E-health and m-health are emerging health technology fields that could possibly give a new scope to health technology assessment (HTA). The Division for Health Technology Assessment (DfHTA) is currently assessing medicines and non-drug technologies (medical devices intended for patient use or for use in hospitals). The experience assessing medical devices for use in hospitals yielded difficulties which could also arise from the critical appraisal of e-health or m-health technologies. The objective of this study was to explore the foundations for HTA guidance on e-health or m-health technologies.

A targeted literature review was conducted to map the current status of technology assessment practices for e-health and m-health technologies and to assess its concordance with current reimbursement processes in countries belonging to the Organisation for Economic Co-operation and Development. Experiences from past evaluations of other medical devices that could not be evaluated under the current guidance guided the literature search. The findings of this research were used to create a recommendation to amend the current Hungarian Guideline for Health Economic Analyses.

The resulting articles of the targeted literature review provided an insight into current practices on of assessing e-health and m-health products, particularly with respect to the domains of safety, quality, and impact. Recommendations suggested including a list of requirements for companies to submit for critical evaluations of e-health and m-health technologies, in support of a self-assessment approach.

As for other HTA bodies, there is an urgent need for the DfHTA to increase its capacity to assess digital health technologies for entry into the healthcare system, with a focus on the relevant clinical domains. The reimbursement process for these technologies remains a challenge for public funding bodies.