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
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.