- What is Infoway Certification Services?
- What are the objectives of Certification Services?
- How can I assess my product's ability to meet Infoway's certification criteria before formally committing to the application process?
- Which technology classes does Infoway offer pre-implementation certification for?
- What are the criteria against which solutions are assessed?
- How does the certification process work?
- What do I have to submit and demonstrate to gain Infoway pre-implementation certification?
- Are there fees for pre-implementation certification?
- Does Infoway publish the names of vendors that are going through the certification process?
- What happens if my product does not meet Infoway certification?
- How do I market my certified product?
- What is the term for Infoway certification?
- What is involved in maintaining my health information technology solutions certification?
- Where can I find information on products that have been certified by Canada Health Infoway?
- Where can I find further information on pre-implementation certification services?
- How does Infoway pre-implementation certification relate to other licenses and evaluations?
A.: Pre-implementation certification is a national process to certify trusted, standards-based solutions for a variety of health information technology solutions
A.: The objectives are to:
- Provide a national program to reduce the cost and risk to vendors and purchasers of health information technology solutions in Canada
- Promote the use of trusted, interoperable health information technology solutions in the Canadian marketplace
- Ensure standards-based solutions are uniformly applied across the country
A.: All of the assessment criteria against which your product will be assessed are available for review prior to making any certification commitments. Furthermore, Infoway will provide guidance to help you understand the assessment criteria and respond to any of your questions.
Infoway wants you to be successful and encourages you to submit the application package, along with the non-refundable certification fee, once you are confident that your product complies with all of the stated criteria. Please keep in mind that 100 per cent compliance is required for certification.
Infoway offers pre-implementation certification for the following technology classes:
- Ambulatory Electronic Medical Record (aEMR)
- Client Registry
- Consumer Health Application
- Consumer Health Platform
- Diagnostic Imaging (DI)
- Drug Information System (DIS)
- Electronic Medical Record (EMR)
- Immunization Registry
- Provider Registry
A.: The standards used in the Certification Service include:
- Privacy: Canada Health Infoway Electronic Health Record Infostructure (EHRi) Privacy & Security Conceptual Architecture; The Canadian Standards Association's Model Code for the Protection of Personal Information (CAN-CSA-Q830-03).
- Security: Canada Health Infoway Electronic Health Record Infostructure (EHRi) Privacy & Security Conceptual Architecture; The International Organization for Standardization's Code of Practice for Information Security Management - ISO 17799:2005; ISO 27001 - Information Security Management Systems Requirements; ISO 27002 - Code of Practice for Information Security Management; ISO 27799:2008 - Information Security management In Health .
- Interoperability: Health Level Seven International's - HL7v3, HL7v2, HL7 Clinical Document Architecture, Release 2, Canada Health Infoway pan-Canadian Standards and Conformance Profile Definitions for laboratory, drug, shared health record, and demographic information.
- Management: The Canadian Standards Association's Risk Management: Guideline for Decision Makers - CAN-CSA-Q850-97; The Information Systems Audit and Control Association's Control Objectives for Information and Related Technology (COBIT).
A.: A vendor wishing to certify their product shall self assess and provide evidence indicating compliance with the assessment criteria. Evidence is provided through attestations, supporting documentation and demonstration of the product. Certification is a four-step process: apply, assess, certify, maintain. The assess process extends over a 90-day period once Infowayreceives a completed application package. Click here to learn more about the four steps in the certification process.
A.: For pre-implementation certification, the assessment consists of two parts:
- Document Review: an expert review of your self-assessment, attestation and supporting documentation.
- Demonstration: scripted test scenarios (and test data) the applicant must follow in demonstrating their product to the assessment team in a non-production environment. This is typically via a web conference.
A.: Yes. Fees are applicable for certification, recertification and reassessment. Fees are dependent on the technology class that is being certified.
A.: For most of Infoway's technology classes, vendors undergoing certification is strictly confidential. Names of products and/or vendors are not published or otherwise made available by Infoway at any time during the process. Safeguards have been put into place around the use and disclosure of all information submitted through the certification process. The Infowayassessment team is bound by strict non-disclosure agreements. Infoway only publishes the names of products that have been successfully certified.
In the case of pre-implementation certification for electronic medical records (EMR), vendors whose product is eligible for physician office system funding should anticipate that an application for certification will be shared with necessary jurisdiction representatives.
Once a product has been certified, details of that product are posted on Infoway's website.
A.: If Infoway does not certify your product, you are entitled to challenge the decision and a formal review will be initiated.
A.: All certified products will receive a certification mark, which bears theInfoway logo. The certification mark can be used in marketing and promotional material related to the certified product. In addition, the product name and certification details are posted on Infoway's website.
A.: Certifications expire either on June 30, or December 31 of each calendar year, depending on the date certification is issued.
Upon receipt of an application, your certification may be extended for two additional one-year terms. If the solution has been materially modified, enhanced or updated since the previous assessment, Infoway may require that the new version undergo a reassessment.
A.: To maintain your certification, you are required to notify Infoway of adverse events as well as any product changes that may affect compliance against assessment criteria.
Q.: Where can I find information on products that have been certified by Canada Health Infoway?
A.: Certified products are listed on the Infoway website upon completion of the certification process.
A.: You can download the Guide to Pre-implementation Certification Services. In addition, you may submit queries via our contact form.
A.: Infoway's pre-implementation certification service complements other regulatory and procurement processes such as licensing by Health Canada's Medical Devices Bureau and conformance testing by the provincial and territorial physician office system programs. Infoway coordinates its certification activities with other organizations in order to provide a seamless process to reduce the number of times a vendor is required to demonstrate their product.
Guide to Pre-implementation Certification Services
- apply for certification
- participate in the assessment process
- receive and maintain Infoway certification for your health information technology solution
A Framework and Toolkit for Managing eHealth Change: People and Processes.