New Challenges in Risk Management for Medical Device IT Networks

1. Welcome New Challenges for Medical Device and Equipment Manufacturers and Hospitals RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL Equipment

2. ABOUT GABA Who We Are • GABA is a member-driven non-profit organization that fosters transatlantic knowledge-sharing and networking among German-American and Californian business and tech communities. GABA is dedicated to encouraging German-American business and trade. • Our programs address critical business, technical and leadership issues, with different industry groups providing specific resources and exchange. What We Offer • Meet with our members through an online membership database and in person at our weekly, monthly and annual networking events. • As a GABA member you receive many benefits and discounts. • If you are looking for specific services or you want to initiate a project together with GABA members, contact our experts with your request for proposal.

3. ABOUT GABA Life Science / Healthcare Interest Group California and Germany stand out as well established centers for the life science and healthcare industry. Some of the key areas that are strongly represented are: • biopharmaceuticals • healthcare and diagnostics • bioprocesses and biomaterials It is essential for global enterprises to tap into the network of complementary companies represented in both of these geographical areas. Cooperation and mutual learning are vital factors in bringing products to market. The GABA Life Science / Healthcare interest group is dedicated to enabling and fostering alliance networks between German and US companies. Seminars, workshops, and conferences are supporting the exchange of business information and enabling synergy by providing a forum for personal contact. On request, our members can provide market analysis and customized consultancy. Our web site is designed to suit these purposes. Our member database provides a concise profile of every interested company. GABA members can access this database with a personal login and password and find companies that fit their needs. This type of database allows for networking and cross-Atlantic exchange.

4. Tonight’s AGENDA • Oliver P. Christ, Co-founder and CEO, PROSYSTEM USA LLC, San Diego, CA • Aruna Ranaweera, Ph.D, Stryker, Corporate Process Owner – Design Controls & Risk Management, San Jose, CA • Simone McCormick, Esq., Senior Associate of Murphy, Pearson, Bradley & Feeney, SF, CA • Allen Hobbs, Ph.D., Health IT Strategy & Policy; Kaiser Permanente, Oakland • Juergen Stettin, CEO PROSYSTEM AG, Hamburg, Germany • Q & A Session

5. Intro New Challenges for Medical Device and Equipment Manufacturers and Hospitals RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES • Networked information technology in the healthcare sector is evolving rapidly. Worldwide, health care practitioners have an increased need to connect medical devices to IT networks, and have to ensure that each patient's right to data integrity and confidentiality and their safety is respected. • The current revision of international safety standards for medical electrical equipment (IEC 60601-1/A1) and the new standard on risk management for IT networks used for medical treatments (IEC 80001-1) together present a new collaboration challenge for hospitals, medical device manufacturers and information technology providers. • We'll address these challenges tonight with experts in hospital IT strategy, medical equipment risk management, legal issues, project management and consulting and discuss why it is so important to risk manage health IT solutions;How we can optimally protect the privacy and integrity of patients' records andhow hospitals and medical device / equipment manufacturers can benefit from the latest safety standards.

6. Oliver P. Christ • Dipl.-Ing. Oliver P. Christ is CEO Healthcare of PROSYSTEM AG • Mr. Oliver P. Christ has been active in International Standardization for more than 21 years. • In Germany he is Chairman of four National Committees two on “Human Factors / Usability for Medical Devices”, one on “Risk-Management for Medical Electrical Equipment” as well as for “Software for Medical Devices and Networked-Medical Systems”. • He represents Germany within International Standard Committees on Programmable Electrical Medical Systems (since 1992), Human Factors (since 1996), Risk Management (since 1996) Software Life Cycle Processes (since 2002), and Risk-Management for IT-networks incorporating Medical Devices (2006) published as IEC 80001-1 in October 2010. • The company PROSYSTEM AG was founded by Mr. Oliver P. Christ together with his business partner Dr. Juergen Stettin in 1999 and is located in Hamburg, Germany having an US-based office in San Diego, California. • He studied Control Engineering at the University of Darmstadt, Germany

7. Aruna Ranaweera, Ph.D, • Aruna Ranaweera, Ph.D, Stryker, Corporate Process Owner Design Controls & Risk Management, San Jose, CA • Aruna Ranaweera is the Associate Director of Design Engineering Processes at Stryker Corporation. • For the past 7 years at Stryker, Aruna has worked in both Product Development and Quality Assurance and he is currently the Corporate Process Owner (CPO) for both Design Controls and Risk Management. • Aruna holds a BSE in Mechanical Engineering from Princeton University and an MS and PhD in Automatic Control Systems from the University of California, Santa Barbara. • Aruna resides in San Francisco.

8. Simone McCormick, Esq. • Simone McCormick, Esq., Senior Associate of Murphy, Pearson, Bradley & Feeney, SF, CA • Simone McCormick focuses her practice on representing businesses and professionals in products liability, personal injury, and medical and legal malpractice claims as well as business disputes. • Ms. McCormick counsels entities and individuals in compliance matters and offers risk management services, including pre-litigation investigations. • Ms. McCormick has successfully handled disputes at all stages of litigation. • She has published numerous papers and is a member of the American Bar Association, the State Bar of California and the Bar Association of San Francisco and the German-American Business Association GABA.

9. Allen Hobbs • Dr. Hobbs is a Analyst with the Department of Health IT Strategy and Policy for Kaiser Permanente (KP). He is currently responsible for coordinating and facilitating KP’s input and involvement in federal cyber security policy. He is also responsible for coordinating and facilitating input and involvement related to mobile device security policy and federal regulations. • Dr. Hobbs actively participates in several standards organizations including: Health Level Seven (HL7), Institute of Electrical and Electronics Engineers (IEEE), World Wide Web (W3C), International Organization for Standardization (ISO), Continua Alliance, HITRUST, the National Health Information Network (NW-HIN) and the ONC S&I Framework. He is a co-chair with the Health Device Working Group for HL7 and an advisor and participant with the Medical Device Innovation, Safety, and Security Consortium (MDISS). • Prior to joining KP, Dr. Hobbs was a Visiting Scholar at Stanford University and conducted research in cognitive neuroscience and informatics. He has approximately 30 years experience in healthcare delivery, teaching and research.

10. Juergen Stettin, MD PhD. • Dr. Juergen Stettin, CEO PROSYSTEM AG / PROSYSTEM USA LLC • Juergen has a background as physicist with a PhD in physics as well as a MD in medicine. • He has been in Software development for medical devices for over 25 years and has experience with almost all major medical device manufacturers. • Among many positions in the medical device industry he was CEO of the Olympus group. Since 1999 he has a chair for Clinical Engineering at the University of Applied Sciences Hamburg, Germany. • Since 2006 he is adjunct professor at Virginia Tech University.

11. Q & A