IEEE-SA Presents:

Wearables and Medical IoT Interoperability & Intelligence (WAMIII) Workshop 2018

Security, trust, privacy and interoperability for a connected medical device ecosystem

The Workshop is intended for attendees to learn about the opportunities and challenges surrounding data interoperability of wearable devices within the connected health wearable system – users, software, communications, networks, data, hardware, services, firmware and more.  The forum will tackle the following educational objectives with the goal of engaging a diverse community of stakeholders – regulatory, sensor developers, technologists, and health professionals – to participate in wireless testbeds and workstreams for technical frameworks for standards and tech policy guidelines for patient privacy and consent.

Wednesday, 25 April 2018

Registration: 07:30
Sessions:  08:30 – 16:30
Reception: 16:30

Johns Hopkins University
Montgomery Country Campus
9601 Medical Center Drive
Rockville, MD 20850
Get Directions


The IoMT market is exploding with millions of new devices and creating both economic boom and promise for improved patient care. According to Nexeon there are 3.7 million connected medical devices in use (as of February 2017) and Allied Research has estimated the IoT healthcare market will reach $136.8 billion by 2021.

The data currently generated from these devices could deliver much promise in advancing the future of medicine and clinical research. The explosive growth of this market has brought upon greater demand for more robust and secure devices that can deliver data interoperability, security and trust. The current vulnerabilities of these devices require vested stakeholders – health professionals, regulators, sensor developers, software developers, device manufacturers – to take critical action in exploring frameworks for technical standards and/or policy guidelines to address these critical concerns.

If these critical issues can be resolved, then the ability to tap this well of highly valuable data can be realized for multitude of different applications including but not limited to: advancing clinical research, precision medicine, patient recruitment and engagement for clinical trials, faster and precise diagnostics, and more. To achieve this, we need you to be part of this Workshop, the initiative and the motivated group of professionals who believe that the interoperability of smart/medical devices can be better utilized to help advance the future of medicine.

This is not just a one-time Workshop. The workshop (Day 1) is a key facilitator in presenting the challenges and opportunities to the relevant stakeholders to engage in developing a framework for tech standards and policy recommendations (Day 2) to “smartly” share, protect and utilize patient device data in advancing the future of medicine.

Who Should Attend?

YOU, if you are in any of the following areas:

  • Clinical Trials Design & Operations
  • Clinical/Medical Professional
  • Health Insurance Payment
  • Health Wearable Start-Up
  • Hospital/Health System – Innovation and Data Project Leads
  • Medical Device Manufacturers – product design or engineering
  • Medical Device Software – design or engineering
  • Micro-Electro-Mechanical Systems (MEMS) product design or engineering
  • Sensor Development
  • Communications Network Engineering
  • Blockchain/DLT Technologists: Blockchain/DLTs
  • Government/Regulatory
  • Research: Academia or Industry
  • Other: Enthusiast not mentioned in this list

The Education

The Workshop is intended for attendees to learn about the opportunities and challenges surrounding data interoperability of wearable devices within the connected health wearable system – users, software, communications, networks, data, hardware, services, firmware and more.  The forum will tackle the following educational objectives with the goal of engaging a diverse community of stakeholders – regulatory, sensor developers, technologists, and health professionals – to participate in wireless testbeds and workstreams for technical frameworks for standards and tech policy guidelines for patient privacy and consent.

Learning Objectives – Opportunities and Challenges

  1. TECHNOLOGY – Raising the caliber of the devices – more processing and security.
  2. INTEROPERABILITY – Hardware and Software Driving Data Interoperability from device to device, device to blockchain, device to patient
  3. SECURITY – Exploring the use of blockchain/DTLs to secure and protect patient data while enabling trusted users to use verifiable patient data in tamper-proof environments
  4. TRUST in DATA – Validation of patient’s data from the devices for use in clinical applications (ie. clinical trials, research, diagnostics, precision medicine, innovation in medicine)
  5. POLICY & PRIVACY – protecting the patient’s data, meeting regulatory guidelines for hardware interoperability, Patient Protection, Policy and Consent – where technical standards and tech policy guidelines can deliver on this


DAY 1: 25 April 2018 – Johns Hopkins University, Rockville, MD
Agenda – as of 20 April 2018

DAY 2: Immersive Cities Working Group Meetings (8:00AM – 3:00PM)

Sessions will take place in Room 207 in Gilchrist Hall

TimeSession NameInvited Speakers
07:30 - 08:15Check-in and Breakfast
08:15 - 08:30Opening RemarksGerard Hayes
Director, Wireless Research Center (WRC)
Chair, of IEEE Connectivity Harmonization of the Digital Citizen Industry Connections Program
08:30 - 09:15Regulatory Preview: Guidance on Interoperability of ALL Medical DevicesJohn F. Murray

Software Compliance Expert, Office of Compliance

FDA’s Center for Devices and Radiological Health (CDRH)

Sandy Weininger, Ph.D.

Office of Science and Engineering Laboratories
FDA’s Center for Devices and Radiological Health (CDRH)
09:15- 09:50A Medical Device Communication Conformance and Interoperability Testing FrameworkJohn J. Garguilo
Computer Scientist, Group Lead, Systems Interoperability Group
National Institute of Standards (NIST)
09:50 - 10:10MORNING BREAK
Coffee, tea and energy snacks served
10:10 - 10:45TIPPSS for WAMII: Blockchain and Beyond
This session will take into consideration blockchain plus other 
technologies and processes needed to ensure TIPPSS - Trust, Identity, Privacy, Protection, Safety and Security -  for the internet of biomedical things, the data, and patients. 
Florence D. Hudson
Editorial Board, Blockchain in Healthcare Today; 

Special Advisor for Next Generation Internet, Northeast Big Data Innovation Hub
10:45 - 11:20Regulatory Aspects & Spectrum Interoperability for Wireless Wearable Devices Michael Violette, P.E., iNARTE Certified EMC Engineer
President of Washington Laboratories; Director, American Certification Body
11:20 - 11:55UNPROTECTED: Rectifying the Lack of Security in Smart/Medical Devices Making Health Organizations, Patients and Clinicians Highly Vulnerable in More Ways than One
This session will provide an understanding of the security risks to clinicians, and patients and healthcare delivery organizations directly related to the insecurity of medical devices - smart or otherwise. Key discussion points will look where to strategically leverage technology, policy and collaboration with the critical stakeholders to eliminate the lack of trust and fear and create a secure, connected ecosystem.
Chris Clark
Principal Security Engineer, Strategic Initiatives, Synopsys
11:55 - 12:15Sensors Certifications: The Value Proposition for Developers and Users of IoTs
The IEEE-SA in collaboration with the IEEE Sensors council has commenced standardization efforts around Quality of Data for Sensors (IEEE P2510). The IEEE Conformity Assessment Program is simultaneously working with industry stakeholders on the development of a certification program for sensors across multiple verticals as well as the creation of the IEEE Sensors Registry. This presentation will introduce the value proposition for a certification program for sensors in IoT applications and also introduce the formation of the IEEE Sensors Certification Committee.
Ravi Subramaniam
Technical Director, Conformity Assessment, 
12:15 - 13:15Clinical IoT/Blockchain Working Group Signup + Networking Lunch
13:15 - 13:50Wearables in Clinical Trials, What We’ve Learned and What’s Next
This session focuses on sharing lessons learned from using wearables in clinical trials; data integrity, data transfer, usability and regulatory compliance and you'll learn from collaborations and proof of concept projects that are driving what’s next
Karin Beckstrom

ERT Innovation Lab
13:50 - 14:25Tech Talk: IoT, Blockchain and Patient Data Can Come Together and Where Can it Go?Robert Barkovich
CEO & Founder, Health Linkages
Coffee, tea and power snacks served
14:45 - 15:20Blockchain, IoMT, and AI Convergence in Obesity and Diabetes Treatment and Research Use-Cases
This session uses obesity and diabetes disease management and clinical research scenarios as a lens to explore the convergence of blockchain, IoMT, and AI, addressing interoperability and cybersecurity of insulin pumps, continuous glucose monitors, and commercial wearables.
Heather Flannery
CEO & Founder, Obesity PPM
15:20 - 16:45Roundtable Discussions

RT1 - Commercialization Side (Buyers and Sellers)
RT2 -Interoperability & Data Security
RT3 - Hardware Interoperability Challenges (Regulatory, technical)
Discussion leaders will be assigned.
16:45 - 17:00Closing Remarks - Next StepsMaria Palombini
Director Initiative and Community Development, IEEE-SA
17:00 - 17:45Networking Reception Mixer
A little bit of networking, adult beverages and some starters.
08:00 - 14:00

Day 2 - 26 April 2018

IEEE-SA Connectivity Harmonization of the Digital Citizen Industry Connections Program Working Groups Meeting

Open to all attendees of the IEEE WAMII Workshop.
Session leader:
Gerard Hayes
Director, Wireless Research Center (WRC)
Chair, of IEEE Connectivity Harmonization of the Digital Citizen Industry Connections Program

Same room location.
Breakfast and Lunch will be served.

Confirmed Speakers

 Robert Barkovich, Ph.D.

CEO & Founder, Health Linkages Inc. 

Robert is a product leader with more than 15 years of experience on the software and IT side of healthcare and life sciences.  Robert is currently the CEO of Health Linkages Inc., a company focused on solving the data provenance problem in the healthcare and life sciences industries.  Health Linkages uses a combination of blockchain and big data technologies to allow organizations to trust, protect and share their data.

Robert has a Ph.D. in Chemistry and Biochemistry from UCLA.  His career includes positions Deloitte, Thermo Fisher Scientific, Affymetrix and Amersham Pharmacia Biotech.  He has also worked with and consulted for many startups and larger companies.


Karin Beckstrom

Director, ERT Innovation Lab

For over 20 years, Karin Beckstrom has been driving software product innovation. In both the human resources and pharmaceutical industries, she has taken advantage of new technology and methodologies to create user-driven, flexible products that fit into the clients’ daily workflow.  Daily in ERT’s Innovation Lab, she seeks to prove out the usefulness of new ideas and technology for clinical trials. She oversees projects that determine if and how these new ideas provide an innovative data stream, a better patient experience or better trial process.  She works collaboratively with clients, partners and patients to positively change the clinical trial paradigm. Karin shares lessons learned through speaking engagements, articles and presentations to extend the conversation and collaboration. In clinical trials putting the patient first, looking at their lives and challenges and matching that against the potential of new technology is a winning combination leading to better outcomes.

Christopher Clark

Principal Security Engineer, Strategic Initiatives,

Chris is a twenty-two-year veteran of the Information Technology world who uses his experience in management, information systems, and cyber security to help organizations effectively integrate meaningful security practices into their environments. Chris holds a Masters in Cyber Security from the University of Maryland University College as well as having held numerous certifications throughout his career. Chris has worn many hats, including roles as Project Manager, Director of Information Systems, hospital system CIO, and Principal Security Engineer. Chris also participates with numerous standards bodies to ensure effective security requirements are included in the development of future standards. Chris currently if focusing on educating customers on how to minimize their cybersecurity risks by engaging with customers and sharing his knowledge and experiences in the hopes of building a more cyber resilient future.

Heather Flannery

Founder and CEO, Obesity PPM Inc

Heather Flannery is the Founder and Chief Executive Officer of Obesity Prevention, Policy, and Management, Inc. (“Obesity PPM”), an innovative provider of disease management, population health, research administration, and information technology managed services for health systems in the Americas, and an early adopter of distributed ledger technology. Ms. Flannery has driven continuous business model innovation via technology early adoption throughout her 23-year career as an entrepreneur and strategist. She has consulted in the public sector in context of international development, and brings a global health perspective to her initiatives. Ms. Flannery is a broad, lateral thinker who applies complex adaptive systems theory to identify, advance, and course-correct the critical path to progress against very large-scale macroscopic challenges, focusing in the health sector since 2006. Due to her personal life experience, Ms. Flannery is intrinsically motivated to impact population health and economic prosperity through non-communicable disease prevention and treatment. She builds mission-driven organizations aligned by shared values: making measurable societal contributions, creating economically sustainable interventions, and prioritizing diversity and inclusion. Ms. Flannery is also a participant in the Blockchain Working Group at the Health Information and Management Systems Society (HIMSS), the Healthcare Working Group in the Government Blockchain Association, a Founding Member at HL7’s FHIR Foundation, the organizer of the DC Distributed Health Blockchain Innovation Working Group, Advisory Board member for the Institute for Healthcare Financial Technology, and a member of the Board of Directors at the non-profit Virginia Obesity Research Institute.

John J. Garguilo

Computer Scientist, Group Lead  of Systems Interoperability Group
Software and Systems Division, 
Information Technology Laboratory, 
National Institute of Standards and Technology (NIST)

John J. Garguilo is a supervisory computer scientist at the National Institute of Standards and Technology (NIST) of the United States Department of Commerce. John’s the Group Leader of the Systems Interoperability Group and leader of the Semantic Interoperability of Medical Devices (SIMD) project focused on medical device communication research and testing and aimed at enabling the adoption of medical device communication standards by acute, point-of-care, and personal health medical device manufacturers.

John currently serves as the Health Level Seven (HL7) Healthcare Device Working Group Co-Chair and over ten years as the test lead as well as four years as the Technical Committee Co-chair for the Integrating the Healthcare Enterprise – Patient Care Device (IHE-PCD) domain. John has recently been elected to a two-year term as the Secretary of the IEEE 11073 Medical Device Communications Point of Care (PoCD) working group.  John’s focus over the past ten years has been on developing conformance test tooling in support of standardization of medical device information exchange and working with device standard and Standards Development Organizations (including HL7 V2 and ISO/IEEE 11073). His work includes testing and promoting adoption of standards for medical device communications throughout the healthcare enterprise as well as integrating it into the electronic health record.  John works and is closely engaged with medical device experts within the HL7, IHE-PCD domain, and ISO/IEEE Healthcare Devices and Personal Health Devices working groups. John also leads the HL7 message validation test tooling effort and development of an industry adopted harmonized medical device terminology database containing ISO/IEEE 11073 terminology.

John holds a Master’s degree from the Johns Hopkins University and Undergraduate degree from the State University of New York, Potsdam, both in computer science.  John has extensive experience over the past 30 years working on and managing software systems to support research, measurement science, testing, automating work flow applications, data communications, and electronic commerce.

Dr. Gerard Hayes

Director, Wireless Research Center (WRC)
Chair, of IEEE Connectivity Harmonization of the Digital Citizen Industry Connections Program

Dr. Hayes has nearly three decades of experience in government and commercial electromagnetic research and design. Prior to working with the Town of Wake Forest to establish the WRCNC in 2010, Dr. Hayes was the Director of Engineering at GreenWave Scientific where he led the development of antenna and RF circuit designs for a diverse range of DoD applications. At Sony Ericsson Mobile Communications (USA) Inc., Dr.Hayes provided global technical leadership in the Technology and Research organization with contributions to handset antenna design, technology, and radiated performance optimization. At Lockheed Martin (formerly Lockheed Missiles and Space Co.), Dr. Hayes supported research and development efforts for space-based, phased array applications. The scope of his experience encompasses electromagnetic theory, bioelectromagnetics, antenna design, RF circuit analysis, and material engineering. He has participated in the development of international standards for OTA, HAC, and SAR evaluation (including IEEE, IEC, CTIA, and C63 standards). With over 70 US patents, Dr. Hayes has maintained a prominent technical role in the wireless industry.

Florence D. Hudson

Blockchain in Healthcare Today Editorial Board
Special Advisor Next Generation Internet for the Northeast Big Data Innovation Hub
Former IBM Vice President and Internet2 Senior Vice President & Chief Innovation Officer

Florence Hudson is a former IBM Vice President and Chief Technology Officer, and Internet2 Senior Vice President and Chief Innovation Officer. She serves on the Editorial Board of the journal Blockchain in Healthcare Today. She works with the IEEE Standards Association on end to end trust and security for the Internet of Things, Blockchain for Clinical Trials, and WAMII (Wearables and Medical Interoperability). She is also Special Advisor to the Northeast Big Data Innovation Hub for Next Generation Internet at Columbia University.

She participated in the Cancer Moonshot Summit hosted by United States Vice President Joe Biden in 2016, and presented in the Academic Medical Centers (AMC) Security & Privacy Conference Series in 2015 on Security and Privacy Strategies for Expanded Communities, and Biomedical Device Security Challenges and Opportunities. She is on the program committee for the Computational Approaches for Cancer workshop at SuperComputing, and was a panelist and speaker at the first IEEE CHASE Conference on Connected Health in 2016 (CHASE = Connected Healthcare, Applications, Systems and Engineering technologies). She speaks in many venues regarding blockchain, the Internet of Things, and smart campus and communities.

Ms. Hudson earned a BSE in Mechanical and Aerospace Engineering at Princeton University, beginning her career at Grumman Aerospace and NASA, prior to HP, IBM, Internet2, Blockchain and the Northeast Big Data Innovation Hub. She has attended executive education at Harvard Business School and Columbia University.

John F. Murray, Jr.

Expert Regulatory Scientific Reviewer
Digital Health Unit
FDA’s Center for Devices and Radiological Health (CDRH)

John currently serves as an Expert Regulatory Scientific Reviewer in the Digital Health Unit in the Center for Devices at the US Food and Drug Administration.

During his 24 years of service at the FDA he was a staff member in the Office Compliance for 15 years and on staff in the Office of Science and Technology for 8 years.

Prior to joining FDA John’s professional experience included Technology Management & Analysis, General Dynamics Electric Boat Division, Telex Computer Products and active duty service with the United States Navy Submarine Service – USS Swordfish.

Mr. Murray earned his BS Electronics Engineering from George Mason University and his MS Computer Science from Rensselaer Polytechnic Institute.

Maria Palombini, MBA

Director, Emerging Communities & Initiatives Development, Global Business Strategy & Intelligence, IEEE Standards Association

Maria is the creator, leader and advocate for the Pharma Blockchain Initiative, which seeks to bring awareness and balanced learning to the pharmaceutical community and its key stakeholders on the viable applications of blockchain within the pharmaceutical framework. The goal of the initiative is advance adoption of blockchain in combination with emerging technologies (ie. AI, IoT, etc) where it will lead to enhanced patient safety and care, and optimize and innovate the drug development lifescyle.

In 2017, Maria joined IEEE-SA with a directive to build communities and advance initiatives to develop standards for enterprise adoption of emerging technologies. Her work includes building communities of technologists, industry executives, academic researchers and industry stakeholders to educate on the benefits and challenges of viable applications of emerging technologies, while building consensus on recommendations for frameworks on technical standards and recommended guidelines for protocol and policies to enhance the outcomes of technology implementation. Her primary areas of focus include the pharma, health, supply chain, energy, and agriculture sectors. In parallel to her work in blockchain standards, she is the project lead for IEEE-SA’s newest initiative, Digital Inclusion through Trust and Agency, a critical program focused on bringing the outstanding 50% of the world’s population online while working with technologists, advocacy groups and policy leaders on developing trusted frameworks that will protect the digital persona, the right to be forgotten, and restoring dignity to digital transactions for ALL members of the global community.

In 2015, Maria left Euromoney Plc, one of the world’s leading information and event producers. She founded DisruptiveRx™, an information company that would produce written and in-person educational programs and bring pragmatic attention on breakthrough innovations that would transform life sciences and healthcare enterprise operations.

Her career started at the prestigious IEEE (Institute for Electronic and Electrical Engineers) and moved onto highly respected media companies including Penton Media, Advanstar Communications, IIR, Reed Business Information and Nielsen Business Media. She successfully led the global branding, marketing and public relations campaign for the world’s largest mining investment networking platform, Mining Indaba™, in Cape Town, South Africa.

Maria currently holds an MBA from the Rutgers Graduate School of Business and a BA and BS from Rutgers College at Rutgers University, the State University of New Jersey. She is an accomplished leader and public speaker having presented at various industry events. You can follow her on twitter @DisruptiveRx or on

Ravi Subramaniam 

Technical Director, Conformity Assessment

Ravi Subramaniam is currently serving in the role of Technical Director, IEEE-SA Conformity Assessment Program. In this role Ravi works closely with working groups on post standards implementation which encompasses test plan development and interoperability. Currently he is focused on developing programs in nuclear, telecommunications, power & energy, imaging and sensor technologies. He is a member and holds leadership roles within numerous committees, including the IEEE Sensors Council Industry Committee and MEMS & Sensors Industry Group (MSIG) Standards Committee.

Prior to taking on this role, Ravi has served in various technology management roles across the globe. He has previously worked for MET Laboratories, Inc., Honeywell and Ericsson. Ravi studied Electrical Engineering at Arizona State University and Johns Hopkins University.

Michael Violette, P.E., iNARTE Certified EMC Engineer

President, Washington Laboratories;
Director, American Certification Body

Mike is President of Washington Laboratories and Director of American Certification Body. He has over 30 years of experience in the field of EMC evaluation and product approvals and has overseen the development of engineering services companies in the US, Europe and Asia.

He is a Professional Engineer, registered in the State of Virginia. He has given numerous presentations on compliance topics and is a regular contributor to technical and trade magazines.

Dr. Sandy Weininger

Office of Science and Engineering Laboratories 
FDA’s Center for Devices and Radiological Health (CDRH)

Dr. Weininger’s current scientific and regulatory focus is the safety and performance assessment of sensors and actuators for physiologic systems, and examining complex systems to understand unsafe interactions. He works with standards development organizations, including UL, AAMI, ASTM, IEC and ISO to construct both horizontal and vertical safety standards. He is actively involved in developing and delivering courses on achieving safety in medical devices using systems engineering principles. He is member of AAMI/UL 2800 – Interoperable Systems, AAMI’s Interoperability Workgroup, past chair of the ASTM Pulse Oximeter Committee and FDA’s liaison to IEC TC 62 and SC 62A, committees responsible for safety of electromedical equipment, and ISO TC 121/SC3 JWG10 – oximeters. Dr. Weininger works with academic partners to develop methods for the safety and performance evaluation of interoperable systems.

Dr. Weininger has been at the US FDA, Center for Devices and Radiological Health, in the Office of Science and Engineering Laboratories since 1990. Currently, Dr. Weininger is a senior engineer with the Division of Biomedical Physics of the Office of Science and Engineering Laboratories within the FDA’s Center for Devices and Radiological Health. Dr. Weininger’s areas of concentration are design and engineering of electronic systems and signal processing as applied to small physiological signals. His responsibilities include supporting the regulatory process with technical consults related to electrical performance and safety, risk management activities, leading industry-government partnership efforts to develop consensus standards, performing forensic engineering analyses, and developing test methods. He provides expert consulting reviews on electrical safety and essential performance aspects of devices, including risk management. His engineered the signal acquisition system for the first mandatory medical device performance standard, the Apnea Monitor Performance Standard and supporting simulation based test methods. This exposure to clinical signal acquisition and simulation lead to to projects in pulse oximeter simulation/calibration; and the sole developer for the NIH Fox (fetal oximetry) trial recording system to assess the effectiveness fetal saturation monitoring.

Dr. Weininger received his BSEE and MS/BME from Drexel University focusing on the properties of the electrode- tissue interface. He received his Ph.D. in Bioengineering from the University of Pennsylvania; where he specialized in signal processing and control systems related to behavioral assessment of newborns. Prior to joining FDA, he worked for Carter-Wallace, Inc., in Cranbury, NJ where he was responsible for setting up and developing their biosensor research program.


Johns Hopkins University
Montgomery County Campus
9601 Medical Center Drive
Rockville, MD 20850
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Parking is FREE for all attendees. You MUST have the parking pass displayed on your dashboard in your car on the day(s) you attend.
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Sessions will take place in Room 207 in Gilchrist Hall


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9751 Washingtonian Boulevard
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The nature of this Workshop is to give ALL participants the opportunity to speak and shape the conversation in addressing the critical challenges facing this vested community of technologists, commercialization leads, medical professionals, and regulatory leaders. Therefore, our Workshop can only accommodate up to 40 attendees.

This event has ended.  See a current list of WAMIII events


  • $199 regular attendee

If you are a current IEEE member please contact for information on how to obtain a 10% discount on your registration.

Please be sure to include this subject line in your email:   IEEE Member Registration Discount. 

Come back for Day 2: 26 April 2018 (Optional)

After the learning, we get to the “doing.” WAMIII is one facet of the IEEE-SA’s Immersive Cities: Connectivity and Harmonization of the Digital Citizen Industry Connections Program, which will officially launch on April 26, 2018. As an attendee of WAMII you are invited to participate in the working group meetings that will take place throughout the day.  WAMII will be one of the many working group meetings going on. Attendance is optional and included for all WAMII attendees, please be sure to indicate whether or not you will be attending on your registration form.


If you are interested in speaking at or sponsoring WAMII, please write to

Interested in joining the IEEE-SA WAMIII Workstream?