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Overview

The electronic Long-Term Services & Supports (eLTSS) Initiative is a ONC-CMS partnership that will focus on identifying and harmonizing electronic standards that can enable the creation, exchange and re-use of interoperable service plans for use by health care and community-based long-term services and supports providers, payers and the individuals they serve. These plans can help to improve the coordination of health and social services that support an individual’s mental and physical health.

This initiative is driven by the requirements of the CMS Testing Experience and Functional Tools (TEFT) in community-based long-term services and supports (CB-LTSS) Planning and Demonstration Grant Program created in the Affordable Care Act (ACA).

Weekly Meeting Schedules

To add these meetings to your calendar, subscribe to the electronic Long-Term Services and Supports (eLTSS) Calendar.

PLEASE NOTE: The eLTSS All-Hands Workgroup meetings scheduled on March 31st and April 7th have been CANCELED. Please check your email for updates.

WorkgroupNext MeetingMeeting InfoAgenda
All-Hands WGThurs. 04/14/16 from 12:30pm-1:30pm ETURL: https://siframework1.webex.com/siframework1/onstage/g.php?MTID=edef16d2a091e1c0563ef1ac8ff0bc8e5
Dial-In:1-650-479-3208
Passcode: 669 251 560
Attendee ID: Provided by Webex upon login
  • Announcements
  • Kick Off eLTSS Core Data Component Phase

Homework Assignments


Pilots who have not already done so should submit a copy of their service plan (or documentation of any output from assessment tools/intake forms/other used for service planning) to the pilot team ASAP.

Looking for the eLTSS Pilot Page? Click here. The pilot wiki page includes the eLTSS tentative schedule, all past presentations and the pilot starter kit.

Announcements

  • Thank you to the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) for presenting a Webinar on the electronic Long-Term Services and Supports (eLTSS) Initiative to the eLTSS Federal Partners. The links to the Webinar can be found here vimeopowerpoint

  • The eLTSS initiative is seeking Pilot candidates. If your organization is interested in piloting, please take a moment to fill out the Pilot Interest Survey.



  • HL7 C-CDA Rendering Tool Challenge Call for Participation has been opened to challenge the community to develop a viewer that enables clinicians (all types--medical and non-medical) to more efficiently review clinically relevant patient data from C-CDA documents. Cash prizes for winning submissions: 1st Place $15,000, 2nd Place $5,000. Submission deadline is May 31, 2016. Click here to review the rules. Click here to submit.

  • The Centers for Medicare and Medicaid Services (CMS) are sharing the CMS 2016 Quality Strategy. This document guides the various components of CMS, including Medicaid, Medicare and the Center for Consumer Information and Insurance Oversight, as they work together toward the common goal of health system transformation. Click here to review the 2016 Quality Strategy and submit public comments.


  • Call for Participation: Help HL7 Help You Reduce C-CDA Implementation Inconsistencies. Interested parties should respond as soon as possible. The survey takes approximately 10-20 minutes to complete. Click here to complete the survey.

  • HHS and ONC have released the State Health IT Policy Levers Compendium. The State Health IT Policy Levers Compendium provides information on how other states are using waivers, Medicaid Health Home State Plan Amendments and other state-level policy levers to advance health IT and interoperability goals. Click here to download the Compendium.

  • NATE and the California Association of Health Information Exchanges (CAHIE) Call for Participation: New National Forum for Provider Trust Community. NATE and the California Association of Health Information Exchanges (CAHIE) recently announced that CAHIE is assuming administration of the NATE Provider-to-Provider Trust Bundle for Direct messaging among providers. They are now looking for participants to serve on a new national forum to help establish a voluntary governance process to manage and govern the new national trust community. Click here for more information.

  • JOIN THE INITIATIVE! In order to vote on eLTSS artifacts, you must be a Committed Member. To join the initiative as a Committed Member or Other Interested Party, SIGN UP HERE.


Timeline

This timeline represents notional estimates of planned activities and will be adjusted as work moves forward through the initiative phases.
  • Pre-Discovery: November 2014 to January 2015
    • Project Charter Development and Consensus
  • Discovery: January 2015 to March 2015
    • Use Case Development and Consensus
  • Implementation: April 2015 to October 2015
    • Standards Solution Plan Development and Consensus
    • eLTSS Implementation Guide Development and Consensus
  • Pilot Execution (Phase 1): October 2015 to April 2016 (minimum 6 month pilot period)
    • Pilot Proposal Development and Execution
  • Pilot Evaluation (Phase 1): May 2016 to October 2016
    • Pilot Evaluation Execution
    • Implementation Guidance updates based on pilot evaluation
  • Pilot Execution (Phase 2): November 2016 to November 2017
    • Implementation Guidance Balloting with Standards Development Organization
    • Implementation Guidance Publication (national standard) and piloting

Initiative Contacts


Initiative CoordinatorEvelyn Gallegoevelyn.gallego@siframework.org
ONC LTPAC LeadershipElizabeth Palena HallElizabeth.PalenaHall@hhs.gov
ONC LeadershipMera Choimera.choi@hhs.gov
CMS LeadershipKerry Lidakerry.lida@cms.hhs.gov
Community LeadMary Sowersmsowers@nasddds.org
Community LeadTerry O'MalleyTOMALLEY@mgh.harvard.edu
Project ManagerLynette Elliottlynette.elliott@esacinc.com
Use Case and Functional RequirementsBecky Angelesbecky.angeles@esacinc.com
eLTSS Plan Content SWG Lead and Pilot Guide DevelopmentGrant Kovichgrant.kovich@accenture.com
Pilots ManagementJamie Parkerjamie.parker@esacinc.com
Pilot Guide DevelopmentGrant Kovichgrant.kovich@accenture.com
Pilots Support TeamKatiya ShellKatiya.Shell@esacinc.com
Pilots Support TeamHolly StoneHolly.Stone@esacinc.com
Standards and Technologies IdentificationAngelique Cortezangelique.j.cortez@accenture.com

How to get involved: The Commitment Process

The success of the Structured Data Capture initiative relies on the participation of a wide range of stakeholders including Health IT vendors, health systems, standards development organizations, patient advocates, and the general public. Any interested party is invited to get involved in the Structured Data Capture initiative, and can choose to either participate as an Initiative Committed Member, or Other Interested Party if he or she is unable to meet the commitment expectations of a Committed Member.
list of SDC members is available on the SDC Charter & Members page.

Committed Member

A Committed Member is an organization or individual who has a particular interest in solving the Challenge Statement and reaching the Initiative Goal and commits to actively achieve the deliverables. The nature of the commitment will vary depending on the deliverables, but must be meaningful and relevant. This includes regularly attending workgroup meetings. Some examples of meaningful commitment include, but are not limited to:

  • Testing implementation specifications in the real-world
  • Supporting providers in real-world pilot implementations
  • Writing code for production or test implementations
  • Writing and editing implementation specifications and/or other deliverable documentation
  • Participation in Federal Advisory Committees (FACAs) or their workgroups


Committed organizations or individuals may assign multiple employees to participate in the workgroups or other activities, but will only have one vote in Consensus decisions. When an individual represents an organization, the individual’s vote represents the organization’s vote. Lastly, organizations and individuals should not create “pseudo-organizations” to gain multiple votes in the Consensus Process.


Join this Initiative

As an open government initiative of the S&I Framework, the success of the SDC initiative relies on the participation of a wide range of stakeholders, including various Payer and Provider organizations, health systems, standards development organizations, and the general public.


 

 

 

Other Interested Party

If you are unable to join as a fully committed participant or an invited expert, you may also join as an Other Interested Party. As an “Other Interested Party” you are invited to participate in discussions and can provide comments and feedback by joining the Wiki. However, only Committed Members have voting rights.

SDC Initiative Charter

Background

With electronic health record (EHR) adoption rising across the U.S., the volume and detail of information captured by healthcare organizations and providers will grow exponentially. Although health care providers and others use various sources and methods to capture and synthesize patient-level data, EHRs have been recognized as the data source with the highest potential to provide timely and relevant data in a form that is quickly usable for quality and safety improvement, population health, and research (sometimes labeled “secondary” use or "reuse" ). EHR data obtained during episodes of care will become increasingly valuable to healthcare organizations striving to leverage electronic information to drive efficiency and quality. Of particular interest are efforts to leverage clinical data captured during episodes of care and link the clinical data to supplemental data collected for other purposes including: 1) research, 2) patient-safety event reporting, 3) public health reporting, and 4) Determination of Coverage. Once captured, aggregated and analyzed, these combined data can be used to identify trends, predict outcomes and influence patient care, drug development and therapy choices.

For example, a clinician treating a patient who is participating in a clinical trial or comparative effectiveness research (CER) would select, through the EHR, the applicable electronic case report form (eCRF) and would be able to complete the form with a combination of information extracted automatically from his or her most recent entry into the patient’s EHR and new information added by the clinician in direct response to the eCRF. Data captured would be stored and ultimately aggregated and transferred to the end users.

Challenge Statement

The utility of EHR data for supplemental purposes has been limited due to a lack of uniformity in the terminology and definitions of data elements across EHRs. This limitation is compounded by the fact that clinician workflow often records patient information in unstructured free-text data well after the episodes of care. Linking EHR data with other data in a uniform and structured way could accelerate quality and safety improvement, population health and research.

A multi-pronged approach is warranted. Various clinical and health services research groups and specialty societies are already engaged in independent initiatives to standardize data collection across projects in their domains in order to maximize the utility of the resulting datasets for subsequent research. Many important efforts that focus on this level of standardization, such as the Patient Reported Outcomes Measurement System (PROMIS), PhenX(consensus measures for Phenotypes and eXposures), and the Federal Interagency Traumatic Brain Injury Research(FITBIR) Informatics System, are funded by the National Institutes of Health (NIH) and other Federal sources. The National Library of Medicine (NLM) is working with the NIH research community and others to identify and coordinate research initiatives that use standardized patient assessment instruments and structured data definitions, also known as Common Data Elements (CDEs). Work is also beginning, under the auspices of NLM and the Department of Health and Human Services (HHS), to consider how to incorporate these CDEs more directly into the data infrastructure for patient-centered outcomes research (PCOR) using EHRs. The Agency for Healthcare Research and Quality (AHRQ) has developed a comparable library of terms and Common Formats to standardize data collected and reported for patient safety events. With such CDEs and standardized assessment instruments, data captured within an EHR could be consistently defined and collected, thereby improving its validity and usability not just in retrospective analysis but also in prospective observational or interventional research, comparative effectiveness research and patient safety monitoring.

The Office of the National Coordinator for Health IT (ONC) Standards & Interoperability (S&I) Framework has demonstrated its value as a forum for addressing complex data architecture challenges, particularly as a means to publicly develop and test alternatives in advance of their inclusion in the regulations implementing the 2009 Health Information Technology and Economic and Clinical Health (HITECH) Act. The Structured Data Capture Initiative will build on both the results of and lessons learned in prior S&I efforts to bring consensus to this next critical aspect of our collective health data infrastructure.

Scope Statement

To define the necessary requirements (including metadata) that will drive the identification and harmonization of standards to facilitate the collection of supplemental EHR-derived data.

This initiative will develop and validate a standards-based data architecture so that a structured set of data can be accessed from EHRs and be stored for merger with comparable data for other relevant purposes to include:

  • The electronic Case Report Form (eCRF) used for clinical research including Patient Centered Outcomes Research (PCOR)
  • The Incident Report used for patient safety reporting leveraging AHRQ ‘Common Formats’ and FDA form 3500/3500a
  • The Surveillance Case Report Form used for public health reporting of infectious diseases
  • The collection of patient information used for Determination of Coverage, as resources permit.


The infrastructure will consist of four new standards that will enable EHRs to capture and store structured data. These will consist of: 

  • a standard for the CDEs that will be used to fill the specified forms or templates;
  • a standard for the structure or design of the form or template (container);
  • a standard for how EHRs interact with the form or template; and
  • a standard to enable these forms or templates to auto-populate with data extracted from the existing EHR


The standards will facilitate the collection of data in such a way that any researcher, clinical trial sponsor and/or reporting entity can access and interpret the data in electronic format. They will also support development of concise, architectural guidance using easy-to-understand documentation, user-friendly tooling and formal models to assist vendors in applying technical requirements for the customized use of specified forms or templates. For the purposes of this initiative, the data collected will not be stored within the EHR system. In sharing this data, ONC recognizes that certain forms of data may be subject to particular state or federal laws regulating use and disclosure. Standard specifications will incorporate the tools necessary for driving interoperability such as XML and the CDISC/ IHE integration profile Retrieve Form for Data Capture (RFD); this does not, however, imply any constraints on data formats that can be used during data capture and processing, as long as they do not prevent interoperability. The RFD integration profile is currently used within the research community to embed structured electronic forms with common data elements within the EHR to facilitate collection of research data. The SDC Initiative will align with and leverage other initiatives of the ONC S&I Framework. It will also build upon external initiatives that are focused on improving the comparability and utility of data derived from independent collection efforts through standardizing definitions of data elements and tools, such as PROMIS, PhenX, caDSR, and other initiatives identified in the NLM-NIH Common Data Element repository, and the AHRQ ‘Common Formats’ and Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (CER).

Value Statement

Given the significant Federal investments made in EHR adoption in the last 4 years, structured data capture within EHRs is poised to be a critical component of a variety of health services, quality measurement and clinical and health services research. Stage 3 Meaningful Use (MU) will focus on creating a learning health system to support quality, research, and improve public and population health. This initiative will lead the national vision to design the trusted mechanisms to enable patient information to flow securely from the system it was collected—the EHR—to other systems, such as research consortia, registries, bio repositories and public health systems, with an authorized use for it. Information will be shared in compliance with policy, regulation, and Patient Consent Directives (e.g., 42 C.F.R Part 2 Confidentiality of alcohol and drug abuse patient records; and 38 USC § 7332-Confidentiality of certain medical records). The identification and harmonization of standards for structured data capture within EHRs will not only help achieve this vision, but they will also help reduce the:

  • Data collection burden on health care providers by enabling secure, single-point data entry that populates to multiple systems
  • Need to make site-specific modifications to EHR system capabilities in order to enable participation in important reporting and research activities
  • Barriers to volunteer adverse event reporting on medical products to public health agencies leading to improvements in population health


These efforts will identify a standard for structured data, whether it is used for a clinical trial, Determination of Coverage, or to report on a patient safety event, which can be collected in a timely manner, then readily compared and aggregated improving the overall quality, value and utility of these data. Furthermore, the development of a national infrastructure will improve access to standardized electronic versions of data collection instruments relevant for use in research and patient care such as validated instruments for collecting data on pain, fatigue, physical function, depression, anxiety and social function. It will be easier to integrate these instruments into EHRs in ways that will ultimately reduce duplicate data entry. Likewise, data collected will be more comparable and therefore more useful in ascertaining what works best for different patient populations.

Target Outcomes & Expected Deliverables

The SDC Initiative will provide an infrastructure to standardize the capture and expanded use of patient-level data collected within an EHR. In the short term, specification of standards for data reuse will support and spur development and implementation of software and pilots that will inform refinement of these standards, prior to their consideration for inclusion in Meaningful Use and EHR certification requirements. In the longer term, the additional functionality will support enhancements and efficiencies in such diverse domains as patient-centered outcomes research and clinical trials, adverse event reporting and public health monitoring and surveillance, Determination of Coverage and patient care.

The value of this initiative will be measured through the attainment of the following immediate and long-term outcomes:

  1. Identification of functional requirements from a Use Case describing key conditions and business rules to enable the capture and storage of specified forms or templates, while protecting privacy and confidentiality
  2. Development of concise consensus-driven architectural guidance using easy-to-understand documentation, user-friendly tooling and formal models to assist researchers, patient safety personnel, software vendors and others in applying technical requirements for the customized use of specified forms or templates. Guidance will be updated and versioned appropriately to allow ubiquitous access to all parties.
  3. Execution of one or more pilots to evaluate the use of the specified form standard in specific contexts, such as patient-centered outcomes research and patient safety event reporting. The pilots will examine the application of specified-form standard for the conduct of PCOR and patient safety event reporting, drawing upon the NLM/NIH common data elements repository, as well as AHRQ ‘Common Formats’ for patient safety events.
  4. Proliferation and use of NIH-identified and curated CDEs for PCOR and AHRQ ‘Common Formats’ for patient safety event reporting
  5. Development or identification of four national standards specific for: CDEs used to fill electronic forms or templates, the structure or design of the form or template, the standardized functions for how EHRs interact with those standards, and the specifications that enable these forms or templates to auto-populate with data extracted from the existing EHR.
  6. Alignment and integration to other health IT infrastructure (through a Learning Health System) to support effective maintenance, distribution, and use of specified forms or templates
  7. Enhancement of patient care through improvements in quality and safety interventions, population health, and research
  8. Improvement in provider experience and workflow when using EHRs for patient care and other purposes

 

Standards

Standardization efforts established by other projects will be leveraged. These include, but are not limited to:

 

Stakeholders and Interested Parties

Stakeholders and interested Parties include but are not limited to the following:

  • Healthcare Providers and Clinical Informaticians
  • Clinical/PCOR Research Community and CER/PCOR Thought Leaders and organizations, such as: Patient-Centered Outcomes Research Institute (PCORI), EDM ForumCDISCElectronic Medical Records and Genomics Network (eMERGE), Distributed Ambulatory Research in Therapeutics Network (DARTNet), Electronic Patient-Reported Outcome (ePRO) Consortium, ASTER-D
  • Patient Safety Organizations (PSOs)
  • Privacy and Security Experts
  • Patient Advocates
  • Pharmaceutical Firms
  • Device manufacturers
  • Government Agencies:
    • Food & Drug Administration (FDA), Assistant Secretary for Planning and Evaluation (ASPE), NIH (NLM & other Institutes/Centers), AHRQ, Centers for Disease Control (CDC), Centers for Medicare & Medicaid Services (CMS), Indian Health Services, Human Resources and Services Administration (HRSA), Institute of Medicine (IOM), Veterans Administration (VA), Department of Defense (DoD), Social Security Administration (SSA), Department of Transportation (DoT), State Medicaid Programs
  • Vendors:
    • EHR/EMR systems, Health Information Exchange (HIE), Data Warehouse/Data Mart, Electronic Data Capture (EDC) and Patient Safety Event Reporting System
  • Standards-Related Organizations: Standards Development Organizations (SDOs), vocabulary/terminology organizations, standards setting organizations
  • Healthcare payers, particularly those with robust research, quality improvement (QI), patient safety and public health activities, including professionals involved in registries and surveillance at a reginonal and national level
  • Professional liability carriers
  • Healthcare Professional associations

 

Proposed Timeline

SDC Timeline Charter
This timeline represents notional estimates of planned activities and will be adjusted as work moves forward through the initiative phases.

Risks

  • Identification of content models for standard that do not compete or overlap with existing or developing models
  • Insufficient engagement and participation by vendor communities, and eventual adoption in Certified EHR products
  • Insufficient commitment by various vendors and organizations to participate in SDC pilots
  • Accessibility of a CDE library or repository in time for pilots and completion of pilots in time for future stages of Meaningful Use
  • Competing definitions of Common Data Element and CDE libraries
  • Identification of a useful but parsimonious set of data elements for forms/templates that can auto-populate with data extracted from the existing EHR in time for pilots
  • Overwriting and/or duplicate data entry
  • Solutions for research, patient safety, and public health reporting may vary; one standard solution may not apply
  • Standards and solutions may not scale to small vendors and small practices
  • Proposed project timeline does not reflect actual deadlines in relevant standards or regulatory bodies
  • Not all EHR systems offer or can support pre-population functionality; if the auto-populate standard is prescriptive, the SDC timeline may be delayed as vendors implement the functionality in their systems
  • Providers may not ‘fill’ all CDEs displayed on an electronic form
  • Accuracy of EHR data and reliability of diagnosis codes for reuse in clinical research
  • Patient privacy: de-identification of EHR data for clinical research

 

Success Metrics and/or Success Criteria

  • Upfront engagement in development of use case requirements and solution from potential pilot sites
  • Balloted standard(s) are included as EHR certification criteria
  • Proliferation and use of NLM-identified and curated CDEs for PCOR and AHRQ ‘Common Formats’ for patient safety event reporting
  • Harmonization of CDEs among federal agencies and research communities in other countries

 

 

SDC Community Members

 

 

 

 

Charter Consensus Voting

Voting on the SDC Project Charter is now closed.

 

 

 

 

PROJECT CHARTERUSE CASEIMPLEMENTATIONPILOT

SDC Initiative Charter

Background

With electronic health record (EHR) adoption rising across the U.S., the volume and detail of information captured by healthcare organizations and providers will grow exponentially. Although health care providers and others use various sources and methods to capture and synthesize patient-level data, EHRs have been recognized as the data source with the highest potential to provide timely and relevant data in a form that is quickly usable for quality and safety improvement, population health, and research (sometimes labeled “secondary” use or "reuse" ). EHR data obtained during episodes of care will become increasingly valuable to healthcare organizations striving to leverage electronic information to drive efficiency and quality. Of particular interest are efforts to leverage clinical data captured during episodes of care and link the clinical data to supplemental data collected for other purposes including: 1) research, 2) patient-safety event reporting, 3) public health reporting, and 4) Determination of Coverage. Once captured, aggregated and analyzed, these combined data can be used to identify trends, predict outcomes and influence patient care, drug development and therapy choices.


For example, a clinician treating a patient who is participating in a clinical trial or comparative effectiveness research (CER) would select, through the EHR, the applicable electronic case report form (eCRF) and would be able to complete the form with a combination of information extracted automatically from his or her most recent entry into the patient’s EHR and new information added by the clinician in direct response to the eCRF. Data captured would be stored and ultimately aggregated and transferred to the end users.


SDC Community Members

 

 

 

Challenge Statement

The utility of EHR data for supplemental purposes has been limited due to a lack of uniformity in the terminology and definitions of data elements across EHRs. This limitation is compounded by the fact that clinician workflow often records patient information in unstructured free-text data well after the episodes of care. Linking EHR data with other data in a uniform and structured way could accelerate quality and safety improvement, population health and research.

A multi-pronged approach is warranted. Various clinical and health services research groups and specialty societies are already engaged in independent initiatives to standardize data collection across projects in their domains in order to maximize the utility of the resulting datasets for subsequent research. Many important efforts that focus on this level of standardization, such as the Patient Reported Outcomes Measurement System (PROMIS), PhenX(consensus measures for Phenotypes and eXposures), and the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System, are funded by the National Institutes of Health (NIH) and other Federal sources. The National Library of Medicine (NLM) is working with the NIH research community and others to identify and coordinate research initiatives that use standardized patient assessment instruments and structured data definitions, also known as Common Data Elements (CDEs). Work is also beginning, under the auspices of NLM and the Department of Health and Human Services (HHS), to consider how to incorporate these CDEs more directly into the data infrastructure for patient-centered outcomes research (PCOR) using EHRs. The Agency for Healthcare Research and Quality (AHRQ) has developed a comparable library of terms and Common Formats to standardize data collected and reported for patient safety events. With such CDEs and standardized assessment instruments, data captured within an EHR could be consistently defined and collected, thereby improving its validity and usability not just in retrospective analysis but also in prospective observational or interventional research, comparative effectiveness research and patient safety monitoring.

Charter Consensus Voting

 

 

 

The Office of the National Coordinator for Health IT (ONC) Standards & Interoperability (S&I) Framework has demonstrated its value as a forum for addressing complex data architecture challenges, particularly as a means to publicly develop and test alternatives in advance of their inclusion in the regulations implementing the 2009 Health Information Technology and Economic and Clinical Health (HITECH) Act. The Structured Data Capture Initiative will build on both the results of and lessons learned in prior S&I efforts to bring consensus to this next critical aspect of our collective health data infrastructure.


Scope Statement

To define the necessary requirements (including metadata) that will drive the identification and harmonization of standards to facilitate the collection of supplemental EHR-derived data.

This initiative will develop and validate a standards-based data architecture so that a structured set of data can be accessed from EHRs and be stored for merger with comparable data for other relevant purposes to include:

  • The electronic Case Report Form (eCRF) used for clinical research including Patient Centered Outcomes Research (PCOR)

  • The Incident Report used for patient safety reporting leveraging AHRQ ‘Common Formats’ and FDA form 3500/3500a

  • The Surveillance Case Report Form used for public health reporting of infectious diseases

  • The collection of patient information used for Determination of Coverage, as resources permit.


The infrastructure will consist of four new standards that will enable EHRs to capture and store structured data. These will consist of: 

  • a standard for the CDEs that will be used to fill the specified forms or templates;
  • a standard for the structure or design of the form or template (container);
  • a standard for how EHRs interact with the form or template; and
  • a standard to enable these forms or templates to auto-populate with data extracted from the existing EHR


The standards will facilitate the collection of data in such a way that any researcher, clinical trial sponsor and/or reporting entity can access and interpret the data in electronic format. They will also support development of concise, architectural guidance using easy-to-understand documentation, user-friendly tooling and formal models to assist vendors in applying technical requirements for the customized use of specified forms or templates. For the purposes of this initiative, the data collected will not be stored within the EHR system. In sharing this data, ONC recognizes that certain forms of data may be subject to particular state or federal laws regulating use and disclosure. Standard specifications will incorporate the tools necessary for driving interoperability such as XML and the CDISC/ IHE integration profile Retrieve Form for Data Capture (RFD); this does not, however, imply any constraints on data formats that can be used during data capture and processing, as long as they do not prevent interoperability. The RFD integration profile is currently used within the research community to embed structured electronic forms with common data elements within the EHR to facilitate collection of research data. The SDC Initiative will align with and leverage other initiatives of the ONC S&I Framework. It will also build upon external initiatives that are focused on improving the comparability and utility of data derived from independent collection efforts through standardizing definitions of data elements and tools, such as PROMIS, PhenX, caDSR, and other initiatives identified in the NLM-NIH Common Data Element repository, and the AHRQ ‘Common Formats’ and Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (CER).

Value Statement

Given the significant Federal investments made in EHR adoption in the last 4 years, structured data capture within EHRs is poised to be a critical component of a variety of health services, quality measurement and clinical and health services research. Stage 3 Meaningful Use (MU) will focus on creating a learning health system to support quality, research, and improve public and population health. This initiative will lead the national vision to design the trusted mechanisms to enable patient information to flow securely from the system it was collected—the EHR—to other systems, such as research consortia, registries, bio repositories and public health systems, with an authorized use for it. Information will be shared in compliance with policy, regulation, and Patient Consent Directives (e.g., 42 C.F.R Part 2 Confidentiality of alcohol and drug abuse patient records; and 38 USC § 7332-Confidentiality of certain medical records). The identification and harmonization of standards for structured data capture within EHRs will not only help achieve this vision, but they will also help reduce the:

  • Data collection burden on health care providers by enabling secure, single-point data entry that populates to multiple systems

  • Need to make site-specific modifications to EHR system capabilities in order to enable participation in important reporting and research activities

  • Barriers to volunteer adverse event reporting on medical products to public health agencies leading to improvements in population health


These efforts will identify a standard for structured data, whether it is used for a clinical trial, Determination of Coverage, or to report on a patient safety event, which can be collected in a timely manner, then readily compared and aggregated improving the overall quality, value and utility of these data. Furthermore, the development of a national infrastructure will improve access to standardized electronic versions of data collection instruments relevant for use in research and patient care such as validated instruments for collecting data on pain, fatigue, physical function, depression, anxiety and social function. It will be easier to integrate these instruments into EHRs in ways that will ultimately reduce duplicate data entry. Likewise, data collected will be more comparable and therefore more useful in ascertaining what works best for different patient populations.

Target Outcomes & Expected Deliverables

The SDC Initiative will provide an infrastructure to standardize the capture and expanded use of patient-level data collected within an EHR. In the short term, specification of standards for data reuse will support and spur development and implementation of software and pilots that will inform refinement of these standards, prior to their consideration for inclusion in Meaningful Use and EHR certification requirements. In the longer term, the additional functionality will support enhancements and efficiencies in such diverse domains as patient-centered outcomes research and clinical trials, adverse event reporting and public health monitoring and surveillance, Determination of Coverage and patient care.

The value of this initiative will be measured through the attainment of the following immediate and long-term outcomes:

  1. Identification of functional requirements from a Use Case describing key conditions and business rules to enable the capture and storage of specified forms or templates, while protecting privacy and confidentiality
  2. Development of concise consensus-driven architectural guidance using easy-to-understand documentation, user-friendly tooling and formal models to assist researchers, patient safety personnel, software vendors and others in applying technical requirements for the customized use of specified forms or templates. Guidance will be updated and versioned appropriately to allow ubiquitous access to all parties.
  3. Execution of one or more pilots to evaluate the use of the specified form standard in specific contexts, such as patient-centered outcomes research and patient safety event reporting. The pilots will examine the application of specified-form standard for the conduct of PCOR and patient safety event reporting, drawing upon the NLM/NIH common data elements repository, as well as AHRQ ‘Common Formats’ for patient safety events.
  4. Proliferation and use of NIH-identified and curated CDEs for PCOR and AHRQ ‘Common Formats’ for patient safety event reporting
  5. Development or identification of four national standards specific for: CDEs used to fill electronic forms or templates, the structure or design of the form or template, the standardized functions for how EHRs interact with those standards, and the specifications that enable these forms or templates to auto-populate with data extracted from the existing EHR.
  6. Alignment and integration to other health IT infrastructure (through a Learning Health System) to support effective maintenance, distribution, and use of specified forms or templates
  7. Enhancement of patient care through improvements in quality and safety interventions, population health, and research
  8. Improvement in provider experience and workflow when using EHRs for patient care and other purposes

Standards

Standardization efforts established by other projects will be leveraged. These include, but are not limited to:

Stakeholders and Interested Parties

Stakeholders and interested Parties include but are not limited to the following:

  • Healthcare Providers and Clinical Informaticians
  • Clinical/PCOR Research Community and CER/PCOR Thought Leaders and organizations, such as: Patient-Centered Outcomes Research Institute (PCORI), EDM ForumCDISCElectronic Medical Records and Genomics Network (eMERGE), Distributed Ambulatory Research in Therapeutics Network (DARTNet), Electronic Patient-Reported Outcome (ePRO) Consortium, ASTER-D
  • Patient Safety Organizations (PSOs)
  • Privacy and Security Experts
  • Patient Advocates
  • Pharmaceutical Firms
  • Device manufacturers
  • Government Agencies:
    • Food & Drug Administration (FDA), Assistant Secretary for Planning and Evaluation (ASPE), NIH (NLM & other Institutes/Centers), AHRQ, Centers for Disease Control (CDC), Centers for Medicare & Medicaid Services (CMS), Indian Health Services, Human Resources and Services Administration (HRSA), Institute of Medicine (IOM), Veterans Administration (VA), Department of Defense (DoD), Social Security Administration (SSA), Department of Transportation (DoT), State Medicaid Programs
  • Vendors:
    • EHR/EMR systems, Health Information Exchange (HIE), Data Warehouse/Data Mart, Electronic Data Capture (EDC) and Patient Safety Event Reporting System
  • Standards-Related Organizations: Standards Development Organizations (SDOs), vocabulary/terminology organizations, standards setting organizations
  • Healthcare payers, particularly those with robust research, quality improvement (QI), patient safety and public health activities, including professionals involved in registries and surveillance at a reginonal and national level
  • Professional liability carriers
  • Healthcare Professional associations

Proposed Timeline

SDC_Timeline_Charter.png
This timeline represents notional estimates of planned activities and will be adjusted as work moves forward through the initiative phases.

Risks

  • Identification of content models for standard that do not compete or overlap with existing or developing models
  • Insufficient engagement and participation by vendor communities, and eventual adoption in Certified EHR products
  • Insufficient commitment by various vendors and organizations to participate in SDC pilots
  • Accessibility of a CDE library or repository in time for pilots and completion of pilots in time for future stages of Meaningful Use
  • Competing definitions of Common Data Element and CDE libraries
  • Identification of a useful but parsimonious set of data elements for forms/templates that can auto-populate with data extracted from the existing EHR in time for pilots
  • Overwriting and/or duplicate data entry
  • Solutions for research, patient safety, and public health reporting may vary; one standard solution may not apply
  • Standards and solutions may not scale to small vendors and small practices
  • Proposed project timeline does not reflect actual deadlines in relevant standards or regulatory bodies
  • Not all EHR systems offer or can support pre-population functionality; if the auto-populate standard is prescriptive, the SDC timeline may be delayed as vendors implement the functionality in their systems
  • Providers may not ‘fill’ all CDEs displayed on an electronic form
  • Accuracy of EHR data and reliability of diagnosis codes for reuse in clinical research
  • Patient privacy: de-identification of EHR data for clinical research

Success Metrics and/or Success Criteria

  • Upfront engagement in development of use case requirements and solution from potential pilot sites
  • Balloted standard(s) are included as EHR certification criteria
  • Proliferation and use of NLM-identified and curated CDEs for PCOR and AHRQ ‘Common Formats’ for patient safety event reporting
  • Harmonization of CDEs among federal agencies and research communities in other countries

More information on the SDC charter can be found on the "About SDC" page.

Announcements

  • SDC Pilots: Attention SDC Pilot participants! For those of you who are interested in participating in an SDC Pilot, please review the following checklist below.

SDC Pilots Participation Checklist

  1. PLEASE READ the SDC overview found below.
  2. Determine which role accurately describes your organization and what you would like to pilot:
    1. Form Manager
    2. Form Filler
    3. Form Receiver
    4. Form / Data Element Repository
    5. Other
  3. Contact the team leads (Jenny Brush and Vijah Shah - contact information provided below) to schedule a pilot planning meeting.
  4. Review the IHE SDC Profile and/or the FHIR SDC Profile to determine which technology best suits your data sharing needs.
  5. If you plan to pilot the IHE SDC Profile, complete the IHE SDC Pilot Plan Template.
  6. If you plan to pilot the FHIR SDC Profile, complete the FHIR SDC Pilot Plan Template (under development).
  7. Work with the team leads to schedule a time to Present your Pilot Proposal to the community (All materials are provided in downloadable format below).

 

Structured Data Capture (SDC) Initiative Overview

With electronic health record (EHR) adoption rising across the U.S., the volume and detail of information captured by healthcare organizations and providers will grow exponentially. Although health care providers and others use various sources and methods to capture and synthesize patient-level data, EHRs have been recognized as the data source with the highest potential to provide timely and relevant data in a form that is quickly usable for quality and safety improvement, population health, and research (sometimes labeled "secondary" use or "reuse" ). EHR data obtained during episodes of care will become increasingly valuable to healthcare organizations striving to leverage electronic information to drive efficiency and quality. Of particular interest are efforts to leverage clinical data captured during episodes of care and link the clinical data to supplemental data collected for other purposes including: 1) clinical research, 2) patient-safety event reporting, 3) public health reporting, and 4) determination of coverage. Once captured, aggregated and analyzed, these combined data can be used to identify trends, predict outcomes and influence patient care, drug development and therapy choices.

The S&I Structured Data Capture (SDC) Initiative aims to define the necessary requirements (including metadata) that will drive the identification and harmonization of standards to facilitate the collection of supplemental EHR-derived data. In 2014, the SDC Initiative published new Implementation Guidance to define how structured data can be accessed from EHRs and be stored for merger with comparable data for other relevant purposes to include:

  • The electronic Case Report Form (eCRF) used for clinical research including Patient Centered Outcomes Research (PCOR)
  • The Incident Report used for patient safety reporting leveraging AHRQ 'Common Formats' and FDA form 3500/3500a
  • The Surveillance Case Report Form used for public health reporting of infectious diseases
  • The collection of patient information used for determination of coverage, as resources permit


The structured standard for data elements in the IHE SDC Profile is based on ISO/IEC 11179-3; the FHIR SDC Profile includes a new DataElement Profile based on DataElement Resource. The structured standard for forms in the IHE SDC Profile is based on ISO/IEC 19763; the FHIR SDC Profile uses Questionaire/Answer Resource which are based on the same SDC conceptual model. The standard for how EHRs exchange information and how they pre-populate and auto-populate forms are in both the IHE and the FHIR profile.

Benefits of Participation as an SDC Pilot Site

The S&I Steering Team is seeking broad participation-by providers, HIT vendors, research communities, patient safety organizations (PSOs), pharmaceutical firms, Public and Private Health Insurance Payers other interested parties-in SDC pilots. SDC pilot participants could realize several benefits, including but not limited to:

  • Ability to leverage initiative resources. Build on the expertise, tools and any open-source code developed through the SDC Pilots SWG and SDC All-Hands to create a better, faster, and higher quality implementation.
  • Demonstrate compliance and increase efficiency of development and maintenance. Use the SDC Implementation Guidance and/or IHE Profile to inform changes to existing HIT systems and the process by which structured data is captured, stored and shared. These specifications are being harmonized with a broad consortium of Standards Development Organizations (SDOs) including HL7, IHE, and CDISC.
  • Contribute to the community. Each pilot has a high profile among Government agencies, ONC grantees, and within the community of volunteers that support the Nationwide Health Information Network.
  • Be recognized as an early adopter. Use participation in this important national initiative to heighten your organization's name recognition.

Value Statement for Participating Entities

The implementation of consensus driven standards for structured data capture from EHRs is expected to improve efficiencies and promote collaboration by:

  • Advancing the Stage 3 Meaningful Use of EHRs Learning Health System where patient information can flow securely from EHRs to other systems like research consortia, registries, bio repositories and public health systems
  • Reducing the data collection burden on health care providers by enabling secure, single-point data entry that populates to multiple systems
  • Improving the comparability of data to better inform research, quality reporting and ultimately, influence patient care
  • Reducing the need for site-specific EHR enhancements so that disparate EHR systems can participate in important reporting and research activities
  • Limiting barriers to volunteer adverse event reporting on medical products to public health agencies leading to improvements in population health

 

Pilot Materials

Document NameDescription
SDC Pilots Planning and ActionsWorking document with current status/signup of participating pilot organizations, along with a printable version of the Pilot Checklsit.
SDC Pilot Overview (in review)An overview of the SDC Pilots Workgroup including a Value Statement for Participating Entities, Benefits of Participation as an SDC Pilot Site and steps for How to Get Started. (A downloadable version of the information on this wiki page)
FHIR SDC ProfileLink to the latest version of the FHIR SDC Profile. Please note there are TWO IG's that are relevant to SDC. The Structured Data Capture IG and the Structured Data Capture - Data Element Exchange IG.
IHE SDC Pilot TemplateA PowerPoint template for potential pilots interested in implementing the IHE SDC Profile. Fill out this emplate with the the details of your proposed pilot project.
FHIR SDC Pilot TemplateA PowerPoint template for potential pilots interested in implementing the FHIR SDC Profile. Fill out this template with the details of your proposed pilot project.

Initiative Contacts

Initiative CoordinatorEd Hammondwilliam.hammond@duke.edu 
ONC LeadFarrah Darbouzefarrah.darbouze@hhs.gov
Project ManagerJenny Brushjennifer.brush@esacinc.com
PM SupportLauren Carusolauren.caruso@esacinc.com
Harmonization and Standards Development SupportPerri Smithperri.smith@accenturefederal.com
Technical Lead and Standards Development SupportVijay Shahvshah@jbsinternational.com
NLM Teaming PartnerLisa Langlangl@nlm.nih.gov

Announcements

The purpose of the Implementation phase is to define the set of Harmonized Specifications and documentation required to solve the challenge, create the necessary reference implementation using the specifications and plan for operational pilot testing if goals and objectives are still justified. Learn more about the S&I Framework Processes & Guidelines and S&I Initiative Overview, Phases and Outputs.

Upcoming Activities

  • Rolling Review of SOAP/SAML IG
  • Please visit the IG page to see latest and earlier versions of the IG document

 

Structured Data Capture IG Development

If you are interested in providing comments to the IG, please click the link below to be redirected to the IG development page.

SDC IG Development Page

Standards & Harmonization Timeline

SDC Harmonization Timeline

Standards Sub-Workgroup

Standards Sub-Workgroup Link

Phase 1: Evaluate Standards

Phase One
All Phase 1 deliverables can be found below:

Standards-UCR Crosswalk Working Documents

The Standards-UCR Crosswalk is used to map selected standards from the Standards Evaluation Spreadsheet against Use Case requirements. UC requirements include Information Interchange, System Functions, and Data Requirements. The crosswalk is used to capture gaps in functionality, dependencies between standards and the gap mitigation plans to resolve how to extend or modify existing standards.

DocumentDate UploadedUpdated Content
7/21/2013-Final Update
Added OAuth to support RESTful implementation; final selection of Standards for Transport, Security and Authentication; Reviewed and identified gaps for Content and Structure Standards - RFD, XD*, IHE DEX, CDA R2; CDA Questionnaire Form and Response IG, and XHTML
SDC UCR Crosswalk - ArchiveAll past versions- All previous updates

Technical Feasibility Analysis of UC Requirements

The Technical Feasibility Analysis is a review of SDC requirements from the Use Case. The Analysis is utilized as a tool to assess technical feasibility of both System Function requirements and Information Interchange requirements. This document is also used to describe successful EHR system pre-conditions and post-conditions.

DocumentDate UploadedNotes
6/7/2013-Requirements for inclusion in the Implementation Guide with initial analysis

Standards Evaluation

Guidance Areas

SDC guidance area updated

Standards Evaluation Documents


The Standards Evaluation Spreadsheet is a tool for objective evaluation of standards from the Candidate Standards List across a matrix of various benchmarks. Standards are evaluated and reviewed by the S&I community for “Maturity”, “Adoptability”, and “S&I Specific” criteria. The former two are based off of the HITSC NwHIN recommendations for standards evaluation. The standards with higher scores are carried into the UCR-Standards Crosswalk for evaluation against SDC requirements.

DocumentDate UploadedUpdated Content
7/10/2013-Corrected an error in Consent Directives rating
Final Update
SDC Standards Evaluation Template - ArchiveAll past versions- All previous updates

Maturity vs. Adoptability Graphs

 

Candidate Standards List and Solution Diagram

The Candidate Standards List is meant to serve as a launching point for Standards & Harmonization activities by capturing a list of standards to be carried into standards evaluation.
The solution diagram is a visualization of how the types of standards can map to the transactions identified in the Use Case.

  • The updated Solution Diagram is posted below. Feedback is closed as of COB 5/14 - thank you for your input!

 

Item Name DescriptionOwnerTargeted Completion Date
Narrowed and Updated Candidate Standards ListFor all of the standards evaluated using the HITSC criteria, the file includes:
  • Name and link to definition
  • Brief description
  • Individual who recommended evaluating this standard
  • Contact information for the community member who requested the standard's evaluation
DC TeamComplete
Candidate Standards List
Structured Data Capture Candidate Standards
SDC TeamComplete:
Solution Diagram Community MembersComplete
Candidate Standards Links and Descriptions SDS TeamComplete

Standards & Harmonization Contacts

NameRoleEmail
Vijay ShahSDC Harmonization Support Leadvshah@jbsinternational.com
Caryn JustStandards Development Support Leadcaryn.k.just@accenturefederal.com
Hector CintronStandards & Harmonization Supporthector.cintron@accenture.com
Jennifer SistoHarmonization Support Leadjennifer.t.sisto@accenturefederal.com

Initiative Contacts

Initiative CoordinatorEd Hammondwilliam.hammond@duke.edu 
ONC LeadFarrah Darbouzefarrah.darbouze@hhs.gov
Project ManagerJenny Brushjennifer.brush@esacinc.com
PM SupportLauren Carusolauren.caruso@esacinc.com
Harmonization and Standards Development SupportPerri Smithperri.smith@accenturefederal.com
Technical Lead and Standards Development SupportVijay Shahvshah@jbsinternational.com
NLM Teaming PartnerLisa Langlangl@nlm.nih.gov

 

Announcements

- Final Use Case Consensus for the Structured Data Capture initiative was achieved on Thursday, May 30th 2013!

Use Case Consensus Document & Votes

DateConsensus DocumentConsensus Votes & DispositionsConsensus Votes

 

5/30/2013


Voting Spreadsheet
Yes: 13
Yes with Comments: 5
Abstain: 2
Total: 20

 

Use Case Development Timeline:

SDC final UC timeline


SDC Use Case Revisions

The below table includes the full Use Case document template and contains content that was covered in the most recent meeting.

DocumentDate UploadedUpdated Content
5/30/2013- Track-changes version of Consensus document with final WG changes
5/17/2013- Consensus version for voting
5/16/2013- Updated with E2E review comments
- Version will be posted for consensus
5/9/2013- Updated with E2E review comments
5/3/2013- Updated with Appendices & community feedback
- Updated Actions & Expressions Data Requirements
4/26/2013- Updated 11.0 Data Requirements & 12.0 Risks, Issues, & Obstacles
4/19/2013- Updated 8.0 Actors & Roles, 10.1 User Stories, 10.2 Activity Diagram, 10.3 Functional Requirements, 10.4 Sequence Diagram with community updates
4/12/2013- Section 10.4: Sequence Diagram to be reviewed
- Updated with comments provided by the community
4/4/2013- Section 10.3: Functional Requirements to be reviewed
- Updated with comments provided by the community
3/28/2013- Sections 2.0 - 4.0: Leveraged from Charter
- Sections 1.0, 5.0 - 10.1: Reviewed by Community
- Sections 10.2 - 10.2.1: New content to be reviewed

Comment Form and Spreadsheet

Use Case Contacts

NameRoleEmail
Jennifer SistoSDC Use Case Support Leadjennifer.t.sisto@accenturefederal.com
Presha PatelUse Case Support Leadpresha.patel@accenture.com
Virginia RiehlUse Case SMEvirginia.riehl@verizon.net

Initiative Contacts

Initiative CoordinatorEd Hammondwilliam.hammond@duke.edu 
ONC LeadFarrah Darbouzefarrah.darbouze@hhs.gov
Project ManagerJenny Brushjennifer.brush@esacinc.com
PM SupportLauren Carusolauren.caruso@esacinc.com
Harmonization and Standards Development SupportPerri Smithperri.smith@accenturefederal.com
Technical Lead and Standards Development SupportVijay Shahvshah@jbsinternational.com
NLM Teaming PartnerLisa Langlangl@nlm.nih.gov

Announcements

  • All of the comments submitted on the SDC specification can be found using the gForge Tracker.
  • The HL7 FHIR DSTU2 Ballot Version (including the FHIR SDC Profile IG) is now available. Click here for the balloting homepage and click here to access the ballot desktop.
  • SDC FHIR Profile Scope Guidelines are available for review and comment. Link also provided below.
  • HL7 FHIR Implementation Guide: Structure Data Capture (SDC), Release 1 was published for HL7 comments only ballot cycle. View here. The ballot cycle is now closed. 
  • Decisions log for HL7 FHIR Implementation Guide: To keep track of all comments submitted on the HL7 ballot, please visit the DECISIONS LOG HERE.

SDC FHIR Profile IG

SDC FHIR Profile IG Timeline

SDC Timeline

Consensus Approved SOAP/SAML IG & Schema

DocumentDate UploadedUpdated Content
3/18/2014Consensus approved version
3/18/2014Zip file containing SDC Schema files
Implementation Guide Archive3/18/2014Archive for all past versions
SDC Data Element Mapping Template4/23/2104Template to map domain-specific Data Elements to the SDC Data Element specification

Open Topics in SOAP/SAML IG

 

 

 

 

 

Thank You

  • The PSE/AE SWG has completed their initial goals and is now closed, with no regular meetings taking place. We will reconvene as a group on an as-needed basis.

Announcements

  • SDC Pilots: Pilot activities have been transitioned to the SDC All Hands Meetings. For those of you who are interested in or have committed to participating in an SDC Pilot, please take a look at our SDC Pilots Planning Document (bookmark it at http://bit.ly/SDCPilots). For anyone who has issues accessing google docs, here is a downloadable MS Word version.
  • PSE/AE Workflows: The workflow to IG mapping document is available here: SOAP/SAML Technical Mapping (updated 5/30/14) (Follow link for downloads and feedback form.)

 

Weekly Meetings

Please select the url first, then use the numbers and codes provided by WebEx to dial-in.

Wednesdays @ 3:00 pmWednesdays @ 4:00 pmThursdays @ 3:25 pm

SDC FHIR Coordination

SDC Pilots

All-Hands Meeting

Meeting Name: SDC FHIR Coordination
Date: March 2, 2016
Time: 3:00 - 4:00 pm Eastern
URL: https://esacinc.webex.com/
Dial In: 1-415-655-0001
Access code: 731 602 925
Password: meeting
Meeting Name: SDC Pilots
Date: March 2, 2016
Time: 4:00 - 5:00 pm Eastern
URL: https://esacinc.webex.com/
Dial In: 1-415-655-0001
Access code: 731 602 925
Password: meeting
Meeting Name: SDC All Hands
Date: March 3, 2016
Time: 3:25 - 4:30 pm Eastern
URL: https://siframework1.webex.com/
Dial-In: 1-650-479-3208
Access Code: 663 397 496

Edit Meeting Info

 

Patient Safety Event / Adverse Event SWG Charter

Goal

The goal of this workgroup is to validate, test and and pilot the SDC interoperability standards identified to date that specify how electronic health records (EHRs) can capture and transmit structured data for PSE and AE reporting.

Objective

Our objective is to identify organization to pilot test the SDC standards, the PSE/AE SWG will focus on achieving the following activities:

  • Identification of Common Data Elements (CDEs) and associated value sets, leveraging AHRQ Common Formats, that can be used for PSE and AE reporting from EHRs
  • Identification of structured forms/templates these CDEs will populate, leveraging AHRQ Common Formats and FDA Form 3500/3500a
  • Development of PSE and AE Reporting end-to-end workflow (from EHR system to AHRQ Repository and from EHR system to FDA Repository)

Value Statement for Participating Entities

This SDC initiative and associated pilot projects will lead the national vision to design the trusted mechanisms to enable patient information to flow securely from the system it was collected—the EHR—to other systems, such as patient safety incident reporting systems, with an authorized use for it. The pilots will also inform upcoming Meaningful Use and EHR Certification Criteria. The piloting of standards for structured data capture within EHRs will not only help achieve this vision, but at a practical level will also help reduce the:

  • Time to complete patient safety and adverse event reports by enabling auto population of key fields found in EHR data
  • Data collection burden on health care providers by integration of the PSE and AE workflows.

Benefits of Participation as an SDC Pilot Site

The S&I Steering Team is seeking broad participation—by providers, HIT vendors (both EHR and patient safety/adverse event reporting software vendors), patient safety organizations (PSOs), States and other interested parties—in SDC pilots. SDC pilot participants could realize several benefits, including but not limited to:

  • Ability to leverage initiative resources. Build on the expertise, tools and any open-source code developed through the SDC PSE/AE SWG to create a better, faster, and higher quality implementation.
  • Gain early insights and test EHR functions that are being considered for future certification criteria. Participants in the SDC pilots will gain knowledge and experience that will facilitate early adoption of potential future required functions.
  • Contribute to the community. Each pilot has a high profile among government agencies, ONC grantees, and within the community of volunteers that support the Nationwide Health Information Network.
  • Be recognized as an early adopter. Use participation in this important national initiative to heighten your organization’s name recognition.

Initiative Contacts

Initiative CoordinatorEd Hammondwilliam.hammond@duke.edu 
ONC LeadFarrah Darbouzefarrah.darbouze@hhs.gov
Project ManagerJenny Brushjennifer.brush@esacinc.com
PM SupportLauren Carusolauren.caruso@esacinc.com
Harmonization and Standards Development SupportPerri Smithperri.smith@accenturefederal.com
Technical Lead and Standards Development SupportVijay Shahvshah@jbsinternational.com
NLM Teaming PartnerLisa Langlangl@nlm.nih.gov

Announcements

  • ALL PARTICIPANTS: Please review the IHE SDC Profile. This is the technical description and guidance for what will be tested at the connectathon

 

SDC IHE Connectathon Working Group Overview

Goal

The goal of this work group is to convene a group of organizations and stakeholders at the upcoming IHE Connectathon in January 2015 to successfully test and evaluate the IHE SDC Profile in a working environment by testing both the form definition and the transactions for moving the form (along with the form responses) between systems. After a successful test and evaluation, the goal is to demonstrate the functionality at HIMSS 2015.

Timeline / Milestones

Oct 30Organizations confirm participation and commitment to test the IHE SDC Profile
Nov 10Content provided to participant partners
Nov 11 - Dec 1Development Activities
Dec 31Technology Stack verification
Jan 6 - 17Beta Testing and Troubleshooting
Jan 20 - 24Dry Runs
Jan 26 - 30IHE Connectathon Demonstrations

 

SDC Profile and Schema

 

Testing Material

NameDescriptionLast Updated
Complete package with updates to endpoints2015-01-29
Complete package of material with updates to HTML and URI files2015-01-29
SDC Partners - Forms TestingList of all Testing Partners and Forms they will support2015-01-06
SDC_Forms_Transaction_Kit_1.5.zipComplete package of material for IHE SDC Testing2015-1-22
Transaction Identifiers FinalForm Content Type: XML, HTML, URI
Form Name: identifies the 5 forms that are part of the Connectathon Testing
Form ID: identification number used within the transactions
Details: Describes the healthcare domain for the form
Status: Describes the completeness of each transaction
Transaction File Name: The name of the files within the it
2014-12-11
Tests for SDCOptions, Transactions, Assertions, Big Picture, Roles, Tests for testing partners 
Tests for RFDOptions, Transactions, Assertions, Big Picture, Roles, Tests for testing partners 
IHE SDC Data Element Details SpreadsheetFirst two tabs are of direct interest:
  • Demographics:
    • Data Element LABEL
    • XPATH CDA R2
    • Data Type
    • NCI Value (sub)Set
    • CodeSystem OID (and Name)
  • DemoPatient Data:
    • Data elements and values for three patients
Also contains pre-pop data values
2014-12-11
SAMPLE FORMS/TRANSACTIONS: HTML XML and URI Transaction Support PackageFor Reference Only: package based on RFD & SDC to support HTML , XML and URI transactions.2014-12-02

 

Questions / Comments / Issues

(Link to form to be added)

 

HE Connectathon Documents and Feedback

Click here to access all of our consolidated IHE Connectathon Documents and Feedback.

 

SDC IHE Connectathon Contacts

List of Vendors, Actor Assignments, and tasks for each ActorLast Updated: 2014-12-10IHE Connectathon - SDC Profile Actors and Participating Vendors
Lead FacilitatorWendy Scharberewy1@cdc.gov
Project Manager and POCSandy Jonessft1@cdc.gov
SDC Technical LeadVijay Shahvshah@jbsinternational.com
SDC PMJenny BrushJennifer.Brush@esacinc.com
SDC PM SupportLauren CarusoLauren.Caruso@esacinc.com
SDC Initiative CoordinatorEvelyn Gallegoevelyn.gallego@siframework.org

Announcements

Please view the transaction document that was discussed at the Standards SWG by clicking here.

Thank you for productive input and support as we’ve gone from a laundry list of candidate standards to a solution plan ready for IG development in just seven weeks

As a reminder, the Standards SWG will be transitioning to an IG Development Working Session starting next week which will feed the content review during the All Hands WG meetings weekly on Thursdays

Attend: IG Development Working Sessions
Weekly on Wednesdays, 2-3pm EST

Vijay Shah (vshah@jbsinternational.com) is the main POC for IG development, feel free to reach out to support drafting & reviewing the sections

The IG development timeline will be shared tomorrow during the All Hands WG call

 

Calendar

Initiative Timeline

 

Purpose of Sub-Workgroup

The goal of the SWG is to drive toward an updated final list of standards for use in the SDC IG, and make recommendations to the SDC All Hands WG. More specifically, they will extend, modify and/or harmonize the standards final list selected for the SDC solution for use in the IG which includes guidance areas around:

  • Interaction of a template/form with the EHR system
  • Auto-population of a template/form with already patient data in the EHR system

 

Solution Planning Diagrams for review

SDC Solution Plan

 

 

 

 

 

 

 

 

Meeting Materials

DocumentDateDescription/Notes
SDC Standards SWG 8.28.138/28/13-Reviewed information interchange requirements. Reviewed system
requirement. Discussed each information interchange in depth.
SDC Standards SWG 8.21.138/21/13-Reviewed solution plan. Discussed Auto-population and IHE DEX. How
to handle CDE mapping was also discussed in detail.
SDC Standards SWG 8.14.138/14/13-Reviewed changes made to Solution Plan from All Hands WG last week.
Introduced Auto-population "IHE profiles". Auto-population was
discussed in detail.
SDC Standards SWG 8.7.138/7/13-Reviewed Solution Plan & proposed, TLS based, security approach.
Discussed leveraging hData, FHIR, RHEx and other IG's for REST
implementation guidance. Discussed potential SOAP use cases that can
be leveraged in IG. Briefly discussed Auto-population requirements.
SDC Standards SWG 7.31.137/31/13-Reviewed Solution Plan & Data Requirement buckets briefly.
Discussed TLS & REST solutions & utilizing other IG's. Discussed RHEx
and the implications of leveraging the RHEx IG
SDC Standards SWG 7.24.137/24/13-Drafted Data Requirements portion of solution
SDC Standards SWG 7.17.137/17/13-Discussed solution planning. Started to discuss API's and its relation to
Information Interchange Transactions
SDC Standards SWG 7.10.137/10/13-This PowerPoint deck is an outline of the Standards SWG goals.
It contains targeted activities, a timeline and a comprehensive table
of potential standards solutions.

 

For Homework

DocumentProvide feedback byStatus
EOD Monday, July 15thSystem requirements to be discussed by group
Provide comments on the solution plan using the form aboveWeekly by EOD MondayComments will be discussed during Standards SWG

Contact Information

NameRoleEmail
Dr. Ken PoolCommunity Leadkpool@oz-systems.com
Jennifer SistoSWG Support Leadjennifer.t.sisto@accenturefederal.com
Hector CintronSWG Supporthector.cintron@accenture.com

Announcements

  • Pilots
    • Updated SDC Phase II Schema files (Jan 26, 2016), have been uploaded to the Pilots shared drive here.
  • IHE Profile
    • The updated version of the IHE SDC Profile is now published. This version is available on the IHE website under QRPH listing here. The updated PDF version of the file is also available here.
  • FHIR Profile
    • Our Wednesday SDC FHIR Coordination Meetings have resumed. Meeting Information can be found in the Weekly Meetings Table below.
    • A list of FHIR SDC issues from the January 2016 FHIR Connectathon are available to view here . These issues have all been entered in the tracker.

Events

  • HealthCa.mp on FHIR Code-a-thon will be held on April 1-2, 2016 in Washington, DC. For more information click here.
    • This two-day code-a-thon is being held in conjunction with the HealthDataPalooza. This event is where developers from Federal and State-based organizations come together with Entrepreneurs, startups, and research organizations to build cool solutions that leverage the HL7 FHIR API.
    • Come on your own or come as a team. Spend two days developing an innovative solutions that uses FHIR and you could win a spot to present your work at the HealthDataPalooza in Washington, DC in May 2016.
    • Registration is $50 per person; federal employees and members of the 1776 DC Incubator may attend for free
  • HealthDataPalooza 2016 will be held May 8-11, 2016 in Washington, DC. Both in person and web-based attendance options are offered. To register click here.

Weekly Meetings

Wednesdays @ 3:00 pm
Wednesdays @ 4:00 pm
Thursdays @ 3:25 pm

SDC FHIR Coordination

 SDC Pilots

 All-Hands Meeting

Meeting Name: SDC FHIR Coordination
Date: March 2, 2016
Time: 3:00 - 4:00 pm Eastern
URL: https://esacinc.webex.com/
Dial In: 1-415-655-0001
Access code: 731 602 925
Password: meeting
Meeting Name: SDC Pilots
Date: March 2, 2016
Time: 4:00 - 5:00 pm Eastern
URL: https://esacinc.webex.com/
Dial In: 1-415-655-0001
Access code: 731 602 925
Password: meeting
Meeting Name: SDC All Hands
Date: March 3, 2016
Time: 3:25 - 4:30 pm Eastern
URL: https://siframework1.webex.com/
Dial-In: 1-650-479-3208
Access Code: 663 397 496

Initiative Overview and Scope

For detailed information on initiative goals, objectives and intended outcomes, please see the SDC Project Charter.

 

Summary: The Structured Data Capture (SDC) initiative will develop and validate a standards-based data architecture so that a structured set of data can be accessed from EHRs and be stored for merger with comparable data for other relevant purposes to include:

  • The electronic Case Report Form (eCRF) used for clinical research including Patient Centered Outcomes Research (PCOR)
  • The Incident Report used for patient safety reporting leveraging AHRQ ‘Common Formats’
  • The Surveillance Case Report Form used for public health reporting of infectious diseases
  • The collection of patient information used for determination of coverage, as resources permit.

 

Following is a visual conceptualization of the initiative workflow.

Use Case Diagram 

 

The proposed infrastructure will consist of four new standards that will enable EHRs to capture and store structured data. These will consist of: a standard for the CDEs that will be used to fill the specified forms or templates; a standard for the structure or design of the form or template (container); a standard for how EHRs interact with the form or template; and a standard to enable these forms or templates to auto-populate with data extracted from the existing EHR. The standards will facilitate the collection of data in such a way that any researcher, clinical trial sponsor and/or reporting entity can access and interpret the data in electronic format. For more information about this initiative, please see the Structured Data Capture Charter.

THIS LINKS YOU TO THE DIFFERENT INITIATIVES

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