IEEE-NIH 2016 Special Topics Conference on Healthcare Innovations & Point-of-Care Technologies Mexico, November 9-11, 2016
SPECIAL SESSION – PANEL
“Moving Discoveries from the Bench to Product Realization in the Marketplace: Standards and Regulatory Considerations”
The intersection of engineering, health and medicine with rapidly evolving new technologies in wireless communications, sensors, “smart” devices and so on have further stimulated cutting edge product development, entrepreneurship, and commercialization of innovative medical devices. Specific areas of interest include imaging, biomaterials, Nano applications, neuroprosthetics, brain-computer interface and many others. The cross-functional collaborations drive innovations and clinical solutions that have foreseeable impact in commercial healthcare products globally. For society to benefit from the breakthroughs in biomedical engineering and enabling technologies, they must be translated into practical clinical applications in the form of devices, drugs or other products. Converting these discoveries, however, can be very challenging — issues such as safety, manufacturability, cost, patients’ acceptance, protection, licensing, and marketing.
This session will bring together professionals who will share case studies and translational engineering experience from idea creation to commercialization. The panel will also discuss the role of standards and provide an understanding of the medical devices premarket regulatory requirements, as the legal gateway to commercialization in the U.S. marketplace.
DATE: November 10, 2016 (Thursday)
Special Session on Standards
Sunday, October 9, 2016, 9:00 – 17:00
The SMC 2016 provides an international forum for researchers and practitioners to report up-to-the-minute innovations and exchange ideas and advances in all aspects of systems science and engineering, human machine systems, and cybernetics.
During this session on BMI-related standards, organized by the IEEE Standards Association, the use of
neurotechnologies for invasive and non-invasive practices will be discussed. How this technology is implemented for surgery, Augmented Reality (AR)/Virtual Reality (VR), or wearables, and how standardization of the technology is needed to support integration and help accelerate the translation of these devices to commercialization. This session is open to the attendants to IEEE SMC conference.
Topics to be discussed:
- What is a BMI standard?
- Should there be a separate set of standards for clinical and non-clinical applications?
- What would a framework for standards on diverse topics, plus their interoperability look like?
- What are the biggest challenges to using these technologies?
- What are the highest priorities or the biggest challenges that can be addressed by standards?
- What needs be addressed in the next 3 years?
- Is there a need for standards on the reliability of these systems in terms of performance?
- Should standards be set to protect from third-party access?
- Is it the role of standards to define which information should or should not be stored? Or whether encryption/anonymization is required.
This session will be composed of short presentations and panels with different stakeholders from the private, academic, and regulatory sectors. Ample time has been reserved for discussions with contributions from the attendants, including breakout discussion sessions on standards gaps for clinical and non-clinical BMI applications. Plenary panels will take place on the Ballroom III. Breakout roundtables (14:30-16:00) will take place in the Ballroom III and Panorama I. The final session will take place in the room Panorama I
The outcome of this workshop will be used to drive establishment of the standards committee on
Panel 2: The Role of Standards
Tackling the Barriers to Adoption of Interoperable Connected Healthcare
Connected Health is realized by integrating technology to support and provide healthcare remotely, and our Connected Health Environment is rapidly changing and complex. The industry is challenged to become more connected, effective, and accessible, and always to maximize healthcare resources.
The Internet of Things, Healthcare Internet of Things, Internet of Medical Things and the like are expanding rapidly, only to be eclipsed by the volume of information generated, and potential barriers of security, interoperability, and scalability are at the forefront. Regardless of the platform design and technology used, e.g., mobile apps, wireless communication, wearable personal health/medical devices, the cloud, or big data analytics, health enterprises, leaders, and consumers want and expect to implement strategies, products, systems, and tools that support clinical decisions and the healthcare delivery systems. Patients and consumers alike need to be well-informed. They want to be involved and empowered in their own healthcare.
Can we help create an environment in which clinicians, EHR/EMR systems, and devices can seamlessly send and receive accurate, secure information while maintaining privacy? Can health data be shared with minimal extra effort and worry, and will 2016 be a turning point?
The goal of this workshop is to bring together professionals to discuss their perspectives on gaps and barriers to the adoption and diffusion of this rapidly changing Connected Health landscape, and the role of standards for solutions in facilitating health information interoperability and portability.
Location and Time Hyatt Arlington 1325 Wilson Blvd Arlington, VA 22209
Date: Wednesday June 29, 2016 Time: 1:30 – 3:00 pm Room: TBD