Day: 5 August 2026

  • New EDiHTA publication maps assessment domains for digital health technologies

    New EDiHTA publication maps assessment domains for digital health technologies

    EDiHTA publishes its third scientific paper on the development of a European framework for Digital HTA

    We are pleased to share our new peer-reviewed paper, published in Value in Health: “Domains in Health Technology Assessment of Digital Health Technologies: A Mapping Review.”

    Authored by Jeremy Dietz, Zoe Garrett, Lynda Ayiku, Livio Battaglia, Iga Lipska, Wija Oortwijn, Dario Sacchini, Joan Segur Ferrer, Emmanouil Tsiasiotis and Dalia Dawoud, the paper maps the health technology assessment domains used in assessing digital health technologies. In doing so, it lays the evidence base for determining which domains should be considered in the EDiHTA framework.

    Across 44 documents, including published studies, HTA agency methods guidance and a sample of European digital health technology HTA reports, the review identifies 13 assessment domains. While areas such as clinical effectiveness, safety and economic aspects appear consistently, environmental, technical, legal, regulatory, and some ethical and human aspects remain inconsistently included.

    The findings highlight where alignment already exists across digital health technology HTA and where further work is needed to reduce divergence in evidence expectations.

    Read the paper: Value in Health | DOI: https://doi.org/10.1016/j.jval.2026.06.017

    Abstract

    Background

    Health Technology Assessment (HTA) plays an important role in evaluating digital health technologies (DHTs) to inform decision-making. Commonly used HTA frameworks have been criticised as inadequate for assessing DHTs leading to the development of many DHT-specific HTA frameworks. The proliferation of frameworks creates a lack of clarity around evidence expectations for DHT HTA and perceptions of divergence in approach to HTA.

    Objectives

    The study, which was completed for the European Digital Health Technology Assessment (EDiHTA) project, reviews the domains used for DHT HTA.
     
    Methods
    The study had 3 parts: (1) scoping review (2) targeted search of HTA agency websites and hospitals for DHT methods documents (3) review of European DHT HTA reports. Data were extracted into a common template and analysed descriptively to identify the domains and topics included in the documents.
     
    Results
    A total of 44 documents were included: 1) 11 published studies 2) 13 HTA agencies’ methods documents 3) a sample of 20 DHT HTA reports. From these documents, 13 domains were identified. Topics relating to HTA domains health condition, technology use, clinical safety, clinical effectiveness, economic aspects, organisational aspects appeared consistently in retrieved documents. Topics relating to environmental, technical, legal and regulatory, and some ethical and human aspects were not consistently included or reported in the documents.
     
    Conclusion
    This study identifies commonalities in DHT HTA across established areas of HTA and areas of DHT HTA where there remains inconsistency in reporting of information and where efforts towards further alignment and refinement are still needed.
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