The Internet of Things (IoT) is a hot topic– especially in the healthcare industry. As the growth of internet medical devices begins to take off, the issue of how to build security into these devices is a major factor. Implementing strong security into a device begins at the developer level, with several factors that need to be considered during the design process that help prevent malicious attracts and secure communications to keep patient data safe.
Some of these issues begin at the ground level, with developers getting an understanding of medical security standards and practices, and making certain their devices can meet them. Any developer working on a medical device should be aware of the conversations surrounding security, and some of the FDA guidelines that have been put in place, including Strong Authentication, Privileged User, Encryption of data, and incident analysis and response. Just to name a few.
Below, we address some of the factors that need to be considered when designing these medical devices.
Connecting your medical device to your network is where the work begins once you have the device in place. There are standards for internet service providers that work in the healthcare industry. Any service provider should have HIPAA compliant security standards and a clear understanding of the HER/EMRR (Electronic Health/Medical Records) requirements. More than that, ensuring that you have your own security standards in place, outside of your provider network, will double the impact against potential breaches.
Security Requirements for Multicore Processing
Development cycles are short, most designers want to get their product out the door as soon as possible, but it’s important for security to begin at this level. Many multicore processors, growing in popularity in the medical device community, come with built-in security IP blocks that establish a strong foundation. With system-on-chip (SoC) processors, the hardware features authenticate software prior to execution. When it comes to security, these processors should be ample in features that include:
- Encoding data-at-rest
- Malware prevention
- Secure boot
- Boot fuses
- Crypto engines
- Device Partitioning
Selecting the Right Operating System
Selecting the right operating system, what your device is essentially built on, provides the strong foundation your device should be built on. When it comes to the medical industry, Linux is growing in popularity, mostly because many enterprise Linux companies offer software-development services that meet the requirements for medical device security. In fact, it’s one of the most secure systems, often used for safety-critical diagnostic and therapeutic applications. Its open source program keeps eyes and ears on the system at all time, ensuring that any breaches will be brought to attention quickly, and addressed even faster than that.
But why does it work so well for the medical community? Many firms offer commercial support to ensure that all tools comply with the relevant standards and regulations. If a developer is looking for a secure, reliable operating system, Linux is the top choice.
Critical Stages of Data Protection
There are three critical stages of data protection that need to be considered when building a device.
Data-at-rest – the state of a device from being powered down to fully operational.
The issues that need to be considered during the data-at-rest stage range widely. One of the first things developers need to think about during this stage is Secure Storage, where data is being stored and whether or not it’s encrypted. Additionally, taking into account whether it vulnerable to attacks and ensuring no one can access the data during this stage.
Next up for data-at-rest is Root of Trust. Root of Trust is the foundation for the Chain of Trust, which is essential in protecting the operating system from security breaches. If there’s not a strong foundation for root of trust, developers should consider implementing a software-based solution. Which brings us to the Chain of Trust – essentially, the boot process.
At this stage, you want to validate and authenticate the bootloader and operating system, then do the same to any hardware or software, double checking that everything is authenticated properly at each stage.
This is the foundation of securing your operation system before the device even gets up and running.
Data-in-Use – A normally operating device with data being generated and processed.
There are three major factors in the data-in-use stage that help to protect data. Hardware-enforced Separation, Software-enforced Separation, User-Space Isolation, and Information Obfuscation. Hardware and Software enforced Separation serve as in-depth security steps that isolate either the hardware or the software from the system itself. Typically, developers want to focus on Hardware separation and move onto software separating if they can’t define the security features needed in the hardware itself.
User-space isolation protects code and data on a per application basis. While Information Obfuscation protects text strings and variable in memory and storage. Essentially, this makes it difficult for bad actors to modify anything within the stored data, and keeps them from attempting to re-engineer device operation.
Data-in-Transit – data entering and leaving a device while it is “on.”
The most important factor here is, how is data protected? At this point, developers begin thinking about security in terms of the where the data is going. The previous steps help to encrypt the data before it even begins its journey, laying a secure foundation. To effectively protect this data, Crypto Engines should be considered, self-contained, redundant cryptographic modules designed to be integrated into devices as an alternative to box devices. The self-containment is what makes it difficult for hackers to gain access to the encryption process and provides the device with the ability to secure data quickly and efficiently.
Securing IoT medical devices is bound to be an ever changing topic with new requirements as technology advances. But understanding the requirements and needs of the healthcare industry is an excellent place to start. Giving a devicea solid, secure foundation at the onset of creation allows it the ability to defend itself in the event of an attack. Whether it’s choosing a processor, operating system, or the right network provider – every step in the development process should include security vetting of some kind.
Transbeam is a nationwide managed services provider of MPLS solutions, Carrier Grade Ethernet, SD-WAN, Fiber, Fixed Wireless, Hosted PBX service, Cloud solutions, and Temporary WiFi Networks.