title: HTA and its legal issues: a framework for identifying legal issues in health technology assessment.
abstract: OBJECTIVE
  Legal analysis can highlight important issues that are relevant when deciding whether a medical technology should be implemented or reimbursed. Literature and studies show that even though the law is an acknowledged part of health technology assessment (HTA), legal issues are rarely considered in practice. One reason for this may be the lack of knowledge about the diversity of legal issues that are relevant for HTA. Therefore, this contribution aims primarily to identify and then explain the relevant legal issues in HTA. This study offers a framework for identifying the legal issues in HTAs in different jurisdictions and provides a basis for further research.
  
  
  METHODS
  After extensive literature search, the authors review Swiss health law to identify legal issues that are relevant to HTA. The authors then categorize these legal issues using a framework with an inside and outside perspective. Finally, they explain a selection of these legal issues with several examples.
  
  
  RESULTS
  This study reveals numerous legal issues that are relevant for HTA and underlines the necessity of incorporating legal analysis in HTAs. The suggested perspectival framework in this study provides a basis to structure the legal analysis. The identified legal issues are relevant in other countries and the perspectival framework is transferable to other jurisdictions.
  
  
  CONCLUSIONS
  The article underlines the importance of in-depth discussion about the role of law in HTA. It provides a structured overview of the legal issues in HTA and suggests a development of more concrete instruments toward a standardized legal technology assessment.
authors: PhD Candidate in Biomedical Ethics and Law at theUniversity of Zurich,daniel@chta.ch.
authors: Daniel
authors: D
authors: Widrig
authors: Professor for Criminal Law, Criminal Procedure and Medical Law at theUniversity of Zurich.
authors: Brigitte
authors: B
authors: Tag
mesh_terms: D003284:Contract Services / Q000331:legislation & jurisprudence; D003299:Cooperative Behavior; D003365:Costs and Cost Analysis; D003657:Decision Making; D003695:Delivery of Health Care / Q000191:economics / Q000331:legislation & jurisprudence; D006282:Health Personnel / Q000191:economics / Q000331:legislation & jurisprudence; D006801:Humans; D011639:Public Opinion; D013557:Switzerland; D013673:Technology Assessment, Biomedical / Q000191:economics* / Q000331:legislation & jurisprudence* / Q000458:organization & administration
keywords: Perspective