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Speakers

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Caston Thomas
President and CEO
InterWorks

Caston is president and CEO of InterWorks. With 30 years in corporate IT, and 20 years focused on security, Caston is a recognized expert designing and deploying innovative technologies. He brings knowledge, perspective, and a pragmatic approach to implementing solutions and processes that improve the management and security of networks and infrastructure – particularly focused on medical device security & technologies that directly help impact patient care. The popular podcast, ITinTheD, claims Caston as its ‘go to’ security expert. Caston also produces and co-hosts Detroit’s local radio station WJR’s “Internet Advisor Show”.  He writes a blog on cyber security common issues and all things tech related.  He has contributed his talents and time to the Salvation Army, Capuchin Soup Kitchen, and building clinics and orphanages in Africa.  A businessman with a heart, Caston is a family-oriented humanitarian who thrives on helping others realize their potential.

Greg Garcia
Executive Director for Cyber Security
Health Sector Coordinating Council

Greg Garcia is the Executive Director for Cybersecurity of the Health Sector Coordinating Council, the convening organization for critical healthcare infrastructure organizations across 6 major subsectors, working in partnership with HHS and other government agencies to protect the security and resilience of the sector, patient safety and public health. Greg was the nation's first DHS Assistant Secretary for Cybersecurity and Communications under President George W. Bush, 2006-09, where among other achievements he initiated the creation of the National Cyber and Communications Integration Center. He also served as executive director of the Financial Services Sector Coordinating Council, and held executive positions with Bank of America, 3Com Corporation, Information Technology Association of America, and Americans for Computer Privacy, all with the responsibility of driving change in public policy and business operations to strengthen the security and resiliency of the nation's critical infrastructures. Greg also served as professional staff on the Committee on Science in the U.S. House of Representatives, where he helped draft and shepherd enactment of the Cyber Security Research and Development Act of 2002. Greg serves on the Information Security and Privacy Advisory Board, a government/industry committee advising the Secretaries of Commerce and Homeland Security, and the Director of OMB, on national information security and privacy policy.

Day One

Wednesday December 11 2019

4:30 pm | Chair’s Closing Remarks

10:00 am | Panel Discussion: HDO & Device Manufacturers - Building Upon the Key Relationship

8:45 am | Chair’s Opening Remarks

Day Two

Thursday December 12 2019

3:00 pm | Chair’s Closing Remarks

9:00 am | Shared Challenge, Shared Responsibility

8:45 am | Chair’s Opening Remarks

Ken Zalevsky
Director, Informatics
Bayer

Ken Zalevsky is the head of Bayer Radiology Medical Device CyberSecurity and the Chair of the CyberSecurity working Group of DITTA (Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association), as well as, an active member of the CyberSecurity teams of MITA (Medical Imaging and Technology Alliance), and AdvaMed (Advanced Medical and Technology Association). Ken is a certified CyberSecurity Leader (Carnegie Mellon University) and has over thirty years of professional and leadership experience, with the last seventeen years in the medical device industry. Ken holds undergraduate and graduate degrees from Carnegie Mellon University and attended the executive management program at Harvard Business School. Ken has been a featured speaker at various events, most recently, the 4th Annual Medical Device Cybersecurity Risk Mitigation Conference in Arlington, VA in July, 2019. Ken was also a Plenary Panel speaker in January, 2019 at the FDA Public Workshop – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and led a breakout session focused on the Cybersecurity Bill of Materials at FDA’s White Oak Campus in Silver Spring, MD. Ken has also authored various whitepapers and articles, including an article appearing in the January/February edition of HealthCare Business News on medical device cybersecurity, and multiple white papers in cooperation with industry trade associations.

Day One

Wednesday December 11 2019

11:30 am | FDA Premarket Guidance Impact on Medical Device Manufacturers

10:00 am | Panel Discussion: HDO & Device Manufacturers - Building Upon the Key Relationship

Jeffrey Tully
Resident Anesthesiologist
UC Davis Medical Center

Jeff Tully is a physician with a passion for the delivery of oxygen to tissues as well as a security researcher with an interest in the intersections between medical technology and patient safety. His work on 911 infrastructure vulnerabilities, simulations of hacked medical devices, and exploitation of HL7 protocols have been featured at RSA-C, DEF CON, and Black Hat. He co-founded the CyberMed Summit, the only multi-stakeholder healthcare cybersecurity conference with a clinical focus.

Day One

Wednesday December 11 2019

9:30 am | Solving the “Last Mile” Problem

Christopher Beeman
Business Development & Connected Technologies Manager
UL, LLC

Day One

Wednesday December 11 2019

1:00 pm | UL LLC Panel Session

Sabyasachi Roy
Senior Director - Regulatory Affairs, Quality Assurance & Compliance
Brainscope Company Inc

Day Two

Thursday December 12 2019

12:00 pm | The Common Vulnerability Scoring System (CVSS) for Medical Devices - Benefits and Limitations

10:30 am | Interactive Panel Discussion: Validating Cybersecurity Framework Selection - Guiding Large to Medium Sized Manufacturers

Soundharya Nagasubramanian
Director, R&D, Product Information Security
HillRom

Day Two

Thursday December 12 2019

1:45 pm | It Starts With Good Architecture – Software & Cybersecurity for Connected Medical Devices

Timothy Berendt
Director of Innovation
Blue Cross Blue Shield of Massachusetts

Tim Berendt is a Director of Innovation at Blue Cross Blue Shield of Massachusetts where he leads the division in incubating, exploring, and building disruptive and transformational health solutions. With over 12 years of experience in the health care arena, Tim’s Blue Cross Blue Shield of Massachusetts experience spans from Fully and Self-Insured Customer Financial Management, Provider Financial Management where his primary role was settling Alternative Quality Care contracts, Market Strategy and Zaffre Investements which is a wholly owned strategic investment subsidiary arm. Tim earned his Master of Business Administration at the F.W. Olin Graduate School of Business at Babson College and has a B.A. from College of the Holy Cross. He is currently an adjunct professor at Wentworth Institute of Technology and has been trained in Design Thinking from Stanford University’s Graduate School of Business. Since Tim could walk, he has been addicted, but allergic to soccer. While being known around the office as a living “Google”, he also thoroughly enjoys playing, listening and seeing music, exploring eateries, and spending time all along New England’s various treasures.

Day Two

Thursday December 12 2019

9:30 am | How can a Healthcare Payer Embrace Disruption through Innovation?

Jim Jacobson
Chief Product and Solution Security Officer
Siemens Healthineers

Jim Jacobson is the Chief Product and Solution Security Officer for Siemens Healthineers. Since 2012, he has been responsible for the global security program for the medical devices and associated IT systems, solutions and services that Siemens Healthineers develops, sells, maintains and supports. Jim leads the cybersecurity curriculum and training program for employees worldwide in all Siemens companies. He has led software development teams in ultrasound, laboratory diagnostics and informatics since 1990 at Siemens and other companies. Jim has a degree in physics from Oberlin College.

Day One

Wednesday December 11 2019

1:30 pm | Information Sharing: How Software Bill of Materials help HDOs Manage Risk

Day Two

Thursday December 12 2019

10:30 am | Interactive Panel Discussion: Validating Cybersecurity Framework Selection - Guiding Large to Medium Sized Manufacturers

Avi Rubin
Professor,
Computer Science and Technical Director of the Information Security Institute
John Hopkins University

Avi Rubin, a professor of computer science, technical director of the Johns Hopkins University Information Security Institute (ISI), and founder of Harbor Labs, is recognized throughout academia, the computer science industry, and government for his expertise in computer security and applied cryptography. Rubin’s extensive research and service encompass the full scope of information security issues from hacking and healthcare cybersecurity to high-tech litigation. The first person to expose the vulnerabilities of electronic voting in his book Brave New Ballot: The Battle to Safeguard Democracy in the Age of Electronic Voting (Random House, 2006), Rubin is the sought-after expert on electronic voting. He has briefed Congress and high-ranking Army officials at the Pentagon on election tampering and other issues of national security, served as an expert witness for numerous court cases involving technology litigation, and has given TED talks on hacking in an increasingly connected world (October 2011 and September 2015). In addition, he holds nine patents for various applications for secure online transactions.

Day One

Wednesday December 11 2019

10:00 am | Panel Discussion: HDO & Device Manufacturers - Building Upon the Key Relationship

9:00 am | The Effectiveness of Static Firmware Code Analysis in Medical Device Security Assessment

David Snyder
President
42TEK, Inc.

David is a Certified Information Systems Security Professional (CISSP), Certified Scrum Master (CSM), and a California-registered Civil Engineer (PE). He is currently researching cybersecurity for network-connected medical devices and ways to use blockchain technology to ensure data quality and security for critical infrastructure devices, including environmental sensors and medical devices. His experience includes companies like Apple, Google, Kaiser, First Data, PayPal, Yahoo!, and various startups for healthcare systems, electronic payments, mobile applications, and data security. 42TEK, Inc. (www.42tek.com) is Mr. Snyder’s consulting company. David is a past board member of the Northern California Chapter of the Healthcare Information Management Systems Society (HIMSS) and has been the organizer, moderator, or speaker for more than 20 conferences and seminars on healthcare, data security, and payments topics.

Kelly Aldrich
Chief Clinical Digital Officer
Center for Medical Interoperability

Dr. Aldrich is a board-certified Informatics Nurse Specialist and has served over 35 years in healthcare clinical, leadership and informatics roles. She is known as a visionary Nursing Informatics Executive leader and is regarded for her innovative solutions dedicated to providing a bridge between nursing practice and technology solutions that best support current patient care practices, as well as find new solutions to solve care environment interoperability hazards and burdens today’s healthcare teams face. Her passion and dedication for a seamless patient-centered care environment from an informatics lens has led to safer, more efficient and effective care environments. Along with her current role as Chief Clinical Transformation Officer at The Center of Medical Interoperability, she continues to serve on the faculty of two universities, teaching Nursing Informatics in graduate and doctoral programs at Vanderbilt University and University of Maryland. In addition, Dr. Aldrich has served on multiple ONC task forces, including interoperability experience, standards, cybersecurity and contributes to the HIMSS data intelligence and nursing informatic executive committees on a national level. She is well published in Informatics for Nursing documentation standards, highly reliable technology innovation introducing the model of BELT, Blending Education Leadership and Technology. Prior to joining the Center, Dr. Aldrich was the inaugural Chief Nursing Informatics Officer for HCA. She holds a Master of Science in Nursing HealthCare Systems Leadership and Nursing Informatics, and a Doctorate of Nursing from the University of South Florida, Tampa.

Day Two

Thursday December 12 2019

11:30 am | Interoperability for Better Care

10:30 am | Interactive Panel Discussion: Validating Cybersecurity Framework Selection - Guiding Large to Medium Sized Manufacturers

Nora Lawrence Schmitt
Attorney Associate
Moses & Singer LLP

Nora Lawrence Schmitt is an associate in Moses and Singer’s Healthcare and Privacy & Cybersecurity practices. She advises academic medical centers, pharmaceutical companies, medical device companies, and biotechnology companies on regulatory and compliance issues related the conduct of research and the privacy, security and management of data. She regularly advises on matters related to HIPAA, HITECH, state privacy and foreign data protection laws, and has particular expertise in the field of genetic privacy.

Day One

Wednesday December 11 2019

3:15 pm | Being Cyber Compliant - From Evolving Regulatory Frameworks to Software & Data Privacy of Your Connected Medical Devices