PRE-CONFERENCE WORKSHOP DAY
8:00 am - 9:00 am REGISTRATION AND MORNING JUMPSTART
9:00 am - 9:15 am WELCOME & INTRODUCTION OF MD PNP LABS OF MASSACHUSETTS GENERAL HOSPITAL, HARVARD MEDICAL SCHOOL
9:15 am - 10:15 am A WALKTHROUGH TOUR OF THE MEDICAL DEVICE PLUG AND PLAY LAB
Speakers:
Julian Goldman Director of the Program on Medical Device Interoperability Massachusetts General Hospital, Harvard Medical School
David Arney Lead Engineer, MD PnP Program Massachusetts General Hospital
David Guffrey Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration Team Partners Healthcare
Julian Goldman Director of the Program on Medical Device Interoperability Massachusetts General Hospital, Harvard Medical School
David Arney Lead Engineer, MD PnP Program Massachusetts General Hospital
David Guffrey Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration Team Partners Healthcare
A true pioneer in the industry, experience first hand how the MD PnP Interoperability Lab is making interoperability the foundation of next generation patient care.
Julian Goldman
Director of the Program on Medical Device InteroperabilityMassachusetts General Hospital, Harvard Medical School
David Guffrey
Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration TeamPartners Healthcare
10:30 am - 12:30 pm WORKSHOP A: ADOPT OPEN STANDARDS AND INTEROPERABLE TECHNOLOGIES TO SECURELY INTEGRATE YOUR MEDICAL DEVICE TO CLINICAL ENVIRONMENTS
Moderator:
Julian Goldman Director of the Program on Medical Device Interoperability Massachusetts General Hospital, Harvard Medical School
Speakers:
David Niewolny Director, Healthcare RTI
Tracy Rausch Founder DocBox
David Guffrey Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration Team Partners Healthcare
David Arney Lead Engineer, MD PnP Program Massachusetts General Hospital
Julian Goldman Director of the Program on Medical Device Interoperability Massachusetts General Hospital, Harvard Medical School
Speakers:
David Niewolny Director, Healthcare RTI
Tracy Rausch Founder DocBox
David Guffrey Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration Team Partners Healthcare
David Arney Lead Engineer, MD PnP Program Massachusetts General Hospital
Hospitals often have a lot of constraints when it comes to how the network is configured and system requirements for medical devices often vary from hospital to hospital. Though manufacturers are certainly experts when it comes to their own devices, at the enterprise level, hospitals need a clear map of device capabilities and constraints and should know how their equipment performs as part of an ecosystem made up of multiple systems and devices. Join this workshop and brainstorm with a nexus of clinicians, clinical engineers, computer scientists, hospital operations and IS Operation experts who work closely with medical device manufacturers, standards organizations, software companies, and other collaborators and
·Explore how the adoption of open standards and interoperable technologies have the potential to dramatically improve patient care
·Hear best practices to evaluate interoperability, plan future products that are interoperable and conceptualize the medical internet of things as the next generation of devices
·Discuss challenges Health IT leaders are facing to safely assemble medical device and HIT components to create a connected clinical system beyond EHR
·Walk away inspired to think about how you can contribute to the medical internet of things
·Learn about a larger body of work that’s been done that can be leveraged to accelerate your own product development so you don’t have to reinvent the wheel
Julian Goldman
Director of the Program on Medical Device InteroperabilityMassachusetts General Hospital, Harvard Medical School
David Guffrey
Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration TeamPartners Healthcare
12:30 pm - 1:30 pm LUNCH
1:30 pm - 3:30 pm WORKSHOP B: AN INCREMENTAL APPROACH TO RISK AND QUALITY MANAGEMENT IN MEDICAL DEVICE SOFTWARE DESIGN
Software Engineers are dedicated to making things work, so a focus on failure can be unusual. However, risk management is essential for all medical devices, especially those involving software. There are many examples that software failures have produced some painful examples of poor risk management with serious consequences.
· Understand “Safety Hazards” related to software
· Evaluate the intersection of medical device standards and their intersection with risk management
· Assess End users and Human Factors to improve safety
· Apply engineering risk methods to software design concepts
· Draw a roadmap for effective risk management
3:30 pm - 3:45 pm BREAK
3:45 pm - 5:00 pm WORKSHOP C: MEDICAL DEVICE CYBERSECURITY IN PRACTICE
Moderator:
David Guffrey Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration Team Partners Healthcare
Speakers:
Andrew O’Keeffe Associate Director, Software Quality Assurance Foundation Medicine Inc.
Michael McNeil Global Product Security & Services Officer Royal Philips
Esmond Kane Deputy Chief Information Security Officer Partners Healthcare
David Guffrey Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration Team Partners Healthcare
Speakers:
Andrew O’Keeffe Associate Director, Software Quality Assurance Foundation Medicine Inc.
Michael McNeil Global Product Security & Services Officer Royal Philips
Esmond Kane Deputy Chief Information Security Officer Partners Healthcare
Wannacry was the first significant global cyberattack that impacted critical infrastructure in multiple countries. Healthcare was not immune to this attack and medical systems across the globe were affected, most notably the UK National Health System. Healthcare cybersecurity attacks rose 320% from 2015 to 2016 according to Healthcare IT News. As the world increases its connectivity creating the Internet of Things, cybersecurity becomes increasingly crucial to robust operation of critical infrastructure. Medical devices are critical to healthcare organizations being able to provide safe and effective care. Medical devices also pose unique challenges since they touch nearly every facet of healthcare delivery including clinicians, patients, biomedical engineering personnel, information systems personnel and infrastructure. Support and maintenance of medical device systems can vary depending on the hospital department, hospital entity, organizational resources and structure and level of support provided by vendors. Design and implementation of security feature-sets and practices can vary by manufacturer and device line.
This workshop brings together experts with diverse experiences representing healthcare delivery organization (HDO) biomedical engineering and information systems and vendor quality, support and security perspectives. The goal of this workshop is to provide an overview of:
- What are lessons learned from last year’s cyberattacks?
- What is the state of the field of medical device cybersecurity from varying viewpoints?
- How do we, as healthcare delivery organizations, vendors and contractors/consultants improve the cybersecurity posture of the medical device ecosystem?
David Guffrey
Biomedical Cybersecurity Specialist, eCare Biomedical Device Integration TeamPartners Healthcare