1. March 26, 2015 Implementation, Usability, and Safety Workgroup David Bates, chair Larry Wolf, co-chair

2. 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 Mickey McGlynn, Cerner Ex Officio Members Svetlana Lowry, National Institute of Standards and Technology Anne Pollock, Centers for Disease Control and Prevention Jeanie Scott, Department of Veterans Affairs Ed Lomotan, Agency for Healthcare Research and Quality-Health and Human Services ONC Staff Ellen Makar, (Lead WG Staff) 1

3. Federal Regulations What is a Federal Regulation? – After Congressional bills become laws, federal agencies are responsible for putting those laws into action through regulations (also known as “rule”). The public plays an extremely important role in the rulemaking process by commenting on proposed rules to help improve them. Why Comment? – We value the publics input. HHS must seek public review and comments before finalizing a regulation. This action is called a “Notice of Proposed Rulemaking” (NPRM) When are Comments Due? – The proposed rule includes a 60 day comment period. Comment period will close on May 29th. After the comment period closes, ONC will publish a “final rule” which may change the NPRM based upon the comments received. 2

4. Process for Responding Cert. NPRM Introduction Small Group Consensus Develop Consensus Review Comments with HITPC 3 Cert. NPRM Overview Discuss process Make assignments Review deadlines Members draft comments and work with small group to prepare consensus comments Prepare materials for assigned meeting Small group reviews comments with workgroup Workgroup refines comments Chairs brief HITPC March 26Offline workApril 3, 21 May 1, 11 May 12 HITPC Meeting

5. IUS Certification NPRM Assignments Group 1Group 2Group 3 Base EHR definition - 8 CEHRT Definition -10 The ONC Health IT Certification Program and Health IT Module -13 Referencing the ONC Health IT Certification Program -256 Design and Performance -261 Principles of Proper Conduct for ONC-ACBs -262 Surveillance and maintenance – 262 Transparency and Disclosure Requirements -276 Complaints Reporting -296 Open Data Certified Health IT Product List (CHPL) - 274 Adaptations and Updates of Certified Health IT -296 Decertification - 298 Safety-enhanced design - 190 Summative testing - 196 Retesting – 196 Quality Management System -197 Accessibility Technology Compatibility – 198 Accessibility-centered Design – 209, 405 Pharmacogenomics Data – Request for Comment - 236 Definitions -240 Subpart E – ONC Health IT Certification Program -250 Modifications to the program - 250 “Removal” of Meaningful Use Measurement Certification Requirements - 252 Types of care and practice settings -253 4

6. HIT Implementation, Usability and Safety Workplan MeetingsTask March 26, 2015 11:30am-1:30pm ET Certification NPRM Introduction Process for commenting on NPRM Break into small groups April 3, 2015 2:30-4:30pm ET Report out from Group 1 April 21, 2015 12:00-2:00pm ET Report out from Group 2 May 1, 2015 2:30-4:30pm ET Report out from Group 3 May 11, 2015 11:30am-1:30pm ET Finalize NPRM Comments RTI report out on the Safety Center Road Map May 12, 2015 HITPC Meeting Certification NPRM Comments