SESIP for Healthcare: How the Mappable Methodology is Keeping IoT Healthy and Secure

By Gil Bernabeu and Carolina Lavatelli

New sectors and use cases are exploring the speed, convenience and functionality that connected devices can bring, yet each vertical and use case has its own unique set of cybersecurity challenges. The healthcare ecosystem is a prime example, with a myriad of innovative, life-saving devices emerging to revolutionize patient care. However, all of these devices face the added pressure of keeping highly sensitive and confidential patient data, and even lives, safe.

Trust and security for HealthTech devices are therefore paramount. It is also important that solutions are affordable and scalable, however, to allow innovations to reach their full potential. This is where the Security Evaluation Standard for IoT Platforms (SESIP) fits in.

What is SESIP?

SESIP provides a common and optimized approach for evaluating the security of connected products that meets the specific compliance, security, privacy and scalability challenges of the evolving IoT ecosystem. It operates as a mappable, multi-vertical scheme that simplifies security evaluation for OEMs, component manufacturers, and the ecosystem as a whole.

Amidst the myriad of different regulations, requirements and certification frameworks stakeholders in the connected device ecosystem must operate within, SESIP makes IoT device security economically viable for the entire value chain. In doing so, it helps drive consistency across IoT certification without incurring additional cost, effort, or time-to-market. This drives down the total cost of ownership, and provides assurance that devices are secure by default.

Securing connected medical devices

Within the healthcare ecosystem, the number of IoT devices is rapidly growing as facilities and medical personnel look for efficient solutions that allow them to provide enhanced care. From wearable patient monitoring devices to sophisticated medical imaging machines, technology is fundamental to the sector, with estimates that the value of the medical IoT device ecosystem will exceed $467.25 billion by 2027.

However, owing to the vast volume of sensitive information that hospitals secure, they are a common target for cyberattacks. IoT manufacturers and developers operating within this space must carefully abide by security by design principles to meet stringent regulatory requirements.

SESIP can therefore be a valuable tool in the efforts being made to harmonize the security evaluation processes of the medical device ecosystem. A streamlined, standardized process that incorporates a risk-based design approach means that mechanisms which are proportional to the risk can be applied to meet the unique requirements of each IoT device.

Furthermore, SESIP enables composition and reuse, helping the medical ecosystem address risks at the core by building IoT devices with platforms and components that have already been security certified.

Case Study: DTSec

One prominent use case for IoT devices in healthcare is remote monitoring. These allow healthcare professionals to measure and record key metrics for their patients without restricting the movements of the wearer, facilitating a data led approach to clinical care. However, these devices must store, process and even transmit sensitive, confidential patient data.

This has been a key area of focus for The Diabetes Technology Society (DTS), who has developed its own Standard for Wireless Device Security (DTSec). Having initially drafted a Common Criteria Protection Profile for medical devices, DTS was approached by Silicon Labs who proposed creating a  SESIP Profile based on the threats the organization had already identified and mapped. Silicon Labs proposed this following its own successful use of SESIP to certify its EFR32BG Series 2 Bluetooth ICs; a certification that included testing for IEEE 2621, the IEEE connected standard for medical devices in diabetes management.

GlobalPlatform was able to quickly define the DTSec SESIP Profile which is now being used to select the requirements needed to meet specific regulations, certify devices and components once and reuse the evaluation across different markets and sectors.

Where these mobile and often resource constrained remote monitoring devices were once seen as a potential security risk, thanks to SESIP, DTSec now has a clear, trusted, independent and scalable framework for certification.

Mapping the methodology

The success of SESIP in an extremely security conscious ecosystem such as healthcare demonstrates that it can be used as a common basis and language for cybersecurity requirements for all type of regulated devices. Silicon vendors can certify their components once using SESIP then choose additional applicable requirements to comply with based on the regulated necessities of the market they serve. This helps speed up the evaluation process through principles of composition and reuse, saving time and money.

SESIP gives confidence to all stakeholders - from the OEMs and component manufacturers to the clinical staff and their patients - that medical records and healthcare data produced and communicated by the device benefit from state of the art security.

SESIP has been adopted by CEN and CENELEC as a European Standard (EN 17927). It is recognized and referenced by bodies including PSA Certified, National Institute of Standards & Technology (NIST) and Car Connectivity Consortium (CCC). Learn more about SESIP on the GlobalPlatform website.