1. Data Access Framework (DAF) Relationship to Other ONC Initiatives 1

2. 2 Data Access Framework (DAF)  Methods for standards based access to clinical documents and discrete data for individual patients, multiple patients or aggregations of patients for patient care and for research from local, targeted and multiple sources  In Phase 1 and 2 for patient care, DAF adopted IHE standards for document query and emerging HL7 FHIR for data element query  DAF Phase 3 for Research focuses on meeting needs of clinical outcomes research communities (PCORI) although its modular design should be extensible to other secondary uses  DAF Phase 3 for Research intends to adopt HL7 FHIR to standardize query, data extraction using APIs, mapping/formatting and results reporting  Initially DAF will only query for common clinical data set as defined by ONC collected during routine clinical workflow and as represented in FHIR resources and profiles  Security & Privacy: DAF Phase 1 & 2 reference defined standards and profiles in the DSTUs. DAF Phase 3 has not referenced standards yet, but is working with HEART  Status of Standards and Implementation Guides:  Data Access Framework (DAF) Data Elements-based Query FHIR Profile Data Access Framework (DAF) Data Elements-based Query FHIR Profile  Published under HL7 on September 23, 2015  DAF FHIR Implementation Guide DAF FHIR Implementation Guide  Published under HL7 on September 23, 2015  The Data Access Framework (DAF) Document Metadata Based Access Implementation Guide The Data Access Framework (DAF) Document Metadata Based Access Implementation Guide  Published under IHE on September 24, 2015

3. 3 Query Health (QH)  QH is the predecessor of DAF, SDC, and CQF initiatives, providing valuable lessons-learned for those subsequent efforts  Methods for distributing queries and retrieval of results for patient or population level data of interest from multiple sources  QH attempted to address requirements of multiple secondary users including quality measures, population health, public health, et.al.  QH could not standardize methods to extract or map query data from diverse data sources but rather focused on the query envelope and results container  QH did not restrict or standardize types of data or information models to be queried

4. 4 Structured Data Capture (SDC)  Methods for distributing patient level data collection forms with semi-automated populated and manually entered data and returning completed forms to central repository from multiple sources  SDC specifies methods for forms creation, distribution, filling and reporting and has adopted HL7 FHIR resources and profiles  SDC does not restrict data elements beyond FHIR resources but secondarily defines a data element dictionary method for standardizing metadata  Security & Privacy: SDC may be limited in the short term by HL7's SMART on FHIR OAuth scopes as well as unresolved HL7 purpose-of-use definition issues  Status of Standards and Implementation Guides:  Structured Data Capture (SDC) FHIR Profile Structured Data Capture (SDC) FHIR Profile  Published under HL7 on September 23, 2015  Structured Data Capture (SDC) FHIR Implementation Guide Structured Data Capture (SDC) FHIR Implementation Guide  Published under HL7 on September 23, 2015  Structured Data Capture (SDC) Data Element Exchange Implementation Guide Structured Data Capture (SDC) Data Element Exchange Implementation Guide  Published under HL7 on September 23, 2015  Structured Data Capture (SDC) (Technical Framework Supplement) Structured Data Capture (SDC) (Technical Framework Supplement)  Published under IHE on September 5, 2014

5. 5 Clinical Quality Framework (CQF)  Methods for developing patient level queries for electronic quality measures, including the Quality Data Model and Clinical Quality Language (CQL) for complex queries, to be used in reporting (eClinical Quality Measures) eCQMs from multiple sources and as a basis for Clinical Decision alerts concerning compliance  CQF provides tools, methods and a standard QM model for quality measure developers to author quality measure definitions and calculations including complex QM queries and their standard reports  CQF uses FHIR resources and profiles although it also supports legacy standards including QRDA  CQF provides methods for distributing and incorporating clinical decision support based on eCQM compliance  Security & Privacy: CQF is in the same arena as DAF Phase 3, but has not directly referenced HEART's work yet  Status of Standards and Implementation Guides (HL7):  Quality Information and Clinical Knowledge (QUICK) model Quality Information and Clinical Knowledge (QUICK) model  Clinical Quality Expression Language Clinical Quality Expression Language  Clinical Quality Common Metadata Clinical Quality Common Metadata  Decision Support Service Implementation Guide, DSTU Updates Decision Support Service Implementation Guide, DSTU Updates

6. 6 DAF Points of Comparison Design  DAF was designed for use of multiple stacks to support evolving technologies and standards  DAF uses existing and does not define data elements or information models  DAF could be used to extract and populate SDC forms  DAF could be used to query for completed SDC forms as document  DAF might be extended to query for eCQM data and use CQL for more complex queries

7. 7 DAF Points of Comparison Patient Care and Secondary Use  Only DAF explicitly supports queries for documents or data elements for individual patient care  DAF uses IHE XD* stack for querying for clinical documents (potential to also use FHIR based MHD) although CQF support for CDS is directed at individual patients  DAF Phase 3 for Research and the other three initiatives are focused on secondary use of data  SDC and QH are designed to support broader communities including public health, clinical research, population health as well as quality measures  DAF Phase 3 for Research is specifically focused on PCORI communities, as CQF is focused on eCQM developers * IHE XD set of profiles (i.e. XDS, XDR, XDM, etc.)

8. 8 DAF Points of Comparison Industry Uptake  DAF profiles have been referenced by Argonaut, which is a project that will accelerate current FHIR development efforts to provide practical and focused FHIR profiles and implementation guides to the industry  DAF Document Metadata IG profiles will be tested at the 2016 IHE NA Connectathon  SDC has tested its IHE Profile at the 2015 IHE NA Connectathon

9. 9 DAF Points of Comparison Standards  DAF, SDC, and CQF use emerging standard FHIR resources and profiles, while QH began before availability of FHIR  Lacking core standards, QH faced multiple challenges in meeting diverse user needs for queries, diverse data formats for extraction and mappings to diverse models  While DAF, SDC and CQF use FHIR core resources and transports, each has defined their own profiles and extensions

10. 10 DAF Points of Comparison Data Definition and Models  Except for DAF, the other three initiatives can define new data elements to be queried  DAF currently restricts data element queries to the common clinical data elements as collected in routine clinical workflow (which are also available to the other three initiatives)  SDC and CQF imply a pre-coordinated definition of the data of interest while DAF and QH are directed to queries for data already captured

11. 11 DAF Points of Comparison Policy Issues  None of the initiatives explicitly address policy issues concerning access, use and disclosure of patient data  Local and Targeted DAF for individual patient’s data generally are within the scope of HIPAA treatment, payment and operations rules  As policy issues are resolved to technical requirements, all the initiatives should be capable to implement these albeit with different methods but with likely preference to FHIR based initiatives such as HEART

12. 12 DAF Points of Comparison Summary DAFQHSDCCQF Purpose Standards based access to clinical documents and discrete data for individual patients, multiple patients or aggregations of patients for patient care and for research Distributing queries and retrieval of results for patient or population level data of interest from multiple sources Distributing patient level data collection forms with semi-automated populated and manually entered data and returning completed forms to central repository from multiple sources Developing patient level queries for electronic quality measures, including the Quality Data Model and Clinical Quality Language (CQL) for complex queries, to be used in reporting eCQMs from multiple sources and as a basis for Clinical Decision alerts concerning compliance Design Designed for use of multiple stacks to support evolving technologies and standards Could not standardize methods to extract or map query data from diverse data sources but rather focused on the query envelope and results container Methods for forms creation, distribution, filling and reporting Tools, methods and a standard QM model for quality measure developers to author quality measure definitions and calculations including complex QM queries and their standard reports Patient Care Explicitly supports queries for documents or data elements for individual patient care Potential CDS for individual patients to support compliance Secondary Use DAF Phase 3 for Research is specifically focused on PCORI communities, Designed to support broader communities including public health, clinical research, population health as well as quality measures CQF is focused on eCQM developers

13. 13 DAF Points of Comparison Summary CONTINUED DAFQHSDCCQF Secondary Use DAF Phase 3 for Research is specifically focused on PCORI communities, Designed to support broader communities including public health, clinical research, population health as well as quality measures CQF is focused on eCQM developers Standards FHIR for Data Elements and Research (XD* for Documents) Various, including HQMF and QRDA FHIR Data Definition and Models Query for existing data – does not define new data or models Query for existing dataCan define new data elements Uses QDM and can define new data elements for eCQM Policy Issues Patient care queries covered by HIPAA TPO Does not address policy issues for Research Policy issues minimally addressed with sand box Does not expressly address policy issues for secondary use Does not expressly address policy issues for eCQM Cross-Overs DAF could be used to extract and populate SDC forms DAF could be used to query for completed SDC forms as document DAF might be extended to query for eCQM data and use CQL for more complex queries Current approaches might be transition to DAF Research Data Dictionary might be shared with other initiatives

14. 14 DAF Points of Comparison Summary CONTINUED DAFQHSDCCQF Status of Standards and Implementation Guides HL7 Data Access Framework (DAF) Data Elements-based Query FHIR Profile DAF FHIR Implementation Guide IHE The Data Access Framework (DAF) Document Metadata Based Access Implementation Guide N/AHL7 Structured Data Capture (SDC) FHIR Profile Structured Data Capture (SDC) FHIR Implementation Guide Structured Data Capture (SDC) Data Element Exchange Implementation Guide IHE Structured Data Capture (SDC) (Technical Framework SupplementStructured Data Capture (SDC) (Technical Framework Supplement) HL7 Quality Information and Clinical Knowledge (QUICK) model Clinical Quality Expression Language Clinical Quality Common Metadata Decision Support Service Implementation Guide, DSTU Updates Security and Privacy DAF Phase 1 & 2 reference defined standards and profiles in the DSTUs. DAF Phase 3 has not referenced standards yes, but is working with HEART N/ASDC may be limited in the short term by HL7's SMART on FHIR OAuth scopes as well as unresolved HL7 purpose-of-use definition issues CQF is in the same shape as DAF Phase 3, but has not directly referenced HEART's work yet