GP Systems Interface Requirements v1 - Draft11
GP Systems Interface Requirements v1 - Draft11
Programme Sub-Prog /Project Prog. Director Sub Prog/Proj Mgr Author GPSoC Technology Office Kemi Adenubi Mike Curtis Tim Tett / Danny Solomon
HSCIC-FNT-TO-TAR-0110.01
Version Date Status 11 16 February 2013 Draft FOR COMMENT
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Amendment History
Version draft 08 draft09 draft10 draft11 Date 29 Jan 13 1 Feb 13 6 Feb 13 16 Feb 13 Amendment History Amendments prior to release for comment to supplier community. Added section being explicit about the need to support internet-facing patient services. Updates following comments from Kemi Adenubi Clean version, updated diagrams, for distribution to supplier community for input and comment
Reviewers:
This document must be reviewed by the following (delegated as necessary). Name Tim Tett Brendan McEnroe Title / Responsibility GPSoC Technical Architect GPSoC Technical Architect Date Version
Approvals:
This document requires the following approvals: Name Mike Curtis Kemi Adenubi Title / Responsibility Lead Technical Architect for GPSoC GPSoC Programme Director Date Version
Distribution:
Reviewers and approvers plus GP System Supplier community.
Document Status:
This is a controlled document. This document is valid from: 16 February 2013 On receipt of a new issue, please destroy all previous issues (unless a specified earlier issue is baselined for use throughout the programme).
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Glossary of Terms:
Term NRD PDS Principal clinical system Subsidiary module RBAC UKTC RBAC UKTC Acronym Definition NRD PDS National RBAC Database a source of nationally defined roles and activities for system users. Personal Demographics Service a national application providing patient demographic data services Integrated system providing majority of clinical IT services within practices.
Functionality that can be provided by an independent supplier, that integrates with principal clinical system via Interface Mechanism. Can also be provided as part of an integrated principal clinical system. Role Based Access Control United Kingdom Terminology Centre responsible for the provision of clinical coding terminologies for use in Healthcare Systems including READ version 2, Clinical Terms Version 3 (CTV3) and SNOMED CT UK edition.
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Contents
1 Introduction .................................................................................................................................... 5 1.1 1.2 1.3 1.4 2 3 4 Audience ................................................................................................................................. 5 Document Scope ..................................................................................................................... 5 Document Overview ............................................................................................................... 6 Definitions ............................................................................................................................... 7
Background ..................................................................................................................................... 8 Requirements Overview ................................................................................................................. 9 System Requirements applicable to both Principal Clinical Systems and Subsidiary Modules .... 10 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 Audit ...................................................................................................................................... 10 Provenance ........................................................................................................................... 11 System Authentication .......................................................................................................... 11 System Context ..................................................................................................................... 11 Appropriate use of integration capability ............................................................................. 12 System Invocation ................................................................................................................. 13 Interface Management ......................................................................................................... 13 Error & failure handling ........................................................................................................ 14 Practice Population Data ...................................................................................................... 14
Principal GP System Requirements ............................................................................................... 16 5.1 5.2 5.3 5.4 User and other non-Patient Data.......................................................................................... 16 Patient Demographics ........................................................................................................... 17 Individual Patient Clinical Data ............................................................................................. 18 Supporting Patient Services .................................................................................................. 20
Subsidiary Module System Requirements .................................................................................... 21 6.1 6.2 6.3 6.4 User Authentication & Access Controls ................................................................................ 21 User Synchronisation ............................................................................................................ 21 Patient Demographic Data .................................................................................................... 22 Individual Patient Clinical Data ............................................................................................. 22
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1 Introduction
This document defines the interface requirements for GP systems. It defines the functional aspects of interface mechanisms that are required in order to support the integration between Principal Clinical Systems and Subsidiary systems, in order to deliver functionality to users within General Practice. Suppliers should be aware that there are commercial aspects to the provision and use of such interface mechanisms, that are provided separately.
This document is DRAFT and is currently provided to the supplier community for their comment.
1.1 Audience
The primary audience for this document is: Principal GP Clinical System suppliers Suppliers of Subsidiary Modules GP Practices and other organisations involved in the purchase of GP Clinical IT Systems may also be interested in the contents of this document.
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1.4
Definitions
The term interface mechanism means any mechanism by which any two systems (for example, a Principal GP system and a system delivering Subsidiary Module requirements) exchange data or otherwise integrate between themselves. It does not imply any particular technology and suppliers are free to adopt whatever technical method(s) they wish providing that the requirements are met. Where used in this document set, the keywords MUST, SHOULD and MAY are to be interpreted as follows: MUST: This word, or the terms "REQUIRED" or "SHALL", means that the definition is an absolute` requirement of the specification. SHOULD: This word, or the adjective "RECOMMENDED", means that there may exist valid reasons in particular circumstances to ignore a particular item, but the full implications MUST be understood and carefully weighed before choosing a different course. MAY: This word, or the adjective OPTIONAL, means that an item is truly optional. One implementer may choose to include the item because a particular implementation requires it or because the implementer feels that it enhances the implementation while another implementer may omit the same item. An implementation which does not include a particular option MUST be prepared to interoperate with another implementation which does include the option, though perhaps with reduced HSCIC-FNT-TO-TAR-0110.01 GP Systems Interface Requirements v1 - draft11.docx
Crown Copyright 2013
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functionality. In the same vein an implementation which does include a particular option MUST be prepared to interoperate with another implementation which does not include the option (except, of course, for the feature the option provides).
2 Background
Suppliers of Principal Clinical Systems to General Practice are required to provide integration capability via an interface mechanism(s). This interface mechanism enables separate third-party systems to access (in bulk, or at an individual patient level) demographic and clinical data held within the system. This includes both the ability to read from and write to the system for purposes such as: data extraction to support secondary uses, data entry from medical devices, integration with specialist software applications such as pathology requesting systems and document management systems. Suppliers of any subsidiary modules that interface to the Principal GP clinical system, and which store patient-specific clinical data, are also required to provide an interface mechanism to support 2way data exchange. The process by which these interface mechanisms are published, and made available for testing and development, is described elsewhere [TBD].
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3 Requirements Overview
The requirements in this document are technology neutral; they describe what an interface must provide and not how it is achieved. They are also data type neutral in that they do not specify any data formats or data types. However, there is an expectation that the data model used by the Principal GP Clinical system in any interface mechanism is the same as the data model used within the system, e.g. that an address comprises 5 lines of 35 characters, an NHS number is 10 digits, etc. The requirements in this version aim to achieve consistency across systems in the functions supported by interfaces.
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4 System Requirements applicable to both Principal Clinical Systems and Subsidiary Modules
Principal GP Systems must meet all the requirements in this section. The nature of each Subsidiary Module, and its intended and/or expected use, will determine which of the requirements within this section apply to a particular Subsidiary Module; in particular, a Subsidiary Module that stores personal data is required to support the requirements in this area. Interpretation note: If the system that meets these requirements is a Principal GP system, then the use of the word system means the Principal GP system and use of the phrase external system means a Subsidiary Module. If the system that meets these requirements is a Subsidiary Module, then the use of the word system means the Subsidiary Module and use of the phrase external system means a Principal GP system or an additional separate system that integrates with the Subsidiary Module.
4.1 Audit
Req ID AP4.1.01 Requirement Text The system MUST ensure that all uses of mechanisms to support integration capability are audited and that audit trials MUST be subject to the standard IG audit requirements around access, tamper resistance, retention, etc. (See IG Requirements for GP Systems ) The system MUST audit the following interface activity: Inbound requests or queries from external systems Outbound responses, including data, to external systems Inbound data writes (including logical deletions) from external systems Outbound data pushed to external systems or to holding areas for collection/use by external systems, including any activity not in response to a request/query (e.g. daily dump of demographic changes) Any other data changes made as a result of activity with external systems through interface mechanisms. AP4.1.03 The system MUST log all successful and unsuccessful (where possible) interface activity. Type MUST
AP4.1.02
MUST
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Req ID AP4.1.04
Requirement Text The system MUST audit all access and data changes within the system as a result of activity through an interface mechanism by an external system in the same way that internal access and changes are recorded. The system MUST include the identity of the external system in the audit data. This SHOULD include the product and the version number.
Type MUST
AP4.1.05 AP4.1.06
MUST
The system MUST, where a user initiates an exchange of data (as MUST opposed to a system event), include the external system user identity in the audit data. (Note: External system users must be synchronised with internal system users. See sections 5.1 User and other non-Patient Data and 6.2 User Synchronisation )
4.2 Provenance
Req ID AP4.2.01 Requirement Text All additions, amendments or deletions to administrative and clinical data made via an interface mechanism MUST be clearly identified at a data-structure level with information regarding the provenance of the data (e.g. timestamp, details of source system, details of user), so it is clear which information has been entered through an interface mechanism rather than the local system itself. Type MUST
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Req ID AP4.4.01
Requirement Text The system MUST provide mechanisms for external systems to be kept aware of the state of the system. This MUST not require any user intervention. The current system context information MUST include, where appropriate: The user The selected patient
Type MUST
AP4.4.02
MUST
AP4.4.03
The current system context information SHOULD include, where appropriate: Functional state (e.g. prescribing module selected, add appointment selected)
SHOULD
AP4.4.04
The current system context information SHOULD include, where appropriate: Data state (e.g. the drug selected, the problem/diagnosis selected)
SHOULD
AP4.4.05
MUST
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Req ID AP4.5.02
Requirement Text When a user initiates an action where it is known that the interface activity may cause adverse performance of either the system or the external system, the system MUST warn the user prior to the activity commencing of the possible consequences. The warning must allow them to continue or to cancel the action. If the user decides to continue, it SHOULD be possible1 to cancel or abort the activity before it has completed. If the system carries out non user-initiated actions/tasks that may affect either Principal GP system performance or Subsidiary system performance it SHOULD be possible for such actions/tasks to be scheduled to occur at times that reduce the impact on the Practice (e.g. to occur outside business hours).
Type MUST
AP4.5.03
SHOULD
AP4.6.01.1
MUST
It is recognised that, depending on the nature of the interface mechanism, it may not be possible to stop an activity in an external system.
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suppliers must only make such changes with the agreement of the Practice(s) using that interface and in co-ordination with any suppliers using that interface, so that arrangements can be made for a managed update which minimises loss of functionality to the Practice(s). It is also accepted that versions of interface mechanisms cannot be expected to be supported forever and that suppliers will want to manage deprecation of old interfaces. Management of such deprecations should be in agreement with Practices and suppliers using those interfaces. Req ID AP4.7.01 AP4.7.02 AP4.7.03 AP4.7.04 Requirement Text The version of the interface mechanism SHOULD be available to external systems as a function of the interface mechanism. The version identifier SHOULD be included in all data exchanges between the system and external systems. The system SHOULD support multiple versions of the same interface mechanism simultaneously. Any change to an interface mechanism MUST NOT cause an external system using that interface to fail. Type SHOULD SHOULD SHOULD MUST
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The use of such data upon leaving the system is covered by the IG requirements which place responsibility for this usage upon the Data Controller (The Practice). It is recognised that some suppliers may provide off-line data for reporting purposes in order to minimise the impact on operational systems.
Requirement Text The system MUST provide a mechanism to provide all the clinical data2 for all registered/active patients of a Practice to an external system. The system SHOULD provide a mechanism to provide all the clinical data for a defined subset/cohort of the registered/active patients to an external system. Information provided by these mechanisms MUST NOT be more than 24hrs old. Information provided by these mechanisms MUST be returned at a rate that is no slower than 10 minutes for every 1000 patients. Where a patients clinical data includes an attached/embedded file/document, the system MUST either include such files in situ in the data or separately. If provided separately the system MUST include a reference in the patient data extract that uniquely identifies the associated file so that the external systems can correctly re-build the association between file and clinical data item. The interface mechanism MUST support the ability to request data both with and without such attachments.
AP4.9.06
MUST
Sufficient data to enable an Subsidiary Module to browse/search the terminology data in order to add coded clinical data to patient records.
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AG5.2.02
MUST
AG5.2.03
MUST
AG5.2.04
SHOULD
AG5.2.05
SHOULD
AG5.2.06
MUST
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Requirement Text The system MUST provide a mechanism for all the clinical data of a selected patients clinical record to be retrieved by a 3rd Party system. The system SHOULD provide a mechanism for a subset of a selected patients record to be retrieved by a 3rd Party system. It SHOULD be possible to define a subset by: Effective/applicable date Date entry made Clinical code(s) Author(s) Data Type(s)4
AG5.3.04
The system MUST provide a mechanism for 3rd Party systems to add new coded clinical entries to the patient record held in the system without the need to invoke any (Principal GP system) user interface. It MUST be possible to add such entries to existing Problems, i.e. to a parent entry in the patient record.
MUST
AG5.3.05
MUST
To be defined by the supplier. May include data types such as problems, medication, document type (e.g. referral), appointment, etc.
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Requirement Text
Type It MUST be possible to add such entries as standalone unlinked clinical MUST entries. It MUST be possible to include attached files (documents) when adding a clinical entry. It MUST be possible to add a reference to an externally held file (document) when adding a clinical entry. The system SHOULD provide a mechanism for 3rd Party systems to add new Problems to the patient record without the need to invoke any (Principal GP system) user interface. The system SHOULD provide a mechanism for 3rd Party systems to (logically) delete entries previously added by the 3rd Party system. Any modification to patient clinical data as a result of interface activity that would, if made by a user of the system, result in an update to other data held in national systems (e.g. SCR, EPS, Choose and Book) MUST result in such changes being communicated to those systems in the usual manner. (i.e. the system MUST treat a change received via an interface mechanism as if it was a change made by a local user.) In an environment where the system provides information-sharing across clinical settings, data provided to 3rd Party systems SHOULD include all data (including that from other settings) that is visible to the principal system user. Where such data is provided to 3rd Party systems, it MUST be made clear to the 3rd Party system which data is managed within the principal clinical system, and which is visible as a result of informationsharing mechanisms. Information provided by the system to a 3rd Party system about a single patient by any of these mechanisms above MUST be up-to-date and SHOULD be returned within a timeframe appropriate to the user scenario being supported, i.e. it MUST NOT subvert the (3rd Party system) user experience or adversely affect the performance of the (Principal GP) system. MUST MUST SHOULD
AG5.3.10 AG5.3.11
SHOULD MUST
AG5.3.12
SHOULD
AG5.3.13
MUST
AG5.3.14
MUST
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Req ID AG5.4.01
Requirement Text The system MUST support the requirements of subsidiary modules that provide services to patients (such as online appointment booking, requesting repeat prescriptions, access to records, patient-clinician communication)
Type MUST
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AS6.1.02
MUST
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Req ID AS6.2.02
Requirement Text Such synchronisation, as a minimum, MUST include: Whether the user is active or inactive The user ID (as shared between the system for audit purposes) The users access rights so that access to appropriate functions/data is controlled within the system and when accessing data in the Principal GP system.
Type MUST
AS6.3.03
MUST
AS6.4.02
MUST