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 to Date
- 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 P2933™ Working Group: Standard for Clinical Internet of Things (IoT) Data and Device Interoperability with TIPPSS — Trust, Identity, Privacy, Protection, Safety, Security
Published Article
The Global Virtual Talk Series
The Global WAMIII Virtual Talk Series commenced in March 2020 with a mission to educate a multi-disciplinary community of producers and consumers of wireless medical device patient data on the challenges impacting trust, validation and maximum utilization of these devices. This series provides a platform for committed industry community members stakeholders.
This ongoing series of one-hour webinars feature global experts introducing challenges and opportunities, sharing insights on latest technology developments, and outcomes standards adoption in the connected wireless medical devices domain.
Topics include:
- Biosensors/Wireless Medical Devices
- Cybersecurity
- Decentralized Clinical Trials
- Digital Therapeutics
- Mobile Health Apps
- Patient Data Privacy & Governance
- Remote Patient Monitoring
- Robotics/Autonomous Systems
- Telehealth
Related Pre-Standards Incubation Activities
Connectivity Harmonization of the Digital Citizen Industry Connections Program (PDF) (IC17-011)
Technology and Data Harmonization for Decentralized Clinical Trials Industry Connections Program (IC19-004)
Digital Inclusion Identity Trust and Agency Industry Connections Program (IC17-002)
Transforming the Telehealth Paradigm: Sustainable Connectivity, Accessibility, Privacy, and Security for All (PDF) (IC20-018)
WAMIII's Wireless Medical Device Security and Privacy 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 (PDF)
Get Involved
We are currently recruiting advisors and participants for this program. If you are interested, please contact Maria Palombini, IEEE SA Healthcare Life Sciences Practice Lead, [email protected]
Healthcare and Life Sciences
The IEEE SA Healthcare and Life Sciences Practice is a global platform of excellence bringing together committed volunteer stakeholders to evaluate, validate, and develop solutions for establishing trust in new technology applications that will afford the right to safety, security and protection of life. The practice is focused on three main priority areas – clinical health, bio/pharmaceutical value chain, and wellness – designed to address the obstacles to universal and sustainable quality of care for all individuals.