UDIs in Personal Health Records 'Making UDI's (Consumer) Relevant Edward Fotsch, MD PDR Network Matthew Emons, MD Doug Gentile, MD Thomas Gross, MD Joann Kern, RN Ted Lystig, Ph.D. Tim McKay, PhD Somesh Nigam, MD Cerner Allscripts FDA GE Healthcare Medtronic Kaiser J&J 2011 2011 PDR PDR Network, Network, LLC. LLC. All Rights All Rights Reserved. "PDR" "PDR" and and "Physicians' Desk Desk Reference" are are registered trademarks of PDR of PDR Network, Network, LLC LLC
Hypotheses 1. The following things don t work: A. Current post-market device communication B. Current device safety signal assessment C. Device identification without EHRs/PHRs D. PHRs without EHRs 2. The following things have the potential to work: 1. PHRs and patient connectivity via EHRs 2. Post-market device communication w/o UDIs in EHRs/PHRs 3. Post-market device communication via UDI's in EHRs/PHRs
Current Status and Challenges Majority of patients with devices are lost to follow-up surgeon s relationship with patient is temporary; ends with CPT payment OTC devices are not tracked primary care physicians lack device detail key facts are not tracked by any physicians (ambulatory status, etc.) Outcomes and Safety tracking not possible Passive reporting inadequate in volume, quality and clinical context Claims data devoid of device identification Direct patient connectivity required for longitudinal device follow-up EHR data inadequate without PHR linkage Expensive Registry studies needed Longitudinal device tracking and resultant quality improvement is currently limited quality improvement, monitoring and public health suffers
Rapid Market Changes EHR Meaningful Use payments mandate patient connectivity Online patient communication and PHRs are required for Meaningful Use payments for EHRs Patient connectivity now growing rapidly largest vendor has >3M actively connected patients; >25M patients connected online 50% U.S. patient connectivity reached in three years Sickest patients (or care-givers) connect online first Patients actually want provider connectivity and info re: THEIR drugs and devices FDA can benefit from patient connectivity to provide patient with credible information to empower information and longitudinal tracking of drugs and devices Manufacturers can benefit from patient connectivity longitudinal data for product design and improvement regulatory compliance- post approval studies, REMS etc. Ongoing direct communications with patients (device + digital svc.)
Online Patient Communications & PHRs are Rapidly Becoming the Standard CONFIDENTIAL
The UDI/PHR Opportunity UDI and EHR/PHR can advance key strategic goals longitudinal patient specific device data data mining from PHRs; far richer data source than claims data opportunity for direct patient surveys direct connectivity for Alerts, Reminders and Warnings bring FDA Sentinel System to life low cost - most of funding has already come from ARRA Patient privacy and HIPPA issues avoided patients opt-in to a service they actually want; customized information Alerts and Warnings specific to their device experience-to-date indicates most patients will not opt-out
Specific Functionality Unique Device Identifier entered into PHR via EHR (CCD) activity tied to Meaningful Use Patient offered ongoing device-specific information via PHR patients opts-in to receive customized warnings/recalls, reminders and information device service is similar to the reminder service required under MU service includes possibility for periodic surveys by FDA or device manufacturer Patients receives device-specific messages via PHR welcome / introductory message (pre and post-surgery device-specific services) periodic updates (suggest semi-annually) Ad-hoc messages (warnings, etc.) Customized disease specific patient surveys device-specific surveys based upon random patient samples device-specific surveys based upon Continuity of Care Document data in PHR i.e., survey only diabetic patients with cardiac wires Patient links to FDA approved relevant consumer information
Case Study Example 1. Patient is scheduled for hip replacement by surgeon A. Patient is connected to surgeons practice via EHR with patient portal B. Patient recieves pre-procedure message(s) about the device that will be implanted via patient portal i. Patient learns that their device comes with an online Concierge Service C. Device Concierge message(s) is FDA-approved and funded by device manufacturer D. Concierge message(s) discuss post-procedure rehab concepts AND describes ongoing device-related messaging i. UDI- what and why ii. Regulary (monthly) device-specific messages including rehab etc. iii. Automated notification of device-related safety issues iv. Communities of interest v. Periodic surveys vi. 'Ask an expert' vii. Patient may opt-out at any time
Case Study Example 2. Patient has procedure A. UDI for the device is scanned into hospital's EHR B. UDI is transmitted to patient's EHR directly or via primary care EHR C. Patient is notified via Concierge service in patient portal of the delivery of UDI and its significance D. Concierge message(s) discuss post-procedure rehab concepts AND describes ongoing device-related messaging i. UDI- what and why ii. Regulary (monthly) device-specific messages including rehab etc. iii. Automated notification of device-related safety issues iv. Communities of interest v. Periodic surveys vi. 'Ask an expert' vii. Patient may opt-out at any time
Case Study Example 3. Post-op communication with patient continues A. Monthly Concierge messages focus on rehab and milestones + areas for caution B. 'Ask an expert' is available online from manufacturer C. Patient opts-into Concierge community of other 'hip' folks D. Manufacturer is able to query patients as per FDA guidelines i. Pain status, ambulatory status, ROM, etc. E. FDA accepts data collected via online patient connectivity and PHRs for postmarket surveillance studies F. FDA may mandate use of online patient connectiviyt and PHRs for specific postmarket studies including follow up on possible sentinel events G. Patient may opt out of Concierge Services at any time
Case Study Example 4. Post-op issue arises with the device A. Possible device-related patient safety issue arises with the device i. Not clear if this is with all devices of this make or type or lot B. UDI database allows idenfication of patient's with the device C. Patient connectivity via Concierge Services allows focused surveying of patients to evaluate safety issue D. Device Lot-related defect is confirmed E. UDI and patient connectivity allows communication with ALL patients who had recieved the impacted devices
Longitudinal Device Tracking via UDIs & PHRs: Gap Analysis Missing for action: 1. Online patient connectivity and PHRs A. Most patients not connected online via PHRs but this is changing rapidly B. ~25M Americans now with connectiity and PHRs- high acuity patients first 2. Concierge programs from device manufacturers 3. Clear guidance form FDA 4. EHR-EHR-PHR UDI communication A. Often device is not identified until in the O.R. B. Transmission of UDI from disparate systems 5. Revenue model A. Who would pay and why? B. Manufacturers might fund IF the UDI/PHR model: i. Reduced current costs of compliance ii. Reduced costs for R&D iii. Enhanced marketing/provided a competitive advantage
Matthew Emons, MD Doug Gentile, MD Thomas Gross, MD Joann Kern, RN Ted Lystig, Ph.D. Tim McKay, PhD Somesh Nigam, MD Cerner Allscripts FDA GE Healthcare Medtronic Kaiser J&J REACTIONS? 2011 2011 PDR PDR Network, Network, LLC. LLC. All Rights All Rights Reserved. "PDR" "PDR" and and "Physicians' Desk Desk Reference" are are registered trademarks of PDR of PDR Network, Network, LLC LLC
UDIs in Personal Health Records 'Making UDI's (Consumer) Relevant Edward Fotsch, MD PDR Network Matthew Emons, MD Doug Gentile, MD Thomas Gross, MD Joann Kern, RN Ted Lystig, Ph.D. Tim McKay, PhD Somesh Nigam, MD Cerner Allscripts FDA GE Healthcare Medtronic Kaiser J&J 2011 2011 PDR PDR Network, Network, LLC. LLC. All Rights All Rights Reserved. "PDR" "PDR" and and "Physicians' Desk Desk Reference" are are registered trademarks of PDR of PDR Network, Network, LLC LLC