Fincchta

Digi-HTA

Digi-HTA is a method developed for digital products and services for social and health care and well-being. It is used to assess the suitability of a product or service for the use of customers and employees in the sector.

The aspects of the assessment are effectiveness, costs, safety, data protection and security, as well as usability and accessibility. In addition, issues affecting the commissioning of a digital product, such as the care process and changes in IT, are examined in particular.

The representatives of the wellbeing services counties can make use of Digi-HTA assessments, for example, before procurement, in connection with the procurement, when starting the piloting of products or in carrying out a market survey.

The Digi-HTA assessment enables a technology company to demonstrate the suitability of its digital product or service for the use in social and health care or in promoting well-being. The assessment allows the company to obtain an evaluation of its product by independent experts, so the company can also use the assessment in product development.

The Digi-HTA method

Health Technology Assessment (HTA) is an evidence-based review of the suitability of methods for use in healthcare. The assessment is used to support decision-making when considering the introduction of new equipment and methods or the removal of old ones.

The Digi-HTA assessment method is licensed under the Creative Commons Attribution-Non Commercial-No Derivatives 4.0 International license (CC BY-NC-ND 4.0).

How is the assessment done?

Experts from FinCCHTA and the University of Oulu assess the product from different perspectives. The assessment of key areas uses a “traffic light model” where the different areas are scored. FinCCHTA makes the conclusion based on the total score and agrees with the company on publishing the assessment on the FinCCHTA website.

What is the assessment based on?

Digi-HTA assessments are based on information provided by the company, supplemented by a literature review, expert reviews and possible additional questions for the companies. The product information is collected using the Digi-HTA questionnaire and the self-assessment form developed by the National Emergency Supply Agency’s Kyber-Health Project.

How long is the conclusion valid?

The conclusion is valid for three years. A company may request a reassessment of an individual component if it has made significant improvements to the product.

Assessment areas

For medical devices, it is noted that the product shall meet the requirements of the MDR (Medical Device Regulation). Medical devices under the MD Directive (Medical Device Directive) are approved within the transitional periods allowed by the MD Regulation.

Medical Device Directive MDD, the European Council’s directive on medical devices

Medical Device Regulation MDR, further regulations on medical devices

If the goal of a product or service is to affect the health of the customer, it is the primary objective of assessment. In other cases, the effectiveness on the purchasing organisation is assessed, for example the impact on the work of the personnel.

The effectiveness assessment utilises the material produced by the company and the studies highlighted by the literature review. The assessment will take into account studies, user surveys and pilot projects. In the summary, the highest quality studies gain the highest weight.

There is evidence of the safety of the product, such as research results.

No patient or customer safety incidents have been reported in connection with the use of the product.

The risks associated with the product and the use of the product have been identified. To prevent or minimise them, a risk management plan is available and updated on an ongoing basis.

The company has processes and a responsible entity to identify, report and correct issues related to the safety of the product. In the case of a medical device, the company is aware of the safety-related notification processes required for medical devices.

The assessment takes into account the operating costs of a product or service and deployment costs for the organisation, such as procurement and IT changes. The cost is compared to a situation where the corresponding product or service is implemented in another way.

The training costs required for the commissioning are also highlighted.

The assessment is based on the security and data protection requirements developed by the National Emergency Supply Agency’s Kyber-Health project.

Information security and data protection requirements for social welfare and healthcare procurements, version 1.06 (NCSC-FI, National Cyber Security Centre Finland)

The assessment objects are the following aspects of the company and the product

risk management and security testing
log management
user management
equipment
data protection.

The assessment will seek answers to the following questions:

Does the design take into account the specific user and age groups (children, elderly) likely to use the product?
Have end-users (patients, customers, healthcare professionals) tested the product and been involved in its development?
Do users have the opportunity to give feedback on the product?
Does the interface design aim at ease of use and simplicity?
How are usability and accessibility being developed?
Has the accessibility been assessed and any shortcomings identified?
Does the product meet the requirements of the Act on the Provision of Digital Servicesif the act applies to the product?

Assessment scale

The assessment of key areas uses a “traffic light model” that scores the different areas. FinCCHTA determines the conclusion based on the total score in the final opinion.

Note! If any domain scores -4 points , the conclusion will always be ”Consider seriously before implementing the product” (red), regardless of the total score.

View Digi-HTA Assessments