WELCOME AND INTRODUCTIONS

Size: px
Start display at page:

Download "WELCOME AND INTRODUCTIONS"

Transcription

1 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 MDepiNet_ppp #MDEpiNet_MTG for meeting questions/comments

2 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

3 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

4 People and organizations that deliver care and services

5 Organizations that pay for care

6 People and organizations that support the public good

7 People and organizations that generate new knowledge, whether research or quality improvement

8 People and organizations that provide Health IT capability

9 People and organizations that support the production and distribution of medical products

10 People and organizations that develop and maintain standards

11 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

12 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

13 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

14 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

15 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

16 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

17 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

18 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