Structured Data Capture (SDC) Initiative

Transcription

1 Structured Data Capture (SDC) Initiative Overview for the S.M.A.R.T. Informatics Think Tank Evelyn Gallego-Haag, MBA, CPHIMS Initiative Coordinator

2 Title Introduction Background Standards Overview: Phase 1 & Phase 2 Implementation Guidance SDC Data Element Framework SDC Pilot Program 2

3 SDC Background Launched in 2013 in collaboration with other Federal Partners: NIH (NLM, NCI), AHRQ, FDA, CMS & CDC Key area of focus is enabling the collection of structured data within EHRs to supplement data collected for other purposes to include: Clinical research (Patient Centered Outcomes Research/ Comparative Effectiveness Research) (NLM FOCUS) Patient safety event reporting (AHRQ FOCUS) & Adverse Event Reporting (FDA FOCUS) Public Health Reporting (CDC FOCUS) Determination of Coverage (CMS FOCUS) 3

4 SDC Standards Focus SDC Initiative has identified four areas that specify how EHR systems can capture and store structured data: 1. Standard for the structure/definition of the CDEs that will be used to fill the specified forms or templates 2. Standard for the structure or design of the form (container) 3. Standard for how EHRs interact with the form or template 4. Guidance to pre-populate and auto-populate form or template with existing patient data 4

5 Structured Data Capture Conceptual Workflow 1 Sends request for form/template Sends requested form/template 2 SDC Scope 3 Converts, populates & displays form 4 Fills, stores/transmits structured data Actor Key xx 5 Forms Filler Forms Manager External Repository x John Doe x x x x Extract, Transform, & Load Data by form/ template

6 SDC Solution Plan: In Scope Transactions SDC Solution Plan presented in terms of 3 Transactions: Transaction 1A: Form/Template Request and Response without Patient data EHR System sends request for blank form/template to Form/Template Repository Form/template Repository sends requested blank form to EHR System Transaction 1B: Form/Template Request and Response with Patient data EHR System sends request for form/template with relevant patient data to Form/Template Repository Form/Template Repository sends form/template with pre-populated patient data to EHR system Transaction 1C: EHR System sends completed form/template to External Data Repository 6

7 Phase 1 Solution: SDC IHE Profile SDC standards identified for Phase 1 are not new ; most are mature standards being used across industry to meet specific interoperability specifications SDC Standards are specified via: SDC IHE Profile: Published in Sept df ; tested at January 2015 IHE North American Connectathon Content & Structure Transport, Security, and Authentication CDA ISO/IEC ISO/IEC IHE RFD IHE ATNA SOAP TLS v1.0 or higher SAML 7

8 SDC IHE Profile Testing: IHE NA Connectathon 2015 Participants IHE Profile Role Description Organization Name Form Filler Form Manager Form Receiver Form Processor Retrieves forms from a Form Manager as and when required. When requesting a form, the Form Filler can optionally provider EHR context information by providing pre-population xml data in the request for use by the Form Manager. Supplies forms to Form Fillers based upon form retrieval requests. In some cases, may return a form whereas in other cases the returned form may be selected or constructed based upon context information supplied in the form retrieval request. Receives and processes completed or partially completed forms instance data from a Form Filler. Performs combined role of both Form Manager and Form Receiver Epic mtuitive, Inc. NHDS GE JBS International National Cancer Institute (NCI) DCG, Inc. (USHIK) Aegis.Net CDC FDA CRG Medical CDPH JBS International JBS International

9 SDC Compliant Forms Tested 1. ecc-adrenal (CAP) 2. Adverse Events (Patient Safety) (AHRQ) 3. MedWatch 3500 (Adverse Event Report) (FDA) 4. Demographics (Clinical Trials) (NCI) 5. Demographics for pre-population (use of PRPH-CA CDA R2 example)

10 Phase 2 Solution: SDC HL7 FHIR Profile Kicked-off in March 2014; intent was to build on emerging content standard FHIR and REST interactions Scope is to define HL7 FHIR CommonDataElement Resource that utilizes ISO/IEC syntax with core attributes to facilitate the definition of common data elements Also includes development of a mechanism for clinical systems to expose CDEs for research use leveraging existing FHIR Questionnaire Resource HL7 SDC FHIR Profile Implementation Guide published as draft for comment in Aug 2014: Develop/sdc.html Received 165 votes (75 Affirmative, 35 Negative, 55 Abstain) Currently in ballot reconciliation phase HL7 FHIR IG will be balloted as DSTU in April 2015; expected publication date is August 2015

11 SDC FHIR Implementation Guide: Representation of SDC DE Model Provide constraints and extensions for each Resource SDC DataElementProfile SDC Questionnaire Profile SDC Questionnaire Answers Profile SDC ValueSet Profile DataElement Questionnaire QuestionnaireAnswers ValueSet REST SDC FHIR Data Element Profile serves as the Logical Model SDC Security Consideration

12 SDC Data Element Definition Framework Logical groupings of data elements Data Set (grouping) Vitals Allergies Problems Medications Lab Results MU2 Data Set Unit of data for which the definition, identification, representation, and permissible values are specified by means of sets of attributes. Data Element (semantics) Systolic BP Diastolic BP Height Set of characteristics that describe DE and help define, use and maintain DE using ISO syntax Data Element Attribute (syntax) DE Concept Common DE Value Domain Common Data Elements (CDEs) are those DEs that are developed, maintained and used based on commonly agreed upon principles by the user community. CDEs are reusable across a variety of clinical and non-clinical domains.

13 SDC PSE/AE Pilot Program SDC Pilot Program: Test & Validation of SDC Standards

14 SDC Content Workstreams Established to validate, test and pilot the SDC Solution Standards Three Workstreams: Public Health Tiger Team Established in Summer 2013 Piloted SDC IHE Profile for Cancer Reporting Patient Safety Event Reporting & Adverse event Reporting Sub- Workgroup Established in Feb Piloted SDC IHE Profile for adverse event reporting from EHRs to AHRQ and FDA PCOR Sub-Workgroup Proposed start Summer 2015; focus on clinical research

15 Aim for Pilot Program Bring awareness on available national standards that will facilitate how non-clinical data like patient safety and public health data is collected and reported by EHR systems Identify additional content and workflow requirements for reporting Provide tools and guidance for managing and evaluating SDC Pilot Projects Create a forum to share lessons learned and best practices Real world evaluation of SDC IHE Profile & FHIR Profile Is this implementable? Useable? Harmonize content data elements and forms

16 Why Pilot SDC Standards? Demonstrate compliance with Federal Reporting Requirements Increase efficiency of development and maintenance of SDC standards Advance National Learning Health System (LHS) where patient information can flow securely from EHRs to other systems Validate criteria for inclusion in ONC EHR Certification Program and ONC Standards Advisory Reduce data collection burden on health care providers Improve comparability of data to better inform research, quality reporting and ultimately, influence patient care Contribute to the Medical Device community Be recognized as an early adopter

17 SDC Leads Contact Information Initiative Coordinator: Evelyn Gallego Federal Lead: Farrah Darbouze Project Manager: Jenny Brush CDE SME: Mark Roche Harmonization/Technical Lead: Vijay Shah Standards Development Support: Perri Smith SDC Wiki Page: Weekly All-Hands Meeting Info (Thursdays): Time: 3:25pm 4:30Ppm Eastern URL: Dial-In Number: Access Code:

18 Thank you!