title: [Information on legal issues in health technologies: methodological proposal to identify them in a systematic and comprehensible manner].
abstract: BACKGROUND
  Rules and regulations form the framework of Health Technology Assessments. Legal issues are directly associated with the technology (as patents/licenses) or to the patients and their basic rights (as autonomy). In order to identify the regulations of interest as well as the relevant publications in a systematic and transparent way a specific methodological approach is required. In the absence of adapted methods, our objective was to develop a methodological approach to the systematic retrieval of information on legal issues.
  
  
  METHODS
  
  
  
  RESULTS
  No publications on adapted methods could be identified. We therefore developed a procedure following the workflow of information retrieval for effectiveness assessments. This workflow consists of 8 steps: 0. pre-search: identification of the relevant rules, regulations and patient-related issues, 1. translation of the search question, 2. concept building, 3. identification of synonyms, 4. selection of relevant information sources, 5. design of the search strategies, 6. execution and quality check, 7. saving the results and reporting.
  
  
  CONCLUSIONS
  There are numerous publications on legal issues associated with health technologies. Specifically adapted procedures are qualified to identify them in a systematic and transparent manner using the appropriate sensitivity and precision. A wider application seems to be reasonable in order to further test its practicality against more topics and to modify the proposed method if indicated.
authors.affiliation: Funktionsbereich Public Health, Universität Düsseldorf. droste.sigrid@web.de
authors.forename: Sigrid
authors.initials: S
authors.lastname: Droste
authors.forename: Stephan
authors.initials: S
authors.lastname: Rixen
mesh_terms: D020811:Biomedical Technology / Q000191:economics / Q000331:legislation & jurisprudence* / Q000379:methods*; D003362:Cost-Benefit Analysis / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000379:methods; D005260:Female; D005858:Germany; D006801:Humans; D016247:Information Storage and Retrieval; D008004:Licensure / Q000331:legislation & jurisprudence*; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D010344:Patient Advocacy / Q000331:legislation & jurisprudence*; D011247:Pregnancy; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence* / Q000379:methods*; D016216:Ultrasonography, Prenatal / Q000379:methods; D057188:Workflow