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    "name": "UV_Vital_Records_Birth_and_Fetal_Death_Reporting",
    "title": "UV_Vital Records Birth and Fetal Death Reporting",
    "description": "### Description\n\nBirth and fetal death reporting includes the transmission of data from health care providers to jurisdictional vital records offices and national health statistics agencies. Data associated with the mother of the baby or delivered fetus may be communicated independently from data associated directly with the labor and delivery encounter at the responsible healthcare facility. Note that for the purposes of this guide, &quot;mother&quot; always refers to the woman who delivered the infant or fetus. In cases of surrogacy or gestational carrier, the information reported should be for the surrogate or the gestational carrier, that is, the woman who delivered the infant. Also, the national statistics agency referred to in this guide is the [National Center for Health Statistics - CDC](https://www.cdc.gov/nchs/index.htm) (NCHS).\n\nThis implementation guide (IG) defines a series of Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) profiles on the Composition resource to represent electronic birth and fetal death reporting (BFDR). It includes the content of medical/health information on live births and fetal deaths for select state and federal birth and fetal death reporting, as indicated in the [2003 Revision of the U.S. Standard Certificate of Live Birth](https://www.cdc.gov/nchs/data/dvs/birth11-03final-ACC.pdf) and the [2003 Revision of the U.S. Standard Report of Fetal Death](https://www.cdc.gov/nchs/data/dvs/FDEATH11-03finalACC.pdf). Additionally, it includes the content that is exchanged between electronic health record (EHR) systems, jurisdictions, and the Centers for Disease Control and Prevention/ National Center for Health Statistics (CDC/NCHS).\n\n### Relationship to Other Standards\nThis BFDR IG standard complements other vital records standards to support the expansion of information flows to and from the national statistics agency. The BFDR STU 1 drew on foundational work of early standards listed in the Background section, below. This current version of the BFDR IG is informed by :\n* [HL7, Vital Records Death Reporting (VRDR) FHIR Implementation Guide](http://hl7.org/fhir/us/vrdr/)\n* [Office of the National Coordinator for Health Information Technology (ONC), United States Core Data for Interoperability (USCDI)](https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi)\n\n### Dependencies\nThis implementation guide re-uses and further constrains profiles from the following guides:\n* [US Core Implementation Guide, STU5.0.1](http://hl7.org/fhir/us/core/STU5.0.1/)\n* [Vital Records Common Profiles Library](http://hl7.org/fhir/us/vr-common-library)\n* [Occupational Data for Health (ODH)](http://hl7.org/fhir/us/odh/)\n\n### Audience\nThis guide is for analysts and developers who require guidance on the use of the HL7 FHIR for providing birth and fetal death reporting information. The IG is informative to health care provider organizations, jurisdictional vital records offices, CDC/NCHS, health information exchange organizations, and other vital records fetal death reporting stakeholders.\n\n### Background \nThis FHIR IG builds on previous electronic data standards for transmitting vital records of death, birth, and fetal death. \n* [HL7, Version 2.6 Implementation Guide: Vital Records Birth and Fetal Death Reporting](https://www.hl7.org/implement/standards/product_brief.cfm?product_id=320)\n* [HL7, CDA® R2 Implementation Guide: Birth and Fetal Death Reporting](http://www.hl7.org/implement/standards/product_brief.cfm?product_id=387)\n* [IHE , Quality, Research and Public Health Technical Framework Supplement - Birth and Fetal Death Reporting-Enhanced (BFDR-E)](https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf)\n\nThis IG provides standardized data strutures for transmission of reliable and relevant clinical information to jurisdictional vital records offices and transfer of information from vital records offices to the national statistics agency. \n\nElectronic vital records work started with the HL7 Vital Records Domain Analysis Model (VR DAM), published as an Informative Specification in 2011. The VR DAM was updated in 2017 with the HL7 Cross-Paradigm Domain Analysis Model: Vital Records, Release 2, in 2018, with Release 3, and in November 2020 as Release 4. [VR DAM, Release 5](http://www.hl7.org/implement/standards/product_brief.cfm?product_id=466) was published in May 2022. Implementers who review or reference the VR DAM should note that the active vital records FHIR IGs (such as BFDR and VRDR) may no longer aligned with the VR DAM. \n\nThis FHIR IG uses the US Core profiles. Where this FHIR IG is unable to use a US Core profile, we have followed the Cross Group Projects Work Group's variance request process, and have provided the US Realm Steering Committee an approved rationale for deviation in the IG.\n\n### How to Read This Guide\n\nThis Guide is divided into several pages which are listed at the top of each page in the menu bar.\n\n* Home: Introduction and background for HL7 FHIR® Vital Records Common Profiles Library\n* [The Specification](the_specification.html): A technical overview of implementing the specification\n* [Use Cases](use_cases.html): The use cases supported by this guide\n* Implementer Guidance: The [worksheet Questionnaire format](patient_worksheet_questionnaires.html), [IJE Mapping](ije_mapping.html), and [Vital Records Forms Mapping](vital_records_forms_mapping.html)\n* [Terminology](terminology.html): A listing of the value sets used in this guide\n* [Downloads](downloads.html): Links to downloadable artifacts\n* [Change Log](change_log.html): Details of changes made in each version of this IG\n* [Artifact Index](artifacts.html): A list of the FHIR artifacts (profiles, examples, and value sets) defined as part of this guide\n* Appendices: Examples of live birth and fetal death reports and worksheets\n\n### Other Information\n\nThis is an update (STU 1.1) of the first FHIR BFDR standard.\n\nThis guide is compliant with FHIR Release 4.\n\nFor Clinical Safety Information please refer to the [FHIR Implementer’s Safety Checklist](http://hl7.org/fhir/safety.html).\n\nDisclaimer: All proprietary documents, guides, guidance, standards, codes, and values contained herein remain the property of their respective Standards Developing Organization (SDO). HL7 does not make any claim to ownership herein.",
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It also provides general information that helps business analysts and technology decision-makers understand the use cases and benefits associated with achieving specific data exchange capabilities. A FHIR IG is as much a business planning tool as it is an educational resource and a technical specification.\n\n### How to Read this Guide and Cautions\nThis Guide is divided into several pages which are listed in the navigation bar at the top each page. The contents of each page are listed in a yellow \"Contents\" box at the top right of each page.\n\n### Value Set Library\n\nRather than creating nearly 1000 profiles covering important concepts for chronic care coordination for use within the MCC FHIR Care Plan profile, we have created 21 foundation profiles which conform to US Core Profiles (where available) adding constraints or extensions pertinent to their representation within a dynamic FHIR care plan and then creating libraries of value sets pertinent to the base profiles for representing chronic conditions, and their related interventions and goals and outcomes. \nThis project has built and houses its value sets in the National Library of Medicine's (NLM) Value Set Authority Center (VSAC). The value sets are not directly bound within the foundation profiles, but value set library pages are provided with links to the value sets in VSAC and descriptions of where within the profile each value set may be used. Because the value sets are housed in VSAC, it is necessary for implementation sites to obtain a free (for the US) UMLS license. In addition, HL7 FHIR Policies requiring everything to be open source in all realms, may present some implementation validation issues when interfacing with a value set housed in VSAC. This IG will provide guidance for this issue.\n\n### History of the Care Plan and Electronic Care Plans\n\nThe concept of a care plan began as a teaching tool for nursing students to research and document the medical conditions their patients had and identify the associated nursing care and family support needed. This was documented in a structured paper format that fostered the nursing process. The nursing process is the identification of health concerns and related goals, and the interventions needed to meet those goals and then evaluating the meeting of those goals – the outcomes. Over the years, the care plan evolved from a student teaching tool to something required for most patients in some format by various regulating or certifying bodies, and further, from a nursing care based plan, to an interdisciplinary patient focused tool.\n\nMost major vendors have electronic Care Plan modules, but the degree to which the modules are implemented and actively used is unknown. Few, if any, are exchange standards ready or mapped to exchange standards. The first HL7 standard representing Care Plan was the C-CDA Care Plan document designed to represent an instance of an EHR Care Plan similar to the Continuity of Care (CCD) CDA. Many of the learnings and designs for the FHIR Care Plan Resource and this IG were derived from the C-CDA Care Plan. There is also an IHE [Dynamic Care Planning (DCP)](https://wiki.ihe.net/index.php/Dynamic_Care_Planning_(DCP)) that provides the structures and transactions for care planning, creating, updating and sharing Care Plans that meet the needs of many, such as providers, patients and payers..  The Office of the National Coordinator (ONC) has put into regulation requirements around goals and health concerns which can currently be met by free text. The Dynamic Care Planning (DCP) Profile provides leveraged FHIR Resources to provide the structures and transactions for care planning and sharing Care Plans that meet the needs of many, such as providers, patients and payers. The DCP profile leverages the FHIR Care Plan resource, but does not specify, describe or define the use of it for representing specific conditions or multiple conditions. We are unaware of any real world implementations of it at this time.\n\nWe believe that this IG will be the first fully defined HL7 FHIR IG leveraging the FHIR Care Plan resources as its backbone structure for representing a dynamic care plan and testing its ability to bring together aggregated patient care plan data including patient outcomes.\n\n### Project Overview\n\nMore than 25 percent of Americans have MCC, accounting for more than 65 percent of U.S. healthcare spending. These individuals have complex health needs handled by diverse providers, across multiple settings of care. As a result, their care is often fragmented, poorly coordinated, and inefficient. Therefore, data aggregation is particularly important and challenging for people with MCC. These challenges will increasingly strain the U.S. health system, with the aging of the U.S. population. Projections suggest numbers of adults aged 65 and older will more than double and numbers of those aged 85 and older will triple by 2050.\n \nCare plans are a prominent part of multifaceted, care coordination interventions that reduce mortality and hospitalizations and improve disease management and satisfaction. In addition, proactive care planning promotes person-centeredness, improves outcomes, and reduces the cost of care. By design, care plans take a patient-centered approach, both by making comprehensive health data available across providers and settings and through the incorporation of data elements that have not traditionally been included in health IT systems (e.g., social determinants of health SDOH, patient health and life goals, patient preferences). While Care Plans have been developed, they remain paper-based in many U.S. healthcare settings and are not standardized and interoperable across care settings when electronic. While care plans focused on a single disease or condition are unlikely to be tenable for patients with MCC or their providers, existing care plans infrequently address individuals with MCC. The development of care plans based on structured data has been proposed as a method for enabling electronic systems to pull together and share data elements automatically and dynamically. Such aggregated data would not only provide actionable information to identify and achieve health and wellness goals for individuals with MCC, but also would reduce missingness and improve quality of point-of-care data for use in pragmatic research.\n \nThe Fast Healthcare Interoperability Resources (FHIR) specification is an open-source standard for exchanging healthcare information electronically based on emerging industry approaches. The FHIR workflow specification includes a CarePlan request resource that may facilitate transfer of data for an e-care plan across healthcare settings. SMART (https://smarthealthit.org/) and SMART on FHIR standards include open specifications to integrate applications with health IT systems and may enable the development of an e-care plan application that can integrate with a variety of electronic health record (EHR) systems.\n\nInitiated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the multiple chronic conditions (MCC) electronic care (eCare) Plan Project aims to develop, test, and pilot an interoperable eCare plan that will facilitate aggregation and sharing of critical patient-centered data across home, community, clinic, and research-based settings for persons with MCC, including chronic kidney disease (CKD), type 2 diabetes mellitus (T2D), cardiovascular disease (CVD), pain with opioid use disorder (OUD), and long COVID. \n\nThe HL7-based activities of the MCC eCare Plan Project include:\n \n - Identified use cases to support the documentation and exchange of MCC eCare plan data within EHRs and related systems.\n - Identified, developed, and prioritized the necessary MCC data elements and clinical terminology standards and FHIR® mappings that will enable the standardized transfer of data across health settings.\n - Develop, test, and ballot an HL7® Fast Health Interoperability Resources (FHIR®) Implementation Guide based on the defined use cases and MCC data elements.\n \nNon-HL7 related activities of the MCC eCare Plan project will be facilitated through the [AHRQ eCare Plan Project Confluence](https://ecareplan.ahrq.gov/collaborate):\n - The project includes the develoment and testing of an open-source clinician and patient facing SMART-on-FHIR eCare plan application for managing persons with MCC.\n\n####  Project Timelines\n - January 2024: A For comment ballot to gather community input prior to the formal STU Ballot\n - September 2024: Formal STU Ballot\n - May 2025 Formal HL7 Publication\n\n\n### Guidance\nThe guidance section provides general implementation guidance and best practices. It describes the relation to and reuse of the US Core Implementation Guide profiles and reuse of its conformance requirements and expectations for the servers and client applications. Vocabulary use and value set binding heuristics are described.\n\n####  Relationship to US Core\n\nThis Implementation Guide reuses US Core profiles either through direct use or by constraining select profiles for representation within a FHIR Care Plan profile. Where US Core does not have a profile or function that is needed for the use cases or data elements, the IG constrains or directly reuses other resources, or profiles defined in other FHIR IGs. \nThis guide will reuse the US Core Care Plan. However, the required US Core CarePlan.text and the required Care.Plan.category:AssessPlan may be limiting factors for this context of use: aggregation of multiple chronic condition care plans and the ability to query for structured data within a structured Care Plan. As such, we recommend adding additional Care Plan categories if deemed more informational to reflect multiple chronic condition care coordination and plans and to hard code “Multiple Chronic Condition Care Coordination Plan” at CarePlan.text\n\n\n#####  General US Core IG Conformance\n\nThis guide will adhere to or build on US conformance requirements, most of its [General Guidance](https://www.hl7.org/fhir/us/core/general-guidance.html), and its [Capability Statements](https://www.hl7.org/fhir/us/core/capstatements.html) where applicable. \n\n#####  Provenance\n\nThis IG recommends implementers adhere to guidelines and definitions provided in US Core’s [Basic Provenance Guidance](https://www.hl7.org/fhir/us/core/basic-provenance.html). \n\n#####  Must Support\n\nThis IG will adhere to the US Core [Must Support](https://www.hl7.org/fhir/us/core/general-guidance.html#must-support) concept and rules.\n\n### Acknowledgements\nThis Implementation Guide was made possible through the visionary leadership of the [National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ](https://www.niddk.nih.gov/)and the [Agency for Healthcare Research and Quality (AHRQ) ](https://www.ahrq.gov/)with funding from the [Office of the Assistant Secretary for Planning and Evaluation (ASPE)](https://aspe.hhs.gov/collaborations-committees-advisory-groups/os-pcortf/explore-portfolio). The joint NIDDK-AHRQ project team can be found [here](https://cmext.ahrq.gov/confluence/display/EC/Project+Team). We would also like to thank the many clinicians, patients, caregivers, researchers, advocates, and subject matter experts who served on our [Technical Expert Panels](https://cmext.ahrq.gov/confluence/display/EC/Technical+Expert+Panels) and [Contract Monitoring Board ](https://cmext.ahrq.gov/confluence/display/EC/Contract+Monitoring+Board) for their time, insight, and support. \n\nThis Implementation Guide was created under the supervision and review of the [HL7 Patient Care Work Group](https://www.hl7.org/Special/committees/patientcare/index.cfm). This is the HL7 project page for the [Multiple Chronic Conditions e-Care Project.](https://confluence.hl7.org/display/PC/Multiple+Chronic+Conditions+%28MCC%29+eCare+Plan)\n\n",
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    "title": "Adverse Event Clinical Research R4 Backport",
    "description": "### Intent The intent of this guide is to provide a profile on the FHIR AdverseEvent Resource suitable for Clinical Research.  ### Overview A single Adverse Event (AE) may need to be reported in multiple ways. Choosing the appropriate form of the reporting is dependent upon workflow patterns. In particular, the implementation guides for Clinical Care adverse events and Clinical Research adverse events provide important extensions, value-sets and examples for implementing AdverseEvent.  This guide, the Clinical Research adverse event implementation guide, is for the clinical research setting. In this setting, the event is tracked and evaluated as part of the clinical research process for the research study.  In the research setting an adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects (this is surfaced in the profile as a constraint of ‘actual’ for the value of ‘actuality’). An example of an adverse event in the clinical research setting would be a patient develops renal failure while on a study drug. These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome.  The context of an adverse event is also important, and captured in the AdverseEvent Clinical Research Profile data elements. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event. This information is represented with corresponding resources (e.g. Procedure Resource for procedures, etc.) and referenced.  A potential adverse event may also be called a near miss or an error, these are not reported with the AdverseEvent Clinical Research Profile.  ### Scope This FHIR IG enables the collection of adverse events in real-world data (RWD) sources such as electronic health records (EHR) and personal health records (PHR) that occur during clinical trials. It ensures the appropriate AE representation required to support clinical research trials within a regulated environment. As the AEs are collected in RWD sources, the data can be transmitted via FHIR to clinical trial management systems, regulatory agencies, sponsors, and clinical research organizations for further processing and reporting.  In the pre-market clinical research setting, serious adverse events must be reported to the sponsor, clinical research organization, and regulatory agencies within a specific time frame for Institutional Review Boards (IRBs) and Data Safety Monitoring Board (DSMB) review. By using this IG, a clinical investigator can document an AE in the EHR, it can be received by a secondary clinical trial management system for triage and then forwarded to the sponsor and regulatory agencies. Similarly, a patient on a clinical trial can record an adverse event in their PHR that is then shared with the clinical investigator and reported to the sponsor and regulatory agencies as necessary. In a post-market situation, a patient, provider, or manufacturer can record the adverse event in a system and then report it to the FDA as a FHIR based MedWatch form.  Within this guide are several examples. Every effort has been made to capture the most important details of the use of the AdverseEvent profile. However, some examples may provide only a stub to referenced resources (e.g. instances of Patient Resource will be referenced using logical ids but are not resolvable, implementation of Patient is left for other guidance and is not the subject of this guide). Connectathons are ideal opportunities to create, compare and consider the holistic implementation of all FHIR Resources.",
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