Medical Devices Cybersecurity – IEEE P2621 Series of Standards

Overview

With connected devices, telehealth and remote patient monitoring becoming more widely used for diabetes, there is an increasing risk of cybersecurity threats. Managing these vulnerabilities can be challenging. It is crucial for device manufacturers, clinicians, hospitals, and testing organizations to work collaboratively to create a safe and interoperable health care environment. Development of standards and an industry adopted conformity assessment program can help in managing these risks.

IEEE P2621 Series of Standards

Medical devices used for monitoring and managing diabetes provide life-saving benefits to patients and effective implementation options to healthcare professionals. With ever-increasing connectivity and data exchange between devices there is an increased risk to the safety and privacy. This standard will aid medical device manufacturers and users to manage their cybersecurity risk.

Conformity Assessment Program

The certification program is being developed by the IEEE P2621 Conformity Assessment Committee (CAC), comprised of stakeholders, that will benefit users, manufacturers, clinicians, regulators, payers, and other potential beneficiaries.

Program Objectives

  • Demonstrate to buyers that connected diabetes devices conform with IEEE P2621 series of standards
  • Program participants adhere to the IEEE P2621 certification scheme
  • Testing is performed by IEEE recognized test laboratories
  • All certified devices bear the IEEE Certified Mark and listed on the IEEE Registry

Who Should Participate

  • Device Manufacturers, Integrators, Solution Providers
  • End-user Communities (Clinicians, Hospitals, etc.)
  • Government Regulators
  • Test Laboratories
  • Academia

Participants

Abbott Logo
BD Logo
Diabetes Technology Society Logo
Eoflow Logo
FDA Logo
Google Logo
Intertek EWA Canada Logo
Lifescan Logo
MedCrypt Logo
Sansum Diabetes Research Institute Logo
ThirdWayv Logo. Connected. Protected.
Join

Medical Devices Cybersecurity Conformity Assessment

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Contact Us

For more information, please contact the ICAP team.

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