OBJECTIVES:

Comprehensive HTA reports include assessments of a technology regarding its benefit and cost, but also regarding ethical, legal, social, and organizational aspects. Legal aspects are rarely addressed in detail in HTA reports. Reasons mentioned include a lack of concepts and resources. Against this background, we examined whether indications of a systematic and pragmatic methodological processing of legal aspects could be inferred from German HTA reports.

METHODS:

Using the software MAXQDA, we extracted all sections of texts on approaches to addressing legal aspects from HTA reports published by the German HTA agency DIMDI between 2008 and 2017 and we performed a content analysis and summary.

RESULTS:

DIMDI published 70 HTA reports between 2008 and 2017. Even though legal aspects were examined in most of the HTA reports, only 43 reports explicitly address legal aspects in their research question. However, in many cases, no or few details were provided on how the questions on the legal aspects of a technology were addressed, that is, what type of methodological approach was used – reproducing the approaches is thus hardly possible.

No report indicated that the processing of legal aspects was based on an underlying concept.

CONCLUSIONS:

The content analysis and summary of the processing of legal aspects did not provide a well-founded basis for future German HTA reports. Nevertheless, the results will be considered in the development of a new concept.