Patients increasingly seek access to data from their cardiac implantable electronic devices (CIEDs), necessitating standardization of terminology and processes for effective implementation. The document outlines a pilot project aimed at enhancing patient engagement through electronic messaging of remote device data, highlighting its potential to improve patient experiences and facilitate communication with healthcare providers. Currently, semi-automated notification systems are in beta testing, paving the way for greater transparency and understanding of device data among patients.

1. Patient Access to CIED Data
David Lee Scher, MD, FACC, FHRS
Clinical Associate Professor of Medicine
Penn State University College of Medicine

2. DISCLOSURES
• Consultant: Medtronic
• Member: HRS IT Subcommittee

3. Background
• Meaningful Use of HITECH Act mandates
patient access to electronic health data.
• RPM is established as best practice for CIED
follow-up.
• Many patients do not know what data their
devices furnish or what it means.
• Many patients do not get printouts or results.
• “All looks good” or “We would like to see you
in the office.”

4. Background: Historical Barriers to
Interoperability of RPM with EMR
• Previous lack of industry standards of
terminology.
• Lack of incentives.
• Lack of regulatory mandate.
• Lack of ‘customer’ (physician) demand.

5. 5
CRM Company Historical Perspective - 2009
Numerous EHR players: Prioritization of vendors needed
– Rapid integration and maintenance with all vendors
impractical
– Need to prioritize EHR vendors
Maturing EHR market: Prioritization strategy needed
– Most clinics do not understand work involved to add an
EHR system
– Many clinics have home-grown systems
Numerous in-clinic/hospital stakeholders
– Players include CIO’s, CEO’s, CTO’s, Clinic Staff, Technical
Staff
– We need customer to push integration: Of the 19 current
clinic requests, 18 delayed due to EHR vendor or clinic IT

6. Clinical Reasons for Patients to Have Their
Data Via Portals
• ? Promotes patient engagement
• Decrease anxiety
• Share data with caregiver
• Visual feedback for medication
adherence
• Knowing basic settings -> decrease
inappropriate shocks
• Diary correlation with events
• ? Crowdsourced research

7. “Nothing About Us Without Us”

8. “Heart Gadgets Test Privacy-Law Limits”
By AMY DOCKSER MARCUS and CHRISTOPHER WEAVER
Wednesday, November 28, 2012 As of 10:31 PM EST

9. So…How do we Get Meaningful CIED
Data to Patients?
• Establish standards for terminology.
– IDCO/IEEE nomenclature project 2006-2012
• Push data to EHRs seamlessly utilizing
standards established.
• ‘Translate’ data into customized patient
notification.
• Data and letter pushed to patient portal for
patient access.

10. Why is IDCO Compliance Important?
• Allows device data to be captured in EHR systems
automatically, reducing workflow complexity.
• Ensures quality of care by conforming data to
standard data format and terminology.
• Less confusion to patients, non-EP providers.

11. • Semantics
– A nomenclature or set of terminology that defines
the information being shared
• Syntax
– The structural arrangement of the information
• Profiles
– The specifications for how an integration will be
accomplished for a specific use case
IDCO Encompasses Three Standards

13. Pilot: Implantable Cardiac Device
Patient Engagement Project

14. Hypothesis
Messaging patients on remote ICD monitoring
with pertinent information through their PHR
will add value to patient's experience with
regard to their ICD / cardiac management by
increasing their engagement in healthcare.

15. Primary Objectives
Demonstrate the value of electronically
messaging patients a standardized patient
summary of remote ICD data capture via:
– Quantitative and qualitative assessment of data
transfer.
– Quantitative and qualitative evaluation of patient
experience.
– Evaluate patient-provider communications.
•

16. Secondary Objectives
Provide essential information for future ICD to
PHR implementation efforts by document
"lessons learned" in three key areas:
– Technological Development
– Patient Interaction with data
– Clinician Interaction with data

17. Stakeholders…

18. Workflow
• Patient’s device data sent to Electronic
Health Record’s (EHR) data management
system.
• Physician reviews data.
• Physician adds Comments and/or Plan of
Care Data to implanted device
observation.
• EHR data management system sends
updated implanted device observation to
patient’s Personal Health Record (PHR) as
Patient Notification.
• Patient views Patient Notification of
implanted device observation in PHR
portal user interface.

20. Related Issues
• Non-CIED RPM being rapidly adopted.
• Emergence of EHR and patient portal apps.
• Patient rights focus of Congress re: privacy and
security of health/medical apps.
• Commercialization of de-identified data for
research and marketing.

21. SUMMARY
• Patients are requesting data from their CIEDs.
• Standardization of terms and IT processes and
portals are necessary foundations for
execution and now a reality.
• Semi-automated notification of customizable
data with explanation is possible and
presently in beta testing in ONC sponsored
pilot program.
• Stay tuned!!

22. “If you ask me a question I don’t
know, I’m not going to answer”
------Yogi Berra