Comparison report of Finnish Digi-HTA and French PECAN assessment criteria

In October 2024, the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) released a report aiming to summarize the results of the comparative analysis of Finnish Digi-HTA and French Early coverage of digital medical devices framework (PECAN) assessment criteria. 

The analysis is divided into two parts: the first focuses on the general aspects of the frameworks, and the second on the cybersecurity requirements. The most important considerations in the comparison of Digi-HTA and PECAN are as follows:

• The product assessed in PECAN must be a CE-marked medical device (all risk classes can be included). Digi-HTA is suitable for medical devices of all risk classes, as well as non-medical devices;
• The PECAN is intended solely for digital therapeutics (DTx) and remote patient monitoring (RPM) applications, which may also incorporate artificial intelligence (AI) algorithms. Digi-HTA is applicable to a wide range of digital health technologies (DHTs), such as digital health applications, DTx, RPM, AgeTech, AI, and robotic solutions;
• In Digi-HTA, there is a dedicated domain for AI products or products utilizing AI, whereas, in the PECAN process, there is also a separate analysis grid for the AI components;
• In Digi-HTA and PECAN, the key assessment domains were named partly differently. Digi-HTA has a specific domain for aspects related to robotics;
• In both assessment models, the assessment of the product takes about 2-3 months;
• The Digi-HTA assessment process and consultation are free of charge for the vendors. The preliminary consultations arranged by the French National Authority for Health (HAS) are voluntary, non-binding, confidential, and provided at no cost. The application for the PECAN process is free for the vendor, but a predetermined fee is charged for the permanent listing in the List of reimbursable products and services (LPPR) or the List of medical remote monitoring activities (LATM);
• Digi-HTA's requirements are based on both national and EU-level regulations, such as the Act on the Provision of Digital Services and General Data Protection Regulation, as well as international standards. The PECAN is based on the legislation of France and European legislation and regulatory requirements;
• The PECAN includes a national reimbursement model based on legislation. In contrast, the Digi-HTA assessment model currently provides informative data that can be used as part of the requirements for regional procurement decisions.

See the full details in Finnish and English here.

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