December 12, 2014 Health IT Implementation, Usability and Safety Workgroup David Bates, chair Larry Wolf, co-chair

Workgroup Members David W. Bates, Brigham and Women’s Hospital (Chair) Larry Wolf, Kindred Healthcare (Co-Chair) Joan Ash, Oregon Health & Science University Janey Barnes, User-View Inc. John Berneike, St. Mark's Family Medicine Bernadette Capili, New York University Michelle Dougherty, American Health Information Management Association Paul Egerman, Software Entrepreneur Terry Fairbanks, Emergency Physician Tejal Gandhi, National Patient Safety Foundation George Hernandez, ICLOPS Robert Jarrin, Qualcomm Incorporated Mike Lardieri, North Shore-LIJ Health System Bennett Lauber, The Usability People LLC Alisa Ray, Certification Commission for Healthcare Information Technology Steven Stack, American Medical Association Ex Officio Members Svetlana Lowry, National Institute of Standards and Technology Megan Sawchuck, Centers for Disease Control and Prevention Jeanie Scott, Department of Veterans Affairs Jon White, Agency for Healthcare Research and Quality-Health and Human Services ONC Staff Ellen Makar, (Lead WG Staff) 1

HIT Implementation, Usability and Safety Draft Workplan MeetingsTask October 10, 2014 Presentation of usability research MedStar and NIST October 24, :00 PM-3:00 PM ET ECRI and TJC results of adverse event database analysis Usability Testing Implementation Science (field reports) November 7, :00 PM-3:00 PM ET Presentation on Usability, NIST Certification presentation – Alicia Morton, ONC December 12, :00 PM-3:00 PM ET Risk Management & Shared Responsibility Health IT Safety Center Road Map Update January 14, :00PM-5:00PM ET Risk Mgmt. and Shared Responsibility Discussion (cont.) February 6, :00 PM-3:00 PM ET TBD February 20, :00 PM-3:00 PM ET TBD March 10, 2015 – HITPC Meeting Charged with commenting on the Certification NPRM March TBD (Mid-Month) Certification NPRM overview and prepare to comment March –April TBD NPRM Comments Potential Safety Work May 12, 2015 – HITPC Meeting Certification NPRM Comments to the HITPC

Agenda Objective: Presentation and discussion of risk management and shared responsibility framework 1:00 p.m.Call to Order/Roll Call Michelle Consolazio, Office of the National Coordinator 1:05 p.m.Review of Agenda David Bates, chair Larry Wolf, co-chair 1:10 p.m.Presentation on HIT Safety and Risk Management Mary Logan and Matt Weinger, Association for the Advancement of Medical Instrumentation (AAMI) 1:40 p.m.Health IT Safety Center Road Map Update Doug Johnston, RTI International 2:05 p.m. Public Comment 3:00 p.m. Adjourn 3

4 © 2014 Association for the Advancement of Medical Instrumentation

7,000 members Passionate Community: Engineers, Physicians, Nurses, Researchers, HTM Professionals, Other Technology Experts, Regulators FDA is “sustaining” member 5 © 2014 Association for the Advancement of Medical Instrumentation

Mission: Support HC in development, management and use of healthcare technology. AAMI’s best role: Convening diverse groups Best known for: Honest broker What Makes AAMI Unique 6 © 2014 Association for the Advancement of Medical Instrumentation

Standards Development Education & Training Patient Safety Initiatives (AAMI Foundation) Certification Publications Benchmarking Tools NO Advocacy AAMI Programs 7 © 2014 Association for the Advancement of Medical Instrumentation

Sterilization suite of standards (e.g., “Ebola” Level 4 Gowns) Human Factors Water Quality/Dialysis Alarms Risk Management Quality Systems 8 Examples: AAMI Standards © 2014 Association for the Advancement of Medical Instrumentation

Cardiac implantable wireless device sensitivity to electronic surveillance gates used by retail stores Small bore connectors (the “Luer” connector) Decontamination of Ebola waste Cybersecurity 9 Examples: 2014 AAMI Standards Success Stories © 2014 Association for the Advancement of Medical Instrumentation

To Propose: A consensus-based process for a risk management standard(s) for Health IT To Show: Why it’s needed To Illustrate: What will be different in the future state To Discuss: How to make it happen 10 Why We Are Here © 2014 Association for the Advancement of Medical Instrumentation

No UI standardization Little actual UCD Not enough human factors engineering (HFE) No formal risk management No systems approach Proprietary features No HDO standardization No clear governance Successes occur one hospital at a time © 2014 Association for the Advancement of Medical Instrumentation HIT Safety: Current State 11 ( Courtesy of Luis Melendez, Partners Healthcare, FDA Interoperability Workshop, ,

Many complex engineered systems are generally reliable (e.g., bridges, power plants) It took many years to understand and iteratively mitigate the myriad hazards of these systems Digital technology is relatively new The deployment of complex software in safety critical environments poses significant risk of harm to humans 12 © 2014 Association for the Advancement of Medical Instrumentation Complex Engineered Systems

Across most industries, humans are not yet able to design and deploy complex software systems that are on time, within budget, meet specified requirements, satisfy their users, are reliable, maintainable, and safe! HIT failures are particularly problematic because they can: – Be unpredictable – Have interactive or multiplicative effects – Be difficult to identify and diagnose – Be challenging to mitigate – HARM PEOPLE! 13 © 2014 Association for the Advancement of Medical Instrumentation Software is Fallible

A 2007 National Academy of Science (NAS) report concluded: – Software systems should be considered “guilty until proven innocent” – It should not be the responsibility of the customer to prove that the software is unsafe – “The burden of proof should fall on the vendor to demonstrate to an independent certifier or regulator that a system is safe” 14 © 2014 Association for the Advancement of Medical Instrumentation Software Reliability & Safety

HIT has often been developed from erroneous or incomplete design specifications – see our 2011 JAMIA paper, Health Information Technology: Fallacies and Sober Truths. HIT often relies on hardware and operating systems not intended for safety critical systems Each implementation is a “custom job” (little standardization) Highly context dependent – if different context or organization, system can be unsafe or fail (emergent properties) 15 © 2014 Association for the Advancement of Medical Instrumentation Unertl KM, Weinger MB, Johnson KB, Lorenzi NM: Describing and modeling workflow and information flow in chronic disease care. J Am Med Inform Assoc (JAMIA) 16: , 2009 Healthcare Work is Complex & Highly Context Sensitive HIT-Specific Issues

Safety is the top priority Safety is considered throughout the product life cycle from initial concept to end-of-product-life management Product development is governed by industry wide standards of practice Both processes and outcomes of these industries have some type of oversight 16 © 2014 Association for the Advancement of Medical Instrumentation Product Safety in High Hazard Industries Figure courtesy of Bruce Hallbert, INL

User-centered design (UCD) is a critical contributor to safe and usable software UCD is a way of design thinking and a structured way of working UCD is but one part of a HFE process Risk management is another part of the overall HFE process needed to attain safety & reliability It has taken almost 20 years for the medical device industry to reach its current state of HFE implementation 17 © 2014 Association for the Advancement of Medical Instrumentation UCD – Important but Insufficient User Centered Design as articulated in HFE standards Figure courtesy of Matthew B Weinger, CRISS, Vanderbilt University

18 Risk Management (RM) Process © 2014 Association for the Advancement of Medical Instrumentation The process should be: Useful to the organization Integral to organizational processes Integral to important decisions Address assumptions & uncertainty Structured and systematic Tailorable and scalable Transparent & Auditable Iterative & responsive to change Continually reassessed & improved After ISO

No other hazardous industry deploys safety critical software without a formal risk management process! HIT risk is not just related to direct user interactions but includes data integrity, cybersecurity, etc. It is time to include risk management in ONC’s required processes to assure HIT safety & reliability AAMI recommends an evidence-based approach to developing and implementing a standardized risk management process for HIT safety 19 © 2014 Association for the Advancement of Medical Instrumentation Managing HIT Risk

20 Examples: ISO – risk management IEC – RM in IT networks IEC – medical device RM ISO – software RM IEC – IT security RM Figure courtesy of Steve Grimes We Can Learn From Other Industries

PSOs, ECRI and The Joint Commission  Learning from Adverse Incidents The FDA  high risk software The ONC  best practices/safer guides What no one is doing yet: Establishing a standardized comprehensive risk management (RM) process for HIT safety and reliability 21 HIT Safety – What’s Missing? © 2014 Association for the Advancement of Medical Instrumentation

22 What RM Standards Are Needed Source: ISO/TC 215 Joint Working Group, Future State Architecture/Framework and Roadmap (September 2014). © 2014 Association for the Advancement of Medical Instrumentation

23 What RM Standards are Needed Source: ISO/TC 215 Joint Working Group, Future State Architecture/Framework and Roadmap (September 2014). © 2014 Association for the Advancement of Medical Instrumentation

One vendor at a time doesn’t work One hospital at a time doesn’t work Too many moving targets Best path: A systems approach to complex socio- technical challenges Proven from other industries 24 © 2014 Association for the Advancement of Medical Instrumentation Why Standardize the RM Process for HIT Safety

HIT progress will be like “dream airplanes” HC will not be safer Big adverse incidents Net cost higher Finger pointing Won’t learn from each other or from mistakes 25 © 2014 Association for the Advancement of Medical Instrumentation What If the RM Process for HIT Is Not Standardized

26 Consensus-based standards development by ANSI- accredited SDO (AAMI) Start in the US EHR Vendor and Provider Co- chairs Committee membership balance Longer-term: integrate with international efforts Key Question: What will get vendors to the table? How to Get From Here to There © 2014 Association for the Advancement of Medical Instrumentation

27 © 2014 Association for the Advancement of Medical Instrumentation Steps to Get Started AAMI submits paperwork to ANSI to get started Committee is formed (key: getting the right multi- disciplinary people who want to participate) Industry must pay AAMI participation or membership fees/no fee for providers Committee develops work plan

Vendors and providers working together Efficient Processes $$$ freed up for innovation 28 Desired Future State of HIT © 2014 Association for the Advancement of Medical Instrumentation

Governance clarity A systems approach to complex socio-technical challenges Full life cycle view Healthcare will be safer 29 Desired Future State of HIT © 2014 Association for the Advancement of Medical Instrumentation

30 Analogy: Evolution of ATM Technology © 2014 Association for the Advancement of Medical Instrumentation : First cash machine 1970s:Refinement of the technology 1980s: ATM networks localized 1990s: U.S. ATM card works in Europe but only easy to find in big cities 2000s: Cash anywhere/everywhere Today: ATM is a highly secure mini-bank

31 Leader in healthcare tech-oriented consensus-based problem solving in areas of complexity Federal government preference for private consensus-based standards to fulfill government aims* Long track record of working with all stakeholders to develop consensus standards (ANSI-accredited; global through ISO and IEC) © 2014 Association for the Advancement of Medical Instrumentation public-comments.pdf public-comments.pdf (see page 21; note prior version as well) * Why AAMI?

32 “AAMI is Switzerland” for working on complex problems; not an advocacy organization; no agenda or positions Expertise in promulgating American standards first that grow into international standards Expertise in the right areas: risk management; human factors; quality systems; deep knowledge of patient safety; This is our core competency © 2014 Association for the Advancement of Medical Instrumentation Why AAMI?

“The future is already here, it just hasn’t been evenly distributed yet” – William Gibson 33 © 2014 Association for the Advancement of Medical Instrumentation

34 © 2014 Association for the Advancement of Medical Instrumentation Pre_Reading%20_ONC_Meeting_December2014.pdf

RTI International RTI International is a trade name of Research Triangle Institute. Health IT Safety Center Road Map Update Health IT Policy Committee Implementation, Usability and Safety Work Group December 12, 2014 Doug Johnston RTI International 35

RTI International Health IT Safety Center Road Map Project  Funded by the Office of the National Coordinator for Health IT (ONC)  Contract Representative (ONC lead): Kathy Kenyon  ONC Task Force Representative: Dr. Andrew Gettinger  One year scope of work, followed by one option year  Three main task groups on this contract: 1. Task Force and Road Map 2. Education and Engagement 3. Analysis and Research – Also administrative and communications tasks 36

RTI International Overview of the RTI Team 37 Douglas Johnston Project Director Linda Dimitropoulos Associate Project Director Dawn McIntyre Project Manager (Tasks and – ) Stephanie Rizk Task Force and Road Map Task Lead (2.4.2 – 2.4.4) Jonathan Wald Education and Engagement Task Lead (2.4.5 – 2.4.6) Mark Graber Analysis and Research Task Lead (2.4.7 – 2.4.9)

RTI International Project Goals and Objectives  Produce a Road Map for a national health IT safety center using a planning process that solicits private sector stakeholder input  Conduct programs and analyses for immediate advancement of health IT safety. Purposes include: 1. Improving safety and safe use of health IT 2. Raising awareness of health IT safety-related initiatives, research and best practices; and 3. Collecting information on stakeholder acceptance and uptake for potential health IT safety center activities. 38

RTI International Define potential activities  Conduct educational programs  Promote opportunities for engagement and research  Analyze evidence  Support tool/intervention development  Identify health IT safety goals, priorities, and related measures  Support measure and evaluate progress toward goals  Collect and share learning/best practices  Provide a forum Governance  Public-private partnership  Build upon and complement existing efforts; avoid duplication Assess funding mechanisms  Sustainable funding models  Develop value proposition Road Map Considerations Related to Health IT Safety Center 39

RTI International Task Force Members – 1 of 2* 40 Terry Fairbanks, M.D., M.S. Director MedStar Health National Center for Human Factors in Healthcare Peggy Binzer, J.D. Executive Director Alliance for Quality Improvement and Patient Safety Rich Landen, M.B.A., M.P.H. Patient Safety Workgroup Vice Chair Electronic Health Record Association (EHRA) Ronni Solomon, J.D. Executive Vice President and General Counsel ECRI Institute Dean Sittig, Ph.D. Professor University of Texas Health School of Biomedical Informatics Tejal Gandhi, M.D., M.P.H. President and Chief Executive Officer National Patient Safety Foundation Rebecca Snead, R.Ph. Executive Vice President and CEO National Alliance of State Pharmacy Associations Steven Stack, M.D. President Elect American Medical Association Diane Jones, J.D. Senior Associate Director, Policy American Hospital Association David Classen, M.D. Associate Professor of Medicine University of Utah Gerry Castro, M.P.H. Project Director, Patient Safety Initiatives The Joint Commission Luke Sato, M.D. Senior Vice President and Chief Medical Officer CRICO * Steering Committee Members in red

RTI International Task Force Members – 2 of 2 41 Gilad Kuperman, M.D., Ph.D. Director of Interoperability Informatics New York Presbyterian Hospital Susan McBride, Ph.D., R.N. Professor Texas Tech University Health Sciences Center, School of Nursing Shafiq Rab, M.D. Vice President & CIO Hackensack University Medical Center; (CHIME member) Eugene Heslin, M.D. Lead Physician Bridge Street Medical Group Stephanie Zaremba, J.D. Senior Manager, Government and Regulatory Affairs Athenahealth Melissa Danforth Senior Director of Hospital Ratings Leapfrog Group Michael Cohen, M.D. Medical Director, Anatomic Pathology and Oncology Division University of Utah Emily Barey, R.N. Director of Nursing Informatics EPIC Marilyn Neder Flack Senior Vice President, Patient Safety Initiatives Association for the Advancement of Medical Instrumentation Martha Hayward Lead for Public and Patient Engagement Institute for Healthcare Improvement Amy Helwig, M.D., M.S. Deputy Director, Center for Quality Improvement and Patient Safety Agency for Healthcare Research and Quality Andrew Gettinger, M.D. Medical Officer & Acting Director Office Clinical Quality and Safety Office of the National Coordinator Bakul Patel, M.B.A., M.Sc. Associate Director for Digital Health (acting) U.S. Food and Drug Administration TBD Centers for Medicare & Medicaid Services TBD Federal Communications Commission

RTI International Education & Engagement - Webinar Series 42

RTI International Analysis & Reports  Report of the Evidence on Health IT Safety and Interventions  Report on Health IT- related Goals, Priorities and Measures  4 Information Briefs 43 Analyze and report on health IT- related events in an adverse event database (medical liability claims) Only cases where health IT has been implicated in patient harm Apply CRICO’s taxonomy to categorize safety events

RTI International 44

RTI International Discussion (Q&A) 45

Next Meeting: Wednesday, January 14, :00 PM-5:00 PM Eastern Time 46