Fill - Free fillable REAL WORLD TESTING PLAN TEMPLATE (Office of the National Coordinator) PDF form

REAL WORLD TESTING PLAN TEMPLATE

BACKGROUND & INSTRUCTIONS

Under the ONC Health IT Certification Program (Program), health IT developers are required to conduct

Real World Testing of their certified health IT (45 CFR 170.405). The Office of the National Coordinator for

Health Information Technology (ONC) issues Real World Testing resources to clarify health IT developers’

responsibilities for conducting Real World Testing, to identify topics and specific elements of Real World

Testing that ONC considers a priority, and to assist health IT developers in developing their Real World

Testing plans.

Health IT developers have maximum flexibility to develop innovative plans and measures for Real World

Testing. As developers are planning how they will execute Real World Testing, they should consider the

overall complexity of the workflows and use cases within the care settings in which they market their certified

health IT to determine the approaches they will take. This Real World Testing plan template was created

to assist health IT developers in organizing the required information that must be submitted for each

element in their Real World Testing plan. While the use of this template is voluntary, health IT developers

may find it useful in preparing their Real World Testing plans. Health IT developers must submit one plan

for each year of Real World Testing (see resources listed below for specific timelines and due dates). ONC

does not encourage updating plans outside the submission timeline and will not post updates on the

Certified Health IT Product List (CHPL). If adjustments to approaches are made throughout Real World

Testing, the health IT developer should reflect these adjustments in their Real World Testing results report.

ONC expects that the Real World Testing results report will include a description of these types of changes,

the reasons for them, and how intended outcomes were more efficiently met as a result. While every effort

has been made to ensure the accuracy of restatements of 45 CFR Part 170, this template is not a

legal document. The official program requirements are contained in the relevant laws and

regulations. This resource should be read and understood in conjunction with the following

companion resources, which describe in detail many of the Program requirements referenced in

this resource.

• Real World Testing–What It Means for Health IT Developers – Fact Sheet

• Real World Testing Resource Guide – Coming Soon

• Real World Testing Certification Companion Guide

Health IT developers should also review the following regulatory materials, which establish the core

requirements and responsibilities for Real World Testing under the Program.

• 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT

Certification Program final rule, 85 FR 25642 (May 1, 2020) (ONC Cures Act Final

Rule)

o Section VII.B.5 — “Real World Testing”

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REAL WORLD TESTING PLAN TEMPLATE

TEMPLATE INSTRUCTIONS

The following template is organized by elements required to be submitted in the Real World Testing plan.

Each section provides a field for submitting responses and/or explanations for how the health IT developer

will address each required element in their Real World Testing approach. These fields serve as a

foundation of information required for developing a Real World Testing plan and can be expanded with

additional rows or columns to address the specific needs of the Real World Testing plan being submitted.

GENERAL INFORMATION

Plan Report ID Number: [For ONC-Authorized Certification Body use only]

Developer Name:

Product Name(s):

Version Number(s):

Certified Health IT Product List (CHPL) ID(s):

Developer Real World Testing Page URL:

JUSTIFICATION FOR REAL WORLD TESTING APPROACH

Provide an explanation for the overall approach to Real World Testing, including an outline of the approach

and how data will be used to demonstrate successful Real World Testing

i

.

All measures should reasonably align with the elements within a Real World Testing plan, the scope of the

certification, the types of settings in which the certified health IT is marketed, and other factors relevant to

the implementation of the certified Health IT Module(s). The justification should reflect how each element

within the plan is relevant to the developer’s overall strategy for meeting the Real World Testing Condition

and Maintenance of Certification requirements.

Note: A single Real World Testing plan may address multiple products and certification criteria for multiple

care settings.

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REAL WORLD TESTING PLAN TEMPLATE

-

STANDARDS UPDATES (INCLUDING STANDARDS VERSION

ADVANCEMENT PROCESS (SVAP) AND UNITED STATES CORE DATA

FOR INTEROPERABILITY (USCDI))

Both required and voluntary standards updates must be addressed in the Real World Testing plan. Real

World Testing plans must include all certified health IT updated to newer versions of standards prior to

August 31 of the year in which the updates were made.

Describe approach(es) for demonstrating conformance to all certification requirements using each standard

to which the health IT is certified. List each version of a given standard separately. For each version of a

standard submit the following:

 Identify standard versio

ns

 I

ndicate what certification criteria in which product(s) has been updat

ed

 I

f reporting for multiple products, identify the certification criteria that were affected by the updat

e

f

or each of the associated product

s

 C

HPL ID for each Health IT Modul

e

 M

ethod used for standard update (e.g., SVAP

)

 D

ate notification sent to ONC-AC

B

 I

f SVAP, date notification sent to customer

s

 M

easure used to demonstrate conformance with updated standard(

s)

 W

hich certification criteria were updated to USCDI and/or to which version of USCDI was t

he

c

ertification criteria updated

?

S

tandard (and version)

Updated certification criteria

and associated product

Health IT Module CHPL ID

Method used for standard

update

Date of ONC ACB notification

Date of customer notification

(SVAP only)

Conformance measure

USCDI updated certification

criteria (and USCDI version)

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REAL WORLD TESTING PLAN TEMPLATE

MEASURES USED IN OVERALL APPROACH

Each plan must include at least one measurement/metric that addresses each applicable certification

criterion in the Health IT Module’s scope of certification. Describe the method for measuring how the

approach(es) chosen meet the intent and purpose of Real World Testing.

For each measurement/metric, describe the elements below:

 Description of the measurement/metric

 Associated certification criteria

 Justification for selected measurement/metric

 Care setting(s) that is addressed

 Expected outcomes

Description of Measurement/Metric

Describe the measure(s) that will be used to support the overall approach to Real World Testing.

Measurement/Metric

Description

Associated Certification Criteria

List certification criteria associated with the measure and if updated to the 2015 Edition Cures Update

criteria.

Measurement/Metric

Associated Certification Criteria

Justification for Selected Measurement/Metric

Provide an explanation for the measurement/metric selected to conduct Real World Testing.

Measurement/Metric

Justification

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REAL WORLD TESTING PLAN TEMPLATE

Care Setting(s)

The expectation is that a developer’s Real World Testing plan will address each type of clinical setting in

which their certified health IT is marketed. Health IT developers are not required to test their certified health

IT in every setting in which it is marketed for use. Developers should address their choice of care and/or

practice settings to test and provide a justification for the chosen approach.

Note: Health IT developers may bundle products by care setting, criteria, etc. and design one plan to

address each, or they may submit any combination of multiple plans that collectively address their products

and the care settings in which they are marketed

List each care setting which is covered by the measure and an explanation for why it is included.

Care Setting

Justification

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REAL WORLD TESTING PLAN TEMPLATE

Expected Outcomes

Health IT developers should detail how the approaches chosen will successfully demonstrate that the

certified health IT:

1) is c

ompliant with the certification criteria, including the required technical standards

and vocabulary codes sets;

2) is exchanging electronic health information (EHI) in the care and practice settings for

which it is marketed for use; and/or,

3) EHI is received by and used in the certified health IT.

(from 85 FR 25766)

Not all of the expected outcomes listed above will be applicable to every certified Health IT Module, and

health IT developers may add an additional description of how their measurement approach best addresses

the ongoing interoperability functionality of their product(s). Health IT developers could also detail outcomes

that should not result from their measurement approach if that better describes their efforts.

Within this section, health IT developers should also describe how the specific data collected from their

Real World Testing measures demonstrate expected results. Expected outcomes and specific measures

do not necessarily have to include performance targets or benchmarks, but health IT developers should

provide context for why specific measures were selected and how the metrics demonstrate individual

criterion functionality, EHI exchange, and/or use of EHI within certified health IT, as appropriate.

Measurement/Metric

Expected Outcomes

SCHEDULE OF KEY MILESTONES

Include steps within the Real World Testing plan that establish milestones within the process. Include

details on how and when the developer will implement measures and collect data. Key milestones should

be relevant and directly related to expected outcomes discussed in the next section.

For each key milestone, describe when Real World Testing will begin in specific care settings and the

date/timeframe during which data will be collected.

Key Milestone

Care Setting

Date/Timeframe

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REAL WORLD TESTING PLAN TEMPLATE

Key Milestone

Care Setting

Date/Timeframe

ATTESTATION

The Real World Testing plan must include the following attestation signed by the health IT developer

authorized representative.

Note: The plan must be approved by a health IT developer authorized representative capable of binding

the health IT developer for execution of the plan and include the representative's contact information.

ii

This Real World Testing plan is complete with all required elements, including measures that address all

certification criteria and care settings. All information in this plan is up to date and fully addresses the health

IT developer’s Real World Testing requirements.

Authorized Representative Name:

Authorized Representative Em

ail:

Authorized Representative Phone:

Authorized Representative Signature:

Date:

i

Certified health IT continues to be compliant with the certification criteria, including the required technical standards and vocabulary

codes sets; certified health IT is exchanging EHI in the care and practice settings for which it is marketed for use; and EHI is received

by and used in the certified health IT. (85 FR 25766)

ii

https://www.federalregister.gov/d/2020-07419/p-3582

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