Non-patient File Sharing (NPFS)
2.2.1-current - ci-build

Non-patient File Sharing (NPFS), published by IHE IT Infrastructure Technical Committee. This guide is not an authorized publication; it is the continuous build for version 2.2.1-current built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/IHE/ITI.NPFS/ and changes regularly. See the Directory of published versions

## 1:47 Non-Patient File Sharing (NPFS) Profile

The Non-Patient File Sharing Profile defines how to enable sharing of non-patient files such as clinical workflow definitions, domain policies, and stylesheets. Those files can be created and consumed by many different systems involved in a wide variety of data sharing workflows.

The NPFS Profile describes a mechanism for sharing non-patient files; it does not require that the actors be able to process the contents of the files being shared.

The NPFS Profile specifies transactions for the sharing of files. Any file type can be shared using this profile; however, specific guidance is given for three types of files:

- Workflow Definitions: files which define the processing rules for a specific clinical/administrative workflow (see ITI TF-1: 30.4.1.1 “XDW Workflow Architecture”)

- Privacy Domain Policies: files which describe a specific privacy policy that applies to, or may be agreed to, by a patient (see ITI TF-1: 19.2 “Creating Patient Privacy Policies”)

- Stylesheets: structured documents that can be used by user-agents (e.g., Web Browsers) to render the content of an XML document

Local policies may extend the types of files that are being shared using NPFS and that can be classified using the metadata model described in this profile.

## 1:47.1 NPFS Actors, Transactions, and Content Modules

This section defines the actors, transactions, and/or content modules in this profile. General definitions of actors are given in the Technical Frameworks General Introduction Appendix A at https://www.ihe.net/resources/technical_frameworks/#GenIntro.

Figure 1:47.1-1 shows the actors directly involved in NPFS Profile and the relevant transactions between them. If needed for context, other actors that may be indirectly involved due to their participation in other related profiles are shown in dotted lines. Actors which have a mandatory grouping are shown in conjoined boxes.

Figure 1:47.1-1: NPFS Actor Diagram

Table 1:47.1-1 lists the transactions for each actor directly involved in the NPFS Profile. To claim compliance with this profile, an actor shall support all required transactions (labeled “R”) and may support the optional transactions (labeled “O”).

Table 1:47.1-1: NPFS Profile - Actors and transactions
Actors | Transactions | Optionality
--- | --- | ---
File Manager | Submit File [ITI-87] | R
Search File [ITI-88] | R
Retrieve File [ITI-109] | R
Update DocumentReference [ITI-89] | R
File Consumer | Search File [ITI-88] | R
Retrieve File [ITI-109] | O
File Source | Submit File [ITI-87] | R
Update DocumentReference [ITI-89] | O

### 1:47.1.1 Actor Descriptions and Actor Profile Requirements

Most requirements are documented in transactions (Volume 2) and Content Modules (Volume 3). This section documents any additional requirements on profile’s actors.

#### 1:47.1.1.1 File Manager

The File Manager stores files provided by the File Source and maintains related metadata. The File Manager responds to search and retrieve requests initiated by the File Consumer. The File Manager responds to metadata update requests initiated by the File Source.

#### 1:47.1.1.2 File Consumer

The File Consumer queries for file metadata meeting certain criteria, and may retrieve selected files.

#### 1:47.1.1.3 File Source

The File Source publishes and updates files produced by either the File Source or by other systems. It is responsible for sending files and related metadata to a File Manager. The File Source can send metadata update requests to the File Manager.

## 1:47.2 NPFS Actor Options

Options that may be selected for each actor in this profile, if any, are listed in Table 1:47.2-1. Dependencies between options when applicable are specified in notes.

Table 1:47.2-1: Not-patient File Sharing - Actors and Options
Actors | Option Name | Reference
--- | --- | ---
File Manager | No options defined | --
File Consumer | File Retrieve | Section 47.2.1
File Source | Update File Metadata | Section 47.2.2

### 1:47.2.1 File Retrieve Option

The File Retrieve Option enables a File Consumer to retrieve a file stored/managed by the File Manager.

A File Consumer that supports the File Retrieve Option shall support the Retrieve File [ITI-109] transaction.

### 1:47.2.2 Update File Metadata Option

The Update File Metadata Option enables a File Source to update the metadata of a file stored/managed by the File Manager.

A File Source that supports the Update File Metadata Option shall support the Update DocumentReference [ITI-89] transaction.

## 1:47.3 NPFS Required Actor Groupings

This profile does not mandate the grouping with other actors.

## 1:47.4 NPFS Overview

### 1:47.4.1 Concepts – distinguishing files from documents

The NPFS Profile uses the term “file” to mark a clear distinction from the IHE Document Sharing profiles.

A “file” represents a collection of information stored on a computer as one unit. For the purposes of this profile, a file is not patient-related, as it does not contain patient health identifying information. It may contain other sensitive information.

Other IHE profiles are used to share (using different sharing paradigms) information related to patients. In IHE terminology, such patient-specific content is a “document.”

### 1:47.4.2 Use Cases

#### 1:47.4.2.1 Use Case #1: Manage Stylesheets

A technician creates a stylesheet to render the XML of CDA® Laboratory Reports produced in all the Laboratory Information System (LIS) involved in the Healthcare Information Exchange (HIE). The technician wants to make the stylesheet available to all the LISs involved in the HIE so that they can search for the stylesheet and reference it as an XSL transformation of the Laboratory Report.

##### 1:47.4.2.1.1 Manage Stylesheets - Use Case Description

A Healthcare Organization desires to use a stylesheet for uniform rendering of XML Laboratory Reports produced within the organization. Mr. Black, a technician of the Healthcare Organization, creates the stylesheet. Then Mr. Black uses his File Source to publish the stylesheet file into a system that manages non-patient files (File Manager) using the Submit File [ITI-87] transaction. Now the stylesheet will be available to all the LISs involved in the organization.

A Laboratory Information System, according to the HIE policy, should be able to identify the stylesheet that can be used to render the CDA document.

Mrs. White uses the LIS to retrieve a patient’s CDA R2 Lab Report document from the HIE. The LIS also issues a query using the Search File [ITI-88] transaction, to search for a stylesheet file published by the HIE Organization, in order to discover the resource URL of the stylesheet applicable to the Laboratory Reports. This URL is used to reference it as an XSL transformation of the Laboratory Report.

##### 1:47.4.2.1.2 Stylesheet’s Management Process Flow

- The Health Information System acting as a File Source issues a Submit File [ITI-87] transaction to the File Manager to submit the stylesheet

- The LIS acting as a File Consumer issues a Search File [ITI-88] transaction to the File Manager, using the class parameter to search for stylesheets, and the author.identifier parameter to search for the organization that submitted the file. The query response contains the URL of the stylesheet, that will be retrieved using a Retrieve File [ITI-109] transaction.

Figure 1:47.4.2.1.2-1: Basic Process Flow in NPFS Profile for Stylesheets Management

#### 1:47.4.2.2 Use Case #2: Replace Privacy Policies

In this use case, the hospital’s privacy office creates files that describe the Privacy Policies that the patient can agree to. When a patient is admitted, the admitting nurse uses a NPFS File Consumer to search the File Manager for the current Privacy Policy files available.

Then, when the patient selects a Privacy Policy, the nurse uses a Basic Patient Privacy Consent (BPPC) Content Creator Actor (see ITI TF-1: 19) to create the patient’s Privacy Policy Consent document for the patient.

##### 1:47.4.2.2.1 Replace Privacy Policies - Use Case Description

A hospital’s privacy office defines a set of Privacy Policies that a patient can agree to. Mr. Blue, a hospital privacy office employee, creates a Privacy Policy file using the HIS. Using a Submit File [ITI-87] transaction, the application makes the file available to all the systems involved in his organization.

Mrs. Black, a nurse of the Goodcare Hospital, wants to search for the current valid Privacy Policy files that the admitting patient can agree to. She uses a combined BPPC Content Creator and NPFS File Consumer to issue a query, a Search File [ITI-88] transaction, to search for the current valid Privacy Policy files and retrieve them. One of the retrieved Privacy Policy files is used, by the BPPC Content Creator, to create the Privacy Policy Consent document that the patient can read and agree to.

Later, a legal health officer informs the Goodcare Hospital that one of the Privacy Policies has changed. Mr. Blue searches to discover the Privacy Policy file and its related metadata (including FHIR resource ids). He thus needs to replace the Privacy Policy file and uses an HIS to perform the Submit File [ITI-87] to replace the Privacy Policy by submitting a new one (linked to the original file via a replacement association, using the relatesTo parameter) and updating metadata for the previous Privacy Policy, changing its status to “superseded”.

This use case is different than Use Case #3 because here the original Privacy Policy file needs to be preserved (i.e., it is not overwritten).

##### 1:47.4.2.2.2 Privacy Domain Policies Process Flow

- The Health Information System, acting as a File Source, issues a Submit File [ITI-87] (create) transaction to the File Manager to submit the original Privacy Policy file and metadata.

- The HIS, acting as a File Consumer, issues a Search File [ITI-88] transaction to the File Manager. The File Consumer uses the class parameter and the status parameter to search for the metadata (i.e., DocumentReference Resources) for current Privacy Policy files. Once the DocumentReference Resource is found, the File Consumer issues a Retrieve File [ITI-109] transaction to the File Manager to retrieve the file.

- The HIS, acting as a File Source, issues a Submit File [ITI-87] (replace) transaction to the File Manager to submit the new Privacy Policy file and metadata, and update the metadata of the replaced file to “superseded” (deprecated). (The new DocumentReference Resource is linked to the previous one via a replacement relationship, using the relatesTo parameter; see ITI TF-2: 3.87.4.3.2)

Figure 1:47.4.2.2.2-1: Basic Process Flow in NPFS Profile for Privacy Policies management

##### 1:47.4.2.3.1 Manage change to Workflow Definitions - Use Case Description

An HIE decides to design the eReferral Process for all the participants involved in that workflow. Mr. Smith, a technician at Goodcare Hospital, records the process in a BPMN Workflow Definition file, and makes it available using the Submit File [ITI-87] transaction.

Dr. Jones, a specialist, uses her HIS to query for the BPMN Workflow Definition file produced by Goodcare Hospital related to eReferral workflow, using a Search File [ITI-88] transaction. The previously submitted Workflow Definition file is found and retrieved, and Dr. Jones can identify the next steps in the eReferral process.

Later the HIE decides that the Workflow Definition file submitted is no longer valid and wants to use a new Workflow Definition file, so it updates the previous file using the Submit File [ITI-87] transaction.

This use case is different than Use Case #2 because here the original Workflow Definition file does not need to be preserved so it is, in effect, overwritten.

##### 1:47.4.2.3.2 Workflow Definitions Process Flow

- The Health Information System acting as a File Source issues a Submit File [ITI-87] (create) transaction to the File Manager to submit the original Workflow Definition file.

- Later, to find the Workflow Definition in order to update it, the HIS acting as a File Consumer issues a Search File [ITI-88] transaction to the File Manage. The File Consumer uses the class parameter and the type parameter to search for Workflow Definitions related to eReferral workflow. Once the Document Reference Resource is found, the HIS issues a Retrieve File [ITI-109] transaction to the File Manager to retrieve it.

- The Health Information System, acting as a File Source, issues a Submit File [ITI-87] (update) to the File Manager to make available the newer Workflow Definition file and metadata (updating the previous resources on the File Manager).

Figure 1:47.4.2.3.2-1: Basic Process Flow in NPFS Profile for Workflow Definition Documents management

#### 1:47.4.2.4 Use Case #4: Update of file’s ownership

A technician creates a stylesheet to render the XML documents produced by document producers belonging to Hospital Hope. After some time, the same stylesheet also needs to be made accessible to Hospital Peace. In order to accomplish this task, the technician updates metadata that describe the file in order to extend the ownership also to Hospital Peace.

##### 1:47.4.2.4.1 Update of file’s ownership - Use Case Description

Hospital Hope desires uniform rendering of XML documents produced within the organization, so it creates a stylesheet file. Mr. Black, a technician of the Hospital Hope, creates the stylesheet. Then Mr. Black uses his File Source to publish the stylesheet file into a system that manages non-patient files (File Manager) using the Submit File [ITI-87] transaction. Now the stylesheet will be available to document producers belonging to Hospital Hope. According to the local policies, the technician needs to extend the ownership of this file also to Hospital Peace. In order to do that, Mr. Black executes an update of the DocumentReference associated with the stylesheet using the Update DocumentReference [ITI-89] transaction. Now the stylesheet’s DocumentReference reflects the ownership of Hospital Hope and Hospital Peace.

##### 1:47.4.2.4.2 Update of file’s ownership Process Flow

- The Health Information System acting as a File Source issues a Submit File [ITI-87] (create) transaction to the File Manager to submit the stylesheet

- The Health Information System acting as a File Source issues an Update DocumentReference [ITI-89] transaction to the File Manager to modify the DocumentReference.author list.

Figure 1:47.4.2.4.2-1: Basic Process Flow in NPFS Profile for Update of file’s ownership

## 1:47.5 NPFS Security Considerations

Non-patient files do not contain Patient Health Information (PHI), but they may contain other sensitive information such as physician reviews, work schedules, etc. In addition, those files can be used in conjunction with patient-related documents in order to satisfy clinical data consuming/sharing workflows. The reader should know that mistakes will be made, and these files may convey private information.

Although this profile does not require actors to audit the transactions that exchange non-patient files, grouping with an ATNA Secure Node or Secure Application is strongly encouraged in order to track file and metadata creation and update. For further considerations about Audit record refer to BALP profile.

User authentication/authorization represents another important factor to consider in order to avoid malicious creation/updating of files. Grouping NPFS actors with actors in the Internet User Authorization (IUA) Profile enables deployments to mitigate these security issues.

## 1:47.6 NPFS Cross Profile Considerations

None.