com/Telehealth
Cleared Class II N/A Yes
Available
upon
request.
Available upon request Available upon request N/A Available upon request
VRI TeleHealth
www.monitoringcare.com
Cleared Class I No Yes All are met. Medicare and Medicaid regulations N/A Available upon request Available upon request
WoundRounds (Telemedicine Solutions)
www.woundrounds.com
None N/A No Yes All are met. HIPAA Privacy Available upon request N/A N/A
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