Connected care depends on a technology ecosystem that includes remote monitoring devices, care management software platforms, electronic health record (EHR) systems, telecommunications infrastructure, and data interoperability standards. Each component plays a role in enabling providers to deliver and bill for care management services at scale.
Remote Monitoring Devices:
RPM devices must meet the FDA definition of a medical device and must transmit data electronically. The most commonly used devices in Medicare RPM programs include:
Blood pressure cuffs:
Cellular or Bluetooth-enabled automatic cuffs that transmit systolic, diastolic, and pulse readings.
Weight scales:
Connected scales that transmit daily weight readings, primarily for heart failure and CKD patients.
Pulse oximeters:
Devices that measure blood oxygen saturation (SpO2) and pulse rate, used for COPD and other respiratory conditions.
Blood glucose monitors:
Connected glucometers that transmit glucose readings, used for diabetes management.
Thermometers and respiratory flow rate monitors:
Less commonly deployed, but included in the CMS definition of eligible RPM physiologic parameters.
Devices may use cellular connectivity, Bluetooth paired with a hub or smartphone app, or WiFi to transmit data. CMS does not specify the transmission technology, only that the device must transmit daily recordings or programmed alerts.
Care Management Platforms:
Care management software provides the operational infrastructure for running CCM, RPM, APCM, and BHI programs. These platforms typically include patient enrollment and consent tracking, care plan documentation, time tracking for time-based billing codes, clinical dashboards for reviewing RPM device data, alert and notification systems for out-of-range readings, communication tools for patient outreach, billing and claims generation, and reporting for compliance and quality measurement.
Electronic Health Records (EHRs):
EHR integration is essential. CCM care plans, RPM data, BHI screening results, and encounter documentation must be recorded in the patient's medical record. Many care management platforms integrate with major EHR systems (Epic, Cerner/Oracle Health, athenahealth, eClinicalWorks, and others) to ensure that connected care documentation flows into the clinical record.
Interoperability Standards:
The Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR) standard is the dominant framework for health data exchange. CMS has increasingly required FHIR-based data exchange in its programs. The ACCESS Model, for example, requires participating organizations to submit outcome data via CMS's FHIR-based APIs and to electronically share clinical updates with a beneficiary's other health care providers.
The 21st Century Cures Act and CMS's Interoperability and Patient Access final rule have established requirements for information blocking prevention and patient data access that are relevant to connected care programs.
HIPAA and Data Security:
All connected care technologies must comply with the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. Protected health information (PHI) transmitted by RPM devices, stored in care management platforms, or exchanged between providers must be encrypted, access-controlled, and auditable. Business associate agreements (BAAs) are required between covered entities (providers) and any technology vendors that handle PHI.
Sources:
FDA medical device definitions (21 C.F.R.);
HL7 FHIR standard (hl7.org/fhir);
21st Century Cures Act § 4003;
HIPAA Privacy Rule (45 C.F.R. Parts 160, 164);
CMS Interoperability and Patient Access Final Rule.
The Advanta team is ready to discuss the details of Connected Care.
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