Medcrypt

Diabetes device cybersecurity, from someone who reviewed them at FDA

Pumps, CGMs and dosing apps have to trust each other. We help you prove they can.

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Where diabetes device cybersecurity gets hard

  1. Devices that must trust each other
  2. Wireless everywhere
  3. Phones in the control loop
  4. Disclosures after launch

Where diabetes device cybersecurity gets hard

  • Devices that must trust each other

    Pumps, CGMs and dosing apps work as one system, so each one has to authenticate the others.

  • Wireless everywhere

    Every connection is a path in, and FDA expects you to show how it's protected.

  • Phones in the control loop

    Mobile apps that inform or control dosing bring their own security requirements.

  • Disclosures after launch

    Vulnerability reports keep coming once the device is on the market.

Where attackers get in

  1. CloudData sharing and remote access

  2. Mobile appDisplays and dosing decisions

  3. Bluetooth pairingHow devices trust each other

  4. Sensor & pumpReadings in, insulin out

Naomi Schwartz, VP of Regulatory Strategy
Naomi SchwartzVP of Regulatory Strategy

A former FDA reviewer of diabetes devices

  • About 6.5 years at FDA's CDRH reviewing connected diabetes devices
  • Reviewed a first-of-its-kind automated insulin dosing system
  • Helped build Class II pathways for three connected diabetes devices
  • Helped draft IEEE P2621.1 to P2621.3, security standards for wireless diabetes devices

How Medcrypt helps

Medcrypt has worked with six diabetes care technology providers, including leading insulin pump and CGM makers.

How an engagement works

  1. 1

    Gap check

    Know where your diabetes device submission stands, starting with a 1‑hour review.

  2. 2

    Build the evidence

    Threat model, SBOM, architecture views and testing, sized to your device.

  3. 3

    Reviewer check

    Former FDA reviewers go through the package before you file.

  4. 4

    After you file

    If FDA sends questions, we typically turn around a full cybersecurity response in about 10 days.

Start with a gap check

Where we've presented

Standards we work to

  • FDA premarket cybersecurity guidancewhat reviewers check
  • Section 524Bthe law for cyber devices
  • ISO 14971safety risk management
  • IEC 62304software lifecycle
  • IEC 81001-5-1secure development
  • AAMI TIR57security risk management
  • IEEE 2621wireless diabetes device security, contributed to by our own Naomi Schwartz

FAQ

Section 524B applies to cyber devices: devices that include software validated, installed, or authorized by the manufacturer, have the ability to connect to the internet, and could be vulnerable to cybersecurity threats. The test is whether the device is capable of connecting, not only whether its intended use involves connecting.

Evidence that each component authenticates the others, that wireless and app connections are protected, and a plan for handling vulnerabilities after launch.

Yes: monitoring, vulnerability management and responding to vulnerability disclosures.

Building a connected diabetes device?

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