SAFE Identity, an industry consortium and certification body operating a Trust Framework for digital identities in healthcare, has formed an Internet of Medical Things (IoMT) working group.
This group, composed of digital identity experts, will establish industry standards and guidance for medical device manufacturers to build trusted, secure, and interoperable credentials into their products on the production line, officials say. This effort will enable hospitals, radiology centers, medical labs, and other consumers of medical devices to use a trusted standards-based credential already on the device as soon as it arrives at their loading docks.
With an average of 10-15 network connected devices per hospital bed, healthcare providers are challenged with identifying and managing all the devices on their network to ensure data confidentiality, integrity, and network security. These challenges have proven to be a systemic issue exacerbated by connected medical devices, an increase in wearable devices and remote patient monitoring, which introduce additional attack vectors and increase risks that impact patient safety, privacy of protected health information (PHI) and data breaches.
The work done by the IoMT working group will provide a standardized requirement for medical device certificate issuance based on industry best practices for device identity and assurance requirements. These issuance practices will define tactics to combat some of the biggest issues in healthcare today, including anti-counterfeiting measures, tampering prevention, encryption, and identity confirmation on the network. The vendor-agnostic requirements defined by the IoMT working group will include testing to enable interoperability across systems.
To help facilitate this effort, SAFE Identity recently hired Priti Dave as the director of solutions strategy. Her 14 years of experience at a leading health information exchange network enables Dave to apply her knowledge in ecosystem development to help solve one of the greatest challenges in the IoMT space through her role as the chair of the SAFE Identity IoMT Working Group, group officials say.
“Providing a path to secure medical device identities is a major step towards building the foundation for digital trust within healthcare,” says Dave. “With the IoMT working group, we have set out to clear this path in a collaborative way, utilizing SAFE Identity’s Trust Framework for a standards-only, product-agnostic approach that fosters interoperability and thwarts vendor lock-in in a decentralized way. The IoMT working group provides an excellent forum for all parties in the healthcare space to share their needs and expertise surrounding medical device security, and we encourage participation from across the industry.”
A Three-Phased Approach to Fostering Interoperability of Medical Device Identities
The IoMT Working Group will carry out its mission in a three-phased approach to ensure maximum productivity of the participants.
Phase I: The IoMT working group will start by modernizing the SAFE Certificate Policy, a set of technical specifications, interoperability criteria, compliance guidelines, and liability rules that govern the SAFE Identity Trust Framework, to meet the needs of the medical device space. The updated policy will establish digital identity standards that leverage cryptography, strong authentication, and consistent assurance levels for medical devices so buyers can securely interact with these products straight out of the box.
Digital identities built into these devices will be issued from a variety of SAFE Certified Credential Providers to enable interoperability with all parties relying on the SAFE Trust Framework. SAFE is also developing procurement guidance to arm healthcare organizations with a strategy for implementing a Trust Framework within their risk management and procurement processes.
Phase II: The working group members will establish operational guidance and implementation strategy to help both device manufacturers and consumers of medical devices adopt industry standards and best practices in their environments. This phase will focus on device auto-enrollment to support large scale issuance of device credentials, credential management, a cost benefit analysis of different public key infrastructure implementation methodologies and procurement strategies for consumers of medical devices.
For organizations such as healthcare delivery organizations (HDOs), the procurement strategies will support the contract and acquisition process by helping measure risk and select appropriate identity requirements for the medical devices they acquire. Leveraging this procurement language takes the burden off HDOs to credential medical devices themselves and provides assurance that they can be used safely on the network immediately.
Phase III: The final phase of the working group will establish guidance for leveraging the SAFE Trust Framework and industry guidance to satisfy various aspects of U.S. FDA pre-market and post-market guidance for medical devices. Given SAFE’s long history of interoperating with the EU and ETSI policies, the group will also explore compliance with EU regulations as part of its final phase.