Katriina Annunen's Master's Thesis on Digi-HTA and Medical Device Regulation
Our QA/RA Specialist Katriina Annunen has graduated from her Master's in Well-being Digital Service Expertise finalizing her studies with an interesting thesis titled "Added Value that Digi-HTA Assessment Brings to Digital Health Technology Products Compared to the Requirements of the Medical Device Regulation".
Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) has developed an assessment method called Digi-HTA. This assessment method is meant for digital health technologies (DHTs) and to support the introduction of novel technologies into Finnish healthcare. There are several national HTA processes developed in the EU and more harmonized approach is in need also.
The aim of Annunen's thesis was to identify differences and similarities between the Digi-HTA assessment method and the medical device regulation 2017/745/EU. The purpose was to clarify the roles of the Digi-HTA assessments and the medical device regulation and to identify possible areas for development of Digi-HTA assessment. Requirements for medical devices are strict and the role of Digi-HTA in this context is unclear. The study was comparing these two and found out that there is no significant overlap, though Digi-HTA assessment could be partially simplified for medical devices. Digi-HTA assessment could help device manufacturers still in the product development phase to produce higher quality and facilitate the decision-making of healthcare providers.