Health ICT systems and the data they handle have more and more come to the forefront as critical business functions for any health care organisation.

The requirements of state-of-the-art software are multiplying and becoming more complex due to:

• the boost of Artificial Intelligence (AI)
• the increasing need for connecting ICT systems
• GDPR compliance
• escalating demands by customers and regulators
• etc.

It is a huge challenge for ICT developers to stay on top of these fast-changing requirements and to implement them accordingly.

Depending on the complexity of the ICT system and the objectives of the assessment, scoping is absolutely necessary. Scoping can be done from a technical, geographical, or medical perspective.

Criteria are the foundations of a high-quality assessment. They have to be fine-grained, unambiguous, auditable and preferably defined In consensus by all parties involved.

In addition to the unambiguous character of the criteria, the criteria need to be documented for the software developers. Auditor SOP’s (standard operating procedures) are always developed as an obligatory requirement to a successful assessment.

During the assessment, the auditors use validated scenarios which have been customised to each assessment project. Test data is required to properly execute the test cases and to verify the expected output in the software application under assessment.

The Audit will be performed by a team of independent multidisciplinary peer auditors.

The auditors provide i~HD, the auditing body, with a draft report identifying the conformities and the non-conformities. i~HD will hand over the final report to the software vendor/sponsor/client.

An assessment may result in an i~HD quality label.

i~HD has access to a repository of over 1700 indexed fine-grained validated criteria, including 60 validated criteria relating to clinical data platforms.

The design, the development and the validation of the criteria sets is executed in close collaboration with RAMIT and EuroRec. Both organisations have a long history as scheme owners.

As new criteria sets are being developed by stakeholders in the health ICT ecosystem, such as regulatory bodies (governments), industry or the software vendor itself, we step in to help define the criteria and to go through the validation phase that is required before integration in a standardised scheme. 

Thanks to our specific expertise in the development, the design and the validation of high-quality and fine-grained criteria, we are well placed to support your criteria validation process.