S.M.A.R.T. Medical Device Informatics Think Tank Specific, Measurable, Achievable, Results-Oriented, Time Bound Collaboration WELCOME AND INTRODUCTIONS James Tcheng, M.D. Joseph P. Drozda, Jr., M.D. Terrie L. Reed, M.S. JOIN the Conversation on Twitter @ MDepiNet_ppp #MDEpiNet_MTG for meeting questions/comments
MDEPiNet SMART INFORMATICS THINK TANK PLANNING Executive Partners Danica Marinac-Dabic Mitchell Krucoff Art Sedrakyan Sharon-Lise Normand Executive Committee Publications Committee Website Team Abby Isaacs Matthew Cioffi Swati Chakraborty Sandi McDanel FDA CDRH Senior Leadership Think Tank Planning Team (>50) Presenters/Breakout Leaders/Scribes/Floaters AHRQ Elise Berliner James Nieberding DCRI Coordinating Center Britt Barham Michelle Smerek Princess Grimes Rebecca Wilgus Wendy Sprintz
People who receive care or support the care of others* * From ONC Connecting Health and Care for the Nation A Shared Nationwide Interoperability Roadmap Draft v.1
People and organizations that deliver care and services
Organizations that pay for care
People and organizations that support the public good
People and organizations that generate new knowledge, whether research or quality improvement
People and organizations that provide Health IT capability
People and organizations that support the production and distribution of medical products
People and organizations that develop and maintain standards
8:45-10:00 Plenary Session: Building a SMART Medical Device Data Capture Infrastructure Purpose of this Session: To highlight key National initiatives that will inform prioritization of Think Tank projects and set a common vision and goals for expected outcomes over the two-day session
8:45-10:00 Plenary Session: The importance of high quality data to the success of FDA s National Postmarket Surveillance Plan: Jeffrey Shuren Development and innovative use of structured data capture assets: links to MDEpiNet vision and goals: Danica Marinac-Dabic Major FDA-sponsored initiatives o o o o Links to National Planning Board: Mark McClellan UDI Roadmap for Adoption in Electronic Health Information: Mark McClellan Device Identification as part of an overall Health IT Plan: Steven Posnack PEW-ONC-FDA Public Meeting on Realizing the Benefits of UDI In Health Care: Josh Rising Vision and Goals for The Two-Day Think Tank: Joseph Drozda
USE CASE ONE: CAPTURING DEVICE ATTRIBUTES 10:00-11:00 Use Case One - Capturing device attributes Session Leader: Mike Schiller Description of Use Case: Capture and exchange of core device identification information within the healthcare provider environment for use as a master source to consistently identify the device in all downstream systems and processes. Using the Data in the FDA Global Unique Device Identification Database (GUDID): Indira Konduri Manufacturer Perspective on capturing device information: Corwin Hee Standards Development Organization work on device identification: Paul Knapp Device lessons to be learned from medication data capture: Julie Suko
USE CASE TWO: LINKING PATIENT AND DEVICE 11:00-12:15 Use Case Two - Making the link between the patient and device Session Leader: Natalia Wilson/Joseph Drozda Description of Use Case: Link of structured device and patient data during a procedure into a patient-device data capture system including ability to exchange data with other systems that support linkage between procedure, device and patient. Structured device reporting as part of patient care: James Tcheng Capturing structured device data at the VA: Paul Varosy Linking device data to Kaiser EHR: Rebecca Love Linking device data to Mercy Cath Lab: Curtis Dudley/Joseph Drozda Implant tracking at Mayo Clinic Arizona Natalia Wilson
USE CASE THREE: DATA FROM IMPLANTABLE DEVICE OUTPUT 12:45-1:30 Use Case Three: Obtaining structured device data from implantable device output Session Leader: Terrie Reed Description of Use Case: Exchange of device information from device itself to/from patientdevice data capture systems Background of IHE IDCO Implementations: David Slotwiner Use for implantable cardiac devices: Manish Wadhwa Use in personal health record: Michael Mirro Lessons Learned from Medical Device Plug n Play (MDPnP) at Partners Healthcare: Julian Goldman
USE CASE FOUR: DOWNSTREAM USE 1:30-2:30 Use Case Four: Extracting structured device data collected in previous uses cases for downstream system use Session Leader: Marc Overhage Description of Use Case: Input and exchange of patient and device information from source systems to a secondary source (e.g. Registry, AE Report or Clinical Trial). This may/may not include addition of supplemental data for purpose of populating secondary source. ONC Structured Data Capture: Evelyn Gallego Cook Medical EHR Registry Data: Neal Fearnot/Ted Heise ACC Project to pull data to ICD Registry: Dino Damales/Kathleen Hewitt/Ganesan Srinivasan AJRR data pulled from EHR to this registry: Caryn Etkin FORCE TJR: Patricia Franklin
ENVIRONMENTAL REVIEW 2:45-3:45 Environmental Review: Opportunities for device data engagement Session Leader: Ed Hammond Purpose of this Session: To provide overviews of related health data capture and downstream analysis initiatives and explore opportunities for engagement of device stakeholders and use cases in these efforts Health Services Platform Consortium: Stan Huff Use of Source Data in Downstream Efforts Sentinel/PCORNET: Lesley Curtis DELTA: Fred Resnic/Mike Matheny International Consortium of Orthopedic Registries (Data Library): Rebecca Love
PANEL DISCUSSION DAY 2 PREP 3:45-4:30 Panel discussion of obstacles/lessons learned; Preparation for day 2 Session Leader: James Tcheng Purpose of this Session: To summarize common themes heard in project summaries and help set priorities on the most important issues to address in Day 2 breakout sessions. Set expectations for Day 2 outcomes and ideas for path to success including envisioning the end to end environment Obstacles to Structured Device Data Capture: Debra Dore A clinician view of impact on workflow: Denise Downing Issues with Device Data Standards Adoption: Hans Buitendijk What s in it for the C-Suite?: Joseph Drozda Opportunities for collaboration with other initiatives: Lesley Curtis