E-Health Compliance and Conformance

To achieve the promised benefits that e-health offers, it is important for healthcare providers and medical software vendors to comply with e-health specifications and standards.

Compliance with these standards has two requirements:

  • conformance in the way medical software systems implement the relevant e-health specifications and standards
  • compliance by organisations that operate an e-health system or supply an e-health service with the relevant laws, codes of conduct, industry standards and principles of good governance.

Conformance, which relates to how products and services implement e-health specifications, is generally conducted through self-assessment by the party implementing the software system or by an independent third party such as a test laboratory. Conformance may also be assessed by a second party, such as a healthcare provider that is evaluating a software system prior to purchase.

Compliance, which ensures consistency among e-health specifications, usually takes the form of self-assessment, but may also be performed by an independent inspection body.

These concepts are explained in more detail in the CCA Assessment Concept of Operations December 2009 document which brings together NEHTA’s work on assessment methodology and describes the issues, terms and recommended framework for assessment, along with initial results as at December 2009. The Assessment Concept of Operations is based on industry standards and provides the foundation and context for a possible future certification program. This is discussed more fully in the National E-Health Certification Capability Discussion Paper currently being circulated for public comment. Both documents, along with the Industry Consensus Statement, can be downloaded from the tab links at the end of this page. Please send any comments or queries to This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Assessment scheme
NEHTA is creating an Assessment Scheme for each of its major e-health specifications. The documentation will describe the process for assessing compliance and conformance for NEHTA’s e-health specifications and the assistance that NEHTA provides to organisations performing the assessment.

The Assessment Scheme documentation will give the following information:

  • who may perform assessment (eg the scope of self assessment and the role of independent test laboratories and inspection bodies)
  • guidance concerning assessment methods, test specifications and test tools
  • levels of conformance and the timeframes for achieving conformance
  • guidance concerning conformance claims by implementers and the presentation of assessment results.

For most e-health specifications, NEHTA will also provide conformance test specifications and a comprehensive list of test cases to be used in conformance testing. NEHTA may also provide test software and assistance in understanding e-health specifications.

Assistance for procurers
NEHTA provides assistance to healthcare providers procuring an e-health system with regard to tender specifications and evaluation. In particular, NEHTA can help in correctly stating compliance and conformance requirements in tender specifications. NEHTA also makes available to procurers its conformance test specifications and test tools to assist in evaluating candidate e-health systems.

Contact
Compliance, Conformance and Accreditation – This e-mail address is being protected from spambots. You need JavaScript enabled to view it

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