March 26, 2015

Implementation, Usability, and Safety Workgroup

David Bates, chairLarry 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

• 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)

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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.

Process for Responding

Cert. NPRMIntroduction

Small Group Consensus

Develop Consensus

Review Comments with HITPC

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• 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 26 Offline work April 3, 21May 1, 11

May 12HITPC Meeting

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IUS Certification NPRM Assignments

Group 1 Group 2 Group 3

• Base EHR definition – 8, 240• CEHRT Definition – 10, 244• 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

• 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

HIT Implementation, Usability and SafetyWorkplan

Meetings TaskMarch 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