Telemedicina e eSaúde

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Telemedicine Standards Telemedicina e e-Saúde 2018/19 Pedro Brandão

References 2

• Sources are indicated by [RefSource] where the complete citation will be at the end • Insite citations will be From: CitationSource

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Standards

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Standards Based on Digital Imaging and Communications in Medicine (DICOM) Part 1: Introduction and Overview, National Electrical Manufacturers Association, 2018 [DICOM-INTRO]

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Objectives 5 • Facilitate imaging medical devices interoperability by specifying: o A set of protocols for network communication o The syntax and semantics of Commands and the protocol information o Data storage services that should be implemented by devices that implement the standard . Includes file formats and directories structure • Reuse international standards as possible • Define the requirements to be conformant with the standard

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DICOM – Does not specify 6

• Implementation details; • Set of capabilities and functionalities that a system with compliant devices should provide; • The test procedure or validation to be compliant with the standard o Only the requirements o Some other consortiums do (e.g.: Wi-Fi Alliance)

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DICOM – Standard parts 8

7. Message Exchange 8. Network Communication Support for Message Exchange

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Protocol Architecture 9

[DICOM-NET]

Medical imaging application DICOM Application Upper Layer Message exchange Service Boundary DICOM Upper Layer HTTP Protocol for TCP/IP

TCP/IP

Network

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Association request example 10

[DICOM-NET]

SAP – Service Access Point UL – Upper Layer ] TeleSaude 18/19 - Standards - pbrandao [d cc

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PACS 11

• Picture Archiving and Communication Systems • Composed of : o Acquisition device(s); o Communication network (secure); o Archive system(s); o Visualization stations; • DICOM is the standard that defines the communication and storage.

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12 [d cc] UMLS Unified Medical Language System Standards Based on UMLS Basics (tutorial) [UMLS-TUTORIAL]

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UMLS [UMLS-Tutorial] 13

• Enable the development of applications that understand biomedical language;

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UMLS Sources of data [UMLS-Tutorial] 14

• The Meta-Thesaurus has more than 100 vocabularies; o ~71.44% in English, with 25 other languages (including PT, 2.08%) (stats) o Concepts: 3,822,832 • Example: Atrial fibrillation ICD-9-CM AF NCI Thesaurus AFib MedDRA Atrial fibrillation (disorder) SNOMED Clinical Terms atrium; fibrillation ICPC2-ICD10 Thesaurus

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Categories [UMLS-Tutorial] 15

• Most important categories of the used dictionaries;

data from 2016

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Entry example [UMLS-Tutorial] 16

• Concept Unique Identifiers (CUI): a meaning of something. Associated with the several names of the concept. Identifier starts with C + 7 digits. C0018681 in the figure. • Lexical (term) Unique Identifiers (LUI): lexical variants. Identifier L+7 digits, example has 3 LUIs. • String Unique Identifiers (SUI): each “name” for the unique concept or string has a unique permanent identifier with S+7 digits. • Atom Unique Identifiers (AUI): sources of the strings/concepts from where the MetaThesaurus is built. Identifier A + 7 digits.

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Semantic [UMLS-Tutorial] 17

• Semantic types o High level categories o Ex.: Physiologic Function • Semantic relations o Relation between types o Ex.: disrupts

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Specialist Lexicon and tools [UMLS-Tutorial] 18

• English lexicon that includes biomedical terms and current words. With the information on: o Syntax o Morphology o Spelling • Tools: o Lexical variants generator o String normalizer o Word indexer

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SNOMED CT Systematized Nomenclature of Medicine Clinical Terms Standards Based on SNOMED Clinical Starter Guide July 2017 International Release, The International Health Terminology Standards Development Organisation [SNOMED-SG]

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SNOMED CT 20

• Aggregation of o SNOMED Reference Terminology (SNOMED RT) by the College of American Pathologists (CAP) o Clinical Terms Version 3 (CTV3) from the UK NHS • Composed by: o Concepts, terms and relationships

• Portugal is a member, represented by Centro de Terminologias Clínicas

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Hierarchies (examples) 21

• Clinical finding • Substance • Physical force • Staging and scales • Procedure • Pharmaceutical/biologic product • Event • Linkage concept • Observable entity • Specimen • Environment or geographical • Qualifier value location • Special concept • Body structure • Record artefact • Social context • Physical object • Organism • Situation with explicit context ] TeleSaude 18/19 - Standards - pbrandao [d cc

Granularity 22

Fonte [SNOMED-SG]

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Identifiers 23

• Concepts o Numerical Identifier Semantic tag  semantic category • Descriptions Uniquely o Numerical Identifier identifies a concept ConceptID 22298006: Fully Specified Name: Myocardial infarction (disorder) DescriptionID 751689013 Preferred term: Myocardial infarction DescriptionID 37436014 Synonym: Cardiac infarction DescriptionID 37442013

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Relationships 24

• Navigation • Kind-of-value • Aggregation • Additional • Definition • Qualification

Fracture of tarsal bone (disorder) IS_A Fracture of foot (disorder) FINDING SITE Bone structure of tarsus (body structure) ASSOCIATED MORPHOLOGY Fracture (morphologic abnormality)

See Summary#Relationships ] TeleSaude 18/19 - Standards - pbrandao [d cc

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Attributes define (examples): 25 • Clinical Findings • Procedures • Evaluation Procedures • Specimen • Pharmaceutical / biologic product • Explicit context • Events

• Physical objects See Editorial Guide 5.1.1 ] TeleSaude 18/19 - Standards - pbrandao [d cc

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Other nomenclatures

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ICD 27

• International Classification of Diseases • Defined by WHO o Current version 11 (18-June-2018) • For clinical and management use;

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ICPC-2 28

• International Classification Primary Care, 2nd Edition o 2018, 2e-v7.0 • WHO accepted the std for encounters’ reasons • It allows to classify: o Reasons for “meeting” (doctor visit) o Diagnostic o Procedure used

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WHO others 29

• ICF – International Classification of Functioning, Disability and Health • ICHI – International Classification of Health Interventions

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LOINC 30

• Logical Observation Identifiers Names and Codes o LOINC Version 2.65, 89 271 Terms • Released 2018-12-14 • Maintained by the Regenstrief institute • Defines codes to identify test results and clinical observations and measures. o On the context of HL7 and CEN TC251 messages • Allows the suggestion of new terms • Freely available.

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LOINC (cont.) 31

• Used by/compatible with other standards o HL7 (used by) o UMLS (maps to) o SNOMED (used with)

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MeSH 32

• Medical Subject Headings • Maintained by the national library of medicine from the USA • Defines an hierarchical structure of medical terms • Used to indexed medical articles; o Books, documents, audio-visuals

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HL7 33

• Health Level International 7 • Defines standards for the exchange, Application integration and search of health

information on an electronic format. Session • Supports the clinical practice and Transport management Network • + 2300 members Logic Physical • The 7 refers to the OSI layer

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HL7 34

• Promotes the interoperability between systems: o Functional Int.: information exchange o Semantic Int.: information usage • Divided in several working groups; • Technical committee for EHR • Standards freely available o HL7 Standards o Some restrictions

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Model 35 • RIM – Reference Information Model: o Object Model that identifies the life-cycle of the events carried by the messages; o Model shared by all domains, i.e., from all create their messages; o Based on the UML (Unified Modelling Language) methodology • HDF – HL7 Development Framework o Supports the extension of the semantic interoperability semantic to “all” medical information.

• Fast Healthcare Interoperability Resources (FHIR®) is on the way… ] TeleSaude 18/19 - Standards - pbrandao [d cc

[d cc] American Telemedicine association (ATA) Standards

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Guidelines 37

• Defined for/by several working groups • Core Operational Guidelines for Services Involving Provider-Patient Interactions o Contains the basic definitions for all other documents; o Defines the nomenclature (glossary), what are the technical, administrative and clinical standards;

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Home Telehealth Clinical Guidelines 38

• Defines terminology, • Criteria for patients, medical institutions, technologies • Interactive services, monitoring • From 2003

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Home Telehealth Clinical Guidelines Example 39

• Use of Sensor Technology Source [ATA-CLINICAL] o If a detached remote sensor is employed for a home communications unit the following is required: . Indication of out of range for wireless operation . Indication for low battery status . Indication that the sensor is working properly o The sensors should not damage or irritate the patient’s skin, and should not irritate the patient during sleep. o The sensors should not contain elements that pose a danger if chewed, licked or otherwise manipulated by the patient.

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Telehealth Practice Recommendations for Diabetic Retinopathy 40

• Defines: o Professional qualifications o Equipment specifications o Legal requirements o Validation o Quality control • From 2011

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Telehealth Practice Recommendations for Diabetic Retinopathy 41

Flow diagram for an ocular telehealth system [ATA-RECDIA]

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Other guidelines 42

• Practice Guidelines for Video-Based Online Mental Health Services, Aug 2009 • Quick Guide to Store-Forward Teledermatology and Live- Interactive Teledermatology, June 2017 • Evidence-Based Practice for Telemental Health Oct 2009 • …

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Guidelines for the Surgical Practice of 43 Telemedicine

• By the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) • With definitions, appropriate use, comments • Revised October 2010 o But currently not in publications site

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Example: 44 Telesurgery (Remote Surgery)

• Definition: o Surgery, procedure or intervention performed on an inanimate trainer, animate model, or patient, in which the surgeon or operator is not at the immediate site of the model or patient being operated upon. Visualization and manipulation of the tissues and equipment is performed using tele electronic devices. • Appropriate Use: o Demonstration and/or teaching technique or procedures using inanimate trainers as the objects of the procedure. o Demonstration and/or teaching techniques or procedures using animate model for purposes of testing technology. o Demonstration and teaching techniques or procedures on patients under strict guidance of an IRB and only when a qualified surgeon is present to intervene in a timely fashion if technical difficulties arise. • Comments: o Remote surgery remains investigational and should be performed with IRB approval and only by surgeons familiar with the technology. The introduction of telerobotic surgery, coupled with improvements in bandwidth and reduction in time has allowed for the remote safe completion of common surgical procedures (19-23). o ....

Fonte: [SAGES] ] TeleSaude 18/19 - Standards - pbrandao [d cc

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HON Code (Health on the net) Standards

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46 What is Source: http://www.hon.ch/

• “HONcode is the oldest and the most used ethical and trustworthy code for medical and health related information available on Internet. “ • Improve the information quality for health professionals and patients

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HONCODE Principles Source : http://www.hon.ch/ 47

• Principle 1: Authority • Principle 5: Justifiability o Give qualifications of authors o Ability to back claims • Principle 2: Complementarity • Principle 6: Transparency o Information to support, not replace o Accessibility, provide valid contact details • Principle 3: Confidentiality o Respect the privacy of site users • Principle 7: Financial disclosure o Provide details of funding • Principle 4: Attribution o Cite the sources and dates of medical • Principle 8:Advertising information o Clearly distinguish advertising from editorial content

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References – Standards 49

• [DICOM-INTRO] Digital Imaging and Communications in Medicine (DICOM) Part 1: Introduction and Overview, National Electrical Manufacturers Association, 2019 http://www.dicomstandard.org/

• [DICOM-NET] Digital Imaging and Communications in Medicine (DICOM), Part 8: Network Communication Support for Message Exchange, National Electrical Manufacturers Association, 2018

• [UMLS-TUTORIAL] UMLS Basics (tutorial)

• [SNOMED-SG] SNOMED Clinical Terms® Starter Guide January 2017 International Release (US English), The International Health Terminology Standards Development Organisation

• [ATA-RECDIA] Telehealth Practice Recommendations for Diabetic Retinopathy, American Telemedicine Association February 2011

• [ATA-CLINICAL] American Telemedicine Association’s “Home Telehealth Clinical Guidelines”

• [ATA-Process] Krupinski EA, Bernard J. Standards and Guidelines in Telemedicine and Telehealth. Healthcare. 2014;2(1):74-93. doi:10.3390/healthcare2010074.

• [SAGES] Guidelines for the Surgical Practice of Telemedicine (archived version on WayBack Machine)

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References – Standards – Sites 50

• American Telemedicine Association, Standards and Guidelines • I do Imaging, Free Software • OpenEHR

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Acronyms 51

• EHR – • HON – Health On the Net • ICD – International Classification of Diseases • ICF – International Classification of Functioning, Disability and Health • ICHI – International Classification of Health Interventions • ICPC – International Classification of Primary Care • IHE – Integrating the Healthcare Enterprise • LOINC – Logical Observation Identifiers Names and Codes • MeSH – Medical Subject Headings

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Acronyms 52 • PACS – Picture Archiving and Communication System • RCT – Randomized Controlled Trial • RIM – Reference information Model • RIS – Radiology Information System • SAP – Service Access Point • SNOMED CT – Systematized Nomenclature of Medicine Clinical Terms • UL – Upper Layer • UMLS – Uniform Medical Language System • WHO – World Health Organization ] TeleSaude 18/19 - Standards - pbrandao [d cc

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