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Delphi VitalPoint Home Monitor Manual de usuario Pagina 42

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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
Advantage Home Telehealth
www.Advtelehealth.com
Listed Class I Yes Yes All are met.
ISO 13485, FDA MDDS, Medicare and
Medicaid Regulations met.
Available upon request Record retention among others. Available upon request.
AFrame Digital, MobileCare Monitor
www.aframedigital.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
Available upon request Record retention among others. Available upon request.
Ambio Health
www.ambiohealth.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid Regulations Met. Available upon request Meets federal record retention requirements Available upon request.
American TeleCare, Inc.
www.americantelecare.com
Cleared Class II Yes Yes All are met.
ISO 13485, FDA MDDS, Medicare and
Medicaid Regulations met. CMDCAS
Available upon request Record retention among others. Available upon request.
Beacon® by HealthInterlink
www.healthinterlink.com
Cleared Class II Yes Yes All are met.
ISO 13485, FDA MDDS, Medicare and
Medicaid Regulations met.
N/A Record retention among others. Available upon request.
Biosign/Healthanywhere
www.biosign.com
Cleared Class II Yes Yes
Available
upon
request.
Medicare and Medicaid Regulations Met. Available upon request. N/A Available upon request.
Cardiocom - Commander FLEX
www.cardiocom.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid Regulations Met. Available upon request. Meets FDA signature and record retention requirements. Available upon request
Cardiocom - Link View
www.cardiocom.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid Regulations Met. Available upon request. Meets FDA signature and record retention requirements. Available upon request.
Cardiocom - NetResponse
www.cardiocom.com
None
Part of
MDDS
Yes Yes All are met. Medicare and Medicaid Regulations Met. Available upon request. Meets FDA signature and record retention requirements. Available upon request.
Cardiocom - TeleResponse
www.cardiocom.com
None
Part of
MDDS
Yes Yes All are met. Medicare and Medicaid Regulations Met. Available upon request. Meets FDA signature and record retention requirements. Available upon request.
Cardiocom - Telescale
www.cardiocom.com
Listed
Class I "510k
exempt"
Yes Yes All are met. Medicare and Medicaid Regulations Met. Available upon request. Meets FDA signature and record retention requirements. Available upon request.
CJPS Medical Systems VitalPoint HOME
www.CJPS.com
Cleared Class II No Yes All are met. N/A N/A
FDA procedures and requirements, ISO procedures and
requirements, U.S. Government (GSA Advantage) - approved
Available upon request.
Connected for Life
sm
www.familyhealthnetwork.com
Listed Class I No Yes All are met.
ISO 13485, FDA MDDS, Medicare and
Medicaid Regulations met.
Available upon request. Record retention among others. Available upon request.
Critical Signal Technologies
www.criticalsignaltechnologies.com
Cleared Class II Yes Yes All are met.
• Medicare and Medicaid Regulations Met
• Additional FCC & FDA Compliance
Measures availabe upon request
Available upon request. Meets State/federal/Payer record retention requirements. Available upon request.
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