Delphi VitalPoint Home Monitor Instrukcja Użytkownika Pobierz pdf (Strona 43)

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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Delphi VitalPoint Home Monitor Instrukcja Użytkownika Strona 43