Digi-HTA Criteria Tool

How the Digi-HTA assessment is conducted, and how to get your product assessed

The assessment is based mainly on information provided by the company on its own product. The information is supplemented by a literature review and the necessary expert assessment. If necessary, additional information will be asked from the company. The resulting HTA recommendation is public.

Digi-HTA Assessment Process

The assessment process starts by contacting FinCCHTA to book your assessment kick-off.

Once the process is started, the company fills the Digi-HTA questionnaire and questionnaires for data security and protection to provide information for the HTA and data security and protection experts to conduct the assessment. This information provided by the company about its own product is then supplemented with a literature review and the necessary expert assessments.

Based on the gathered information, HTA experts publish the Digi-HTA recommendation for the product on the FinCCHTA website (only the recommendation is public, other information is kept between the company and the experts conducting the assessment).

How does Digi-HTA differ from CE marking?

A CE mark is a manufacturer’s assurance about the product’s compliance with requirements of related directives and regulations. Digi-HTA is an assessment tool that provides an opportunity for objective analysis about the product or service’s suitability for healthcare use based on information from real-life operating environment.

The Digi-HTA assessment covers the HTA domains for digital healthcare services, summarized below.

More detailed description of the criteria and the questions can be found from:
Haverinen J et al (2019) Digi-HTA: Health technology assessment framework for digital healthcare services.
Finnish Journal of eHealth and eWelfare, 11(4), 326–341. https://doi.org/10.23996/fjhw.82538.

The Digi-HTA recommendation provides healthcare service providers an unbiased and detailed assessment of the key features of digital service or product. It also highlights issues that healthcare providers need to consider in their own operations when implementing a product in their organization.

Digi-HTA recommendations are published by Finnish Coordination Centre for Health Technology Assessment (FinCCHTA).

Digi-HTA recommendations can be found on the FinCCHTA website (Go to tab Suositukset Assessments)