The HTA core model: a novel method for producing and reporting health technology assessments.

OBJECTIVES: The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). METHODS: Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. RESULTS: The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. CONCLUSIONS: The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.

Ambiguity of the embryo protection in the Human Rights and Biomedicine Convention: experiences from the Nordic countries.

Until 1998 research on in vitro human embryos concentrated on the issues related to assisted reproduction. The situation changed dramatically when the first scientific report on the laboratory culture of human embryonic stem cells was published. This scientific breakthrough with new therapeutic promises put human embryo into a new, more vulnerable position. Combined with creation of embryos via somatic cell nuclear transfer, it inveigles into mass production of embryos, first for scientific purposes, but later perhaps for the healing of people. This article examines the efficacy of the Convention on Human Rights and Biomedicine in protecting embryos in this new era of embryo research. The interpretative latitude of Article 18 of the Convention is demonstrated, and legislation in three Nordic countries with highly variable approach to embryo research regulation is analysed. I examine how this divergence is possible in the light of the Convention text. In the end, potential reasons for variation in regulation in the otherwise similar Nordic countries are discussed, as well as under what conditions harmonisation of regulation on embryo research, a highly value-charged matter, could be possible at the European level.