Difference between revisions of "2009 TSC Product Visibility"

From HL7 TSC
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SPL
 
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Structured Product Labeling (SPL) defines the content of human prescription drug labeling in an XML format. This format is defined within the SPL schema and is displayed in a web browser using the SPL stylesheet. It is approved by Health Level Seven (HL7) and has been adopted by FDA as a mechanism for exchanging medication information. (from [http://en.wikipedia.org/wiki/Structured_Product_Labeling Wikipedia])
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SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).
 
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The benefits that accrue to all stakeholders in the drug regulatory process by adoption of Structured Product Labeling (SPL) make the business case for implementation of SPL overwhelming. The benefits of SPL derive from use of standard, universally adopted information standards such as XML, from the specific aspects of the SPL model for describing prescription drug content, and from adoption of an open standard for SPL. (from [http://www.fda.gov/oc/datacouncil/SPL_Release_2a_3_25.pdf FDA Publication], see Appendices)
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[http://www.fda.gov/oc/datacouncil/spl.html US FDA]
 
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* [http://www.hl7.org/Special/committees/rcrim/index.cfm RCRIM WG]
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* SPL [http://wiki.hl7.org/index.php?title=Structured_Product_Labeling Project Wiki]
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* SPL [http://spl-work-group.wikispaces.com/ Work Group Wiki]
 
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Revision as of 19:54, 4 May 2009

2009 TSC Product Visibility

Tentative Product List and Template Descriptions
Product Summary Description (<500 words) Business Case Benefits Implementation/ Case Studies Resources

CDA (R1)

The Clinical Document Architecture (CDA) is a specification for the exchange of electronic clinical documents. It can contain coded data and narrative and is compatible with the electronic health record and document management systems. CDA is at the core of virtually all standards-based exchange networks in the US and abroad and is adaptable for dictated notes and highly-structured public health and quality reporting.

Clinical documents are the core of a patient's lifetime health record. HL7’s CDA standard provides an exchange model for clinical documents such as discharge summaries and progress notes. A consistent approach to electronic clinical documents means that critical information contained in the documents can be used independently of the application on which it was produced. For example, CDA documents can be displayed using XML-aware Web browsers or wireless applications on mobile devices.

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CDA R2

Clinical documents are the core of a patient's lifetime health record. HL7’s CDA standard provides an exchange model for clinical documents such as discharge summaries and progress notes. A consistent approach to electronic clinical documents means that critical information contained in the documents can be used independently of the application on which it was produced. For example, CDA documents can be displayed using XML-aware Web browsers or wireless applications on mobile devices.

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From HIMSS 2009

CCD

HL7 and ASTM International created the Continuity of Care Document (CCD) to integrate two complementary healthcare data specifications ASTM’s Continuity of Care Record (CCR) and HL7’s Clinical Document Architecture (CDA). The CCD is endorsed by the Healthcare Information Technology Standards Panel (HITSP) as the harmonized format for the exchange of clinical information, including patient demographics, medications and allergies.

The HL7/ASTM Continuity of Care Document (CCD) is an implementation guide for sharing Continuity of Care Record (CCR) patient summary data using the HL7 Clinical Document Architecture (CDA). CCD establishes a rich set of templates representing the typical sections of a summary record and expresses these templates as constraints on CDA. These same templates—for vital signs, family history, plan of care, and so on—can then be reused in other CDA document types, establishing interoperability across a wide range of clinical use cases. The CCD is the basis for interoperability in the US Health Information Technology Standards Panel (HITSP) and Integrating the Healthcare Enterprise (IHE) use cases.

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HIMSS 2009 CCD Presentation

SPL

Structured Product Labeling (SPL) defines the content of human prescription drug labeling in an XML format. This format is defined within the SPL schema and is displayed in a web browser using the SPL stylesheet. It is approved by Health Level Seven (HL7) and has been adopted by FDA as a mechanism for exchanging medication information. (from Wikipedia)

SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).

a

The benefits that accrue to all stakeholders in the drug regulatory process by adoption of Structured Product Labeling (SPL) make the business case for implementation of SPL overwhelming. The benefits of SPL derive from use of standard, universally adopted information standards such as XML, from the specific aspects of the SPL model for describing prescription drug content, and from adoption of an open standard for SPL. (from FDA Publication, see Appendices)

US FDA

EHR FM

The healthcare industry will reap tremendous benefits by adopting a common standard for electronic health record systems (EHR-S). The HL7 EHR-S Functional Model outlines important features and functions that should be contained in an EHR system. Through the creation of functional profiles, this model provides a standard description and common understanding of functions for healthcare settings. To date, HL7 has developed or is developing profiles for areas such as child health, emergency care, long term care, behavioral health and vital statistic reporting. The EHR-S Functional Model is also in the final stages of vetting as an international standard through ISO.

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From HIMSS 2009

Personal Health Record System Functional Model (PHR-S FM)

The PHR-S FM defines the set of functions for Personal Health Record (PHR) systems and offers guidelines that facilitate health information exchange among different PHR systems and between PHR and Electronic Health Record systems. The PHR-S FM is was published as a Draft Standard for Trial Use (DSTU) in December 2008. During the period of trial use, consumers can begin requesting standards-based functionality when they select PHR systems for their use, vendors can begin incorporating the model’s requirements into their products and organizations that certify PHR systems can begin using the model’s conformance criteria for certification development and testing purposes. Groups such as the Certification Commission for Healthcare Information Technology (CCHIT) and the Centers for Medicare and Medicaid Services have already begun using components of the PHR-S FM

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From HIMSS 2009

SAEAF

description
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Claims Attachments

In response to the federal mandate under HIPAA, HL7 and ASCX12 collaborated for a number of years to develop standards for claims attachments. This joint development effort has resulted in standards for attachments to healthcare claims, and pre-certification / pre-authorization transactions. HL7 attachments standards are based on the Clinical Document Architecture (CDA) and have been proposed by the Department of Health and Human Services (HHS) as the standard for claims attachments under HIPAA. In the HHS proposal, six attachment types developed by HL7 have been put forward for adoption: clinical reports; rehabilitation services; laboratory results; medications; ambulance services; and emergency department.

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HIMSS 2009 presentation on WPS case study

Clinical Genomics Pedigree Topic

The HL7 Clinical Genomics Pedigree Topic includes the Family History Model describing a patient’s pedigree with genomic data. It has the ability to transmit complete family history information for clinical decision support. This model is ANSI-approved and is the HITSP-accepted standard. This standard allows EHR/PHR interoperability, and is in use by the Surgeon General in his family history collection website: My Family Health Portrait. It is also in the process of becoming of an international standard through ISO.

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From HIMSS 2009

Version 2 Messaging Standard

The Version 2 Messaging Standard is one of the most widely implemented standards for healthcare information in the world. First released in October 1987 as An Application Protocol for Electronic Data Exchange in Healthcare Environments, Version 2 is a messaging standard that allows the exchange of clinical data between systems. It is designed to support a central patient care system as well as a more distributed environment where data resides in departmental systems. Version 2.6, representing the latest update to the Version 2 Standard, was published in January 2008. Version 2.7 is in the final stages of balloting and is expected to be released later this year.

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Version 3 Normative Edition

Version 3 is HL7’s family of standards developed with a model-driven methodology. The release of HL7’s Version 3 Normative Edition marks a quantum leap in the functionality and interoperability of messaging standards. Version 3 is one of the first in the industry to embrace XML. Several countries throughout the world have already begun significant Version 3 implementations, including the United Kingdom, Canada, the Netherlands, Mexico, Germany and Croatia.

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From HIMSS 2009