Panelist questions for ONC’s 2/25 hearing on EHR patient safety issues

I wrote last Wednesday about some background material for a panel I’ll be attending Thursday, as part of the government’s process to encourage adoption of electronic medical records. In the current administration all such discussions are wide open to the public. Here are the questions we’ll be asked – I’d welcome your input.

Lots to cover between 9 and 3 including lunch!

HIT Policy Committee
Adoption/Certification Workgroup
February 25, 2010
9:00 a.m. – 3:00 p.m. (Eastern)
OMNI Shoreham Hotel
2500 Calvert Street, NW
Washington, DC 20008

Instructions and Questions for Panelists

Testimony from this hearing will help the Adoption/Certification Workgroup formulate recommendations to the HIT Policy Committee and National Coordinator on patient-safety issues related to use of electronic health records – both risks and approaches to mitigating those risks. If you have any questions, please contact Kathy Kenyon at

Format of Presentation:
The Workgroup respectfully requests that panelists limit their prepared remarks to 5-7 minutes. This will allow the Workgroup to ask questions of the panelists and allow every presenter time to present his or her remarks. We have found that this creates a conversation for a full understanding of the issue. You may submit as much detailed written testimony as you would like, and the Workgroup members will have reviewed this material in detail before the hearing. PowerPoints will not be needed.

Pre-Presentation Questions/Themes:
The questions below represent areas the Workgroup intends to explore at the hearing. Please feel free to use them in preparing your oral and written testimony; the Workgroup recognizes that certain questions may not apply to all presenters.

The Workgroup respectfully requests panelists to provide written testimony by February 19, 2010. Please submit the testimony to Kathy Kenyon and Judy Sparrow at and


9:15: Panel 1: Identifying the Issues

Ross Koppel, University of Pennsylvania (author of the JAMA paper described in the webcast); David Classen, CSC; Gil Kuperman, Columbia University; Alan Morris, Intermountain Healthcare

  • What are patient-safety risks that may be introduced inadvertently through the use of electronic health records (EHRs) or other HIT products? Are there specific types of risks that are more common than others?
  • What are the causes of those risks?
  • What are ways to prevent and/or mitigate those risks?
  • How would you weigh the benefits and risks of using EHRs in patient care?
  • How might data on risks best be identified as greater HIT adoption occurs?What are the factors that might impact an organization from reporting adverse events or known concerns about HIT products?

10:45: Panel 2: Stakeholders

Dave deBronkart, ePatientDave; Justin Starren, Marshfield Clinic; Jeanie Scott, Veterans Health Administration; Susan Edgman-Levitin, National Patient Safety Foundation [invited]; Gay Johannes, Cerner; Carl Dvorak, Epic

  • What experiences have you had with EHR-associated patient safety risks?
  • How have you identified those risks?
  • What steps have you taken to prevent harm or to mitigate the safety risks?
  • What approaches would you recommend to prevent or mitigate harm associated with the use of EHRs?
  • What are the benefits and concerns about making those risks and/or adverse events publicly known?

12:15: lunch

1:00: Panel 3: Possible Approaches

Jeff Shuren, FDA/medical devices; William Munier, AHRQ; James Walker, Geisinger; Edward Shortliffe, AMIA

General Question: What approaches would you recommend policy-makers and the health care industry consider to address safety issues? How might these approaches affect innovation, timing of getting products to market, costs, etc.?

If you are a government representative:

  • Describe the current status of regulatory activities or other programs related to patient safety, including your legal authority.
  • Describe considerations that may impact government efforts in the future.
  • Describe approaches for reporting and tracking patient safety concerns and addressing these concerns.

If you are conducting research and evaluation of safety issues related to EHRs:

  • Describe main options for activities by government and private entities to address safety concerns regarding EHR, including reporting.
  • Describe advantages and disadvantages of different approaches.

Industry Perspective:

  • Describe organizations or processes you rely upon to have confidence you are buying a safe EHR?
  • What approaches to EHR safety would give users confidence?
  • What do EHR vendors do with customer-reported safety issues? How are other customers notified of potential issues? What is the counterpart to product recalls and notifications to customers?
  • What are the advantages and disadvantages of government regulation?
  • What are the advantages and disadvantages of private, voluntary programs to certify safety?
  • What role should safety reporting have? Who should receive such reports? What are the characteristics of an organization that receives EHR safety reports? How should the aggregate data be used? How should the findings and recommendations be disseminated?


2:30 p.m. Summary Comments from the Workgroup
2:45 p.m. Public Comments
3:00 p.m. Adjourn


Posted in: medical records | policy issues | positive patterns | reforming hc | trends & principles




15 Responses to “Panelist questions for ONC’s 2/25 hearing on EHR patient safety issues”

  1. ePatientDave says:

    New on Panelist questions for ONC's 2/25 hearing on EHR patient safety issues

  2. Deborah Bell says:

    My concern always is with the potential damage to someone’s career. I’m very pro-EMR. However, there have to be safeguards to ensure that the information does not become public.

    I would be thrilled to see us reform our healthcare system and remove the illegal but very real barriers to employment that openness about illness can create.

  3. Brian Ahier says:

    Panelist questions for ONC's 2/25 hearing on EHR patient safety issues (via @ePatientDave)

  4. Howard Luks says:

    That’s quite an agenda for a short one day session!!!

    I know you have some very well thought out *answers* to these questions already :-)

    I think the there are a multitude of approaches to take to *protect* the patient. There are many parties involved, and all must work together to see that the *system* allows for uniform access, data sharing and a means to correct inaccurate data (within a closed loop so a physician could respond to corrections… in case a change in treatment plan is indicated because of said corrections).

    Industry needs to step up, minimize proprietary practices that allows for uniform sharing, access and computability. They need to include a robust patient portal that allows for data retrieval, review and a *corrections loop* so the corrected data is acted upon (if necessary).

    I believe many physicians are waiting for robust (open or interoperable) platforms that will truly enable the sharing of information instead of creating siloed electronic copies of a paper chart. I also know that physicians and institutions believe the cost of these “systems” is unrealistic, and many physicians do not feel they should shoulder the entire economic burden of a system that will improve the lives of many, and improve the workflows (and corporate profits) of the insurers, gov, and a multitude of third parties— but I digress.

    The patient needs to be the center (or at least share the center) of the EMR/EHR concept. Yes the systems need to emulate the workflows physicians have utilized for 100 years, and perhaps facilitate and improve upon workflow inefficiencies— but the bottom line is that these systems need to be created for the purpose of creating meaningful, actionable data sets about patients and their health, and they (EMR/EHRs) should not be created solely for the purpose of improving the through-put in a physicians’ office or the physicians bottom line.

    The patient must be empowered through robust portals to review the data generated following an interaction with the health care system, and they must be able to suggest edits to the record, and the portal should have a closed feedback loop so the patient knows that someone has reviewed their suggestions and acted upon them…if necessary. Having patients edit directly is open for discussion— but I would not favor this out the outset.

    I believe the FLOWER concept, based on the belief that “We are all patients” and that we(as patients) own the data and need unified access to it, should also incorporate the concept of the potential benefits inherent in monitoring the data to minimize risks associated with inaccurate inputs.

    Lastly, if patients are going to insist on data *ownership* then they need to have a significant role (and responsibility) to manage the data to ensure it accurately reflects their interactions with providers or institutions.

    Not sure I helped… good luck with your prez… and keep up the good work!!!!

    • Great comment, Howard. Give us a link to what the “FLOWER” group has been doing, eh? Best would probably be a quick overview, since I have the idea that not much has been blogged about it.

      Yesterday while writing my testimony (which gets submitted in advance for the group to read, BEFORE the meeting) I revisited my original post about my PHR data transfer last spring. Open it and check out my recommendations at the end – search for “advice”, particularly the last bullet. :-)

      • Howard Luks says:

        I remember that post well. It struck a chord.
        Check out We can try and get you a few bullet points or a one pager if it will help????
        good luck!

        • I don’t think SpeakFlower is on target as a handout for this particular meeting, but I presume it’ll be appropriate in the discussion.

          Ours is a 90 minute panel. 6 panelists at 5-7 minutes each for opening comments, then 45-60 minutes of open discussion.

          Regina Holliday and Cindy Throop and @Modulist (Claudio) have a great new campaign cooking – “the empty USB” – having patients carry empty USB sticks or bracelets, symbolizing that they/we don’t have our data – and the edgier among us can start asking our doctors’ office at checkout for a copy of the visit notes. Ought to raise some eyebrows :-), and it’s a great symbol, IMO.

  5. Howard Luks says:

    Panelist questions for ONC's 2/25 hearing on EHR patient safety issues

  6. Fred Trotter says:

    Of course you are already saying “give us the data”… but perhaps even more important to patient safety is “let us fix the data”. Despite the fact that HIPAA requires the ability to amend information in your health record. It is really really difficult for people to get inaccurate information out of a doctors EHR system.

    • > “let us fix the data”

      Great point, Fred. To a large extent you read my mind – once I got over my alarm at the issues raised in Rob Koppel’s webcast and JAMA article about usability and reliability of EMR systems, I asked “So, what can we do that would be useful??” And I realized we could help a lot by just adding a second set of eyes: let the patients and families view the records.

      I hope to upload my testimony document later today – the PDF that I sent the workgroup for pre-reading. In the meeting itself we’ll only have a few minutes for comment, then discussion.

      There’s little point in responding to the challenges by bitching about them: it won’t do a bit of good for the families with hospitalized patients today or next month. But opening access to our data could very well produce immediate improvement.

      But I doubt any hospital worker or manager or board will want to do that if it will bring down a rain of hell on their heads. So I think to enable that we’ll need amnesty – a truly shared commitment to improving data quality, above all else.

  7. […] noted in my previous post, this is a busy day, and each of us gets only 5-7 minutes to speak, followed by Q&A. We submit […]

  8. Sherry Reynolds says:

    It might seem obvious but a critical EHR safety issue is making sure that you have correctly identified the patient before you with the records on your screen. Most providers will “believe” the documents long before the patient and there are numerous cases of people being given the wrong treatment as a result of a provider simply failing to verify that they are looking at the correct chart.

    I know of an Orthopedic Surgoen who scheduled the wrong surgeries on two patients who had the same last name and were seen on the same day. One funny example involved a provider who documented very thouragly how he removed stitches from a patient who was deceased. (documented in the wrong chart) In another case I know of a female 40 year old patient who was given the discharge instructions for a 60 year old male and it was only because she asked for her own records within a day that she realized they had missed a collapsed lung in her and couldn’t hear it in him (the x-ray showed it on her but when they listened to his chest he was fine) .

  9. Cindy Throop says:

    Here’s the troublemaker, I mean, e-Patient Dave in action (pics)!

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