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Delphi VitalPoint Home Monitor Instrukcja Użytkownika Strona 42

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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
Ambio Health
www.ambiohealth.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid Regulations Met
www.ambiohealth.com/
pages/terms
Meets federal record retention requirements Available upon request
Beacon
®
by HealthInterlink
www.healthinterlink.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
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 - TeleResponse
www.cardiocom.com
None N/A 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 N/A Yes Yes All are met. Medicare and Medicaid Regulations Met Available upon request Meets FDA signature and record retention requirements Available upon request
Cardiocom - Attentiv
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 - Telescale
www.cardiocom.com
None Class I 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-medicalsystems.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
Family Health Network Connected for Life
www.familyhealthnetwork.com
Listed Class I Yes Yes All are met. Our component is a software platform Available upon request N/A Available upon request
GrandCare Systems
www.grandcare.com
Listed Class I Yes Yes All are met. ISO 13485, FDA MDDS, FDA QSR
http://www.grandcare.com/
privacy-policy/
N/A Available upon request
Healthsense, Inc.
www.healthsense.com
Listed Class I No Yes All are met. UL-1069, UL-1637 N/A N/A Available upon request
Honeywell HomMed - Genesis DM
www.hommed.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid regulations
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
http://www.hommed.com/
privacy-statement/
N/A Available upon request
Ideal Life, Inc.
www.ideallifeonline.com
Cleared Class I & II No Yes HIPAA FDA, CAMDCAS, ISO 13485 N/A N/A Available upon request
Independa
www.independa.com
None N/A No Yes All are met. N/A
http://independa.com/
privacy-policy
N/A Available upon request
Intel-GE Care Innovations™ Guide
www.careinnovations.com
Cleared Class II Yes Yes All are met. FDA
http://www.
careinnovations.com/
privacy
Meets requirements of California Health and Safety Code,
Division 104, Part 15, Chapter 8, Sections 119400119402
Reserved for customer
engagements
Philips
telehealth.philips.com
Cleared Class II Yes Yes All are met. Medicare and Medicaid regulations N/A N/A Available upon request
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