EHR TC WGM Minutes

EHR TC WGM Minutes Date: September 19, 2007 – Quarter 1 – Technical Salon

Presiding Chair: Linda Fischetti

Members Present: Bernd Blobel, Beth Acker, Calvin Bebee, Crystal Kallem, David Staggs, David Tao, Don Mon, Ed Larsen, Gary Dickinson, Glen Marshel, Harry Rhodes, Hideyuki Miyohara, Jamie Ferguson, Jason Carley, Jason Rock, Jim Kretz, John Ritter, Julie Evans, Kristofer Spahr, Lenel James, Lori Havener, Marlene Haddad, Mitri Rocca, Pat Van Dyke, Sue Mitchell, James Tosone, Barabra Hoffma, Hetty Khan, Jay Crawthers, James Mhyre, Pete Gilbert, Chad Chaplin, Gora Dotta, Richard Dixon Hughes, Jan Forrester, Terry Quinn, Bill Branch, Joe Forbes, Yvonne Pynacker Hordyh, Edward Tripp, Allen Jones, Steve Ward, Edward Helton, Geraldine Wade, Becky Kush, Dave Iberson-Hurst, Chad Bennett, Bill Pankeg, Mike Davis, John Moehrvice, Diane Wold, Joyce Hernandeo, Matthew Greene, Robert Dilaura, Jim McCain, Bren Kisler, Mary Ann Slack, Gaby Jewell, Barry Brown, Margarei Marshbura

Topic: 1. Security / Legal EHR Glen: “Legal EHR” terminology issue – means one thing in the United States and a different one abroad. Implications of security Gary: We recognize the issues, designate it as a us realm activity. Hoping affiliates will develop their own realm models Don: The Legal EHR Profile does not mean all others are ill legal Wouldn’t everything need the legal profile implemented? Don to Berndt – why is legal EHR overloaded in the international committee? It is important to have a profile because U.S. realm requirements are different. Harry Rhodes on legal EHR: Completed an environmental scan on the legal EHR, did have some members from Canada. It was originally referred to as a Trusted business record or business record rules (what you do in normal course of business in order for it to be trusted) Linda: need to be careful of what we are communicating Beth Acker: perhaps call it Legal EHR for disclosure. Linda: task group to rename so that these issues do not keep coming up Environmental scan not adequate Don - 3 key points: 1. Take Glen and Berndt up on their offer. They will be involved in our teleconferences and will write use cases 2. Whether it is 1.x or 2 (EHR-S FM) we have to look at if legal EHR stays as profile or moves up or parts move up. Everyone can get involved in this process. Thus far with public comment period had 8 respondents 2 of which were vendors. Encouraging involvement. 3. Request to turn legal EHR profile into a white paper. This can’t happen. It would be a downgrade, we need to get keep this an open/transparent process. Not a white paper at this point, move forward in chain.

This was provided as supplemental information:

of 7 EHR_FDA HL7 Atlanta Presentation_17SEP07_final_dist

Topic: 2. RCRIM Some of the RCRIM representatives: Julie Evans CDISC Terry Quinn NCSI Enterprise Vocabulary services Christopher Spar Ed Trip – RCRIM CO-chair Steve Klein Sass Institute Ron Kessler Jason Rock Becky Cushion Diane Mold Bob Lord

San Diego was the last full meeting, there was a quick tutorial in cologne EHR-S FM profile from RCRIM with e-clinical forum Linda: What are your impressions of doing a profile? RCRIM: We’re going to work with e-clinical forum, not going to do something separate. Position: Provide input and stay in tune. Move to ballot in January. (Lenel – we are waiting for them to submit a registered profile and then we will check with RCRIM to make sure they are comfortable). RCRIM did not check with e-clinical forum when they would be submitting. Lenel: piloted first conformance class. Went through process with e-clinical forum. Our registration process is through NIST. They have a website. EHR TC will announce ballot and send it out (RCRIM would prefer it that way) Reconciliation process – who should have what role? E-clinical forum cannot run the process. EHR TC will provide e-clinical forum with amalgamated files Linda – will we get in trouble for out sourcing? Lenel – there is a precedent set elsewhere (behavioral health), not sure RCRIM responsible for reconciliation (not e-clinical forum). More than one quarter will be needed. EHR TC will provide a facilitator. Intellectual property issues? HL7 derives income from the standards. EHR has been in the public space. Do not want e-clinical forum to have something they think they can copyright. Name of profile is clinical research profile. We need to change our lingo, do not call e-clinical forum profile. Linda: How to attribute proper credit? RCRIM: co-chair and main contributor. RCRIM: put both co-chairs and main contributors. RCRIM wants to Push this out as a DSTU, need to check with e-clinical forum before we say that. Lenel gave a cliff notes version of the NIST website. The NIST website has a number of hits from around the world

of 7 Topic: 3. CDA (Calvin and Gary) Gary gave an overview of the IM. CDA R2 mapped nicely to 48 of 58 requirements in the Interoperability Model. Calvin: of the 10 identified issues (of 58), 5 were a big problem. There is a slide that has all 5 on them. Harry Rhodes: these challenges are also being addressed in the Legal EHR Profile, would like the opportunity to contribute CDA is not a sufficient component to meet all the requirements. Could this be an enhancement? Want well defined use cases first. The 5 do not have well documented use cases, it could be a possibility as an addition. Provide addendums (of the auditing type information) to the original indelible document. Jim K.: Audit type information by system not by documents in system. (this is why they want a use case). Harry: Horror stories of record getting out and it doesn’t keep restrictions Problem of having patient own their record and following them - getting into PHR issues. Gary: wrapping up next steps. Want to put something out for ballot for 49 done and 9 outstanding and have something to react to. Lenel: We need to be careful about the “open items” they need to be labeled as open, no decision made.

Gary Dickinson Moved that “We will proceed to ballot draft for the CDA release 2 profile of the EHR interoperability model and that model will contain 49 resolves and identify that 9 items outstanding and that work will proceed through various groups as required”

John: going to be informative with DSTU? Gary added to the motion: It will be a non normative ballot

Glen Marshal seconded Open for discussion. Could this be consumed by HITSP? Is this a like enough version of CDA. Does CCD have correct document transfer?

Abstentions: 12, Opposed: 0, Approved: 49 - Motion Carries

Quarter Adjourned

of 7 EHR TC WGM Minutes Date: September 19, 2007 – Quarter 2 – Clinical Salon

Presiding Chair: Linda Fischetti

Members Present: Bernd Blobel, Beth Acker, Jamie Ferguson, Jason Carley, Jim Kretz, John Ritter, Larry McKnight, Lenel James, Marlene Haddad, Michelle Dougherty, Mitra Rocca, Pat Van Dyke, Sue Mitchell, James Tosone, Barbara Hoffma, Hetty Khan, Jay Crawthers, James Mhyre, Chad Chaplin, Geraldine Wade, Brian DeCamp, Lois Hall, Nancy LeRoy, Mark Dietal, Kay Avant, Andrew McIntyre

Topic: 1. Virtual Medical Record (vMR) Robert Dunlop, Barbara McKinnon presented the vMR:

vMR for CDS Project

Linda: very important that we stay aligned

Want to explore how the project might interface with this group. What is important outreach? Chose the title (vMR) so that those who have an interest in clinical decision support will gravitate towards it. We are not talking about a new HL7 data model. (on slide 4)Already have business cases lined up. Referencing projects on slide. SOA active clinical decision support services (no messaging). There is a joint HL7 RFP out due in the next few days – looking for implementations to explore in practical detail. (Slide 7 – paragraph 2) Non CDS members of HL7 – want standards for transmitting clinician guidance, some standards do exist but are not recognized by HL7 or ANSI. Has been a desire for a metamodel for these to be inter changed for clinical guideline content. Derive 80-90% of representation of actual clinical guideline.

(Slide 7) Decision is audited in record? Yes. Don – concerns from physicians tracking compliance and behavior. Issues raised by vendors and implementers - this causes much overhead in the system Concerns have been expressed in every implementation. Trying to openly address in beginning. Physicians find it useful to track variance vs. paper based records (provides protection against liability law suits). Implementation is not mandatory. These are safety critical systems – analogous to flying aircraft by wire.

(Slide 8) extensive outreach before finalizing scope. This is part of that process. Stakeholders are listed and those involved. Action: Stakeholder list needs to be clarified. Don – CCHIT commissioner is big on CDS. She champions CDS, you should reach out to her. Jim Kretz – Terminology? We haven’t talked to them yet. Talk to Cecil Lynch. Everything is posted by CDS list serve. It has been approved by

of 7 HL7 project and has project # and will be on the new website. Concern about vMR terminology. What about clinically computable medical record? This is why we wanted to do outreach? How does it vary from EHR? Probably doesn’t, need to make sure it is in sync. Jim – what is the enduring aspect of CDS (inputs, outputs, both?) It is both, keep a complete record of everything at every step (doesn’t have to be that way, but it covers all the bases) Thanks vMR is good – CDS needs current view and back end can vary. IN software terms it is a virtual interface. There will be a project update in san Antonio.

Topic: 2. Patient Care Linda – History: Discussing methodology – how do we take a clinical group and get their desired outcome in HL7? Domain model or functional statement or CDA? Our throughput process (# of people looked at HDF, represented there). How to move forward? New group will focus on clinical need. Informatics council put together by board. A process for clinicians to get things out of HL7.

Misconceptions of CIC – role of CIC is to look at clinical specialties and come up with requirements for the EHR-S FM and then modeling through patient care down to the SIGS which will be an event taken on by HDF. SIGS doing it now, but stumbling. No good documentation of people following steps. New steering division. Have 8 SIGS under us and they are doing clinical models and vital signs. How are those going to mesh? HL7 is in a state of change and don’t know clear path but have identified issues. Clinical model groups don’t reside anywhere – they are going to try to be a part of HL7.

Don – Ed characterized it as this would be the kick off meeting. More like an introduction kind of a thing to get people on board. Many parts of hl7 involved in this process.

Linda: touch point has not changed between two committees. We do have a new community, it’s a good thing, we need to work out procedures.

Ed Hammond is setting up this CIC. The agenda is full of information of what we are doing now. Going to meet during lunch to discuss further. Topic: 3. Workgroup Sessions

Quarter Adjourned

of 7 EHR TC WGM Minutes Date: September 19, 2007 – Quarter 3

Presiding Chair: John Ritter

Members Present: Beth Acker, Corey Spears, Gary Dickinson, Harry Rhodes, Jason Carley, Lenel James, Lynne Rosenthal, Mark Skall, Marlene Haddad, Michelle Dougherty, Nancy Orvis, Pat Van Dyke, Dipak Kalra, Barbara Hoffma, Hetty Khan, Jay Crawthers, James Mhyre, Chad Chaplin, Gaby Jewell, Ann Wrightson

Topic: 1. EHR-S Registry

REGISTRAT

Action: Lynne – follow up with everyone and give deadlines for the registry. Advertise it at least every 9 months. Comment: Tooling should be able to seamlessly manage conformance to multiple profiles

Topic: 2. Lifecycle Model The draft model did not support a holistic (problem with ack record) record that is attested, before stored it has what is in this model. What about previous stage where it can be built up through a work flow?

Dipack – presented comments on lifecycle model. There was an issue between Dipack and Gary on vocabulary. Gary did not want to change the terms because they are pulled from the IM which has already met DSTU.

Quarter Adjourned

of 7 EHR TC WGM Minutes Date: September 19, 2007 – Quarter 4 Workgroup Session