Table of Contents
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Effective public health and research action depends on access to timely, relevant, and complete data. Unfortunately, the availability and quality of data to public health, particularly data captured in EHRs, remains limited: current data systems and exchange standards are siloed, and existing interoperability standards are administratively cumbersome, underutilized, or otherwise limited in application and scope. Many state and local programs do not have the data necessary to assess hepatitis C disease burden and its distribution in their communities, let alone monitor trends in key epidemiological parameters and health outcomes, like those captured in the Hepatitis C Virus (HCV) care cascade (as shown in Figure 1 below). In the absence of such situational awareness, public health programs lack the information necessary to efficiently and effectively direct public health action and population health research activities. The public health consequences of this current state are illustrated by, but certainly not unique to, hepatitis C surveillance.
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The lab performs the recommended testing. In this case, the anti-HCV test is reactive, so an FDA-approved NAT assay for HCV Ribonucleic Acid (RNA) is performed on the same specimen (reflex testing). This, too, is reactive, indicating that Mom is currently infected with HCV. The lab sends results electronically to Dr. A. Receipt of any HCV antibody and/or HCV RNA test result in the EHR automatically triggers an electronic initial case report (eICR) to public health, as well as any clinical registry with which Dr. A’s practice is affiliated.
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NOTE: the hospital “delivery” and pediatrician “exposure” reports triggered under this flow allow for public health follow up to ensure the exposed infant receives appropriate care. In an ideal world, the “infant” flow outlined further below would itself ensure such follow up care. But the reality is often far messier, especially when it comes to communication of data across different institutions and providers for different individuals (mom, baby). Adding these reporting steps better positions public health to help ensure those connections are made—and that providers like the pediatrician know what steps to take when caring for an exposed infant.
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At her first appointment with Dr. Z, he orders a transient elastrography test (to evaluate the degree of hepatic fibrosis present); HCV genotype; and a series of lab tests, including complete HAV serology, HBV serology, complete blood count (CBC), HIV tests, and a complete metabolic profile including a hepatic function panel (i.e., albumin, total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), calculated glomerular filtration rate (eGFR)). The results of these will be used by Dr. Z to inform his recommended HCV treatment strategy. Dr. Z’s office receives the results from these follow-up tests.
Since HCV appears on Mom’s problem list, an eICR will be sent to public health and/or the clinical registry after the encounter ends.
Mom has a second appointment with Dr. Z to discuss options. The results, which are shared with Mom, indicate that there is no liver cirrhosis present and Patient X is infected with genotype 1b. Mom indicates that she is breast feeding breastfeeding and would like to continue to do so until Baby is at least 6 months old. Dr. Z and Mom thus decide to defer treatment for several months, until Baby has transitioned to bottle feeding.
Approximately 5 months later, Mom has a follow-up visit with Dr. Z. Mom is no longer breast feedingbreastfeeding, and she and Dr. Z agree to initiate treatment for her hepatitis C. From here, the flow for Mom is identical to User Story #1 (treatment and cure).
Testing, Diagnosis, and Treatment Flow for Infant
Based on the records he received from the hospital, Dr. P knows that Baby was exposed to HCV. During Baby’s follow-up well-child check, Dr. P orders an FDA-approved Nucleic Acid Test (NAT) intended for the detection of hepatitis C virus ( HCV ) RNA. An onsite lab tech draws a blood specimen from Baby and sends the specimen to an offsite lab.
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Dr. P makes a referral for Baby to see Dr. G, a pediatric gastroenterologist. During Baby's first visit with Dr. G., Dr. G explains to Mom that it is too early to initiate treatment for Baby—and that there is a possibility that Baby’s viremia will prove transient.
Because HCV direct-acting antivirals (DAAs) are not approved for use in children as young as Baby, Dr. G does not initiate treatment at this time. Instead, he will continue to monitor Baby’s health until she reaches age 3.
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A FHIR Enabled EHR exposes FHIR APIs for other systems to interact with the EHR and exchange data. FHIR APIs provide well-defined mechanisms to read and write data. The FHIR APIs are protected by an Authorization Server which authenticates and authorizes users or systems prior to accessing the data. The EHR in this use case is a FHIR Enabled EHR.
Backend Services App: A system that resides within the clinical care setting and performs the reporting functions to public health and/or research registries. The system uses the information supplied by the PHA to determine when reporting needs to be done, what data needs to be reported, how the data needs to be reported, and to whom the data should be reported. The term “Backend Service” is used to refer to the fact that the system does not require user intervention to perform reporting. The term “App” is used to indicate that it is similar to a SMART on FHIR App which can be distributed to clinical care via EHR specified processes. The EHR specified processes are followed to enable the Backend Services App to use the EHR's FHIR APIs to access data. The healthcare organization is the one who is responsible for choosing and maintaining the Backend Services App within the organization.
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Preconditions describe the state of the system, from a technical perspective, that must be true before an operation, process, activity, or task can be executed. Preconditions are what needs need to be in place before executing the use case flow.
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Use Case Trigger: a hepatitis C RNA positive test result has been recorded in the EHR
EHR and public health systems expose HL7 FHIR APIs
Pertinent data elements are captured discretely in the EHR
Public Health uses allowed by HIPAA and other statutory authority authorities have been defined and implemented
Provisioning workflows have been established. The provisioning workflow includes activities that publish the various metadata artifacts required to make EHR data available to public health and/or research. These activities include publishing value sets, trigger codes, reporting timing parameters, survey instruments, structures for reporting, etc. These artifacts are used subsequently in data collection and reporting workflows.
Data use agreements are in place when needed
All patient encounters required to initiate and move through the care cascade take place (i.e., the patient attends) with authorized providers, and requisite steps (e.g., tests ordered, tests performed, test results received, drug prescribed) are performed and captured in the EHR using approved standards
Registry and state/local consent protocols are followed when sending supplemental reports for non-reportable conditions
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Data Element Name | Definition | Sample Values | USCDI | USCDI Element | US Core Profile / FHIR Resource | US Core Profile / FHIR Element | eICR Profile.element |
HCV Test |
| Anti-HCV, HCV RNA, HCV genotype | Laboratory | Tests | US Core Laboratory Result Observation Profile | code | US Core Laboratory Result Observation Profile.code |
Hepatitis C Diagnosis |
| Acute, Chronic | Problems | n/a | USCoreCondition | code | eICR Condition.code |
HCV Treatment |
| Prescribed direct-acting antiviral (DAA) | Assessment and Plan of Treatment? | n/a | US Core MedicationRequest | medication[x] | eICR Composition.section:slicePlanOfTreatmentSection.entry:sliceUSCoreMedicationRequest.medication[x] |
HCV Cure (SVR) | Negative HCV RNA level 6 months after starting treatment |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value |
Pregnancy Status* | If pregnant, infants of HBV or HCV infected women should be tested for infection (see disease-specific guidelines) | HCG result positive | n/a |
| Pregnancy Status Observation | value[x] | Pregnancy Status Observation.value[x] |
Last Menstrual Period |
|
| n/a |
| Last Menstrual Period | valueDateTime | Last Menstrual Period.valueDateTime |
Pregnancy Outcome |
|
| n/a |
| Pregnancy Outcome Observation | valueCodeableConcept | Pregnancy Outcome Observation.valueCodeableConcept |
Gestational Age at Outcome |
|
| n/a |
| Pregnancy Status Observation | component:sliceEstimatedGestationalAgeOfPregnancy.valueQuantity | Pregnancy Status Observation.component:sliceEstimatedGestationalAgeOfPregnancy.valueQuantity |
Infant Born with Neonatal Abstinence Syndrome (NAS) |
|
| Problems | n/a | US Core Condition Profile | code | eICR Condition.code |
Injected Drug Use (ever) |
|
| Clinical Notes? | History & Physical | US Core DocumentReference Profile | text | |
Current Drug Use |
|
| Clinical Notes? | History & Physical | US Core DocumentReference Profile | text | |
SUD/OUD Diagnosis |
|
| Problems | n/a | USCoreCondition | code | eICR Condition.code |
MAT Prescribed |
|
| Assessment and Plan of Treatment? | n/a | US Core MedicationRequest | medication[x] | eICR Composition.section:slicePlanOfTreatmentSection.entry:sliceUSCoreMedicationRequest.medication[x] |
MAT Administered | RxNorm or NDC codes |
| Medication |
| Medication Administration | medication[x] | Medication Administration.medication[x] |
Patient Name |
|
| Patient Demographics | First Name Last Name | US Core Patient Profile | name.given name.family | eCR Patient.name |
Patient Address |
|
| Patient Demographics | Current Address | US Core Patient Profile | address | eCR Patient.address |
Patient Age | Core variables (NEDSS standards) |
| n/a |
| Calculated from eCR Patient.birthDate | ||
Patient Sex | Core variables (NEDSS standards) |
| Patient Demographics | Birth Sex | US Core Patient Profile | us-core-birthsex | eCR Patient.us-core-birthsex |
Patient Race | Core variables (NEDSS standards) |
| Patient Demographics | Race | US Core Patient Profile | us-core-race | eCR Patient.us-core-race |
Patient Ethnicity | Core variables (NEDSS standards) |
| Patient Demographics | Ethnicity | US Core Patient Profile | us-core-ethnicity | eCR Patient.us-core-ethnicity |
Origin of report* | Site requesting viral hepatitis testing |
| n/a |
| |||
State of report* | Core variables (NEDSS standards) |
| n/a |
| eICR Encounter.location.location.address.state | ||
County of report* | Core variables (NEDSS standards) |
| n/a |
| eICR Encounter.location.location.address.district | ||
Zip code of report* | Core variables (NEDSS standards) |
| n/a |
| eICR Encounter.location.location.address.postalCode | ||
Date of birth* | Core variables (NEDSS standards) |
| Patient Demographics | Date of Birth | US Core Patient Profile | birthDate | eCR Patient.birthDate |
Date of illness onset* | First sign or symptom of hepatitis |
| Problems | n/a | USCoreCondition | onsetDateTime | eICR Condition.onset[x] |
Presence of symptoms of acute hepatitis* | Verifies case definition |
| Problems | n/a | USCoreCondition | code | eICR Condition.code |
Presence of jaundice* | Verifies case definition |
| Problems | n/a | USCoreCondition | code | eICR Condition.code |
ALT level* | Verifies case definition |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] |
Hospitalization for hepatitis* | If yes, verify dates of hospitalization |
| n/a |
| USCoreEncounter | hospitalization | eICR Encounter.hospitalization |
Hospitalization for hepatitis dates* |
|
| n/a |
| USCoreEncounter | period | eICR Encounter.period |
Death from hepatitis* | If yes, review death certificate and medical records to rule out other potential causes of death and to confirm acute liver failure as the cause of death |
| n/a |
| Condition | outcome (extension) | |
IgM anti-HAV* | Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] |
HBsAg* | HBsAg positive test results require confirmation by an additional more specific assay
Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] |
IgM anti-HBc* | Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] |
anti-HCV* | anti-HCV positive test results require confirmation by an additional more specific assay or for anti-HCV, a S/CO ratio ≥3.8. Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] |
anti-HDV* | Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] |
Date of diagnosis* | Date of test result confirming infection |
| Problems | n/a | USCoreCondition | onsetDateTime | eICR Condition.onset[x] |
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MedMorph will use existing frameworks (e.g., FHIR APIs) for the exchange of data.
When there is a third party, a data use or business use/associate agreement may be needed (e.g., Association of Public Health Laboratories (APHL)).
Public Health Agencies Authorities (PHAs) may have state-specific restrictions on collecting protected classes of data (e.g., AIDS status, mental health status, Substance Use Disorder/Opioid Use Disorder (SUD/OUD)).
If the patient gives consent for sharing of AIDs, mental health, etc. data the burden would be on the sending system.
For research use cases, there must be consent before the data is sent.
For jurisdictional restrictions on data that can not be collected, the MedMorph Reference Architecture will make provisions for defining actions (e.g., redaction, filtering, removal, validation) before submission. The actions could be triggered based on the content of specific data elements.
The MedMorph Reference Architecture will do an additional validation check on the data before the data leaves the healthcare organization. This is important in cases of a healthcare organization reporting to multiple jurisdictions.
What if more data is sent that what is requested?
Registries may have restrictions on collecting certain information. For example, cancer registries collect comorbidity information, but some of them are restricted from collecting information about AIDS or mental health conditions as a comorbidity
This should be handled by policy and processes around the data received.
The data generator should be clear on what data is being requested and the data provided should only be the data requested.
The Reference Architecture IG will ask for feedback during the ballot process on if the MedMorph Reference Architecture should define an acknowledgment mechanism for notifications when additional data is received.
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Onboarding of EHRs and or tracking systems
The use, IT/data governance, and or versioning of FHIR between trading entities
Consent models for data exchange:
For public health purposes, existing authorities are sufficient and no consent is required.
For research use cases:
Institutional Review Boards (IRB) approvals, intended purpose, and consent for the intended purpose is included
Other areas to investigate:
https://www.hl7.org/fhir/consent.html (Look at ResearchSubject and ResearchStudy resources in FHIR and their relationship to Consent Resource)
Patient Level -level data, Limited Data Set (LDS), Deidentified data sets, and relationships to consent.
The activity network query space has not been reconciled with FHIR RESTFUL queries. How do queries on eHealth exchange, CommonWell map into authorities?
Data that is stored outside the EHR (e.g., PDMP data) may not be available (e.g., Hepatitis C wants drug use data) may not be available
Any activities that are not associated with a clinical order or clinical visit (e.g., drive-up COVID test, STD test, adult immunization at the pharmacy )
Data lag vs. real-time (especially for research use cases) - the difference in time for use cases.
The Reference Architecture defines trigger events and timing offsets in relationship to trigger events, and actions to be performed based on trigger events.
Data provenance (recognized authority - but how much do we trust the data from those systems outside of the EHR and the EHR ingests the data - and the detail of information and method of transmission e.g., orally reported, substantiated with material or electronic)
The MedMorph Reference Architecture IG would recommend (or require in available) support for Provenance as defined by USCDI and apply to all data classes being reported.
Registries will capture what they are required to capture by state laws and standards setters, but research use cases might want to capture complications, etc. related to cancer.
Acknowledgment that state laws and standards can preempt/modify/exclude data that could occur in a content (use case) specific IG.
Appendices
Related Use Cases and Links
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