ICSA Labs

ONC Health IT Certification Program

Product Update Form

October 18, 2017

www.icsalabs.com


ICSA Labs

ONC Health IT Certification Program

Product Update Form

Instructions

Overview of the Requirements

This form must be submitted as necessary for product updates or other changes to the product as they occur, when changing a product name after certification has been granted, when requesting certification inheritance of criteria previously successfully tested, or requesting that previous versions of a product be hidden from the CHPL listings. Please be advised that any of the data submitted as part of or along with this form may be made publicly available by the ONC or ICSA Labs.

Completing this Form

Ø  All required fields must be completed. Incomplete forms will not be accepted.

Ø  All supporting documentation and a high level change log must be included for any products that have been updated. It can also provide evidence to help expedite the review process and assist ICSA Labs staff when making a determination of whether to retest the product, where applicable.

Ø  All documentation must be submitted using the following naming convention. The filename must include your customer name or customer ID at the beginning of the filename and the submission date at the end. For example, if your customer ID is 123456 and you are submitting a document on September 30, 2016, the filename would read 123456_Product Update Form_2016.09.30. All supporting documentation must be specified by filename in the appropriate field of the form.

Ø  Once your form has been submitted, it will undergo a review. If deficiencies are found during the review, you will be notified and asked to submit a revised form. When submitting revisions, be sure to update the date in the filename of all submitted documents. The new date should reflect the date that the materials were submitted.

Ø  If you need to make any changes to a previously approved form you must notify ICSA Labs immediately.

Please contact us if you have any questions as you complete this form or any of the supporting materials.

Submitting this Form

You must submit this form and all supporting documentation via the Certification Body File Upload web page then send an email to with the name of the file or files you uploaded.

Section 1: Developer Updates

The following information is required for all developers who have changed their organization name or other organization information, including for instances of mergers, acquisitions, and corporate name changes.

1.1 / Former Developer Information
Select this box if there are no changes or updates to the existing developer information then skip to Section 2.
1.1.1 / Former Organization Name
1.1.2 / Former Customer ID
1.1.3 / Applicable Certification IDs
1.2 / New or Updated Developer Information
All of the following fields are required.
1.2.1 / Organization Name
1.2.2 / Organization website
1.2.3 / Address Line 1
1.2.4 / Address Line 2
1.2.5 / City
1.2.6 / State
1.2.7 / Zip
1.2.8 / Country
1.3 / Reason for the Change
The following field is required.
1.3.1 / Provide the reason for the organization name change (e.g., merger, acquisition, etc.)
1.4 / Changes to Existing CHPL Listings
In some cases an organization may continue to operate as an independent identity under the new organization, and therefore may want to continue to list their existing certified products under the original developer information. Please select from the options below to indicate your preferences for how existing certifications will continue to be listed on the CHPL web site.
1.4.1 / Select one of the options below:
Select this box if existing certified Health IT products listed on the CHPL should retain the original developer information.
Select this box if existing certified Health IT products listed on the CHPL should be updated with the new or updated developer information.

Section 2: Contact Information Updates

This section is required to be completed if you would like to update your contact information. It is also required if you are changing your organization name (see previous section) due to an acquisition or merger.

2.1 / Primary Contact
Select this box if there are no changes or updates to the primary contact information previously submitted to ICSA Labs then skip to Question 2.2.
2.1.1 / First Name
2.1.2 / Last Name
2.1.3 / Title
2.1.4 / Email Address
2.1.5 / Phone
2.2 / Technical Contact
Select this box if there are no changes or updates to the technical contact information previously submitted to ICSA Labs then skip to Question 2.3.
2.2.1 / First Name
2.2.2 / Last Name
2.2.3 / Title
2.2.4 / Email Address
2.2.5 / Phone
2.3 / Marketing Contact
Select this box if there are no changes or updates to the marketing contact information previously submitted to ICSA Labs then skip to Section 3.
2.3.1 / First Name
2.3.2 / Last Name
2.3.3 / Title
2.3.4 / Email Address
2.3.5 / Phone

Section 3: Certified Health IT Product Updates

The following information is required for all developers who have updated a certified Health IT Module. Certification is granted to the specific product and version tested. It is normal for Health IT products to be updated during the software product’s lifecycle, and it is possible for a product to be changed or updated and inherit certification. Complete this section to report if any changes or updates have been made to the product that affects certified functionality.

Ø  Changes and updates (including no changes) must be reported to ICSA Labs at a minimum quarterly.

3.1 / Existing Certified Health IT Module
Identify the product certification you have updated. If the product has multiple certifications listed on the CHPL web site you should only list the most recent one.
Select this box if there are no product updates to report then skip to Section 4.
3.1.1 / Product Name
3.1.2 / Version
3.1.3 / Product Certification ID
3.1.4 / Certification Edition / Select one2014 Edition2015 Edition
3.1.5 / Certification Scope / Select oneModularCompleteN/A (2015 Edition Certification)
3.1.6 / Product Classification / Select oneAmbulatoryInpatientAmbulatory + InpatientN/A (2015 Edition Certification)
3.2 / New or Updated Product Information
3.2.1 / New Product Name
(leave blank if no change)
3.2.2 / New Version
(leave blank if no change)
3.2.3 / Change Type (select all that apply):
Major change (architectural changes, user interface overhauls, significant changes to certified functionality)
Changes to Safety Enhanced Design Criteria (indicates changes to criteria with associated safety enhanced design requirements) Please submit updated usability attestation documents.
·  2014 Edition criteria affected: a(1), a(2), a(6), a(7), a(8), a(16), a(18), a(19), a(20), b(3), b(4), b(9)
·  2015 Edition criteria affected: a(1), a(2), a(3), a(4), a(5), a(6), a(7), a(8), a(9), a(14), b(2) and b(3)
Minor change (adding alternative workflows, new features or small adjustments to product performance capabilities and user interface)
Maintenance (bug fixes or patches)
Other (specify):
3.2.4 / Briefly describe the scope and type of changes for this updated product and version compared to the previously certified product and version. Identify the names of any files submitted as supporting evidence. Examples may include:
·  Release notes
·  High-level software change logs
·  Excerpts from user/admin manuals
·  Screenshots
·  Generated files (CCDA XML, HL7 immunization messages, etc.)
3.2.5 / Describe how previously tested and certified criteria were affected by the update, if applicable.

Section 4: Removal of Certified Health IT Modules from CHPL

The following information is required for all developers who would like to remove or ‘withdraw’ a Certified Health IT Module from the CHPL web site.

4.1 / Withdrawal of CHPL Listing
Certified Health IT Modules that are no longer in use by eligible providers or hospitals, are no longer supported, or are no longer maintained in production can be removed or ‘withdrawn’ from the CHPL. Products that customers will be using for attestations should not be withdrawn. Complete this section to report any Certified Health IT Modules listed on the CHPL that should be withdrawn.
Select this box if there are no Certified Health IT Modules you would like to have withdrawn from the CHPL then skip to Section 5.
4.1.1 / List any Certified Health IT Modules that you wish to have withdrawn by their Certification ID.
4.1.2 / Provide the reason for removal.

Section 5: Signature Page

The Signature Page is required to be completed by an authorized representative of the organization submitting the above information prior to each form submission. Completing and submitting this page attests to the accuracy of the statements provided above.

Submitter’s Name:

Ø  This field must include the name of the individual responsible for collecting and submitting the above information to ICSA Labs. The applicant name should be typed in text format. A handwritten signature is not required.

Date Submitted:

Ø  This field must include the date this document was submitted to ICSA Labs and should be updated with each subsequent submission.

Next Steps

You must submit this form and all supporting documentation via the Certification Body File Upload web page then send an email to with the name of the file or files you uploaded.

Be sure to include your customer name or customer ID at the beginning of the filename and the submission date at the end. Upon receipt of this form and any additional supporting documentation, ICSA Labs will review the document for completeness and to identify any questions or concerns.

DO NOT DOCUMENT BELOW THIS LINE *FOR ICSA LABS STAFF ONLY*

Product Update Form APPROVED

Product Update Form APPROVED – pending further testing required as specified below

Product Update Form REJECTED – incomplete or insufficient evidence

Product Update Form REJECTED – reason specified below

Please document the reason for the rejection, any required conditions, or other notes below.
Reviewed by:
Name / Title / Date

Page 4 of 9 Document Version 3.4

©2016-2017 ICSA Labs. All rights reserved. Effective date: October 18, 2017

Printed copies are not controlled and may not be official.