Page 88 Telehealth and Remote Patient Monitoring RPM for Long Termand Post Acute Care A Primer and Provider Selection Guide 2013
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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 Company's Cyberliability List Any Other Legal Requirements

Legal/Regulatory/ List Applicable Regulatory Provide a Link to Provide link to Sample
Cyberliability Requirements Met Policy Contract



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