Build a SMART Medical Device Research Infrastructure Putting Informatics to Work. Terrie L. Reed, Project Leader, DCRI 10/15/2014

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Sharleen Darlene Holland
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1 Build a SMART Medical Device Research Infrastructure Putting Informatics to Work Terrie L. Reed, Project Leader, DCRI 10/15/2014

2 Device research informatics infrastructure: Shared Tools Capture Integration Quality Analysis Controlled vocabularies Facilitate workflow Establish quality measures Open Source Queries Discrete data Elements Structured source documents Automated transmission Link through TPLC Define Governance and Workflows

3 Key Issues to Consider Device research informatics infrastructure activities OFTEN: Involve a closed set of stakeholders working to obtain data for a specific device area Limit deliverables and learnings to the area of interest Exclude stakeholders involved in other parts of the health ecosystem (e.g. clinical electronic health information architecture development) Lament the lack of a broad-based medical device data infrastructure that would make the implementation of device research less costly, less complex and more timely

4 What Currently Works Well Recognition that cost and time savings could be achieved if we made better use of existing clinical and other electronic data sources Demonstrations with limited collaborators show the possibility of capturing, transmitting, linking and analyzing structured, standardized device information across IT systems to meet specific research goals Regulators and policy makers FDA, ONC, CMS, AHRQ support development and use of structured data innovative platforms that include adoption of unique device identification as a core way to standardized device identification internationally.

5 What Currently Does Not Work Well Lack of Shared Vision: No practical, achievable path forward that leverages predicate work Competitive Silos: Each stakeholder is independently solving problems in their segment of device infrastructure Lack of Resources: Creation of a innovative research infrastructure to support policy goals is not being supported with money and other resources Lack of Transparency: No public forum for addressing data research infrastructure issues and linking them to methodology and analytics efforts

6 Next 3-5 Years What if Trust: There was a way to ensure that a device data collection program (e.g. clinical trial, registry, post approval study) followed a specified set of data management principles acceptable to an agreed upon certifying or accreditation body? Constructive Collaboration: A group of committed individuals from areas such as data standards, regulatory, clinical systems, device research, and implementation of IT systems worked collaboratively brainstorm and prioritize a new informatics infrastructure that would result in improved decisions regarding device approval based upon knowledge of device safety and effectiveness? Innovative Platform: collection,data transmission and sharing protocols were coordinated in a way that would facilitate interoperability, sharing, and linking of data between device-related data sources (e.g. Clinical Systems, Networked Devices, Quality Improvement Registries, and Research-related registries)?

7 SMART Informatics Think Tank: Feb Specific Present and refine use case(s) that include data standards, interoperability, and change to current infrastructure Measurable Define measurable outcomes to evaluate progress Achievable Require tangible commitments to work on defined activities Results-Oriented Incorporate tools/processes that are already working in other settings by distributed networks and be inclusive of all who are willing to solve the problem Time Bound A Call to Action Join Us Develop and Stick to a timeline that promotes success

Re: Electronic Standards for Public Health Information Exchange

NCVHS June 16, 2014 Honorable Sylvia Mathews Burwell Secretary, Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Re: Electronic Standards for Public Health Information