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This page contains general information and links to the relevant sources for the Licensing and Terms and Conditions of Use of the Code Systems on which the MVC is based; it tries to help deploying countries by bringing them together in one single location.

For more detailed information contact the SDO (Standard Development Organization) or Institution directly.

The MVC

The MVC to be used by deploying countries in the CEF eHDSI is the evolution of the MVC developed in previous projects (epSOS and EXPAND); it is a collection of terms used within certain parts of the eHDSI pivot documents (either parts describing the patient demographics or the clinical problems, for example) based on standardised code systems such as ICD-10, SNOMED CT, ATC Classification system, EDQM Standard Terms, and UCUM.

Code System

Basic information

For more detailed information visit:

ATC Classification

The ATC Index/ATC Codes are copyright (c) of the WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway.

Use of all or parts of the materials require reference to the WHO Collaborating Centre for Drug Statistics Methodology. Copying and distributing for commercial purposes is not allowed. Changing or manipulating the material is not allowed. The complete content of the ATC Index should not be downloadable by external users.

The WHO Collaborating Centre publishes a new issue of the complete ATC Index plus DDDs every year; it is important therefore to specify which version is being used. The ATC/DDD Working Group meets two times per year, after which the new ATC Codes are published online until the regular annual update.

The WHO Collaborating Centre for Drug Statistics Methodology publishes the official ATC Index/ATC Codes only in English and Spanish; these are the only quality assure language versions.

https://www.whocc.no/copyright_disclaimer/
EDQM Standard Terms

The list of Standard Term was initially prepared by the European Pharmacopoeia Commission following a request from the European Commission to be used in marketing authorization applications, summary of products characteristics, labelling, and in electronic communications. Currently, it is the European Directorate for the Quality of Medicines and Healthcare (EDQM) of the Council of Europe, the organization responsible for continuing issuing the Standard Terms.

Originally, the list of Standard Terms was a printed publication, until the 5th Edition (December 2004), when it was published along with an online database. Since April 2008, the Standard Terms are only available as an online database. In 2014 the database was completely revised and in 2016 the current new version was released and includes now APIs (application programming interfaces or web services) to retrieve the content.

Access to the Standard Terms APIs is free of charge and without guarantee. It is stated that additional developments and maintenance of the API tools may occur, requiring and the service will become unavailable without previous notice. The use of the APIs service requires the necessary IT knowledge for their implementation according to the documentation provided.

The use of the web services implies the agreement to specific conditions. When data from the EDQM Standard Terms database is reproduced in any system or website, the conditions mentioned below apply:

  • "It must be clearly stated that the data is from the EDQM Standard Terms database (http://standardterms.edqm.eu), and that it is reproduced with the permission of the European Directorate for the Quality of Medicines & Healthcare, Council of Europe (EDQM).
  • The Standard Terms data must not be modified independently, and no other data may be represented as being part of Standard Terms. If any additional data is presented alongside, it must be made clear  that is does not originate from Standard Terms.
  • The date on which the data was retrieved from the Standard Terms database must be clearly stated, with a notice that the EDQM Standard Terms database is not a static list and content can change over time."

The Standard Terms are created in English after consultation with the Standard Terms Working Party and, where appropriate, adoption by the European Pharmacopoeia Commission. Translations are provided by relevant national authorities on an ongoing basis. Currently, the Standard Terms are available in 33 languages.

https://www.edqm.eu/en/standard-terms-590.html

https://www.edqm.eu/register/

HL7 vocabularies

HL7 owns copyrights of all vocabulary content from the HL7 Version 2 and Version 3 Vocabulary tables; although, HL7 allows its use and distribution subject to the provisions of a specific licensing agreement. The codes and text may be used without further license in all applications, databases, and derivative works except those that seek to circumvent, compete or replace the HL7 Vocabulary table values.

The HL7 Vocabulary Copyright and License grants permission in perpetuity, without payment of license fees or royalties, to use, copy, or distribute HL7 Vocabulary, for any commercial or non-commercial purpose, subject to the terms and conditions specified.

Those terms and conditions, state that users shall not use HL7 Vocabulary for the purpose of developing or promulgating a competing standard for use in data exchange messages or other health related standards. Neither shall  users change the meaning of any of the HL7 codes, neither the name of, or any contents of, any fields in the HL7 Vocabulary.

Users may add new fields or attach additional information to existing fields as long as the meaning of the existing concepts are not changed by such additions. They are allow as well to delete entries to deal with local requirements and to add locally defined value sets and code systems, with their associated codes and terms to the HL7 Vocabulary provided that the added code systems and registered value sets have a sponsor other than HL7.

HL7 Vocabulary content may be used in electronic messages  without the need to include the Copyright Notice and License or a reference to it in the message and without to include specific fields.

Users may incorporate portions of the HL7 Vocabulary into another vocabulary database or software program for distribution outside the user organization, provided that such database, software program, or computable representation includes the following fields: codeSystemId or Code system identifier (OID), conceptCode, and designation or printName. The following notice should also be included: "This product includes all or a portion of the HL7 Vocabulary, or is derived from the HL7 Vocabulary, subject to a license from Health Level Seven International. Your use of the HL7 Vocabulary is subject to this license, a copy of which is accessible through the following link: http://www.hl7.org/permalink/?VocabTables. The current complete HL7 Vocabulary is available through this link. The HL7 Vocabulary is copyright (c) 1989-2010, Health Level Seven International. All rights reserved. THE HL7 VOCABULARY IS PROVIDED "AS IS". ANY EXPRESS OR IMPLIED WARRANTIES ARE DISCLAIMED, INCLUDED, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE."

HL7 Governance and Operations Manual
ICD-10

WHO is the copyright holder of ICD-10 and can grant licenses for its use worldwide for commercial and non-commercial purposes.

There are three types of licenses granted by WHO:

  1. Licensing WHO classifications for commercial use
  2. Licensing WHO classifications for internal use within an organization
  3. Licensing WHO classifications for non-commercial use or research purposes

ICD-10 is available in print in the six official languages of WHO, Arabic, Chinese, English, French, Russian, and Spanish. In database format, only the English and French versions are available. Other translations of ICD-10 exist, but WHO does not publish them and cannot authorize their use. Users wishing to obtain those versions need to contact the relevant authorities - WHO facilitates a list of available languages.

http://www.who.int/about/licensing/Internettext_FAQ.pdf
LOINC

The LOINC Codes, LOINC Table (regardless of format), LOINC Release Notes, LOINC Changes File, and LOINC User's Guide are copyright (c) 1995-2017 of the Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee.

The LOINC panels and forms file; LOINC document ontology file; and the LOINC hierarchies, LOINC linguistic variants files, LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table (all subject to the copyright above with respect to the LOINC Codes and LOINC Table) are copyright (c) 1995-2017 of the Regenstrief Institute Inc.

All these Licensed Materials are granted permission in perpetuity to be used, copied, or distributed without payment of license fees or royalties, for any commercial or non-commercial purpose, subject to the terms and conditions specified in the Copyright Notice and License.

First, using LOINC Codes and Table should not pursue the development or promulgation of a different standard that will dilute the purpose of LOINC, i.e. providing a definite standard for identifying clinical information in electronic reports.

Additionally, users shall not change the meaning of any of the LOINC Codes, neither the name of, or any contents of, any fields in the LOINC Table. Although, it is permitted to the users to add new fields to the LOINC Table to attach additional information to existing LOINC records. It is possible as well to add or delete records from the LOINC table to deal with user's local requirements - provided that, if new records are added, all new entries must contain in the LOINC_NUM field a leading alphabetic "X", so they can be differentiated from the existing or newly released LOINC codes.

It is also not permitted to change the content or the structure of the LOINC document ontology file, or the LOINC panels and forms file.

The use of LOINC Codes and other information from the LOINC Table in electronic messages containing laboratory test results and clinical observations does not require the inclusion of the Copyright Notice and License; even more, it is not required to include a set of defined fields. It is only encouraged that when the LOINC Code (from the LOINC_NUM field) is included in the message, to also add the corresponding LOINC short name or the LOINC long name, when the message provides a space for a text name representation of the code.

Users may incorporate portions of the LOINC Table into another master term dictionary or software program for distribution outside of the user's organization, provided that such master term dictionary or software program includes the following fields in their entirety from the LOINC Table: LOINC_NUM, COMPONENT, PROPERTY, TIME_ASPCT, SYSTEM, SCALE_TYP? METHOD_TYP, STATUS, and SHORTNAME. Users are also required to include a specific notice (see Section 9 of the LOINC Copyright Notice and License for the text).

It is possible to translate the Licensed Materials into a language other than English and shall be notified to the Regenstrief Institute, Inc. via email at loinc@regenstrief.org. Translations constitute derivative work and users agree to assign all right, title, and interest in and to such derivative work to the Regenstrief Institute, Inc. and the LOINC Committee in the case of translations of the LOINC Codes. Translations shall be electronically transmitted to the Regenstrief Institute, Inc., who will make publicly available all linguistic variants (credit will be given on the LOINC website to the user and/or entity responsible for the translations).

https://loinc.org/license/

https://loinc.org/faq/basics/

SNOMED CT

Using SNOMED CT always requires a license. The purpose of the license is to protect the intellectual property of SNOMED International and its Members and to fairly share the costs of maintaining and continuing to enhance SNOMED CT.

For the eHDSI Project and up to December 31, 2017, SNOMED International agreed on the use at no cost of a number of SNOMED CT concepts (those included in the epSOS MVC). After this date, deploying countries require an Affiliate License to be able to continue using SNOMED CT in the context of the CEF eHDSI cross-border services - i.e. to be used inside the NCPeH and to display SNOMED CT coded data to healthcare professionals.

The SNOMED CT Affiliate License Agreement covers worldwide use of the SNOMED CT International Release and is required by all those developing, maintaining, and/or distributing any type of system, application, or service that incorporates or uses SNOMED CT.

Regarding the limitations and obligations of the Affiliate License:

  • Affiliate Licensees wanting to translate SNOMED CT content need additional formal permission from SNOMED CT. The reason for this requirement is the concern from SNOMED International to protect the quality and ownership of SNOMED CT; that is why usually only Members of SNOMED CT are permitted to undertake translations of the terminology.
  • Affiliate Licensees using SNOMED CT in non-Member countries are required to notify SNOMED International prior to start using the terminology as well as reporting and paying fees for use. The Affiliate is required to submit to SNOMED International an annual report of usage in non-Member countries, indicating the hospitals and practices in each non-Member countries where SNOMED CT is used by them or by their sublicensees. Based on the report, the Affiliate is required to pay fees for usage in non-Member countries. Fees are calculated based on the wealth of the country as determined by World Bank Metrics.

To obtain an Affiliate License, an organisation may do it:

  • from the National Release Center (NRC) in a Member country
  • or centrally from SNOMED International

If the organisation requesting the Affiliate License has a primary place of business in a Member country, it is encouraged to obtain the license from the Member country as this will ensure they will be informed of any National Extension or requirements. On the other hand, organisations from non-Member countries or in Member countries whose NRC does not provide its own licensing service, should obtain their license directly from the central membership licensing and distribution service provided by SNOMED International at https://mlds.ihtsdotools.org/ - the registration on this central service is also needed in the case of obtaining the license from a Member country.

It should be noted that, wherever a SNOMED CT Affiliate License is obtained, the terms of the License Agreement are the same and in all cases the agreement is between the Affiliate Licensee and SNOMED International.

This link provides information about SNOMED International Members in the EMEA Region indicating whether they possess a licensing system and distribution system as well as contact details.

A special case is the licensing regarding browsers that provide access to SNOMED CT. Organisations providing browsers giving access to SNOMED CT content must be SNOMED International Affiliates and comply with the Affiliate License Agreement; users need to accept a sublicense before they use the browser. In general, all tools providing access to SNOMED CT shall display information about the version of the SNOMED CT International Release and information about any extensions included. Additionally, it should be indicated the possibility to access the current release through the browser provided by SNOMED International. All browsers or software tools that include or provide access to SNOMED CT do so by permission of the SNOMED International subject to the terms of the SNOMED CT Affiliate License Agreement. The use of publicly available software and tools that include or provide access to SNOMED CT is governed by the conditions of the sub-license issued by the provider of the software. Unless otherwise stated in the sublicense a number of conditions apply (see "Conditions of Use when accessing SNOMED CT with publicly available browser and software").

http://www.snomed.org/snomed-ct/get-snomed-ct

https://mlds.ihtsdotools.org/

http://www.ihtsdo.org/resource/resource/117

https://confluence.ihtsdotools.org/display/DOC/SNOMED+CT+Browsers+-+Online

UCUM Codes

The UCUM Codes, UCUM table (regardless of format), and UCUM Specification are copyright (c) 1999-2009 of the Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization, collectivelly referred to -in the Copyright Notice and License- as The Organization.

The use of those Licensed Materials (UCUM Codes, UCUM Table, and UCUM Specification) is permited in perpetuity, without any payment of license fees or royalties, as well as copying or distributing them, provided that the terms and conditions specified are followed.

Importantly, The Organization stipulates that, to prevent the dilution of the purpose of the Licensed Materials, which is the provision of a definitive standard for identifying units of measures in electronic documents and messages, users shall not use them with the aim of developing or promulgating a different standard for identifying the units of measure. Additionally, the Licensed Materials cannot be modified by the users neither can the users distribute modified versions of the UCUM Table or the UCUM Specifications.

UCUM Codes and other information from the UCUM Table may be used in electronic messages to communicate measurements without the need to include the Copyright Notice and License or a reference to it in the message.

Parts of the UCUM Table and definitions may be incorporated into another master term dictionary or software program  for distribution outside the user's organization, provided that such master term dictionary or software program includes a specific notice (see Section 7 of the UCUM Copyright Notice and License for the text).

 http://unitsofmeasure.org/trac/wiki/TermsOfUse
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