If you have an implanted medical device, have been hooked up to a machine in a hospital, or have accessed your electronic medical records, you might assume the infrastructure and data are secure and protected against hackers. That isn’t necessarily the case, though. Connected medical devices and systems are vulnerable to cyberattacks, which could reveal sensitive data, delay critical care, and physically harm patients.
The U.S. Food and Drug Administration, which oversees the safety and effectiveness of medical equipment sold in the country, has recalled medical devices in the past few years due to cybersecurity concerns. They include pacemakers, DNA sequencing instruments, and insulin pumps.
In addition, hundreds of medical facilities have experienced ransomware attacks, in which malicious people encrypt a hospital’s computer systems and data and then demand a hefty ransom to restore access. Tedros Adhanom Ghebreyesus, the World Health Organization’s director-general, warned the U.N. Security Council in November about the “devastating effects of ransomware and cyberattacks on health infrastructure.”
To help better secure medical devices, equipment, and systems against cyberattacks, IEEE has partnered with Underwriters Laboratories, which tests and certifies products, to develop IEEE/UL 2933, Standard for Clinical Internet of Things (IoT) Data and Device Interoperability with TIPPSS (Trust, Identity, Privacy, Protection, Safety, and Security).
“Because most connected systems use common off-the-shelf components, everything is now hackable, including medical devices and their networks,” says Florence Hudson, chair of the IEEE 2933 Working Group. “That’s the problem this standard is solving.”
Hudson, an IEEE senior member, is executive director of the Northeast Big Data Innovation Hub at Columbia. She is also founder and CEO of cybersecurity consulting firm FDHint, also in New York.
A framework for strengthening security
Released in September, IEEE 2933 covers ways to secure electronic health records, electronic medical records, and in-hospital and wearable devices that communicate with each other and with other health care systems. TIPPSS is a framework that addresses the different security aspects of the devices and systems.
“If you hack an implanted medical device, you can immediately kill a human. Some implanted devices, for example, can be hacked within 15 meters of the user,” Hudson says. “From discussions with various health care providers over the years, this standard is long overdue.”
More than 300 people from 32 countries helped develop the IEEE 2933 standard. The working group included representatives from health care–related organizations including Draeger Medical Systems, Indiana University Health, Medtronic, and Thermo Fisher Scientific. The FDA and other regulatory agencies participated as well. In addition, there were representatives from research institutes including Columbia, European University Cyprus, the Jožef Stefan Institute, and Kingston University London.
“Because most connected systems use common off-the-shelf components, everything is now hackable, including medical devices and their networks.”
The working group received an IEEE Standards Association Emerging Technology Award last year for its efforts.
IEEE 2933 was sponsored by the IEEE Engineering in Medicine and Biology Society because, Hudson says, “it’s the engineers who have to worry about ways to protect the equipment.”
She says the standard is intended for the entire health care industry, including medical device manufacturers; hardware, software, and firmware developers; patients; care providers; and regulatory agencies.
Six security measures to reduce cyberthreats
Hudson says that security in the design of hardware, firmware, and software needs to be the first step in the development process. That’s where TIPPSS comes in.
“It provides a framework that includes technical recommendations and best practices for connected health care data, devices, and humans,” she says.
TIPPSS focuses on the following six areas to secure the devices and systems covered in the standard.
- Trust. Establish reliable and trustworthy connections among devices. Allow only designated devices, people, and services to have access.
- Identity. Ensure that devices and users are correctly identified and authenticated. Validate the identity of people, services, and things.
- Privacy. Protect sensitive patient data from unauthorized access.
- Protection. Implement measures to safeguard devices from cyberthreats and protect them and their users from physical, digital, financial, and reputational harm.
- Safety. Ensure that devices operate safely and do not pose risks to patients.
- Security. Maintain the overall security of the device, data, and patients.
TIPPSS includes technical recommendations such as multifactor authentication; encryption at the hardware, software, and firmware levels; and encryption of data when at rest or in motion, Hudson says.
In an insulin pump, for example, data at rest is when the pump is gathering information about a patient’s glucose level. Data in motion travels to the actuator, which controls how much insulin to give and when it continues to the physician’s system and, ultimately, is entered into the patient’s electronic records.
“The framework includes all these different pieces and processes to keep the data, devices, and humans safer,” Hudson says.
Four use cases
Included in the standard are four scenarios that outline the steps users of the standard would take to ensure that the medical equipment they interact with is trustworthy in multiple environments. The use cases include a continuous glucose monitor (CGM), an automated insulin delivery (AID) system, and hospital-at-home and home-to-hospital scenarios. They include devices that travel with the patient, such as CGM and AID systems, as well as devices a patient uses at home, as well as pacemakers, oxygen sensors, cardiac monitors, and other tools that must connect to an in-hospital environment.
The standard is available for purchase from IEEE and UL (UL2933:2024).
On-demand videos on TIPPSS cybersecurity
IEEE has held a series of TIPPSS framework workshops, now available on demand. They include IEEE Cybersecurity TIPPSS for Industry and Securing IoTs for Remote Subject Monitoring in Clinical Trials. There are also on-demand videos about protecting health care systems, including the Global Connected Healthcare Cybersecurity Workshop Series, Data and Device Identity, Validation, and Interoperability in Connected Healthcare, and Privacy, Ethics, and Trust in Connected Healthcare.
IEEE SA offers a conformity assessment tool, the IEEE Medical Device Cybersecurity Certification Program. The straightforward evaluation process has a clear definition of scope and test requirements specific to medical devices for assessment against the IEEE 2621 test plan, which helps manage cybersecurity vulnerabilities in medical devices.
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