title: The tidal waves of connected health devices with healthcare applications: consequences on privacy and care management in European healthcare systems.
abstract: The market for Connected Health Devices (CHD) with healthcare applications is growing fast and should be worth several billion euros in turnover in the coming years. Their development will completely transform the organisation of our healthcare system, profoundly change the way patients are managed and revolutionizes disease prevention.
  
  
  
  The CHD with healthcare applications is a tidal wave that has societal impact calling into question the privacy of patients' personal and healthcare information and its protection in secure systems. Rather than trying to stop the use of CHD, we must channel the wave by clearly examining the advantages versus the risks and threats to the patients, and find counter-measures for implementation. The main difficulty is channeling the wave in a way that is acceptable to CHD developers who otherwise will bypass the rules, even if they can be sued for it. Therefore, it appears necessary to implement guidelines that can be used by all developers, defining the minimum requirement for assuring the security of patient privacy and healthcare management.
  
  
  
  In European Healthcare Systems, there is an imperative need for establishing security guidelines that CHD producers could use to ensure compliance, so that patient privacy and healthcare management is safeguarded. The aim would be to implement the guidelines a posteriori rather than a priori control so as not to hamper innovation.
authors.affiliation: Medical Evaluation Chair ESC and CEN Biotech, Dijon, Bourgogne, France.
authors.forename: Francois-André
authors.initials: FA
authors.lastname: Allaert
authors.affiliation: Bourgogne Franche-Comté University, Dijon, France.
authors.forename: Noël-Jean
authors.initials: NJ
authors.lastname: Mazen
authors.affiliation: Biostatistics and Bioinformatics (DIM), University Hospital, Dijon, France; Bourgogne Franche-Comté University, Dijon, France.|CNRS UMR 6306, Le2i, Bourgogne Franche-Comté University, F-21000, Dijon, France.
authors.forename: Louis
authors.initials: L
authors.lastname: Legrand
authors.affiliation: Biostatistics and Bioinformatics (DIM), University Hospital, Dijon, France; Bourgogne Franche-Comté University, Dijon, France. catherine.quantin@chu-dijon.fr.|INSERM, CIC 1432, Dijon, France; Dijon University Hospital, Clinical Investigation Center, clinical epidemiology/clinical trials unit, Dijon, France. catherine.quantin@chu-dijon.fr.|Biostatistics, Biomathematics, Pharmacoepidemiology and Infectious Diseases (B2PHI), INSERM, UVSQ, Institut Pasteur, Université Paris-Saclay, F-21000, Paris, France. catherine.quantin@chu-dijon.fr.
authors.forename: Catherine
authors.initials: C
authors.lastname: Quantin
mesh_terms: D003219:Confidentiality / Q000592:standards*; D003695:Delivery of Health Care / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D008491:Medical Informatics Applications
keywords: Connected health devices; Healthcare applications; Privacy; Protection; Security; Societal impact