• DocumentCode
    3202357
  • Title

    Patient in control in clinical trials - European initiatives for improving patient empowerment in clinical trials through technical implementation of legal norms

  • Author

    Forgo, Nikolaus ; Goralczyk, Magdalena ; Hanold, Stefanie

  • Author_Institution
    Inst. fur Rechtsinformatik, Gottfried Wilhelm Leibniz Univ. Hannover, Hannover, Germany
  • fYear
    2013
  • fDate
    3-7 July 2013
  • Firstpage
    4187
  • Lastpage
    4190
  • Abstract
    Patient empowerment is acclaimed as one of the major trends in the health care area bringing forward new conceptions how to involve patients in clinical research in a more (inter)active way. Patients and clinicians could benefit from more flexible consent-management and improved communication processes. This is where technology comes as an asset - the novel technological approaches promise to give more control to the patient, lessen the burdens on the researchers and all that in compliance with the legal and ethical requirements (e.g. data protection). The views of the European projects EURECA and p-medicine serve as examples for European approaches to patient empowerment.
  • Keywords
    biomedical engineering; ethical aspects; health care; law; medical administrative data processing; security of data; EURECA; European approach; European initiative; European project; clinical trial; data protection; ethical requirement; flexible consent-management; health care trend; legal norm technical implementation; legal requirement; p-medicine; patient empowerment; patient interactive involvement; patient-clinician communication process; technological approach; Art; Clinical trials; Ethics; Europe; Law; clinical trial; data protection; informed consent; patient empowerment; technical applications;
  • fLanguage
    English
  • Publisher
    ieee
  • Conference_Titel
    Engineering in Medicine and Biology Society (EMBC), 2013 35th Annual International Conference of the IEEE
  • Conference_Location
    Osaka
  • ISSN
    1557-170X
  • Type

    conf

  • DOI
    10.1109/EMBC.2013.6610468
  • Filename
    6610468