Padrões e Interoperabilidade

Transcrição

1 Oficina Telessaúde Brasil: Segunda Opinião FormaDva Padrões e Interoperabilidade Beatriz de Faria Leão Consultora do Telessaude Relatora GT 8 ABNT CEE- InformáDca em Saúde 29 e 30 Setembro, em Brasília

2 Agenda da Apresentação Introdução Comitê ISO TC 215 Informá=ca em Saúde ABNT CEE- IS Experiência Internacional em Padrões para ehealth Padrões necessários para o Telessaúde Brasil Teleconsultoria SOF

3 O que são Padrões? (I) Segundo a ISO, "padrão" é um documento estabelecido por consenso e aprovado por um grupo reconhecido, que estabelece um conjunto de regras, protocolos ou caracterís=cas de processos com o obje=vo de ordenar e organizar a=vidades em contextos específicos, para o benexcio de todos.

4 By Abel Grimmer,1563

5 A questão da padronização Fonte: Heather Grain, Seminário Internacional: Regulacao de Saude Suplementar,2008

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7 h_p:// impact.org/

8 Atributos de um Padrão Especificidade Universalidade Adaptabilidade Concisão Facilidade de Uso Flexibilidade Legi=midade Dependem de Conhecimento Inter- disciplinar Depende do Processo de Obtenção

9 Metodologias de Padronização Devem ser abertas, Baseadas em solicitações de propostas Amplo uso da Internet Não re- inventar a roda Envolver todos os atores Reuniões presenciais Papel do governo

10 Comitê ISO TC 215 Health Informa=cs Chair : Yun Sik Kwak (Rep. of Korea) Secretária : Ms. Audrey Dickerson (USA) Escopo: Padronização na área de informação em saúde e tecnologias de informação com o obje=vo de a=ngir a compa=bilidade e a inter- operabilidade entre sistemas independentes. Garan=r a compa=bilidade de dados para fins de análise estaos=ca, reduzindo redundâncias e duplicação de esforços. h_p:// Fonte: Yun Sik Kwak, Jul 2003 list_of_iso_technical_commi_ees/iso_technical_commi_ee.htm?commid=54960

11 Organização do Comitê ISO TC 215

12 Programa de Trabalho ISOTC 215 / WG1

13 Programa de Trabalho ISOTC 215 / WG2

14 Programa de Trabalho ISOTC 215 / WG2

15 Programa de Trabalho ISOTC 215 / WG3 DIS and FDIS Ballots Health informatics Categorical structure for terminologies of surgical procedures Jean Marie Rodrigues pren1828 Health informatics System of concepts to support continuity of care Part 1: Basic Concepts François Mennerat EN Common Terminology Services (Release 1) Chute/Solbrig IS#27951 Submitted to ISOCS for DIS ballot Submitted to ISOCS for DIS ballot On FDIS ballot ( ) Sending for Publication HI: Guidelines for terminology development organizations (name change 2009 Edinburgh) Anne Casey TR# HI: Conceptual Framework for patient findings and problems in terminologies Phil Brown TS/ISO#22789 Submitted to ISOCS for publicaiton Submitted to ISOCS for publicaiton Published - Systematic Review Integration of a reference term model for nursing Chute/Saba IS Published Published Items Vocabulary for Terminological Systems Thurin IS Published 2007 Cont Hlth Vocab - Vocab structure hi-level qual Indicators Peter Elkin TS Published

16 Programa de Trabalho ISOTC 215 / WG4 WG 4 Security Ross Fraser, convener ITEM PROJECT LEADER DESIGNATION CURRENT STAGE Preliminary (Not yet ready for NWIP ballot) HI: Guidelines on data protection to facilitate trans-border flows of personal health information IS Preliminary HI: Guidance on the application of risk analysis and management across the health informatics domain TR Preliminary HI: Security aspects of EHR record migration TR Preliminary NWIP/DTR Ballot Active Items after NWIP Approval HI: Security and privacy requirements for compliance testing of EHR systems -Part 1: Foundation HI: Security and privacy requirements for compliance testing of EHR systems -- Part 2: Protection profile for small-scale electronic patient record systems L.Kiatake A. Pastorino N. Gardner L.Kiatake A. Pastorino N. Gardner TS TS HI: Classification of data purposes for processing of personal health information D. Kalra, E. Sawatsky TS HI: Application of clinical risk management to the manufacture of health software (name change 2007 Brisbane) Ray Rogers TS #29321 Passed NWIP ballot Passed NWIP ballot Passed NWIP ballot Failed DTS ballot HI: Guidance on the management of risk to ensure the patient safety of health software systems in deployment and use (name change 2007 Brisbane) Ray Rogers TR #29322 Failed DTR ballot Audit trails for Electronic Health records Luuc Posthumus IS #27789 Passed CD ballot DIS and FDIS Ballots HI: Directory Services for healthcare providers, subjects of care and other entities (renamed Brisbane) Lori Fourquet IS # Revision of TS Passed DIS ballot

17 Programa de Trabalho ISOTC 215 / WG4 Sending for Publication Health informatics - Dynamic on-demand virtual private network for health information infrastructure Health informatics - Information Security Management for Remote Maintenance of Medical Devices and Medical Information Systems - Part 1: Requirements and Risk Analysis Health informatics - Information Security Management for Remote Maintenance of Medical Devices and Medical Information Systems - Part 2: Implementation of ISMS Hiroshi Shimada; Kouichi Kita TR #11636 Hideyuki Miyohara TR # Hideyuki Miyohara TR # HI: Secure Archiving of electronic health records Part1 Principles and Requirements Pekka Ruotsalainen TS HI: Secure Archiving of electronic health records Part2 Guidelines Pekka Ruotsalainen TR Submitted to ISO CS for publication Submitted to ISO CS for publication Submitted to ISO CS for publication Submitted to ISO CS for publication Submitted to ISO CS for publication HC Info Privilege Mgmt & Access Control P-3 AC Mgmt B. Blobel TS Submitted to ISO CS for publication Published - Systematic Review HI: Privilege Mgmt and AC-1 Overview & Policy Mgmt B. Blobel TS Published HC Info Privilege Mgmt & Access Control P-2 Priv Mgmt B. Blobel/Klein TS Published

18 Programa de Trabalho ISOTC 215 / WG4 Published Health informatics Electronic health record communication Part 4: Security Dipak Kalra TS Published 2009 HI: Functional and Structural Roles Blobel-Fourquet-Klein TS Published 2008 Pseudonymisation Lori Fourquet TS #25237 Published 2008 HI: Information Security Mgmt in Health using ISO/IEC (name change 2007 Montreal and Brisbane) Fraser/Mynott IS #27799 Published 2008 HI: Public Key Infrastructure-1 Framework and Overview Fraser ISO Published 2008 HI: Public Key Infrastructure-2 Certificate Profile Fraser ISO Published 2008 HI: Public Key Infrastructure-3 Policy Mgmt of Cert Auth Fraser ISO Published 2008 Classification of Safety risks from health software Ray Rogers TS #25238 Published 2007 HI: Measures for Ensuring Patient Safety of Health Software - APSOHIP Ray Rogers # TR Published 2007 Health Informatics Public Key Infrastructure-1 TS Published Health Informatics Public Key Infrastructure-2 TS Published Health Informatics Public Key Infrastructure-3 TS Published Directory Services for security, communication and identification of professionals and patients. Lori Fourquet DTS #21091 Published GL on data protect to facilitate trans-border flow of p h i Rogers/Seaton IS Published

19 Programa de Trabalho ISOTC 215 / WG6 Ian Shepherd, Convener ITEM PROJECT LEADER DESIGNATION CURRENT STAGE Preliminary (Not yet ready for NWIP ballot) HL7 Structured Product Labeling standard Beeler/Hammond Failed HL7 Product Stability data standard Beeler/Hammond Failed NWIP/DTR Ballot HI: Requirements for the implementation of the standards for the identification of medicinal products for the exchange of regulated medicinal product information Tim Buxton TR#14872 On NWIP ballot ( ) Active Items after NWIP Approval Health informatics Pharmacovigilance Test names and units for reporting laboratory results (name change 2007 Brisbane) IS#11595 Passed NWIP ballot Business Requirements for the Reporting of Pharmacist Services Nigel Cox TR #10895 Passed NWIP ballot DIS and FDIS Ballots Health Informatics Identification of medicinal products Data elements and structures to uniquely identify medicinal products (MPIDs) for the exchange of regulated medicinal product information (name change 2007 Brisbane, 2009 Edinburgh) Health informatics Identification of Medicinal Products Data elements and structures to uniquely identify and exchange pharmaceutical products (PhPIDs) (name chage 2007 Brisbane, 2009 Edinburgh) Health informatics Identification of Medicinal Products Data elements and structures to uniquely identify and describe substances and specified substances (name change 2009 Edinburgh) Health informatics Identification of Medicinal Products Data elements and structures to uniquely identify pharmaceutical dose forms, units of presentation and routes of administration (name change 2009 Edinburgh) Health informatics Identification of Medicinal Products Data elements and structures to uniquely identify Units of Measurement (name change 2009 Edinburgh) Health informatics -- Pharmacovigilance - Individual case safety report -- Part 1: The framework for adverse event reporting (name change 2007 Brisbane) Health informatics -- Pharmacovigilance - Individual case safety report -- Part 2: Human pharmaceutical reporting requirements for ICSR IS#11615 IS#11616 IS #11238 IS #11239 IS #11240 IS# IS# Passed NWIP/CD ballot Passed NWIP/CD ballot Passed NWIP/CD ballot Passed NWIP/CD ballot Passed NWIP/CD ballot Failed DIS ballot Failed DIS ballot

20 Programa de Trabalho ISOTC 215 / WG7 WG 7 Devices Todd Cooper, Convener ITEM PROJECT LEADER DESIGNATION CURRENT STAGE To be submitted for Preliminary Health informatics Medical waveform format Encoding rules, DICOM-ECG Hirai NP/TS pre-preliminary Health informatics - Personal health device communication - Technical report - Overview Bogia NP/TR pre-preliminary Health informatics Medical waveform format Encoding rules, long term ECG Hirai NP/TS pre-preliminary HL7 Annotated ECG Waveform Data Standards Beeler/Hammond Failed Preliminary (Not yet ready for NWIP ballot) Health informatics Medical waveform format Encoding rules, Reporting with HL7 clinical document architecture (CDA) Hirai NP/TS Preliminary Health informatics Medical waveform format Encoding rules, SCP-ECG Hirai NP/TS Preliminary Health informatics Personal health device communication Device specialization Common framework Bogia NP/IS Preliminary Health informatics Point-of-care medical device communication Application profile Common networking infrastructure NP/IS Preliminary Health informatics Point-of-care medical device communication Transport profile Ethernet Schnell NP/IS Preliminary Health informatics Point-of-care medical device communication Transport profile RF wireless Local area network (wlan) NP/IS Preliminary HI: Point-of-care medical device communication Technical report Guidelines for the use of RF wireless technology Morrissey/Cooper p/nwip/ Preliminary Health informatics Medical waveform format Encoding rules, 12-lead ECG Hirai NP/TS Preliminary HI: Point-of-care medical device communication - Device specialization - Dialysis device Cooper/Torrini pnwip/ : Preliminary Health informatics - Personal health device communication - Device specialization Cardiovascular fitness and activity monitor Health informatics - Personal health device communication - Device specialization Strength fitness equipment HI: Application of risk management for IT-networks incorporating medical devices Guidance for health delivery organizations White NP/IS pre-preliminary White NP/IS pre-preliminary TR Preliminary

21 Programa de Trabalho ISOTC 215 / WG7 Active Items after NWIP Approval Health informatics - Personal health device communication - Device specialization Passed ballot White IS/ Medication Monitor 20 HI: Point-of-care medical device communication - Application profile - Optional package, Remote control Cooper/Reynolds DIS/ DIS HI: Point-of-Care Medical Device Communication - Framework & overview Harrington/Cooper IS/ DIS HI: POC Medical Device Communication - Application profiles MIB Elements Cooper/Wittenber IS/ DIS HI: Point-of-care medical device communication Application profile, Association Control Function Cooper/Steubesand IS/ DIS HI: Point-of-Care Medical Device Communication - Application profile, Polling Mode Cooper/Hassing IS/ DIS HI: Point-of-care medical device communication Application profile, Asynchronous Mode Cooper/Hassing IS/ DIS HI: Point-of-care Medical Device Communication - Application gateway, HL7 (v2) observation reporting interface Harrington/Cooper DIS/ DIS HI: Point-of-Care Medical Device Communication - Nomenclature Annotated ECG Brown/Schluter IS/ DIS HI: Point-of-care medical device communication - Nomenclature, Implantable Device, Schluter IS/ DIS DIS and FDIS ballots ISO/IEC Part 1: Application of Risk Management for IT -- Networks incorporating medical devices Health informatics Personal health device communication Device specialization Pulse oximeter Health informatics Personal health device communication Device specialization Blood pressure monitor Health informatics Personal health device communication Device specialization Glucose meter Health informatics Personal health device communication Device specialization Thermometer Health informatics Personal health device communication Device specialization Weighing scale Health informatics - Personal health device communication - Device specialization Independent living activity hub Health informatics Personal health device communication Application profile Optimized exchange protocol Cooper/Eagles Bogia Bogia Bogia Bogia Bogia White Bogia ISJWG/IEC # (changed from 28680) NP/IS NP/IS NP/IS NP/IS NP/IS NP/IS NP/IS On DIS ballot ( ) Passed 30 day Enquiry ballot Passed 30 day Enquiry ballot Passed 30 day Enquiry ballot Passed 30 day Enquiry ballot Passed 30 day Enquiry ballot Passed 30 day Enquiry ballot Passed 30 day Enquiry ballot

22 Programa de Trabalho ISOTC 215 / WG7 Published - Systematic Review Health informatics Point-of-care medical device communication Domain Info Model Reynolds/Cooper IS Published/IEEE Health informatics Point-of-care medical device communication Application Profile - Base Standard Reynolds/Cooper IS Published/IEEE Health informatics Point-of-care medical device communication Transport Profile - Infrared Wireless Reynolds/Cooper IS Published/IEEE Health informatics Point-of-care medical device communication Transport Profile - Cable Connected Reynolds/Cooper IS Published/IEEE Health informatics Point-of-care medical device communication Nomenclature Reynolds/Cooper IS Published/IEEE Published Items CEN en1064:2007, ISO Health informatics Standard communications protocol, ECG (SCP-ECG) HI: Point of care medical device communication - Part 90101: Analytical instruments- Point of care test Use of mobile wireless communication and computing technology in HC facilities recommendations for mgmt of electromagnetic interference with medical devices ISO/IEEE/ HI: Point-of-care medical device communication - Medical waveform format Encoding rules (formerly ) IS Published 2009 Cooper/Reynolds IS/ Published 2008 Morrissey TR# Published 2007 Hirai/Reynolds TS/ Published 2007

23 Programa de Trabalho ISOTC 215 / WG8 WG 8 Business Requirements for an EHR Convener - Marion Lyver Item PROJECT LEADER DESIGNATION CURRENT STAGE Preliminary (Not yet ready for NWIP ballot) HI: EHR standards Map David Rowlands Business Requirements for Public Health Standards Lyver TR Preliminary NWIP/DTR Ballot HI: ehealth enterprise architecture for emerging and developing countries - Part 1: Environmental Scan HI: ehealth enterprise architecture for emerging and developing countries - Part 2: Business Requirements Active Items after NWIP Approval B.Leao, P.Whitaker TR B.Leao, P.Whitaker TR On NWIP ballot ( ) On NWIP ballot ( ) Personal Health Records: Definition, Scope and Context Kalra/Datta TR Knowledge Management of Health Information Standards Andrew Grant TR Passed NWIP ballot Passed NWIP ballot DIS and FDIS Ballots Requirements for EHR reference architecture ISO#18308 EHR System functional model Gary Dickinson IS# On Second DIS ballot ( ) On FDIS ballot ( ) Sending for Publication Published Items HI: Business Requirements for Health Summary Records - Part 1: Requirements Marion Lyver TR Published 2009 HI: Business Requirements for Health Summary Records - Part 2: Environmental Scan Marion Lyver TR Published 2009 Requirements for EHR reference architecture TS Published 2004

24 Programa de Trabalho ISOTC 215 / Health card task force Health Card Task Force Task Force Chair, Open ITEM PROJECT LEADER DESIGNATION CURRENT STAGE Preliminary (Not yet ready for NWIP ballot) Study for the use of cards and other technologies in the health care area, not specified as patient data cards Frans Van Bommel TR Overview of National Healthcare Professional Card Projects and/or Plans Frans Van Bommel TR NWIP/DTR Ballot Active Items after NWIP Approval DIS and FDIS Ballots Patient Health Card Data Part 8 Links Van Bommel/Sembritzki IS Passed DIS ballot Sending for Publication Published - Systematic Review Patient Health Card Data Part 1 General Structure Hopkins IS Published Patient Health Card Data Part 2 Common Objects Hopkins IS Published Patient Health Card Data Part 3 Limited Clinical Data Hopkins IS Published Published Patient Health Card Data Part 6 Administrative Data Sembritzki IS Published 2008 Patient Health Card Data Part 5 Identification Data Sembritzki IS Published 2008 Patient Health Card Data Part 7 E-Prescription to Med Data Shepherd IS Published 2007 Health Cards - General Characteristics Kita IS Published 2006 Health Cards - Numbering System/Registration Procedure Kita IS Published 2006 Patient Health Card Data Part 4 Extended Clinical Data I. Emelin IS Published 2006

25 ABNT/Comissão de Estudo Especial de Informá=ca em Saúde - CEE- IS Fundada em Dezembro de 2006, espelho do Comitê ISO TC 215 Brasil se tornou membro P do ISO- TC 215 em agosto de 2007 e tem par=cipado desde então de todas as plenárias Em maio de 2010 a plenária será no Rio de Janeiro

26 ABNT/CEE- IS Grupos de Trabalho GT1 Conceitos e Modelos GT2/7 DisposiDvos e Interoperabilidade TELEMEDICINA GT3/6 Vocabulários Livelink GT4 Segurança GT5 Cartões GT8 Requisitos de Negócio do RES GT9 Harmonização

27 A=vidades da ABNT/CEE- IS Adoção de Normas A CEE- IS estuda as normas ISO existentes e escolhe as de relevância para o país; Cada GT traduz as normas sob sua responsabilidade; A tradução é subme=da à consulta pública interna, por 30 dias; Uma vez aprovada pela plenária da CEE- IS, a norma é subme=da à consulta pública nacional, por 30 dias; Após avaliação da consulta pública a norma é publicada e passa a ser uma NBR/ISO. Recursos Disponíveis para a CEE- IS Ferramenta de colaboração: Livelink (ABNT/ISO); Web- conferência (Adobe Connect), graças à Unifesp; Video- conferência para 8 cidades, nas plenárias, graças à Unifesp, RNP e Datasus.

28 Normas ABNT/CEE- IS publicadas Outubro/2009

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30 Trabalho Realizado pela CEE- IS Elaboração de Normas Estudo e Colaboração com Normas ISO Adpatação de Normas ISO à realidade brasileira Desenvolvimento de Normas NBR Iden=ficação do Sujeito da Atenção Estudo e Tradução Simultânea de normas relevantes

31 Padrões de Troca da Informação Como garan=r que a informação clínica coletada em um sistema possa ser transmi=da (interoperabilidade sintá=ca) e entendida pelo outro sistema?

32 architecture policy models structural roles func=onal roles purposes of use care se{ngs privacy record structure and context Ontology, Consistent Knowledge Management representa=on, Seman=c access interoperability and Quality and Governance interpreta=on EHR reference model data types near- pa=ent device communica=ons archetypes templates workflow guidelines care pathways con=nuity of care clinical terminology systems terminology sub- sets value sets and micro- vocabularies term selec=on constraints terminology binding to archetypes seman=c context model categorial structures terminology systems Dipak Karla,2008

33 HL7 Health Level Seven Troca de informações entre sistemas clínicos, financeiros e administra=vos Exemplos : envio de resultados laboratoriais, etc. Fundado em 1987, com mais de 1400 membros padrão ANSI em 1994 Mais u=lizado para comunicação com sistemas internos a organização Muito u=lizado nos Estados Unidos, Austrália e Nova Zelândia

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35 HL7 CDA R2 Norma=ve Edi=on 2005 CDA = Clinical Document Architecture Faz parte do padrão HL7 v3 Tem sido u=lizado no mundo inteiro Trata- se de padrão que permite a incorporação de qualquer documento clínico de forma estruturado ou não, num documento XML, definido pelo schema do CDA No Brasil a SMS- SP u=lizará para integração de sistema de laboratório clínico h_p://healthinfo.med.dal.ca/hl7intro/cda_r2_norma=vewebedi=on/

36 CDA Modelo de troca de qualquer documento clínico (sumário de alta, resultados de laboratório) Documentos legíveis por humanos e pelo computador (requisito obrigatório) Usado internacionalmente em grande escala Criação de Perfis e Guias de Implementação

37 CDA: Especificação para a troca de documentos clínicos Isto é um CDA Isto também é E isto E isto E isto E isto 37

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39 Quais os Padrões para o Telessaúde Brasil?

40 Hospitais, PS e PA Gestão Hospitalar S I H Regulação AE, SADT Regulação S I G A U B S

41 Padrões necessários para o Telessaúde ARQUITETURA DE SAÚDE Visão do todo Não aos sistemas ver=cais e isolados!!!! Terminologias Termos Estrutura e relacionamentos Codificação Conteúdo Funções específiocas Repositórios Transmissão / comunicação Mensagens, Objetos, XML Segurança Assinatura digital (ICP- Brasil) Legislaçao Objetos de Aprendizagem Brasil?

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44 Telessaúde Brasil e Padrões SOF e Teleconsultoria Padrões necessários - Iden=ficação Iden=ficação do NTS (Quem realizou o serviço de Telessaúde?) Qual profissional que respondeu a teleconsultoria e/ou SOF? Quem foi a unidade solicitante? (CNES) Quem foi o profissional solicitante?(cns)

45 Telessaúde Brasil e Padrões Teleconsultoria Que aspectos da Teleconsultoria desejamos armazenar? Para que funções? Cenários de uso Qual a importância desta informação para o processo assistencial / referência e contra- referência? Qual é o conjunto de dados que queremos? Como representá- lo? Como compar=lhá- lo?

46 h_p:// interop.nen.nl/publica=es/2860

47 Prioridades Definição e priorização dos casos de uso Adoção / adaptação / criação de padrões Desenvolvimento e MANUTENÇÃO dos diferentes PERFIS FERRAMENTAS bancos de teste cer=ficação Adoção de melhores prá=cas

48 Como definir os padrões a serem u=lizados? Especificações de Interoperabilidade Casos de uso (cenários de u=lização) Perfis Blocos intermediários de interoperabilidade Padrões Conjunto de padrões que se aplicam ao perfil

49 h_p://

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51 h_p://

52 Padrões para SOF Representação dos objetos de aprendizagem Uso de padrões abertos Ontologias disponíveis Integração com outras inicia=vas UNASUS

53 Repositório de Objetos de Aprendizagem Fonte: Ricard de la Vega1, Jordi Conesa2, Julià Minguillón2

54 Para discussão amanhã: cenários do Telessaúde Brasil?

55 Reflexões sobre padrões Necessidade de ampla discussão U=lização de padrões abertos Inves=mento em capacitação Vocabulários Procedimentos Medicamentos Segurança Qualidade de Serviço em Telessaúde O papel da CEE- IS Integração dos projetos nacionais

56 Knowledge is knowing that a tomato is a fruit. Wisdom is not pu{ng tomatoes in a fruit salad. Peter Kay Fonte: Charles Jaffe, MEDINFO 2010, Capetown, Setembro 2010

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