WAMIII Event Banner

WAMIII - Virtual Talk Series

WAMIII Virtual Talk Series

The WAMIII virtual talks series will continue to convene and educate the global community of technologists, clinicians, healthcare professionals, regulatory, patient advocates, bio/pharma professionals and any other stakeholder who have a common interest in developing solutions around the safe, responsible and validated use of connected wireless medical devices in, on, and around us.

The WAMIII Virtual Talk Series is a critical educational and outreach program under the Clinical Health Workstream of the IEEE SA Healthcare and Life Science Practice.

Learn more about the WAMIII Program

UPCOMING SESSIONS


 

 

 

WAMIII Virtual Series – Session 25
8 December 2021 3:00 PM – 5:00 PM UTC | 11:00 AM – 12:00 PM ET

Going Beyond Design in Connected MedTech Innovation: Navigating the Pitfalls of Liability and Policy in Garnering User Trust for Adoption

  • Moderator: Maria Palombini, Director, Healthcare and Life Science Practice Leader, IEEE SA
  • Paul Kostek, IEEE Senior Member; Systems Engineer, Air Direct Solutions LLC
  • Nick Leighton, Class Underwriter, AEGIS London

As an engineer or software/hardware developer of a connected medical device (ingestible, implantable, wearable or otherwise), it usually begins and ends with innovation. As an entrepreneur or a lead engineer in an established medical device organization, there are many critical considerations beyond verifying “does the technology work?” These could include considerations of feasibility, safety, security, privacy and more, all of which may impede market acceptance or adoption of your cutting-edge medical technology. Ensuring patient safety is vital and of utmost priority, however minimizing risk and exposure to your start-up or current organization should be top of mind. Tune into this special session to get a better understanding of hidden risks and pitfalls and tactical strategies that may better protect the personal and organizational brand, while reassuring users of commitment to responsible business conduct.

Key questions discussed in this session include:

  • What are some of the challenges with policy in this genre of connected medical devices and downstream impact on the overall market entrance of this product?

  • What is holding back liability underwriters when it comes to product coverage of in-body connected wireless medical devices?

  • What are the overall risks to tech start-ups or lead engineers (in larger organizations) developing new in or on-body technologies for healthcare diagnosis, monitoring or research?

  • What are the implications of physician and patient trust and usability when devices are too far ahead of the curve?

  • Where do limitations begin and end for software developers with the right to protect privacy if information collected for healthcare can be mandated for disclosure in criminal and civil litigations?

  • Where can global technical standards development alleviate some of these challenges?
     

This session will feature experts in regulatory, insurance and healthcare fields to explain the many challenges impeding trust in adoption of the latest cutting-edge devices and some potential solutions that will begin to open the pathways for all developers.

If you are currently in the design or development process and/or about to release a connected medical device/application into the healthcare market, this is one session you may want to tune in to stay ahead of the bumpy curve ahead. Sign up for this free session at https://ieeesa.io/wamiiisessions.


+ Read Maria Palombini's Bio

Maria currently leads the IEEE SA Healthcare & Life Sciences Practice working with a global community of stakeholder volunteers who are committed to establishing trust and validation in tools and technologies that will change the approach to discover therapies, deliver care, and ultimately enable a sustainable and universal quality of care for ALL. Maria is the founder of DisruptiveRx, an information gateway addressing the critical need for pharmaceutical and life sciences executives to connect innovation with business strategy to re-think the process of the drug development and distribution value chain. She has extensive experience in building global media brands in multiple industry sectors. She holds a B.S. and B.A. from Rutgers College and an M.B.A. from Rutgers Graduate School of Business at Rutgers University.


+ Read Paul J. Kostek's Bio

Paul J Kostek is a Systems Engineer with Air Direct Solutions LLC, a consulting firm in Seattle, Washington. He works with companies in the aerospace, defense, medical device/healthcare, commercial space and ground transportation industries. Paul is experienced in requirements development/management, architecture, risk management, interface definition, verification, MBSE and project planning. This includes defining user needs, system/subsystem requirements, system architecture, risk analysis, interface control documents and verification and validation planning.

He is a member of the IEEE Humanitarian Activities Committee and chairs the Education Committee. Paul supports the IEEE Visibility activities with interviews and articles on aerospace, commercial space, UAVs and medical devices/healthcare for IEEE and other general news publications. In 1999 Paul was the President of IEEE-USA, and a member of the IEEE Board of Directors. He served as President of the IEEE Aerospace & Electronics Systems Society in 2000-2001 and was a candidate for IEEE President-Elect in 2001. He Chaired the American Association of Engineering Societies in 2003. And served as VP Conferences for the IEEE Intelligent Transportation Systems Society. He was the Secretary for the P1616 WG revising the Motor Vehicle Event Data Recorder Standard.

He was General Chair of the 2004 IEEE Intelligent Transportation Systems Conference, Chaired the 2006 IEEE/AIAA Digital Avionics Systems Conference and was the Chair of the 2011 and 2012 IEEE Global Humanitarian Technology Conference.

Paul is a Senior Member of the IEEE, an Associate Fellow of the American Institute of Aeronautics and Astronautics and a member of the International Council on Systems Engineering, SAE, and the Project Management Institute. He is an adjunct professor at Seattle University and received his BS from the University of Massachusetts, Dartmouth.


+ Read Nick Leighton's Bio

Nick began his underwriting career in 1982 with the J.S.Marsh Syndicate, writing all classes of E&O and joined AEGIS London in 2012. He has experience leading a wide range of PI classes and has led a number of market facilities for many years. Specialties include architects & engineers, insurance brokers and miscellaneous risks, focusing mainly, but not exclusively, in the US. As a binding authority specialist, he has written many facilities for specific affinity groups and industry associations and is used to creating bespoke solutions to address their needs.


 

 

 

SESSIONS ON DEMAND

Browse all of the recorded sessions for the WAMIIII Virtual Talk Series - or view by related topics. All of the sessions provide insight on the latest innovations from Industry experts either by presentations or a moderated panel. Register to gain access to all sessions for free. 
 

Latest Session On-Demand

 

Fireside Chat Mini Series

On the Front Lines with Government Health Executives - Connected Tools, Tech and Data for Public Health

  • Host: Maria Palombini - Director, Healthcare and Life Sciences Practice Leader, IEEE SA
  • Guest Interviewer: John Cyrus - PMP, SMIEEE, Retired US Federal IT Executive (USPTO Commerce); Director, IEEE Northern Virginia Section and Senior member of IEEE, Director, Emerging Technologies, HighPoint Global

The IEEE SA WAMIII Virtual Talk Series has a deep well of on-demand sessions focused on technical and trust challenges, viable use cases, and cutting-edge development of connected medical technologies to choose from and yet, this new mini-series will be distinctly compelling. The series will feature four (4) senior IT executives within US federal health agencies who are embracing and utilizing new tools and applications such as artificial intelligence (AI), machine learning (ML), blockchain/DLTs, data modernization and interoperability to better prepare for public health challenges while minimizing public risk.

The fire-side chat interviews will engage government IT Executives in the use of new technologies and applications to address significant challenges with efficiency, interoperability and overall patient safety in the healthcare ecosystem. This session provides a bird's-eye-perspective to our global audience of engineers, technologists, industry professionals and patient advocates on how government organizations are utilizing these technologies to make the critical breakthroughs needed to better preserve public health.

These are experts who appreciate the weight of their responsibility in understanding how to responsibly use these tools to ensure citizen safety and enhance patient outcomes. These sessions get beyond policy development and get to the core of understanding the impact of these technologies in preserving public health.


+ Read Maria Palombini's Bio

Maria currently leads the IEEE SA Healthcare & Life Sciences Practice working with a global community of stakeholder volunteers who are committed to establishing trust and validation in tools and technologies that will change the approach to discover therapies, deliver care, and ultimately enable a sustainable and universal quality of care for ALL. Maria is the founder of DisruptiveRx, an information gateway addressing the critical need for pharmaceutical and life sciences executives to connect innovation with business strategy to re-think the process of the drug development and distribution value chain. She has extensive experience in building global media brands in multiple industry sectors. She holds a B.S. and B.A. from Rutgers College and an M.B.A. from Rutgers Graduate School of Business at Rutgers University.


+ Read John Cyrus' Bio

Mr. John Cyrus is a retired Federal senior information technology (IT) executive with more than 25 years of experience in technology. A Harvard University-certified cybersecurity executive, and a thought leader on emerging technologies such as Zero Trust, AI, robotic process automation (RPA), and intelligent automation. Mr. Cyrus was Senior IT Executive Corporate and Trademarks Portfolio Manager in the United States Patent and Trademark Office (USPTO), where he served as principal leader for IT investments associated with the office’s Corporate, Trademarks (NextGen and legacy), Policy, Technology Sustaining, Dissemination, and Enterprise Business Systems portfolios. Mr. Cyrus was a founding co-lead of the USPTO’s Intelligent Automation COI. Mr. Cyrus earned his MS in electrical engineering at Wichita State University (KS). He is a Project Management Professional and a graduate of the Federal Executive Institute (FEI) Leadership for a Democratic Society, He is an elected senior member of the Institute of Electrical and Electronics Engineers (IEEE), Director of the IEEE section of Northern Virginia for 2021 and serves on the Artificial Intelligence and Autonomous Systems Policy Committee. Mr. Cyrus served as representative to industry-government partnerships, including ACT-IAC, Professional Services Council, and AFCEA. As a member of the Intelligent Automation Working Group Emerging Technology Community of Interest at ACT-IAC. He is one of the authors of the ACT-IAC white paper on RPA.Mr. Cyrus participates and moderates panel discussions on AI, Cybersecurity, Intelligent Automation and RPA at different forums including AFCEA and ACT-IAC.


 

 

Episode 1: 20 July 2021 | 12:00 PM ET – 12:30 PM ET
Executive Interview with FDA:
Utilizing Artificial Intelligence and Machine Learning in Exploring and Understanding Pre & Post Regulatory Processes

Guest Dr. Qais Hatim, Data Scientist, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (US FDA)


+ Read Dr. Qais Hatim's Bio

In my role as data scientist at U.S. Food and Drug Administration (FDA) I am leading research in artificial intelligence/machine learning, and statistical/operational modeling. I am applying advanced AI/ML, statistical modeling and scientific computing techniques to computationally intensive tasks that are encountered in regulatory and scientific applications. I am utilizing various statistical and operation research methodologies such as machine learning and data mining algorithms, natural language processing (NLP) techniques, and deep learning methodologies to extract meaning, patterns and hidden structures in structured/unstructured data; identifying the most feasible approach to analyze problems and recommend technology based solutions.


 

Episode 2: 11 August 2021 | 12:00 PM ET – 12:30 PM ET
Executive Interview with Department of Veteran Affairs:
Using Trustworthy AI to Improve Veteran Well-Being through R&D

The National Artificial Intelligence Institute cultivates trustworthy AI pilots that improve the well-being of our nation’s Veterans through the use of data and targeted R&D efforts.

Guest Dr. Gil Alterovitz, PhD, FACMI, FAMIA Director, National Artificial Intelligence Institute, US Department of Veterans Affairs


+ Read Dr. Gil Alterovitz's Bio

Dr. Gil Alterovitz is the inaugural Director of the National Artificial Intelligence Institute at the U.S. Department of Veterans Affairs. He is focusing on leveraging health information for AI as well as building AI research and development capacity to help our nation's Veterans through the Office of Research and Development. He is also a faculty member with Harvard Medical School.
Dr. Alterovitz was one of the core authors of White House Office of Science Technology and Policy’s The National AI R&D Strategic Plan from 2019. He has also spearheaded the “AI-able Data Ecosystem” pilot, creating a new approach for public-private collaborations with personnel/resources across a dozen agencies and working with companies internationally.


 

Episode 3: 5 October 2021 | 12:00 PM ET – 12:30 PM ET
Executive Interview with CMS:
Advancing Interoperability to Improve Transparency and Efficiency in the Health System

Dr. Greene will provide an overview of work the Centers for Medicare & Medicaid Services (CMS) is doing to create efficiencies in the health system and make clinical and administrative data accessible to patients, providers, and other stakeholders. Topics include Application Program Interfaces (APIs), requirements library, prior authorization, digital quality measures, care coordination, and health equity.

Expert Guest Dr. Mary Greene Director, Office of Burden Reduction & Health Informatics, Center for Medicare and Medicaid Services (CMS/OBRHI)


+ Read Dr. Mary G. Greene Bio

Dr. Mary G. Greene is the Director of the Office of Burden Reduction & Health Informatics. She is responsible for unifying CMS's efforts to reduce regulatory and administrative burden for beneficiaries and the medical community, enabling the health system to focus on providing higher quality care at lower cost and to foster innovation in health care delivery. She oversees initiatives to modernize regulations, drive interoperability, and improve the adoption and enforcement of HIPAA Administrative Simplification national standards and operating rules, and engages external stakeholders through listening sessions and onsite observational visits.
Previously, Dr. Greene served as senior advisor to the CMS Office of the Administrator leading and supporting CMS's burden reduction initiatives. Prior to that, Dr. Greene was the Director of the Governance Management Group in the CMS Center for Program Integrity (CPI), where she led CPI's vulnerability management, program risk assessment, regulation development, strategy development, and performance oversight functions.
Before joining CMS, Dr. Greene led strategy and operational support projects to stand up new programs, improve operational efficiencies, build collaborations, and foster professional development. Dr. Greene, a pediatrician and Fellow of the American Academy of Pediatrics, completed her medical education at the Yale School of Medicine, clinical training at the Johns Hopkins Hospital, Masters in Public Health at the Yale School of Public Health, and Masters in Business Administration at Loyola College in Maryland.

Episode 4: 20 October 2021 | 12:00 PM ET – 12:30 PM ET
Executive Interview with the CDC:
Data Modernization Initiative at CDC and the Lessons learned From the Pandemic

Dr. Sim will discuss CDC’s Data Modernization Initiative to unlock the full potential of data for disease detection and elimination. He will highlight how the influence of the lessons learnt from the pandemic on this comprehensive strategy to support public health surveillance, research and, ultimately, decision-making.

Guest - Dr. Alan Sim, Ph.D. Chief Data Officer (CDO), Center for Disease Control and Prevention (CDC)


+ Read Dr. Alan Sim, Ph.D.'s Bio

Dr. Alan Sim is an epidemiologist with extensive experience in population health informatics and translational data science. He currently serves as CDC’s Chief Data Officer (CDO) and has over twenty years of experience with healthcare data management, analysis, public health informatics, and data science with multiple federal and military organizations. Prior to joining the CDC, Dr. Sim served as the chief data scientist with the Enterprise Intelligence and Data Services (EIDS) PMO within the Department of Defense (DoD).


Additional Resources: Learn more about the IEEE SA Transforming the Telehealth Paradigm Industry Connections Program bringing a global community together to address the issues of connectivity, security, privacy and accessibility for all.

Category: Telehealth

SUPPORTING PARTNERS

REGISTRATION

Note:  When you register for the Series you get access to the recorded sessions. You'll receive a weekly email announcing new sessions for the week, links to ALL recorded sessions and you will receive reminder emails (24 hour and 30 minutes) prior to each session.

The WAMIII virtual talks series will continue to convene and educate the global community of technologists, clinicians, healthcare professionals, regulatory, patient advocates, bio/pharma professionals and any other stakeholder who have a common interest in developing solutions around the safe, responsible and validated use of connected wireless medical devices in, on, and around us. Participation in these sessions includes the following:

  1. Hearing global expert perspectives (from every corner of the world) on the technical and regulatory challenges and viable clinical applications of wireless medical devices on, in around the patients.
  2. Learning, sharing ideas and building consensus for development of solutions to address challenges impeding trust and adoption of these technologies for diagnosing, monitoring and treating patients.
  3. Access to a platform without geographic bounds enabling a global community of progressive thinkers with common initiatives to harmonize recommendations and form collaboratives to drive solutions through the development of technical and data standards.

Register Now