Product Classification In Healthcare
Product Classification in HealthcareApril 2015Executive SummaryThe purpose of this document is to provide an overview of the global classification and nomenclature landscape inhealthcare and to offer guidance. This is intended for those who are investigating options for classifying products inthe healthcare sector.Product classification and nomenclature in the global healthcare sector is quite complex for many reasons. Therehave been discussions within the GS1 Healthcare community for many years regarding the potential to standardiseproduct classification by providing a global standard, such as other industries have done with GS1’s Global ProductClassification (GPC).In the past, GS1 has surveyed the global healthcare community via the GS1 Member Organisations, to betterunderstand the current status and developments as they relate to the use of classification and nomenclaturesystems. In late 2014 and early 2015 we again surveyed the global community in an effort to determine leadingtrends and practices. While the survey results do not point to a clear trend or use of one single system over another,there are some general observations and recommendations which can be offered. Table 1 provides a listing ofvarious purposes for classification based on the responses to our surveys.It should be noted that there is a subtle but specific distinction which should be made between classification andnomenclature. This document offers a simple differentiation intended to assist in the evaluation of the systems listedin Table 2.While most people will agree that a single global classification standard is desirable, it is very impractical andperhaps even impossible to migrate the hundreds of thousands of users (i.e. hospitals, manufacturers, regulators)from the current systems they use to a single global standard. This is further evidenced by the recent regulationsthat have mandated specific systems. For this reason the Global Data Synchronisation Network (GDSN) enables the1
Product Classification in Healthcarecommunication of any of the classification or nomenclature systems associated with a specific product in thenetwork.This paper provides an overview of the systems currently used across the world and a listing of the business reasonswhy products are classified. This document can serve as a reference tool in the process of determining which systemTrading Partners may choose to use.Current SituationThere currently there are over 20 different Classification and Nomenclature systems used across the world for theclassification of products in the healthcare sector. Classification and Nomenclature systems serve different purposes.A simple distinction between a Classification systems and a Nomenclature system is as follows: Classification –A form of cataloguing, or identifying, products and can be defined as a process for groupingproducts into categories based on an understanding of the essential properties and relationships betweenthem. A classification system is used to group like products such as Medical Devices, versus PharmaceuticalDrugs. Example classification systems are UNSPSC, GPC, eClass and ATC among others. Nomenclature – A system with rules to name individual items. A nomenclature system is used to providecommon descriptions to products which have the same performance characteristics and thereby can besubstituted for each another (i.e. two syringes, with differing product descriptions from two differentmanufacturers which are designed for the same purpose or use).Classification and Nomenclature systems are usually developed for specific purposes, such as tariff codeharmonization by the World Customs Organisation, Anatomical Therapeutic Chemical (ATC) classification by theWorld Health Organization (WHO) and more general purposes such as purchasing and spend analytics or regulatorypurposes such as Global Device Nomenclature (GMDN) used by the U.S. FDA for their Unique Device Identifier (UDI)regulation. The GMDN is also required by regulators in many countries for regulatory submission purposes.2
Product Classification in HealthcareThere are many business reasons why products need to be classified. A survey of the global healthcare communityhas identified specific reasons why people use classification systems. The order of the systems listed below is basedon the original survey of the global healthcare community when asked why they classified products.Business ProcessDefinitionSpend AnalysisSpend Analysis is the process of collecting, cleansing, classifying and analysingexpenditure data with the purpose of reducing procurement costs.Spend analysis can provide answers to such questions as: What was bought? Who bought it? (requisitioner, buyer, department, location) From whom did we buy it? When was it bought? How much did we pay for it?Financial Analysis refers to an assessment of the viability, stability andprofitability of a business or business unit, as a basis for making businessdecisions. Based on the results, management may decide to: Continue or discontinue a part of its business; Make or purchase certain materials in the manufacture of its goods; Buy or lease certain equipment used in the production of its goods; Issue stocks or negotiate a bank loan to increase its working capital; Make decisions regarding investing or lending capital.Financial analysis deals with issues such as profitability, cash flow, liquidity andsustainability.Procurement is the business process of obtaining goods and services—fromrequisition through payment. It commonly involves purchase planning standards determinationFinancial AnalysisProcurement (Sourcing,Acquisition)3
Product Classification in HealthcareStrategic SourcingTendering (Request forQuotation (RFQ), Requestfor Proposal (RFP), Call forBids)Enterprise ResourcePlanning (ERP) specifications development supplier research (“discovery”) and qualification value analysis financing price negotiation purchasing (PO, Acknowledgement, Invoice ) supply contract administration inventory control and stores disposals and other related functionsStrategic sourcing is an institutional procurement process that continuouslyimproves and re-evaluates the purchasing activities of a company.The steps in a strategic sourcing process are: Assessment of a company's current spend (see Spend Analysis) Assessment of the supply market (who offers what?) Development of a sourcing strategy (where to buy what, while minimizingrisk and costs) Identification of suitable suppliers Negotiation with suppliers (products, prices) Implementation of new supply structure Track results and restart assessment (continuous cycle)Tendering is a process by which a company seeks prices and terms for aparticular product or service to be provided under a contract. The sealed offersthemselves, typically including company information, a description of theproposed product or service, and a price quote, are known as tenders or bids.Tendering is often mandated and regulated in the public sector.Enterprise Resource Planning (ERP) is an information system designed tocoordinate all the resources, information, and activities needed to completebusiness processes such as order fulfilment or billing. ERP systems come in4
Product Classification in HealthcareMaterials ManagementInformation System(MMIS)Asset ManagementCategory Management(Merchandising)many different forms, most including multiple modules for various businessprocesses.Materials management is the branch of logistics that covers the acquisition ofsupplies, quality control of the purchasing process, and the standards involved inordering, shipping, receiving, and warehousing those supplies. Most large UShealthcare providers operate MMIS. It is common usage to refer to MMIS as asubset of ERP systems.Asset Management is the practice of managing the whole lifecycle of anorganization’s assets, both physical and non-physical.Asset lifecycle includes design, construction, commissioning, operating,maintaining, repairing, modifying, replacing and decommissioning/disposal.Examples of physical assets include buildings and capital equipment. Examples ofnon-physical assets include IT assets, network configurations, software, digitalasset, electronic media and data.Category Management refers to where a large company manages groups ofproducts as separate business units responsible for their own inventory turns,profit, etc. It also refers to where a manufacturer and a retailer collaborate todevelop a marketing strategy for a group of products. Also (merchandising)refers to activities aimed at increasing inventory turns, such as special offers,bundling, free samples and displays.Table 1In 2009 GS1 Healthcare recommended the creation of two overarching Bricks in the GS1 Global ProductClassification (GPC) standard which provide a very high level classification of the two major product groups inhealthcare, while enabling the adoption of the Global Data Synchronisation Network (GDSN) in Healthcare. Adecision was also taken by GS1 Healthcare to not develop further classification granularity for GPC within thehealthcare sector. The rationale for this decision is that there is no desire on the part of the global healthcare5
Product Classification in Healthcarecommunity to migrate to a single classification system globally from many systems currently in use. In some cases,it is not possible to migrate to a single system because regulations may require the use of a particular system.Subsequently, an extension of these two bricks was approved. The two additional bricks allow for the separation ofdevise and pharmaceutical items intended for human use and consumption from those specifically designed foranimal welfare (veterinary).Therefore the GPC standard currently consists of four main Bricks (classification codes), one for Medical Devices, onefor Pharmaceutical Drugs, Biologics and Therapeutic Nutritionals, one for Veterinary Medical Devices, and one forVeterinary Pharmaceutical Drugs, Biologics and Therapeutic Nutritionals, plus an additional 135 Bricks which hadbeen previously developed mostly for the retail industry, which includes retail pharmacies, prior to the 2009 GS1Healthcare recommendation.For a list of the GPC Brick codes which may be used for healthcare products visit the GS1 website.Support for Other Classification SystemsIn addition to the GPC system as the mandatory classification for GTINs in the GS1 Global Registry, the Global DataSynchronisation Network (GDSN) provides support for other classification systems. This feature allows for the use ofvarious classification systems outside the GDSN, as needed in specific countries, sectors or as required by tradingpartners.Classification systems, such as UNSPSC, CLADIMED, eClass, NHS e-class and others are identified within the GDSNby using the “Additional Classification Agency” attribute. This function provides structured identification andmanagement of a relationship-specific classification system.The GDSN attributes for additional classification systems are listed below. additionalClassificationo additionalClassificationAgencyName6
Product Classification in ditionalClassificationCategoryDescriptionAs adoption of global standards increases in healthcare globally, stakeholders in many countries turn to GS1 for arecommendation on a classification system to adopt for their local market. Because the decision was made not tofully developed GPC for healthcare, GS1 and its Member Organizations are unable to make a specificrecommendation.In late 2014 GS1 conducted a survey of the global healthcare community in order to get a more currentunderstanding of the classification landscape. The survey results highlight the considerable complexities which existsin this area and that no one system, or few systems, emerge as the clear leader across the board. In fact, theresults further validate the original understanding of why it is impractical and perhaps impossible to migrate tosingle system globally.Below is a listing of the various Classification and Nomenclature systems used in healthcare and the declaredpurpose for each system. It should be noted that some of these systems, such as MedDRA and SNOMED, are alsoused for medical terminology classification or indications and diagnosis and as such may be attached to theproduct’s data in addition to other systems.SystemAHFSDefinition/Descripti Maintenancone AgencyAmerican HospitalFormulary Service andPharmacologicTherapeuticClassification classification allowsthe grouping of drugswith similarAmericanSociety ofHealthSystemPharmacistsWebsiteDeclared ificationsystem.aspxClinical: The mission of AHFSDrug Information (AHFS DI )is to provide an evidence-basedfoundation for safe and effectivedrug therapy.7
Product Classification in Healthcarepharmacologic,therapeutic, icalWHOhttp://www.whocc. Research: The purpose of theTherapeutic Chemical Collaborating no/atc/structure a ATC/DDD system is to serve asClassification - activeCentre fornd principles/a tool for drug utilizationsubstances areDrugresearch in order to improvedivided into differentStatisticsquality of drug use.groups according toMethodologythe organ or system(WHOCC)on which they act andtheir therapeutic,pharmacological andchemical propertiesClassification desdispositifs médicauxis the classification formedical device usedin France and BelgiumClaDiMedassociationCanadian MedicalHealth CanadDevice Regulationsa's Therapeut(CMDR)ic ProductsPreferred Name CodeDirectorate(PNC)The Keyword Index toAssist Manufacturersin Verifying the Classof Medical Devices isintended to assistmanufacturers inhttp://www.cladim Modelled after the ATC, toed.com/english- provide a generic nomenclatureversion/for healthcare providers anddevice suppliers.CMDR is found atthe followinglocations twolocations(part OR-98-282/page1.html#s-1.Regulatory: To aid devicemanufacturers in registeringproducts with regulatory agencyprior to sale in Canada.(part 2)8
Product Classification in Healthcareconfirming theclassification ofmedical deviceproducts afterapplication of theClassification Rules forMedical Devices setout in Schedule 1 ofthe Medical DevicesRegulations.CNDCPVClassificazioneNazionale deiDispositivi medici(CND) - Italianclassification systemfor medical ns/SOR-98-282/page5.html#s-32.PNC is found /guideld/keyword motscles2-eng.phpMinisterodella ale deifarmaci e deidispositivimediciUfficioIII, Vialedella portale/temi/p2 6.jsp?lingua italiano&id 328&area dispositivimedici&menu classificazioneAssessments of adverseevents, transparentprocurement processes by thenational health system.Common Procurement The Office for http://simap.euro The CPV establishes a singleVocabulary (CPV)Officialpa.eu/codes-and- classification system for publicestablishes a singlenomenclatures/co procurement aimed at9
Product Classification in Healthcareclassification systemPublicationsfor publicof theprocurement aimed atEuropeanstandardising theCommunitiesreferences used by(OPOCE)contracting authoritiesand entities todescribe the subjectof procurementcontractsdes-cpv/codescpv en.htmstandardizing the referencesused by contracting authoritiesand entities to describe thesubject of procurementcontracts.DM&DThe NHS Dictionary ofThe dm dMedicines and Devices Programme(dm d) containsBoard isunique identifierschaired by(codes) andthe Directorassociated textualof Medicines,descriptions forPharmacyrepresentingand Industrymedicines andGroup,medical devices inDepartmentinformation systemsof Health.and electroniccommunications.http://www.dmd.n a more integrated and saferhs.uk/index.html healthcaresystem interoperability,opportunities for comparisonand reducing variation,enhancing patient safety.The dm d uses SNOMED-CTcodes throughout to classifypharmaceuticals. They have alsocreated a dm d SNOMED-CT UKDrug extension which definesthe relationships betweenSNOMED-CT identified conceptsThis webinar provides anoverview introduction 0/pack/6/subpack/71/releaseseCl@ssStandardized MaterialeCl@sshttp://www.eclass. cross-industry product dataand ServiceAssociation ( de/eclasscontent/st standard for classification andClassification andhttp://wiki.ec andard/search.htm clear description of products andDictionary - crosslass.eu/wiki/l.enservices. procurement,industry product datacontrolling and10
Product Classification in Healthcarestandard forThe eCl@ssclassification and clear association)description ofproducts and services(GIVD)(previously knownas EDMA)USCGMDNGlobal In VitroDiagnosticClassification formedical devicesdistribution company-wideprocess data management aswell as engineering.Europeanhttp://www.edma- to support the collection andDiagnosticivd.eu/index.php?p analysis of market statistics.Manufacturer age Global-IVDs AssociationClassification(EDMA)Uniform System ofIMS Health http://www.imshea The USC provides logicalClassification (USC) - Pharmaceutic lth.com/deployedfil groupings of pharmaceuticalprovides logicalal Actiones/ims/Global/Cont products considered to competegroupings ofCommittee ent/Insights/Health in the same or similar markets;pharmaceutical%20Services%20R each category provides theproducts consideredesearch%20Networ manufacturer a solution toto competek/USC Classiificati determine the market share forin the same or similaron Process 2011.p their product(s), as well as theirmarketsdfcompetitors.Global Medical DeviceNomenclature -To givea common genericdescriptor for medicaldevices having similarfeatures,characteristics andintended use forexchange of databetween regulatorybodies.GMDNAgencyhttps://www.gmdn The main purpose of the GMDNagency.com/is to provide health authoritiesand regulators, health careproviders, medical devicemanufacturers and suppliers,conformity assessment bodiesand others with a single genericnaming system that will supportpatient safety. The GMDN isused for:- Data exchange betweenmanufacturers, regulators andhealthcare authorities11
Product Classification in Healthcare- Exchange of post-marketvigilance information- Supporting inventory control inhospitals- Purchasing and supply chainmanagementThe work was mandated by theEuropean Commission in orderto provide the necessary tool tocarry out the implementation ofthe Medical Devices Directive,including the Europeandatabank for medical devices,Eudamed.GPCGlobal ProductClassification - Asystem that gives acommon language forgrouping products inthe same wayGS1http://www.gs1.o GPC is the mandatoryrg/gdsn/gpcclassification system for theGS1 Global DataSynchronization Network(GDSN).GPC gives buyers and sellers acommon language to groupproducts the same wayglobally to ensure effectivedata synchronization in theGlobal Data SynchronizationNetwork (GDSN). GPC enablesthe following processes:- Item Registration- Subscription- Validation- Search- Publication/SubscriptionMatch12
Product Classification in HealthcareHCPCSICPSMedDRAHealthcare CommonCenters forProcedure CodingMedicare andSystem - aMedicaidstandardized codingCMSsystem for describingthe specific items andservices provided inthe delivery of healthcareWorld HealthOrganization (WHO)InternationalClassification forPatient Safety Note:Code still al Dictionary forICH hasRegulatory Activities – contracted astandardizedMaintenanceinternational medical and Supportterminology forServicesregulatoryOrganizationcommunication in the – MSSO - toregistration,maintain,documentation anddevelop andsafety monitoring ofdistributemedical productMedDRAhttp://
Enterprise Resource Planning (ERP) Enterprise Resource Planning (ERP) is an information system designed to coordinate all the resources, information, and activities needed to complete business processes such as order fulfilment or billing. ERP systems come in
classification has its own merits and demerits, but for the purpose of study the drugs are classified in the following different ways: Alphabetical classification Morphological classification Taxonomical classification Pharmacological classification Chemical classification
makers in healthcare management. 2 / 2022 Media Kit / ache.org The American College of Healthcare Executives is an international professional society of more than 40,000 healthcare executives who lead hospitals, healthcare systems and other healthcare organizations. Healthcare Executive e-TOC Published bimonthly, e-TOC is a
used in these Classification Rules have the meaning given to them in the Glossary to these Classification Rules. 1.12 References to a 'sport' in these Classification Rules refer to both a sport and an individual discipline within a sport. 1.13 The Appendices to these Classification Rules are part of these Classification Rules
Function 1: Develop recovery processes for the healthcare delivery system 12 P1. Healthcare recovery planning 12 P2. Assessment of healthcare delivery recovery needs post disaster 13 P3. Healthcare organization recovery assistance and participation 13 Function 2: Assist healthcare organizations to implement Continuity of Operations (COOP) 13 P1.
healthcare industry through local support initiatives like GS1 Healthcare US in the United States. About GS1 Healthcare US GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to help improve patient safety and supply chain efficiency.
Google Cloud FHIR APIs Dharmesh Patel Google Cloud Healthcare & Life Sciences. Agenda Healthcare Interoperability & FHIR SMART on FHIR 1 2 3 Google's Cloud Healthcare FHIR API. Healthcare 01 Interoperability & FHIR. The Interoperability Challenge in Healthcare. FHIR as the Data Model and API Spec for Interoperability
healthcare workforce and increase the use of telehealth.5 Base (unweighted): Total healthcare leaders (United States n 200; 14-country avg. n 2800; France n 200; Germany n 200; Netherlands n 200) Healthcare leaders who agree that current healthcare policies and plans in their country are contributing to building a resilient healthcare system
healthcare professionals. The next steps for healthcare reform. The pandemic potentially set the stage for . healthcare reform along three dimensions: COVID-19-era waivers that could become permanent; actions that may be taken to strengthen the healthcare system to deal with pandemics; and reforms to address COVID-19. Between early March 2020 and
