SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 1 Notification Messaging to Support FDA Building an HL7 Version 3 Based Approach for Disease Notification & Applying it to Drug Reaction Reporting

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 2 A Basic Premise for the Discussion There is a core concept that is something like “Notification”. That concept is sufficiently applicable to a wide range of public health activities, ranging from disease notification to drug reaction reporting, for the work done to support NEDSS to be relevant to FDA’s reporting needs.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 3 Presentation Objectives  A little NEDSS  CDC Messaging Development Notification message contents as an example of the process  Using Notification Messaging to address FDA requirements Introduce the E2BM mapping Review mapping contents  HL7 standardization of Notification Messaging Proposed next steps  A little NEDSS  CDC Messaging Development Notification message contents as an example of the process  Using Notification Messaging to address FDA requirements Introduce the E2BM mapping Review mapping contents  HL7 standardization of Notification Messaging Proposed next steps

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 4 A Vision for National Electronic Disease Surveillance System (NEDSS)  Gathers health data automatically from a variety of sources on a real-time basis  Monitors the health of communities  Assists in ongoing analyses of trends and detection of emerging public health problems  Provides information for setting public health policies  Is a system of interoperable systems like the Internet is a network of interoperable networks  Gathers health data automatically from a variety of sources on a real-time basis  Monitors the health of communities  Assists in ongoing analyses of trends and detection of emerging public health problems  Provides information for setting public health policies  Is a system of interoperable systems like the Internet is a network of interoperable networks

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 5 NEDSS & National Standards  Using Use wherever possible Use and publish “design specifications” in order to do the work Have a very high bar to change vs. derive Be prepared to follow the refinement of standards  Influencing See that public health issues are represented in national standards Document specification development activities Use opportunities to promote the sometimes more difficult approach of using standards  Using Use wherever possible Use and publish “design specifications” in order to do the work Have a very high bar to change vs. derive Be prepared to follow the refinement of standards  Influencing See that public health issues are represented in national standards Document specification development activities Use opportunities to promote the sometimes more difficult approach of using standards

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 6 Design Philosophy for CDC Messaging Projects  Develop HL7 Version 3 messages. Use the RIM and the Message Development Framework. Use HL7 vocabulary domains Create a consistent set of work products across the projects. Standardize by forwarding messages within HL7  Influence HL7 Suggest RIM changes and vocabulary items Plan to submit message formats for standardization  Work within the technical architecture developed by NEDSS  Develop HL7 Version 3 messages. Use the RIM and the Message Development Framework. Use HL7 vocabulary domains Create a consistent set of work products across the projects. Standardize by forwarding messages within HL7  Influence HL7 Suggest RIM changes and vocabulary items Plan to submit message formats for standardization  Work within the technical architecture developed by NEDSS

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 7 Using the MDF - CDC Style  Document messaging requirements  Map relevant data to the RIM. Use data mapping as a source for the R-MIM. (These two can be documented together with simple source data.)  HL7 tooling supports definition of HMDs, message types, and XML schemas.  Create mappings between message elements and source and target databases  Address vocabulary issues by looking at HL7 domains first, but not last.  Document messaging requirements  Map relevant data to the RIM. Use data mapping as a source for the R-MIM. (These two can be documented together with simple source data.)  HL7 tooling supports definition of HMDs, message types, and XML schemas.  Create mappings between message elements and source and target databases  Address vocabulary issues by looking at HL7 domains first, but not last.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 8 Current CDC Projects  Notification Messaging Communicate notifiable disease reports from states to CDC. Core component of the NEDSS Base System.  Vital Statistics Provide a specification for Birth and Death information. Also support “verification/certification”.  Antimicrobial Use Reporting Periodic (monthly) reporting of antibiotics use and organism susceptibility from providers to CDC.  Notification Messaging Communicate notifiable disease reports from states to CDC. Core component of the NEDSS Base System.  Vital Statistics Provide a specification for Birth and Death information. Also support “verification/certification”.  Antimicrobial Use Reporting Periodic (monthly) reporting of antibiotics use and organism susceptibility from providers to CDC.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 9 The Elements of Messaging Analysis  Use Case Model Statement of Requirements We did not do formal use case analysis. This would be important for a “new” area. To a certain extent, documentation for the NEDSS Base System addresses this requirement.  Use Case Model Statement of Requirements We did not do formal use case analysis. This would be important for a “new” area. To a certain extent, documentation for the NEDSS Base System addresses this requirement.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 10 Messaging Analysis Continued  Interaction Model Messaging Scenarios – This documents needs for communication, as well as the discussion around those needs. Interaction Diagram A record of the interactions to be supported Interaction Grid Documents Trigger events, and message dependencies.  Interaction Model Messaging Scenarios – This documents needs for communication, as well as the discussion around those needs. Interaction Diagram A record of the interactions to be supported Interaction Grid Documents Trigger events, and message dependencies.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 11 Notification Messaging Scenarios I.Condition Notification State or other reporting base system sends a notification to CDC. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed. II.Change/Retraction of Prior Notification State or other reporting base system sends a notification update/change/retraction. This message will always provide a reference to the earlier notification that is being updated, changed, or retracted. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed. I.Condition Notification State or other reporting base system sends a notification to CDC. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed. II.Change/Retraction of Prior Notification State or other reporting base system sends a notification update/change/retraction. This message will always provide a reference to the earlier notification that is being updated, changed, or retracted. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 12 Notification Messaging Scenarios III.Summary Notification State or other reporting base system provides total amounts for the reporting, during a specified time period, of a specific disease or condition to CDC. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed. IV.Notification Response CDC will provide a response to the state or other reporting base system once the CDC base system has processed the message. This message will indicate that the message was successfully processed by the interface engine. The state or other reporting base system will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed III.Summary Notification State or other reporting base system provides total amounts for the reporting, during a specified time period, of a specific disease or condition to CDC. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed. IV.Notification Response CDC will provide a response to the state or other reporting base system once the CDC base system has processed the message. This message will indicate that the message was successfully processed by the interface engine. The state or other reporting base system will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 13 Interaction Specification

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 14 Diagram Based Mapping  Used to discover detailed data requirements.  Can be constructed in a group session.  Becomes an education on the HL7 RIM.  Leads naturally into RMIM construction.  This is the stage we have reached with the FDA specifications.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 15 R-MIM for Notification  Message header to carry transactional information  Identification of the notification sender and receiver  Case specific information  Other notifications related to the case  Patient encounters associated with the case  Case participants including the patient or subject of the case and locations associated with the case.  Associations between participants in the case  Case related specimens and specimen collection procedures.  Observation information, such as laboratory tests, about participants or specimens related to the case.  Message header to carry transactional information  Identification of the notification sender and receiver  Case specific information  Other notifications related to the case  Patient encounters associated with the case  Case participants including the patient or subject of the case and locations associated with the case.  Associations between participants in the case  Case related specimens and specimen collection procedures.  Observation information, such as laboratory tests, about participants or specimens related to the case.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 16 R-MIM Part 1  Diagram should contain the V3 Outer wrapper and Controlled Act wrapper.  Content determined by HL7 consistently for all messages.  Diagram should contain the V3 Outer wrapper and Controlled Act wrapper.  Content determined by HL7 consistently for all messages.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 17 A Few Comments  This section of the message will change for consistency with new HL7 developments  HL7 will offer a single structure “Outer Wrapper”: Captures the message header & message sender and receiver. This is basic transactional information. “Message Control Act”: A single way to model data for the “trigger event”, the event that causes data to flow.  This section of the message will change for consistency with new HL7 developments  HL7 will offer a single structure “Outer Wrapper”: Captures the message header & message sender and receiver. This is basic transactional information. “Message Control Act”: A single way to model data for the “trigger event”, the event that causes data to flow.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 18 Notification Payload V1

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 19 Comments on the “Payload”  The original design was based on the current NETSS system.  It only reluctantly added data concepts that were not supported there.  Glaring deficiencies are already clear. Insufficient data for persons Only observations are linked to the case Does not address materials, e.g., vaccines. Insufficient information on specimens.  The original design was based on the current NETSS system.  It only reluctantly added data concepts that were not supported there.  Glaring deficiencies are already clear. Insufficient data for persons Only observations are linked to the case Does not address materials, e.g., vaccines. Insufficient information on specimens.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 20 Downstream Artifacts  Hierarchical Message Description  XML Schemas  Notification Messaging Documentation  Implementation Guides (Disease Specific)  Database/Message Mapping  Messaging Subsystem  Hierarchical Message Description  XML Schemas  Notification Messaging Documentation  Implementation Guides (Disease Specific)  Database/Message Mapping  Messaging Subsystem

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 21 Working on FDA Messaging  Initial Premise – We can use the Notification Messages. Note, this will require enhancement to what is there today.  First Step – Review the E2BM specifications, and recast in HL7 terms. This was done by mapping the data to the RIM.  Second Step – Determine additional requirements for the Notification Message specification. I have an initial cut at these.  Initial Premise – We can use the Notification Messages. Note, this will require enhancement to what is there today.  First Step – Review the E2BM specifications, and recast in HL7 terms. This was done by mapping the data to the RIM.  Second Step – Determine additional requirements for the Notification Message specification. I have an initial cut at these.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 22 Produced so Far  High level outline of the E2BM transaction.  Diagrammatic mapping of the specification.  Excel spreadsheet containing the mapping details.  List of proposed updates to the Notification R-MIM  High level outline of the E2BM transaction.  Diagrammatic mapping of the specification.  Excel spreadsheet containing the mapping details.  List of proposed updates to the Notification R-MIM

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 23 Drug Incident Notification

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 24 E2BM Mapping

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 25 Two Forms of Mapping

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 26 Report Patient & Other Parties

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 27 Case Safety Report Details

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 28 Drug Reaction

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 29 Associated Administration

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 30 Proposed Notification Enhancements  Entity identification Name and multiple identifiers for persons, organizations, and locations. Addresses and phone numbers also. [Supports: drug reaction responses, vaccinations. BT Response contacts.]  Material Information about products – materials – that are used in patient treatment, and in clinical trials. [Supports drug reporting, clinical trials.]  Entity association Relevant time span associations between parties. [Supports BT Response contacts].  Specimen Specimen source, accession number, specimen details. [Supports BT Response and disease surveillance.]  Entity identification Name and multiple identifiers for persons, organizations, and locations. Addresses and phone numbers also. [Supports: drug reaction responses, vaccinations. BT Response contacts.]  Material Information about products – materials – that are used in patient treatment, and in clinical trials. [Supports drug reporting, clinical trials.]  Entity association Relevant time span associations between parties. [Supports BT Response contacts].  Specimen Specimen source, accession number, specimen details. [Supports BT Response and disease surveillance.]

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 31 More Notification Enhancements  Location context for environmental specimens. Detailed information describing the place where specimens were collected. Includes detailed location information, and managing the association between locations. [Supports BT Response investigations]  Observation information Descriptive text related to an observation. [Supports Drug incident reporting]  Intervention information Interventions, e.g., vaccinations, related to a case. [Supports BT Response, enhanced surveillance, drug incident reporting]  Materials information Add materials, in particular drugs and vaccines, to the list of entity types that can be related to a case, and to the acts associated with a case. [Supports vaccine preventable disease surveillance, drug reaction reporting.]  Location context for environmental specimens. Detailed information describing the place where specimens were collected. Includes detailed location information, and managing the association between locations. [Supports BT Response investigations]  Observation information Descriptive text related to an observation. [Supports Drug incident reporting]  Intervention information Interventions, e.g., vaccinations, related to a case. [Supports BT Response, enhanced surveillance, drug incident reporting]  Materials information Add materials, in particular drugs and vaccines, to the list of entity types that can be related to a case, and to the acts associated with a case. [Supports vaccine preventable disease surveillance, drug reaction reporting.]

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 32 Notification V2 - Today

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 33 Later: HL7 Specification Process  Start discussions in HL7.  Pick the time to move forward with a proposal.  Work out whether a new message format is needed – I think it will be.  Address Committee Issues.  Frame a concrete proposal.  Start discussions in HL7.  Pick the time to move forward with a proposal.  Work out whether a new message format is needed – I think it will be.  Address Committee Issues.  Frame a concrete proposal.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 34 Next Steps for Us  Verify the detailed mapping This has been done  Move forward with a standard message Create an enhanced Notification Message Prepare a proposal for HL7 discussion Carry out education within HL7  Start process within FDA to lay out the steps leading towards message implementation.  Verify the detailed mapping This has been done  Move forward with a standard message Create an enhanced Notification Message Prepare a proposal for HL7 discussion Carry out education within HL7  Start process within FDA to lay out the steps leading towards message implementation.

SAFER – HEALTHIER – PEOPLE CDC NEDSS Drug Reaction Notification 2 October Page: 35 Any More Questions? Mead Walker healthcare informatics consultant Voice: Fax: