Health ICT systems and the data they handle have more and more come to the forefront as critical business functions for any healthcare organisation.
The requirements of state-of-the-art software are multiplying and becoming more complex due to:
Trustworthy Health ICT Systems
Scaling up the quality of your health ICT system to get the most out of health data
The increasing need for connecting ICT systems
GDPR compliance
Escalating demands by customers and regulators
It is a huge challenge for ICT developers to stay on top of these fast-changing requirements and to implement them accordingly.
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
- Criteria
- Documentation & auditor SOPs
- Scenarios & test data
- Audit
- Report
- Quality label
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
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.
Audit
The audit will be performed by a team of independent multidisciplinary peer auditors.
Report
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 1,700 fine-grained validated criteria
- Validation of new criteria sets
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.