Implementation Guide BBS version 1.0.0-alpha.2

This IG is currently under development and can not be considered stable and ready for use. For questions and change requests regarding this IG, please create a ticket op the Servicedesk.

1 Introduction

1.1 Background

In 2018, the Dutch Association for Radiologists (NVvR) and the Dutch Association for Health Providers (VZVZ) released the collaborative document “Landelijke beschikbaarheid radiologische beelden voor zorgverlener en patiënt: functionele vereisten” (translates as “National availability of radiological images for the health professional and patient: functional requirements”)[1]. This document states that in 2016, for almost 1 out of 4 radiology patients, there is the potential need to exchange documents (radiology imaging studies and reports) between multiple healthcare professionals and/or referrers in different locations. It also states that the infrastructure used for information exchange in the Netherlands is currently not acceptable.

The current situation provides some local information exchange between affiliated healthcare providers but is a long way from the goal of a nationwide, fully integrated, document sharing infrastructure. Currently, it takes a lot of effort to transfer the documents of interest from one place to another, often needing manual intervention to do so.

Since the current infrastructure is not nationwide, the available documents might only represent a part of a patient’s complete dossier, meaning that the healthcare professional might be missing relevant and important information about the patient’s total history. This introduces a risk to the continuity of care and to patient safety.

The main objectives mentioned in [1] are:

1. Within 3 years it should be possible to access all the radiology imaging studies and reports belonging to a single patient, no matter where the information is stored, in the form of a timeline: each imaging study and report is an entry in the timeline ordered chronologically.
2. This timeline should be available to every authorized radiologist in their own workspot (work environment) regardless of where they are working at that time.
3. This single timeline should provide much-needed insight and overview to the radiologist treating the patient.
4. Access to any underlying imaging studies and/or reports of interest (retrieval to the radiologist workspot) should be possible by entry section out of the timeline.

1.2 About this document

This BBS (Dutch: Beeldbeschikbaarheid, English: Image Availability) implementation guide is a technical derivation of the aforementioned document between NVvR and VZVZ [1]. Additionally, input is also taken from “eHealth Network guideline on Medical imaging studies and imaging reports”[7] and “Definitief rapport praktijkbeoordeling beeldbeschikbaarheid en toelichting 1.0”[2].

The implementation guide does not define how the NVvR goal of a nationwide, fully integrated, document sharing infrastructure should be achieved from the current situation. It does describe the use of appropriate IHE document sharing profiles to assist in achieving the goal.

Inspiration for the choice of document sharing profiles has been taken from the IHE Multi-country Working Group “Recommendation on Standards Positioning for sharing imaging information at the national/regional level” [3] activities which defines three deployment architectures for document sharing:

1. A country (or a single stand-alone region) with a central document registry both with distributed PACS and or VNAs.
2. A country with federated regional document registries and regions with distributed PACS and or VNAs.
3. A country (or region) with a central document registry and a central VNA.

In all above architectures distributed or centralized Document Repositories should be possible.

The deployment architecture for the Netherlands will be a mixture of the MCWG deployment architectures 1 and 2; recommending the usage of the IHE document sharing profiles based on:

1. XDS-I.b: Cross-enterprise Imaging Document Sharing (1)
2. XCA-I: Cross-community Access of Imaging (2)
3. MHD/WIA: Mobile access to Health Documents / Web-based Image Access (1)

This document assumes reader familiarity with these IHE profiles. This document is not an introduction to XDS-I.b, XCA-I, MHD/WIA and will only focus on requirements from the IHE profiles, combined with the (NIHEMDS) metadata set for BBS, which are relevant for national use in the Netherlands.

This implementation guide is a supplement to the IHE document sharing profile descriptions intended to provide additional information for implementation/deployment needs in the Netherlands. This document is part of an evolving strategy, features will likely be added, adjusted and/or removed in future versions.

1.3 Glossary

Term	Description
Affinity Domain	An administrative structure containing various healthcare entities that have agreed to share clinical documents in the common infrastructure
Beeldbeschikbaarheid (BBS)	The Dutch name of this project, often abbreviated to BBS. Image Availability is the international name for this project.
BSN	The citizen service number (BSN) is a unique 9-digit personal number allocated to everyone registered in the Personal Records Database (BRP). Everyone who registers with the BRP is automatically given a BSN.
DICOM	Digital Imaging and Communications in Medicine is the international standard for medical images and related information. It defines the formats for medical images that can be exchanged with the data and quality necessary for clinical use.
Documents	Describes reports and/or images (via an image manifest / DICOM KOS object) which include patient identification, patient demographic details, author, creation date/time, content type and other metadata needed to define the source and provenance of the contained information.
FAIR	FAIR data refers to data that meet the following principles: Findability: Data should be easy to find and accessible with clear metadata and identifiers. Accessibility: Data should be openly available and retrievable by both humans and machines. Interoperability: Data should be structured in a way that allows integration with other datasets. Reusability: Data should be well-described and licensed for reuse.
FHIR	Fast Healthcare Interoperability Resources
IHE	Integrating the Healthcare Enterprise
Image Availability	The name of this project, in the Netherlands known as Beeldbeschikbaarheid (abbreviated to BBS).
Imaging Report (Report)	An imaging report reflects the observations and interpretations of one or more imaging studies. It usually contains elements such as the reason why the study is requested, relevant contextual medical information, the used modality and its settings, procedures and body localisations that were used, a description of the observations and findings, exposure information, conclusion and advice. An imaging report is signed off/approved by a senior diagnostic consultant and should not be changed thereafter.
Imaging Study (Image)	An imaging study comprises a set of objects, including images and other objects, that were made for a specific purpose and usually in response to a request from a healthcare provider. The Imaging Study does not include the Imaging Report (current scope is unstructured PDF report only).
Imaging Study Manifest (Manifest)	A document listing the key information about the content of an imaging study. It acts as a summary for the actual imaging study that is large (typically megabyte or gigabyte size) and complex (hundreds of data elements). It includes location pointers to its image content and organises this information according to the well-established model of an imaging study made of one or more series and each series made of instances or images.
HCIM	Health and Care Information models (HCIM) or Zorginformatiebouwstenen (ZIB's) are used to capture functional, semantic (non-technical) agreements for the standardization of information used in the care process.
MCWG	(IHE Europe) Multi-Country Working Group: a group of national (country) representatives sharing deployment experiences and best practices in imaging report and study sharing.
MedMij	MedMij is an initiative of the Dutch Patient Federation and was embraced as one of the five focus programs in 2015. The Healthcare Information Council then opted for the MedMij program. To make healthcare better, more affordable and more accessible, the Information Council is working on a sustainable information system for healthcare, in which healthcare data is exchanged securely and reliably. To this end, agreements, standards, and facilities are made, together with the participants of the Information Council.
Metadata	Metadata are information parameters that provide contextual information about the actual information within a document (or other information container). Examples are: date of event and/or publication, size in bytes, technical format, template, standard version, document version, author specialty, functional category et cetera.
MHD	IHE Mobile access to Health Documents
NIHEMDS	The NIHEMDS is the National IHE MetaData Set (Dutch: Nationale IHE MetaData Set)
NVvR	Nationale Vereniging van Radiologen: The Dutch Association of Radiologists
Studies	Grouping of images and reports relating to a single patient for a common diagnostic need.
SWF	IHE Scheduled Workflow
Timeline	A time-ordered representation of all the radiology encounters (visits) a patient has had. Each encounter produces some type of radiology information relating to the patient in the form of images and/or reports.
VZVZ	Vereniging van Zorgaanbieders voor Zorgcommunicatie: Dutch Association for Health Providers
WIA	IHE Web-based Image Access
XCA-I	IHE Cross-Community Access for Imaging
XDS-I.b	IHE Cross-Enterprise Imaging Document Sharing
XDS	IHE Cross-Enterprise Document Sharing
Zib	A Zib (Zorginformatiebouwstenen) defines a clinical concept in such a way that it can be used as a building block in various healthcare situations and information systems. ZIBs form the basis for the standardization of healthcare information.

Table 1.1 Glossary

2 Boundaries and relationships

This BBS implementation guide applies to the exchange of documents (imaging studies and reports) and other related information between radiology healthcare professionals in the Netherlands. It does not specify how documents and/or images are generated or stored, but rather how they are made available to other healthcare professionals. Therefore, healthcare professionals are not only responsible for the documents that are provided to the community, but also how their infrastructure is connected to the said community to provide cross-community access.

This version of the implementation guide only covers the exchange of radiology imaging studies and reports. It is, of course, realized that this is a limited scope. Future versions will include other imaging study and report types (examples: cardiology, pathology, encounter based imaging, etc).

All patients must be identified by a BSN (national patient identifier) with guidance on the use of the BSN in DICOM objects given in [6]. Only national citizens that have a BSN are in scope for this release.

Only PDF report document types are in scope for this release, other report document types (including DICOM SR documents) will be addressed in future releases.

No requirements are defined regarding the performance (bandwidth) of any network implementing the transport infrastructure. It is assumed that there are no network limitations on access (end-point addressing or firewall restrictions) to any actors, defined in the IHE profiles, needing to communicate with each other.

There is also an shared focus and effort being put in alignment with:

1. NvVR "Landelijke beschikbaarheid radiologische beelden voor zorgverlener en patiënt: functionele vereisten"
2. NEN 7541 Beeldbeschikbaarheid
3. TA Beeldbeschikbaarheid
4. eHN Guideline on Medical Imaging Studies and Reports
5. Xt-EHR - D7.2 Medical imaging studies and related imaging reports: EEHRxF, requirements and specifications for EHR systems
6. MyHealth@EU - Medical Imaging Studies (MIS)

The implementation guideline assumes that a generic infrastructure is available to provide for services like:

• Identification [NEN-7518] (of client and provider - who are you?)
• Authentication [NEN-7518] (establish that you really are who you say)
• Localization [NEN-7519] (where/what information known about the client and provider?)
• Consent [NEN-7517] (from the patient for the sharing of medical information)
• Authorization (what information are you allowed to access?)
• Addressing (digital address of provider or organization)
• Logging [NEN-7513] (audit trail - who did what, where, when and why?)