title: Information technology law and health systems in the European Union.
abstract: OBJECTIVE
  This study aims to examine the impact of European Union (EU) law relating to information technology (IT) on health systems.
  
  
  METHODS
  The study identifies EU directives relating to IT, analyzes them in terms of their impact on the use of IT in health systems, and outlines their implications for health technology assessment (HTA). Analysis is based on a review of literature identified through relevant databases and Internet searches.
  
  
  RESULTS
  Developments in IT have serious implications for EU health systems, presenting policy makers with new challenges. The European Commission has adopted a range of legal measures to protect consumers in the "information society" However, as few of them are health-specific, it is not evident that they have implications for health, health systems, or HTA, and they may not be effective in protecting consumers in the health sector.
  
  
  CONCLUSIONS
  In light of the growing importance of IT in the health sector, legal and nonlegal measures need to be further developed at EU and international level. Where possible, future initiatives should pay attention to the particular characteristics of health goods and services and health systems. Although definitions of HTA usually recognize the importance of evaluating both the indirect, unintended consequences of health technologies and the legal aspects of their application, it seems that, in practice, HTA often overlooks or underestimates legislative matters. Those involved in HTA should be aware of the legal implications of using IT to provide health goods and services and compile, store, transfer, and disseminate health information electronically.
authors.affiliation: London School of Economics and Political Science, UK. e.a.mossialos@lse.ac.uk
authors.forename: Elias
authors.initials: E
authors.lastname: Mossialos
authors.forename: Sarah
authors.initials: S
authors.lastname: Thomson
authors.forename: Annemarie
authors.initials: A
authors.lastname: Ter Linden
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence / Q000639:trends; D003219:Confidentiality / Q000331:legislation & jurisprudence; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D005062:European Union; D006291:Health Policy / Q000331:legislation & jurisprudence; D007256:Information Systems / Q000331:legislation & jurisprudence*; D018973:Intellectual Property; D020407:Internet / Q000331:legislation & jurisprudence / Q000639:trends; D016365:Liability, Legal; D010067:Ownership; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence*