Exploring security, trust, privacy and interoperability for a connected clinical device ecosystem
There are millions of connected wireless medical devices (ie. IoT, IoMT, IoIMTs, biosensors etc) in the health ecosystem that monitor and/or deliver life-saving treatment for patients. The goal of these devices is clear: helping patients achieve better health either by better understanding the impact of therapeutic conditions, providing real-time treatment and/or a more proactive approach to diagnosis.
These connected devices can be found in, on or around the patient running autonomously in real-time serving as the source of a critical yet highly coveted data supply chain.
As fast as these connected wireless medical devices enter the market the challenges to trust, validation and adoption grow just as quickly. This class of devices is continuously evolving and becoming more innovative yet carrying the same legacy issues that impede maximum utilization of these devices for clinical research, health practice and overall health/wellness.
The WAMIII program cultivates a global community of multi-disciplinary stakeholders to openly collaborate, build consensus, and develop solutions that will enable the following:
- Develop standard frameworks for a seamless, secure and validated PPAN (Personal Patient Area Network) both at home and beyond
- Data portability, compatibility and interoperability from device to device and device to EHR connected wireless medical device data interoperability
- Explore frameworks enabling patients with the ability to consent to share their device data with designated entities (ie. clinicians, hospitals, researchers, etc) utilizing supporting technologies such as blockchain/DLTs
- Build consensus on a global certification system that can assure patient security and privacy in the use of wireless connected medical devices
- Establish trust and validation of data outputs to apply intelligence for diagnosis, clinical research, and patient recruitment through development of trusted solutions
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The Global WAMIII Impact Workshops
The WAMIII’s Impact Workshops presents an educational and collaborative platform enabling technology and application experts to share successful case study outcomes and growing challenges with the use of connected wireless medical devices in clinical research and health practice. The in-person workshops provide a platform for open collaboration enabling participants to incubate ideas, share knowledge and experiences, and identify viable solutions. The workshops also feature discussion on current standards in development or recently published within the domain to help participants understand the impact of the standard and the opportunity for continued innovation.
The themes of the workshop are directly aligned with the outlined objectives of the Global WAMIII Program. The workshops not only address the core issues but create a simulated working group environment for participants to understand the experience in enabling innovation and progress through development of standards.
Outcomes
- Formation of an Blockchain-Clinical IoT Pre-Standards Workstream to assemble a key group of stakeholders to collaborate and begin preliminary building of specification for a standard and achieve consensus if there was viability to move towards official standards development project
- White Paper: Pre-Standards Workstream Report: Clinical IoT Data Validation and Interoperability with Blockchain
- IEEE/UL 2933-2024: Standard for Clinical Internet of Things (IoT) Data and Device Interoperability with TIPPSS — Trust, Identity, Privacy, Protection, Safety, Security
Published Article
Related Pre-Standards Incubation Activities
IC20-018 - New Frontiers in the Continuum of Care for Connected Health
Working to develop solutions that increase access to telehealth for underserved and unconnected populations while protecting patient privacy and security.
IC23-003 - Zero Trust Cybersecurity for Health Technology Tools, Services, and Devices
The goal is to build conventional, general-purpose zero trust microsegmented IT infrastructure and guidelines in healthcare for remote patient monitoring tools, workforce, services, platforms, health systems, EHR (Electronic Health Record) and more.
IEEE Medical Device Cybersecurity Certification Program
Our first certification (IEEE 2621) use case is focused on medical devices used for monitoring and managing diabetes. These types of devices provide life-saving benefits to patients and effective implementation options to healthcare providers and include blood and continuous glucose monitors, insulin pumps, pens and other insulin delivery devices, and closed loop artificial pancreas systems and others.
With ever-increasing connectivity and data exchange between these diabetes devices, other devices (such as smartphones), and the Internet, there is an increased risk to the safety and privacy of the patient and to the integrity of the healthcare provider. The standard IEEE P2621, therefore, is needed to aid medical manufacturers in the development of more secure, and therefore safer, products as well as to provide the framework for enhancing assurance across the relevant stakeholder community.
Certify Connected Wireless Medical Devices are Secure and Safe for Patients
The Next Chapter
The IEEE WAMIII program has evolved into a range of initiatives focused on cybersecurity, interoperability, and artificial intelligence in connected medical devices. For additional information about these programs and related activities, please visit the IEEE SA Global Healthcare and Life Sciences webpage.