What will be assessed?
Based on the Digi-HTA assessment criteria that were used, new digital health services, such as mobile applications, artificial intelligence, and robotics, can be assessed.
For medical devices, please note that the product complies with the Medical Device Directive's (MDD) requirements. After the transition period ends (the deadline is 5/2021 for new products and 5/2024 for previously approved products), the products must comply with the new Medical Devices Regulation (MDR).
What is the recommendation based on?
Product-specific Digi-HTA recommendations are based on the product information provided by the company. This information is supplemented by a literature review, an expert assessment, and possible additional questions for the company. Product information is collected using a Digi-HTA questionnaire.
As for information security and data protection, the information is collected on two documents. These documents are based on the National Cyber Security Centre's information security and data protection requirements.
Medical Device Directive MDD, the European Council's directive on medical devices
Medical Device Regulation MDR, further regulations on medical devices
Information security and data protection requirements for social welfare and healthcare procurements, version 1.06 (NCSC-FI, National Cyber Security Centre Finland)
By default, the recommendation is valid for three years. The product will be reassessed if significant new information becomes available and the company requests a reassessment.
Key Assessment Domains
|
2 |
Sufficient |
Sufficient |
Reasonable |
Sufficient |
Sufficient |
|
1 |
Promising but more evidence is needed
|
Probably at a sufficient level but not known well enough |
High |
Minor shortcomings |
Minor shortcomings |
|
-4 |
Weak or unknown |
Weak or unknown |
Unreasonably high |
Shortcomings |
Shortcomings
|
Recommendation Scale
|
10 |
USE OF THE PRODUCT IS RECOMMENDED
The use of this product is recommended because of strong evidence for its effectiveness. Safety, data security and protection, and usability and accessibility of the product are at an adequate level. The cost of using the product is reasonable.
|
|
9 |
THERE IS ONE THING TO CONSIDER WHEN USING THE PRODUCT
An organization considering the deployment of the product should note that
in one key area there are things to consider. Information about the effectiveness of the product could be promising, but the information is scarce. Product safety could be at a sufficient level but not known well enough. Product costs may be high. There could be minor shortcomings in the product's data security and protection or in usability and accessibility.
|
7-8
|
THERE ARE A FEW THINGS TO CONSIDER WHEN USING THE PRODUCT
An organization considering the deployment of the product should note that
in two or three key areas there are things to consider. Information about the effectiveness of the product could be promising, but the information is scarce. Product safety could be at a sufficient level but not known well enough. Product costs may be high. There could be minor shortcomings in the product's data security and protection or in usability and accessibility.
|
5-6
|
THERE ARE MANY THINGS TO CONSIDER WHEN USING THE PRODUCT
An organization considering the deployment of the product should note that
in four or five key areas there are things to consider. Information about the effectiveness of the product could be promising, but the information is scarce. Product safety could be at a sufficient level but not known well enough. Product costs may be high. There could be minor shortcomings in the product's data security and protection or in usability and accessibility.
|