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[Connected health objects and medical devices].

Jacques Belghiti1, Claire Oget-Gendre2

  • 1"Professeur émérite de chirurgie, université de Paris-Diderot ; ancien membre du collège de la Haute Autorité de santé et président de la Commission d'évaluation des actes et des dispositifs médicaux, Paris, France".

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Summary

Connected health devices require clear distinction. Medical devices need CE marking for reliability and data security, with potential community financing in France to reduce the digital divide.

Keywords:
Equipment SafetyMedical Device LegislationMobile ApplicationsTelemedicineWearable Electronic Devices

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Area of Science:

  • Digital health
  • Medical device regulation
  • Healthcare technology

Background:

  • Distinguishing between connected health objects for well-being and those for medical care is crucial.
  • Connected devices impacting patient care require stringent regulatory oversight.

Purpose of the Study:

  • To outline the regulatory requirements for connected medical devices.
  • To explain the financing mechanisms for health technologies in France.
  • To highlight the role of reimbursement in bridging the digital divide in healthcare.

Main Methods:

  • Analysis of regulatory frameworks for connected medical devices.
  • Examination of CE marking requirements for physical devices and software.
  • Review of French healthcare financing policies for digital health solutions.

Main Results:

  • Connected devices with medical objectives must undergo CE marking, verifying hardware, software, and data hosting.
  • Devices improving disease diagnosis or treatment may be eligible for community financing.
  • French reimbursement policies aim to leverage connected health to reduce the digital divide.

Conclusions:

  • Clear regulatory pathways and financial incentives are essential for the adoption of connected medical devices.
  • CE marking ensures the safety and reliability of medical technology.
  • Community financing of impactful connected health solutions is a key strategy in France to promote equitable access to care.