Scaling up the quality of your health ICT system to get the most out of health data

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.

ICT companies need solutions to keep the trust of their stakeholders.

Assessing health ICT systems will improve their effectiveness, reliability and meaningful use

i~HD expertise in health ICT system assessment related to health data

i~HD has developed expertise and programmes to cover functional testing of ICT systems with the focus on data handling and data flows.

Benefits of an independent assessment

i~HD guarantees independent assessments performed by international peer auditors. The outcome of the assessment is always a report, which can be accompanied by an i~HD quality label

Obtaining an i~HD quality label means that your organisation can
  • demonstrate the conformity of its products, services, organisational processes and practices with specified requirements outlined in standardised schemes based on validated criteria
  • enhance its reputation with users, regulators, industry and all other interested stakeholders and boost your customer satisfaction
  • facilitate trade, market access, fair competition and consumer acceptance at a national and international level and in an expanding health systems landscape
  • improve the quality of the internal processes

Good software, great data

Fundamentals of an i~HD systems quality assessment

An independent i~HD systems quality assessment always includes the following fundamentals:

Scoping & objectives

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.

Documentation & auditor SOPs

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.

Scenarios & test data

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.

Quality label

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

i~HD as your partner for criteria selection and validation

Over 1700 fine-grained validated criteria

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.

Validation of new criteria sets

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.

We guarantee high-quality, peer-reviewed, validated, fit-for-purpose and auditable fine-grained criteria

Interested? Get in touch!

Are you interested to learn more about our repository of quality criteria? Would you like more information regarding an assessment of your health ICT system?

Contact our Systems Quality Programme Manager Tom de Vree for a free intake meeting.