Doc. HITN051 Preliminary agendas for the meetings of the the AAMI Health IT Standards Committee, AAMI/HIT Working Group 1, HIT Risk management, and AAMI/HIT/Working Group 2, HIT Quality systems 27‐29 June 2016 AAMI Offices Harken Conference Room 4301 North Fairfax Drive, Suite 301 Arlington, Virginia 22203 Monday, 27 June 2016 AAMI HIT Committee Opening Session—10:30 a.m. to 5:00 p.m. Tuesday, 28 June 2016 AAMI/HIT/WG 01, HIT Risk Management—9:00 a.m. to 12:30 p.m. AAMI/HIT/WG 02, HIT Quality Systems—1:30 p.m. to 5:00 p.m. Wednesday, 29 June 2016 AAMI HIT Ad hoc meeting to discuss possible new work on usability—9:00 a.m. to 12:00 p.m. AAMI HIT Committee Closing Session—1:00.m. to 3:00 p.m. Directions to AAMI Hotels near AAMI RSVP to Joe Lewelling at [email protected] AAMI Health IT Committee Monday 27 June 2016 10:30 to 5:00 p.m. 1. Opening (10:30 a.m.) Welcome by AAMI staff and the committee cochairs Introduction of the attendees (committee members and guests) Review of AAMI Antitrust Statement (Attachment A), Standards Committee Code of Conduct (Attachment B) and AAMI Patent Policy (Attachment C) 2 Approval of the agenda/Review of the plans for the meetings 3. Approval of the minutes of the 19‐20 January 2nd meeting of the AAMI Health IT Committee (to be distributed) 4. Review of work programme of the AAMI Health IT Committee
Committee structure Review of approved work programme International role (providing input to ISO/TC 215‐IEC/SC 62A JWG 7) Relationship between this work and ongoing work on medical device software and health IT 5. National Health IT sector—Activities and initiatives
The committee's primary role is to promote the safety, efficacy and security of Health IT through the development of American National Standards. The committee will review current regulatory and industry trends as well as the efforts of other organizations to address HIT safety and efficacy in order to assess the continued relevance and appropriateness of the AAMI Committee's work. 5.1 5.2 5.3 5.4 5.5. 5.6 5.7 5.8 5.9 5.10 Update on ONC activities relating to Health IT (ONC representative) Legislative update Update on the VA Health IT Initiative Update on NQF effort "Prioritization and Identification of Health IT Patient Safety Measures" Update on ECRI efforts on Health IT and "Safe Practice Guidelines for Cut and Paste Should the AAMI HIT Committee endorse these guidelines?" Review of the work of NIST and plans for the 7 September NIST Stakeholder Workshop on “The Role of Standards in Managing & Mitigating Health IT Patient Safety Risks” Cosponsored by ONC, AAMI, AHRQ, VA, DOD, Medstar, and NIST (Lana Lowry) AAMI White Paper on Health IT Risk Management (Michelle Jump) IMDRF update CMS update Other? Lunch break 6. International Health IT sector—Activities and Initiatives
The committee's secondary role is to provide U.S. input into the development of address HIT safety and efficacy in order to assess the continued relevance and appropriateness of the AAMI Committee's work. 6.1 6.2 6.3 6.4 6.5 6.6 Update on the work of IEC/TC 215, Health informatics and the Amsterdam meeting (Lisa Spellman) Update on the work of ISO/TC 215 and ISO/TC 215‐IEC/SC 62A Joint Working Group 7 on health software and health IT systems, and the Amsterdam meeting Plans to review international work proposals to develop standards for health software and health IT systems, including those that incorporate medical devices or health software (to help develop the U.S. position) Plans to ballot ISO 80001‐2‐8:2016, Application of risk management for IT‐networks incorporating medical devices ‐‐ Part 2‐8: Application guidance ‐‐ Guidance on standards for establishing the security capabilities identified in IEC 80001‐2‐2, for adoption as an AAMI/ISO Technical Information Report. Plans to ballot ISO 80001‐2‐9, Application of risk management for IT‐networks incorporating medical devices ‐‐ Part 2‐9: Application guidance ‐‐ Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001‐2‐2 security capabilities, to help develop a U.S. position and for adoption as an AAMI/ISO Technical Information Report. Other 7. Presentation by drafting teams on the approach taken in preparing the working drafts of HIT 1000 (risk management) and HIT 2000 (quality systems) drafts for initial consideration by the responsible working groups, HIT/WG 1 and HIT/WG 2 (meeting on Tuesday, 28 June) 8. Review and discussion of status of new items to develop a standard and TIR addressing HIT usability (to be discussed in detail, the morning of 29 June) 9. Other business (additional work, education, other initiatives?) Adjournment of opening session 5 p.m. Health IT Working Group 1, HIT Risk Management, Tuesday, 28 June 2016 9:00 a.m. to 12:30 p.m. 1. Opening (9:00 a.m.)
Welcome by Committee cochairs/Introduction of the attendees (committee members and guests) 2 Approval of this agenda for the HIT task group meeting 3. Review of the plan of work for developing AAMI HIT 1000, Risk Management Processes for Health Software and Health IT Systems 4. Review of initial draft (and any comments) on AAMI/HIT 1000, Risk Management Processes for Health Software and Health IT Systems
A draft will be issued in late May or early June for comment and discussion at the 28 June meeting 5. Review of action items and work assignments 6. Next steps/plans for next meeting of HIT/WG 1, Risk Management Lunch 12:30 pm. AAMI HIT/WG 2, HIT Quality Systems Tuesday, 28 June 2016 1:30 p.m. to 5:00 p.m. 1. Opening (1:30 p.m.)
Welcome by Committee cochairs/Introduction of the attendees (committee members and guests) 2 Approval of the agenda for the HIT/WG 02 meeting 3. Review of the plan of work for developing AAMI HIT 2000, Application of Quality System Principles for Health IT 4. Review of initial draft (and any comments) on AAMI/HIT 2000, Application of Quality System Principles for Health IT
A draft will be issued in late May or early June for comment and discussion at the 28 June meeting 5. Review of action items and work assignments 6. Next steps/plans for next meeting of HIT/WG 2, HIT Quality Systems Adjournment 5 p.m. Health IT Committee Ad Hoc Session on Usability Standards for Health IT Wednesday, 29 June 2016 9 a.m. to 12 noon 1. Opening (9:00 a.m.)
Welcome by Committee cochairs/Introduction of the attendees (committee members and guests) 2 Approval of this agenda for the Ad Hoc Session on HIT usability 3 Review of the status of the proposals to develop a standard (User‐centered design process for electronic health record design) and a Technical Information Report (Guidelines for designing user interfaces for electronic health records)
Two new work proposals (doc. HITN048 and doc. HITN049) were issued for AAMI public review and distributed to the AAMI Health IT Committee, the AAMI Human Factors Engineering Committee, and ISO/TC 215‐IEC/SC 62 JWG 7 for review. The comments received on these proposals have been circulated as doc. HITN050. The proposals and all comments (including any response to the comments from the proposers) will be considered by the AAMI Standards Board at a meeting on 5 June 2016. At that meeting, the Standards Board could approve the proposals as written, approve work in this area but with conditions or instructions, or decide that AAMI should not do any work in this area. The results of the Standards Board's deliberations will be distributed for discussion at this 29 June meeting. Assuming the work has been authorized further development, the committee will begin organizing that effort during the 29 June session. 4. Review of existing standards and guidance that may be applicable to the development and implementation of health IT The committee will review existing usability documents and standards (e.g. the NIST guidelines) that might inform the development of guidelines or standards for usability practices and processes in the Health IT sector. 5. Review of Action items and work assignments Lunch 12:00 pm.
AAMI Health IT Committee Wednesday, 29 June 2016 1:00 p.m. – 3:00 p.m. 1. Reconvene (1:00 p.m.) 2 Review of the progress of HIT/WG 1 Health IT Risk Management 3. Review of the progress of HIT/WG 2 Quality Systems 4. Review of plans with regard to work on Health IT usability 5. Review of action items and work assignments 6. Review of plans with regard to international work/adoptions 7. Other work 6. Next steps/plans for next meeting of the AAMI Health IT Committee and affiliated working groups Adjournment 5 p.m.