Day 1

08:15 AM

CHAIRPERSON’S OPENING REMARKS & KEYNOTE ADDRESS: THE IoMT LANDSCAPE AND FUTURE TRENDS

Numerous acquisitions and company closings have reduced the number of medical device connectivity vendors. At the same time, the IoMT market has seen new entrants and established IoT companies offer their solutions in health care. This presentation will consider various market segments that are shaping the IoMT market and offer insight into the IoMT and medical device connectivity ecosystem. An overview of product and service providers, emerging standards and technologies that are shaping the health care industry will be presented. A review of the changing regulatory landscape will be discussed with references to applicable guidance and other information that is available. The presentation will conclude with an analysis of market trends, both retrospective and prospective. Emerging opportunities for vendors will also be discussed. Tim Gee, Principal, Medical Connectivity Consulting

09:00 AM

PANEL DISCUSSION: INTEROPERABILITY FOR IOMT APPLICATIONS – PRACTICAL CONSIDERATIONS

Our panel will discuss the factors driving market demand for interoperability, the barriers to interoperability and what a practical interoperability solution might look like.
  • What are the specific use cases where IoMT interoperability offers advantages over proprietary end-to-end solutions?
  • Are proprietary end-to-end solutions generally broad enough to preclude the need for interoperability?
  • What are the technical means available to industry to implement IoMT interoperability?
  • How does the need for interoperability impact addressing interstitial markets, markets that include various different health care trading partners?
  • What are the various different sources of IoMT data that are driving the need for interoperability?
Moderator:

Tim Gee, Principal, Medical Connectivity Consulting

Panelists:

Bridget A. Moorman, MSBME, CCE, President, BMoorman Consulting, LLC

Shahid Shah, Chairman, Netspective

10:15 AM

MEDTECH AND THE INTERNET OF MEDICAL THINGS: HOW CONNECTED MEDICAL DEVICES ARE TRANSFORMING HEALTH CARE

Major advances in technology are driving innovation in Medtech, leading to the development of an increasing number of connected medical devices that are able to generate, collect, analyze and transmit data. The data, along with the devices themselves, are creating the Internet of Medical Things (IoMT) —connected infrastructure of medical devices, software applications and health systems and services. With IoMT market estimated to be worth $158.1 billion in 2022, how can medical technology (Medtech) companies get IoMT right from a business perspective and how they can use the opportunity to deliver more value to health care? Learn about:
  1. How connected medical devices are transforming the way health care is being delivered
  2. The impact on the current and future business models of MedTech companies
  3. How to overcome the challenges in deploying connected medical devices
Pedro Arboleda, Managing Director, Strategy & Analytics, Deloitte Consulting

10:45 AM

IS FDA’S NEW SAMD DESIGNATION A BREAKTHROUGH FOR AI/ML/HEALTH IOT OR JUST A DIFFERENT KIND OF INVESTIGATION?

The medical device, and Health IoT, sector is seeking to match the recent pace of innovation driven by digital health vendors. Unlike traditional digital health solutions, which aren’t subject to much regulation beyond HIPAA, Health IoT devices and software are subject to FDA’s MDDS, Class I, Class II, and Class III designations. To help move from an “inspection oriented” regime to “operational excellence” (OE) driven regulations, the FDA is spearheading a new Software as a Medical Device (SaMD) designation.   Machine Learning (ML) and Artificial Intelligence (AI) solutions, which seek to eliminate or augment clinical decision making, are good test cases for SaMD. Join Shahid Shah, an award-winning and internationally recognized Health IoT Business Modeler and Systems Architect, as he explains what SaMD is, what the OE focus is, and why it matters to next generation software platforms seeking to help patients make medical decisions via educational and diagnostic algorithms. Shahid Shah, Chairman, Netspective

11:15 AM

PUTTING PATIENT-GENERATED HEALTH DATA TO WORK

The presentation will discuss the concerns that clinical users and health IT teams have when incorporating PGHD into clinical workflows.
Robert Havasy, MS, Senior Director, Connected Health, HIMSS

11:45 AM

PATIENT CARE DOESN’T STOP AT THE INFUSION PUMP: HOW TO MITIGATE IOT AND MEDICAL DEVICE SECURITY RISK

According to ECRI,there are 14-17 connected medical devices for every hospital bed. However, Ponemon reports only 51% of device makers say they follow guidance from the FDA to mitigate or reduce inherent security risks in medical devices, which creates additional security blind spots and increases the cyberattack surface for hospitals and healthcare systems. This session will define the security and operational challenges associated with connected endpoints, including IoT and medical devices, and will discuss how hospitals and healthcare delivery organizations (HDOs) can reap the rewards of IT adoption to achieve operational efficiencies, provide a better patient care experience and reduce the overall risk to patient safety. We will discuss:
  • Emerging issues and trends that are risky to healthcare IT systems and can directly affect patient safety,violate their trust and impact revenue
  • Best practices for shoring up network security blind spots and mitigating the risk of IoT and medical devices
  • Why real-time endpoint visibility and intelligence is the key to achieving an effective and proactive cybersecurity strategy
Ty Powers, Technical Director/Solutions Architect, Great Bay Software

12:15 PM

DEALING WITH THE TSUNAMI OF UNMANAGED DEVICES

The explosive growth of connected devices in healthcare environments—infusion pumps, ventilators, ICU telemetry, medication carts, and many more—provides a new attack surface which can’t be protected by legacy security tools. Attackers are increasingly targeting these unmanaged devices to penetrate healthcare environments without detection. This session will provide examples of attacks on these devices and discuss new strategies that fill the gaps left by traditional security architectures.
To Be Announced, Armis
Day 1 Track A

01:45 PM

TIPPSS FOR CONNECTED HEALTHCARE AND CLINICAL IoT

The imperative to ensure we deploy medical IoT with TIPPSS - Trust, Identity, Privacy, Protection, Safety and Security - is becoming more and more important as the plethora of clinical IoT devices grows. IEEE and the US NSF have been working with the research, industry, academic and regulatory community to develop the TIPPSS framework since 2016. Learn about the IEEE Standards Assocation pre-standards workstream on clinical IoT data validation and interoperability with blockchain which Florence is leading with regulators, device manufacturers, industry leaders, startups, academic researchers, pharmaceuticals and other members of the medical IoT device ecosystem to develop recommendations on a TIPPSS framework for clinical IoT device and data interoperability with blockchain.
Florence Hudson, Special Advisor, TrustedCI, NSF Cybersecurity Center & Special Advisor, Next Generation Internet, Northeast Big Data Innovation Hub

02:15 PM

IMPACT OF EMERGING PRIVACY REGULATIONS ON MEDICAL DEVICES AND IoTs

The European Union (EU) General Data Protection Regulation (GDPR) has triggered a ‘Butterfly Effect’. Since May 25th, 2018 when GDPR became effective, new privacy regulations have sprung across the globe. These regulations are going to change the way personal information is managed in today’s global connected world. Under the new regulations, Privacy has a very broad definition. Users will demand full visibility and control of their data - how/what/why data is used/shared and for long data is to be kept. The ‘privacy’ driven data protection process will require a new approach to embedding “Privacy by Design” in all apps including medical devices and IoT powered solutions. Privacy is no longer viewed simply as a ‘compliance’ activity but rather an ‘enterprise data management’ activity that requires reengineering of your organization’s data management practices, its data flows, analytics and data sharing model. Takeaways:
  1. What is General Data Protection Regulation (GDPR)? What happened since GDPR enacted on May 25th, 2018. The California Consumer Privacy Act (CCPA) of 2018, Vermont Data Broker Law, Other Global Data Protection Regulation What GDPR and CCPA mean to your product design strategies
  2. Impact of GDPR and other Privacy regulations on Medical Devices, SaMD, IoTs, distributed systems, Blockchain, and Analytics
  3. Embedding ‘Privacy by Design’.  Comparing HIPAA and GDPR. The technical and data management considerations for Privacy design.
Naeem Hashmi, Digital Health Solutions Strategic Advisor, Boston Scientific

03:30 PM

THE USA AND EU: DIFFERENT HEALTH INFORMATION PLATFORMS AND MEDICAL DEVICE INTEGRATION

The USA and the EU have gone in different directions with regard to medical device connectivity and that is due to their different emphases on what types of health information technology platforms to fund at a ‘federal’ level. In the USA, the HITECH Act has predominated with the end result of a focus on electronic health record applications. In the EU, the focus has been more on remote monitoring and integrated care systems. This presentation will compare and contrast the different approaches while showing those differences as well as similarities with regard to the of medical device data.
Bridget A. Moorman, MSBME, CCE, President, BMoorman Consulting, LLC

04:00 PM

DELIVERING ON THE PROMISE OF WIRELESSLY ENABLED DIGITAL HEALTH AND THE INTERNET OF HEALTH (IOH); WIRELESS CONNECTIVITY ISSUES, RISKS, TECHNOLOGIES AND PRACTICAL ADVICE

Wireless medical systems have unique hazards and risks that need to be addressed in the concept, design, testing, and operation phases. These are especially important to consider and address in medical device systems where serious injury or death can occur related to the failure, disruption, or loss of information via wireless transmissions. This session is focused on these issues with information about the technology trends, design and regulatory considerations, and practical advice that includes how to deal with the risks related to important aspects such as wireless coexistence and security. The session includes a survey of the trends for wireless medical devices over the last 20 years, information about the most widely used wireless technologies, considerations for digital health and the IoH (Internet of Health) and practical information that can help take the research concepts through some of the hurdles that lead to fruition and into deployment.
Phil Raymond, Director, Wireless Competency Center, Philips Healthcare


04:30 PM

CONNECTIVITY CHOICES FOR YOUR MEDICAL DEVICE AND IOMT APPLICATION

Medical Devices and IoMT encompasses a wide variety of wireless technologies across a numerous array of applications. From requirements of Enterprise WiFi to operate within a RF challenging Hospital environment to supporting zero provisioning for home healthcare applications. There are considerations for Bluetooth interfacing with the millions of smartphones and tablets available to a connectivity technology for low cost sensor deployment and wire replacement. Devices, machines, buildings, and countless other products; virtually anything can be connected to the internet. With an abundance of technologies available at your fingertips such as Bluetooth, Wi-Fi, LoRa and Cellular, where do you start?  Come join our session to discuss with us the IoMT wireless technologies for embedded connectivity along with gateways and sensors for use in the Acute care, Clinical, and Home Healthcare environments. Dan Cusick, Strategic Business Development Director, Medical, Laird Connectivity

05:00 PM

OPTIMIZING WI-FI POWER AND ROAMING CAPABILITIES

  • Power consumption:
    1. Description of problem.
    2. History of power save in WLAN
    3. Current available opportunities functions to optimize power
    4. The future.
  • Roaming:
    1. Description of problem.
    2. Description of process and behavior.
    3. Parameters that impact behavior.
    4. How these can be optimized.
    5. Impact of 11r on this solution.
Y. Zachary Freeman, Vice President - Silex Technology America
Day 1 Track B

01:45 PM

INTEGRATION AND INTEROPERABILITY – AN EHR PERSPECTIVE

Data is only useful when it is easily accessible to clinicians, and can be sorted, graphed, and analyzed. In this presentation, Justin Armstrong will explore how medical devices currently interface with Electronic Health Records (EHRs), the security challenges, and the improvements being made. Interoperability also plays a significant role, and Mr. Armstrong will discuss how REST APIs are transforming this space. REST APIs are currently used for decision support, interfacing with tools, and empowering app developers to create Patient Portal apps which can serve patient data directly to patients. Lastly, secure development processes that enable innovation and security will be considered.
Justin Armstrong, CISSP, Security Architect, System Technology Division, MEDITECH

02:15 PM

STOP BURNING THE CANDLE AT BOTH ENDS WITH SMARTER DATA

Medical device connectivity is becoming a standard IT program in most healthcare systems.  The clear advantages to improving data integrity and clinical workflow efficiency supported implementation initiatives.  Costs for such solutions are coming down as more vendors enter the market, and there are more IT and Healthcare Technology Management (i.e. CE or Biomed) professionals with experience to support these programs in house.

At the same time, the introduction of smart phone-based personal health records (i.e. Apple Health and Google Fit) has fueled the growth of the consumer wellness market, including a wide range of connected health devices.  Many hospitals have opened their EHR-supported patient portals to import this data as part of patient engagement initiatives. For many, the next step is to feed this data into algorithms to either guide clinical care or calculate the probability that the patient requires a new level of medical attention.  Several of these tools are ad hoc solutions, customized to address the patient while in a certain level of care (rightfully so).

Healthcare leaders are beginning to look at all the possible solutions in order to develop a cohesive strategic roadmap that provides the appropriate level of predictive analytics that can follow the patient throughout the enterprise, including the home, while on a remote monitoring program.

The objective of this talk is to review the existing trends in predictive analytics, highlight certain innovative approaches, and discuss potential strategies to align these solutions with executive strategy.
Jennifer Jackson, Director, Connectivity, Masimo

03:30 PM

OVERCOMING CHALLENGES IN IMPLEMENTING IoT TECHNOLOGIES AT SCALE AT HEALTHCARE PROVIDER ORGANIZATIONS

Innovation in healthcare is complex. Fortunately, there are many opportunities to innovate. But, those opportunities are often tempered with the reality that healthcare is an environment rich of latent trials and tribulations for newcomers and the well-informed alike. Delivering innovation, and its adoption, presents obstacles. Along with all the “typical” challenges associated with product or systems development, healthcare can pose additional layers of complications not encountered in other settings or industries. One such complication is that healthcare is a broad term; one which incorporates and/or touches many specialties, sub-specialties, regulations, standards and industries. Innovating in healthcare, particularly at-scale, nearly always requires absolute dedication to a clear objective. To grow from concept to adoption (with sustainable operations) requires focus and perseverance – nearly to a fault. Organizations need to evaluate the potential benefits of unrelenting tangential opportunities versus a near-obsessive focus on their vision. It is a dichotomy of sort, extreme focus in a vast and sometimes poorly defined technological landscape. This presentation will discuss the challenges encountered by healthcare delivery organizations, and providers, when adopting technology and related process changes. Attendees will gain insight into hospital operations, resources, general patient care needs and other useful information they can then impart to their products, and/or implementation processes, as the Internet of Medical Things comes of age.
Luis Melendez, Principal, Melendez Consulting
Day 2

08:15 AM

CHAIRPERSON’S OPENING REMARKS

Tim Gee, Principal, Medical Connectivity Consulting

08:30 AM

KEYNOTE ADDRESS: AT THE CUTTING EDGE OF TECHNOLOGY INNOVATIONS: AN EXPLORATION OF THE MEDICAL INTERNET OF THINGS (MIOT) VIA DEVICE APPLICATIONS AND CYBERSECURITY CONSIDERATIONS

How do we build a future with more connectivity when much of that future uses old, non-secure technology? By understanding the significant differences between the Internet of Medical Things (IoMT) and the Medical Internet of Things (MIoT), discussing the mindsets we need to have when addressing cyber-security issues, and looking at how the Medical Device Interoperability & Cybersecurity Program at Massachusetts General Hospital addresses these and other important issues, this address will provide a lens through which one can more deeply explore and appreciate the related topics being presented at this conference, enabling participants to implement effective strategies and solutions in their respective workplaces.
Julian M. Goldman, MD, Medical Director, Partners HealthCare Biomedical Engineering & Director, Program on Medical Device Interoperability & Cybersecurity (MD PnP)

09:15 AM

THE IMPACT OF AN INTEGRATED CLINICAL ENVIRONMENT (ICE) MEDICAL INTERNET OF THINGS PLATFORM ON A CRITICAL CARE ENVIRONMENT

This talk will include the processes went through to deploy an ICE IOMT platform as well as the potential impact to the patient environment when deploying such solutions both clinically and operationally.  It will also include the cybersecurity and data benefits of collecting data in a datacentric manner.
Tracy Rausch, CEO, DocBox

09:45 AM

REMEMBER THE CHESHIRE CAT?

Looking at today's health IT environment may remind us of the Cheshire Cat in Alice in Wonderland - it is disappearing in front of your very eyes. Your data centers are moving into the cloud. Your users are expecting access to critical information anytime, anywhere, and from any device. Patient care devices are moving into the patients' homes and consumer devices are now providing medical data. The physical perimeter used to be the ultimate control point, but it is no more. How do healthcare organizations utilize these new technologies, while they, on the other hand, meet compliance requirements and assure information privacy and infrastructure security?

This session will review how these trends impact care delivery, provide new business opportunities, and how they can be implemented without taking undue risks. From cloud-based data centers to EKG's straight from the patient's wrist, as we transform our technology platforms so do we need to change our approach to security and privacy.
Axel Wirth, CPHIMS, CISSP, HCISPP, Healthcare Architect, Symantec

10:45 AM

CHALLENGES IN MANAGING MEDICAL DEVICE CYBERSECURITY

Ransomware and other cybersecurity threats was listed by ECRI Institute as the top health technology hazard for 2018 due to their ability to disable hospital IT systems, causing delays to patient care, altering clinical workflows, and even resulting in facility closures. Effective management of cybersecurity with connected medical devices in a clinical setting is particularly difficult due to a range of practical limitations. Many medical devices still require hands-on updates and facilities are often faced with the burden of managing large fleets of old legacy devices from hundreds of different vendors. During this session we will discuss through key challenges with managing medical device cybersecurity faced by ECRI Institute’s member hospitals and outline practical recommendations on how to address each.
Juuso Leinonen, Senior Project Engineer, Health Devices Group, ECRI Institute

11:15 AM

HOW THE LACK OF MEDICAL DEVICE SECURITY COULD HARM PATIENTS: WHAT STEPS WE NEED TO BE TAKING NOW

Today’s medical devices are increasingly complex, integrated and ubiquitous. Securing them can be daunting. Safeguards that are appropriate for traditional IT equipment can have disastrous effect when applied to medical devices. This session will provide an overview of the problem and will offer specific guidance and tools appropriate for addressing medical device security. The session will
  1. Describe the digital security challenges presented by a largely unmitigated fleet of connected biomedical devices and discuss commonly available mitigation actions when addressing cyber vulnerabilities
  2. List examples of how data compromised to medical devices can have a major impact on patient safety Estimate the number of medical devices existing in their organizations that are vulnerable to data compromise using typical industry benchmarks
  3. Describe major reasons why data on microprocessor-based medical devices can be both more vulnerable and significantly more difficult to secure than data found on most IT equipment
  4. Identify best practice guidelines and tools available to help healthcare delivery organizations identify and mitigate medical device security risks
Stephen L. Grimes, FACCE, FHIMSS, FAIMBE, Managing Partner, Strategic Healthcare Technology Associates, LLC


Rickey Hampton, Wireless Communications Manager, Partners HealthCare

11:45 AM

PANEL DISCUSSION: ASK THE EXPERTS

Participate in this interactive panel discussion to ask industry experts your toughest questions about designing and launching your connected medical device. The group will be prepared to provide guidance on the following topics, and more:
  • Product requirements elicitation
  • Radio selection and integration
  • Data security requirements and solutions
  • Product architectures and best practices
  • FDA submission requirements for connected medical devices
  • Technology selection considerations and recommendations
  • Defining the “whole product solution"
Moderator:
Tim Gee, Principal, Medical Connectivity Consulting
Panelists:
Y. Zachary Freeman, Vice President - Silex Technology America
Additional Panelists To Be Announced

01:30 PM

MD PnP OPEN HOUSE

The MD PnP program, established in 2004, has become a recognized leader in the development of the concepts and capabilities for integrated clinical environments of the future. We have been working to accelerate the adoption of medical device interoperability by providing interoperability building blocks (use cases, standards, a neutral lab environment, and open research tools) and by changing clinical and market expectations of what can be achieved.



Our interdisciplinary, multi-institutional program team collaborates with diverse stakeholders (clinicians, biomedical and clinical engineers, academic engineering programs, healthcare delivery systems, regulatory agencies, medical device vendors, standards development organizations). Since the program’s inception, more than 800 clinical and engineering experts, and representatives of more than 100 companies and institutions have participated in plenary workshops / conferences, working group meetings, and focus groups to help shape the common goals and contribute their expertise. The MD PnP Lab provides a vendor-neutral “sandbox” to evaluate the ability of candidate interoperability solutions to solve clinical problems, to model clinical use cases (in a simulation environment), to develop and test related network safety and security systems, and to support interoperability and standards conformance testing. For additional information on the MD PnP program, please visit: http://mdpnp.mgh.harvard.edu/

The lab tour will include demonstrations of MD PnP’s open-source interoperability platform, OpenICE, as well as an overview of our work on securing medical devices.

The MD PnP open house is complimentary for all Summit attendees. The open house will be held in Cambridge, MA, a short cab ride from the Inn at Longwood Medical, where the Summit will be held. Food and drinks will be served.