The following proposals for new work were submitted to AAMI for consideration.

Transcription

1 Doc. HITN053 COMMENTS RECEIVED DURING PUBLIC REVIEW OF PROPOSALS FOR NEW WORK ADDRESSING HEALTH IT USABILITY (Doc. HITN48 and HITN049) AND RESPONSES FROM THE PROPOSERS The following proposals for new work were submitted to AAMI for consideration. AAMI HITN048, User-centered design process for electronic health record design (proposed new American National Standard) AAMI HITN049, Guidelines for designing user interfaces for electronic health records (proposed new AAMI Technical Information Report) These proposals were placed on 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. Following are the comments received and the responses to the comments from the proposers. These were submitted to the AAMI Standards Board for consideration for approval by the AAMI Standards Board at its 5 June 2016 meeting. The responses to the comments included revision of the NPs (titles of the proposed work) which are provided in Attachment A and Attachment B. The results of the Standards Board's deliberations will be provided for discussion at this 29 June 2016 session of the Health IT committee. Assuming the work has been authorized further development, the committee will begin organizing that effort at that meeting.

2 RESPONSES TO PUBLIC REVIEW OF PROPOSALS TO START NEW WORK ADDRESSING HEALTH IT USABILITY (Doc. HITN048 and HITN049) Electronic Health Records Association Leigh Burchell, Chair, EHR Association, Allscripts Sarah Corley, MD, Vice Chair, EHR Association, NextGen Healthcare Pamela Chapman, e-mds Richard Loomis, MD, Practice Fusion Meg Marshall, JD, Cerner Corporation Rick Reeves, RPh, Evident Richard Landen, QuadraMed Corporation Sasha TerMaat, Epic Representing more than 30 EHR developer companies that serve the vast majority of acute care and ambulatory providers in the US that are using health IT to deliver more efficient, effective patient care, we believe that this guidance should not replace, invalidate, or duplicate existing usability standards that are available and in use. We request that the proposed American Association for Medical Instrumentation (AAMI) work product on human factors for health IT follow the approach being used for HIT 1000 Risk Management and HIT 2000 Quality Systems, and not introduce a new standard. Both the HIT 1000 and HIT 2000 standards recognize the entire health IT lifecycle, the organizations involved at each stage in the lifecycle, and how information flows across organizational boundaries and processes. Human factors engineering is an integral component of the risk management process and serves as a control that can help mitigate risk. The work product should provide more specific guidance on how human factors engineering should be applied across the software development lifecycle, both during risk assessment and as part of the quality system. However, this work product should not introduce a new standalone activity or standard, especially when so much prior quality work exists, and methods are constantly evolving and improving. Instead, we support the development of a consensus companion work to the NIST guidance, providing best practices for applying human factors engineering when meeting the HIT 1000 and HIT 2000 standards. The Association looks forward to further discussion of this important topic Comment: The proposed standard (Doc HITN048) will serve as a resource for the EHR development community, providing EHR developers with best practices for applying HFE during EHR development (wherever in the lifecycle such development occurs). The work item is intended to be a voluntary standard that stakeholders may use at their discretion as a resource to aid in EHR development. It is not intended to be compulsory in any way and its application, or lack thereof, is not intended to influence a particular HIT s market access. We recognize that recommending (but not requiring) a usability design process within the HIT development ecosystem creates unique challenges, as are being addressed in HIT 1000 (risk management) and HIT 2000 (quality systems). We agree that any voluntary standard must address these unique challenges, be usable within the risk management and quality system framework presented by those standards, and will require definition of the responsibilities and expectations of all stakeholders in the Health IT lifecycle. The details of this approach will be determined by the Health IT committee as this document is drafted.

3 Mike Marchlik, McKesson Technology Solutions Are HITN048 and 049 companion works or alternatives? It will be important that the proposed AAMI work product on Human Factors for Health IT follow the approach being used for HIT 1000 Risk Management and HIT 2000 Quality Systems. Both standards are considering the entire Health IT lifecycle, the organizations involved at each stage in the lifecycle, and how information flows across organizational boundaries and processes. There appears to be consensus that human factors engineering is an integral component of the risk management process and serves as a control that can help mitigate risk. I believe that the work product needs to take that approach, providing more specific guidance on how human factors engineering should be applied across the lifecycle both during risk assessment and then as part of the quality system, not as a standalone activity or standard. I have discussed the Human Factors standard proposal with a number of stakeholders and they have expressed concern in developing a new standard, but would support the development of a consensus companion work to the NIST guidance, providing best practices for applying human factors engineering when meeting the HIT 1000 and HIT 2000 standards Comment: HITN048 and HITN049 are companion works. HITN048 will describe best practices for implementing a user-centered design process during the design and development of EHRs. HITN049 will provide a detailed set of UI design recommendations for reference when designing safe, effective, and usable EHRs (in the same manner that AAMI HE75:2009 provides design guidance for medical device development). We expect that HIT049 will draw upon existing knowledge of what features and approaches promote usability and patient safety and will reference work in other sectors, such as aviation, IT, and other sectors of healthcare. Regarding the second comment, please reference the response above to the EHRA. Wayne Ho, MEng, Managing Principal, Healthcare Human Factors I m in favour of the proposed new work item. Please let me know how we can support this project and how we can be placed on the appropriate mailing lists, etc. Comment: We appreciate Mr. Ho s support for the proposed work item. Daryle Gardner-Bonneau, Principal, Bonneau and Associates I have a few comments on new work item proposal on EHRs. While I applaud the effort, I wonder if it isn t just a little bit late, given the stranglehold a small number of EHR developers seem to have on the market, despite (in many cases) the poor user interface design of their products. I wonder if it might not be a good idea, therefore, to extend the coverage of this TIR (or develop a separate standard?), to address user interface design guidance for apps that use the contents (output) from the EHR (e.g., apps that use EHR data to aid practitioner decision-making). Or maybe that is implied already? Also, it sounds like the focus is on EHR-specific user interface guidelines, - not a bad thing, but I do worry that a TIR or a standard that is a long laundry list of micro-level specific guidance may miss some big picture issues that are at the heart of some of the problems with EHRs. As a specific example, I would offer the issue of situational awareness the idea that the EHR user needs the EHR to convey the patient s overall situation at a macro level, and also needs the EHR to convey information in such a way that the he/she is always certain of whose record he/she is looking at (or entering data into). This seems more a like high level principle than a micro-level guideline, but I think some of these higher-level principles ought to be included in the TIR. (Interestingly, in the NWIP itself, on the second page where

4 use errors are discussed, one of the more serious errors that is not at all uncommon is entering data into the WRONG patient record, but that error is not mentioned. Another similar higher-level concept, I think, is that historical information needs to be conveyed in a way that allow users to easily grasp what happened to the patient when without having to a read a line by line endless description. I would suggest perhaps looking at a standard like ISO (which provides high-level principles for humansystem dialogues), as a basis for some of this kind of macro-level guidance. Another new work item proposal is mentioned in the proposal you sent for review. Will you be sending that out for people to look at, as well? Finally, I would note that I am very interested in this effort, but as I am already serving on three AAMI Committees, and I can t become an active member of a fourth, but would be happy to be on your reviewer list for reviewing drafts that are produced, if such a thing would be acceptable. Some years back, I turned down an opportunity to work with NIST folks on EHR user interface issues because I felt that any guidance human factors folks could provide would be like putting a band aid on a gaping wound. The companies building EHRs had been at it a long time, and were doing it with VERY LITTLE concern or attention to the needs of people who would actually USE the EHR, namely practitioners (but also patients). As with many giant database systems, they were much more concerned about getting data INTO the system, and totally unconcerned about getting any data out in a form that would actually be useful. They were also so burdened with interoperability and security issues, that very little else got much attention. And when the FDASIA report came out and said that EHRs were, effectively, low-risk IT, I could not even believe it and that was pretty much the last straw for me. Comment: We appreciate Dr. Gardner-Bonneau s support for the proposed work item. We agree that higher-level principles or guidelines are a necessary part of the proposed design guidance (HITN049). We plan to include both macro-level principles, such as with respect to patient identification, alongside more specific or micro-level principles in the proposed design guidance document. At this time, we do not plan to extend the work item s scope to cover applications that use EHR output. However, much of the UI design guidance provided in HITN049 will apply to HIT applications in general, so this document should also serve as a useful resource for their development. Peter Goldschmidt, World Development Group Inc. Joe: I received your latest s on these subjects. As you know, I enthusiastically support the development of the standards and guidelines. One point to consider is the title of N048. The focus of EHR design should be for the benefit of the patient rather than the convenience of the provider (although the latter may on occasion lead to the former). Thus, perhaps the title should be 'Functioncentered design...' I m looking forward to participating in these standards development initiatives. Comment: We appreciate Dr. Goldschmidt s support for the proposed work items. Based on this and other feedback, we plan to revise the work item titles as follows: HITN048: Process Guide for Designing EHR User Interfaces HITN049: EHR User Interface Design Guidance Note that the final titles are subject to committee and AAMI input. Richard Botney, MD, Department of Anesthesiology and Perioperative Medicine, Oregon Health and Science University A few months ago (January-February, I think), I was in touch with Mike Wiklund about this very topic. For one reason, I am currently conducting a usability study of reading anesthesia notes from a certain manufacturer, with the aim of improving the display of these notes and making them more readable, efficient, and effective to use. At the time, I expressed an interest in participating in work on HIT/EHR

5 usability. In that light, I would like to respond to your request for comments regarding this work proposal and its companion, "Guidelines for designing user interfaces for EHRs". Before providing my comments, perhaps a word about my background would be informative and helpful. First, I am a practicing clinical academic anesthesiologist, starting my career about I have an academic interest in Human Factors and Patient Safety, and have published some on these topics. I've been on the AAMI HF committee for probably 20 years or so, starting with the revision of HE 48 into HE 74, and continuing on to HE75, and now its current revision. My current effort at my institution, Oregon Health and Science University (OHSU), has to do with usability of the Epic user interface for anesthesiologists. This is admittedly somewhat different in nature than broader EHR use, though I'm sure many principles overlap. Briefly, the work I am doing involves what I call the input side, i.e., data entry of patient information, and the output side, i.e., the display of said information, usually in some form of note. I can provide more information on this if you wish. First, I am wholeheartedly in support of an effort to apply user-centered design to EHRs. In addition to my own experience with Epic, and Centricity before that, I hear from non-anesthesia colleagues about how awful they consider the use of their EHRs. In their cases, I suspect they are more concerned with the input side of things, however. Second, the sections you have defined in the Design Process proposal seem generally appropriate. With regard to specific items, I have some thoughts. The value of a user-centered design approach probably needs to include a number of things, including readability, efficiency (the time and effort to read or enter information), and effectiveness (in part, the ability to extract meaningful and accurate information from the EHR). With regard to user-interface requirements, one important thing I am discovering from my testing is the close relationship between data input and its display (output). The way in which data is entered can affect directly the readability of the generated notes. For example, if it is possible to select/click on many different inputs (checkboxes or buttons, e.g.) and these are all checked, it will produce a note that is very cumbersome and cluttered. Further, interspersing positive findings and negative findings makes reading a note much more laborious. A third aspect has to do with the ability to enter free text, which can also cause clutter in a note. Another aspect of this is the use of natural language in the translation of input data to displayed text that is actually readable. Yet another aspect is the ability to enter free text, which can lead to bloated, cumbersome notes. All of this affects the clinical meaning that users seek when reading notes or reviewing information in the EHR, and may affect the user's ability to analyze said information and make clinically relevant decisions. Of course, much of what I have described has to do with the output side, although as I have learned, that is heavily influenced by how the input side is designed and therefore used by clinicians. One element that probably should not be ignored, though, is that EHR data is used by multiple users with varying needs, e.g., clinicians of varying types, billing staff, risk management, researchers, compliance staff, etc. This goes towards the determination of user needs-all user types should be considered. Finally, in conducting evaluations, I have found that it is very difficult to design a note that meets the needs of our clinicians, although their feedback is serving to improve my efforts. Despite little objective evidence of usability (e.g., reading times, recall of information), the user satisfaction is where design improvements seem to standout. Finally, I have read through the NIST report, and while I found it informative, I felt it was more heavily slanted toward the input side, with relatively little that applied to the notes generated and their display. While HF design principles for computer displays are well-established, I am finding that while necessary, they are not sufficient at creating usable notes. Since this is how clinicians will ultimately obtain their information, it seems important not to ignore that aspect of EHR design. We have much to learn about

6 that aspect. As indicated therein, I firmly support and believe in the value of the development of guidelines for EHR design, as part of a user-centered design process, and hope I can contribute to and be part of what I see as an important effort. Based on my recent attendance at the HFES Health Care Symposium in San Diego, EHR developers are sorely in need of such guidelines. Having said that, and having attempted to apply existing HF guidelines to the display of an electronic note, I am learning it is not that simple. The first paragraph of the proposal defines two benefits of such guidelines: helping EHR developers ensure that clinicians are well-supported, and avoiding common user interface design flaws. I have discovered that mere application of guidelines to EHR design, such as in my case, for displayed notes, isn't wholly sufficient to ensure readability, simplicity, efficiency, and effectiveness, defined in part as extraction of meaningful information from said notes. There are several reasons for this, but I think they boil down to essentially two or three: (1) the EHRs provide such a degree of flexibility that there are many many ways for data (clinical information) to be input, and in many cases this carries through to how it is displayed in notes; in other words, how the information is captured and passed through to the reader can depend on how it is entered, (2) there will always be more varieties of information than can be captured by input data elements such as checkboxes, hence there will always be a need for free text entry; once that is allowed, it again can make notes and data display much more complex, cumbersome and cluttered, and this also will affect the input side, as in how cumbersome and cluttered the data entry elements are to use, and (3) how information is translated from input to output, that is, the language that is used differs dramatically from how people actually write or speak it, making for stilted verbiage, redundant display of information, etc. Because of these and the great variation in user types, needs, capabilities, etc, guidelines will be limited in what they can accomplish unless user considerations are carefully studied to see what their needs are (as intended by having a user-centered design process). As for the suggested topics for guidance, it seems to me they are heavily weighted toward data entry, the input side, as it were. I feel like guidance for the display of information, e.g., notes, is missing or given short shrift. Since that is where a lot of information transfer between clinicians will occur, it cannot be ignored. Comment: We appreciate Dr. Botney s comments regarding the relationship between data entry and display, and recognize that data display is a key contributor toward EHR usability and use-safety. HITN049 will include a considerable number of guidelines concerning data display, covering such details as clinical decision support, conceptual models, content organization, feedback, information density, status indication, color, graphics, typography, and general visual design. We recognize the importance of clinician notes as a key method of information transfer among clinicians. Because these notes typically consist of unstructured text, the committee will need to carefully consider what guidance could be helpful regarding this aspect of electronic health record design.

7 Revised NP (previously circulated as doc. HITN048) in response to public comments ATTACHMENT A AAMI NEW WORK ITEM PROPOSAL FORM Section A: Project Information Proposed project title: Process Guide for Designing EHR User Interfaces Type of project: AAMI/American National standard Anticipated use environment: Health IT industry use, particularly by Electronic Health Record (EHR) developers Scope: This standard is intended to help EHR developers plan and implement a user-centered design process that results in safe, effective, and usable applications. Document sections might include: Overview of user-centered design approach Value of user-centered design approach Determining user needs Identifying use-related risks Developing user interface requirements Designing and prototyping the user interface Mitigating use-related risks Conducting formative and summative evaluations Proposed project contacts: Michael Wiklund, General Manager Human Factors Engineering, UL LLC; michael.wiklund@ul.com Limor Hochberg, Human Factors Specialist, UL LLC; limor.hochberg@ul.com Section B: Market/Stakeholder Relevance Purpose/justification: Introduction EHRs serve a critical function in healthcare delivery, facilitating high-quality, efficient, and affordable patient care. Considering the expansive content and complexity of EHRs, as well as the frequency with which healthcare providers use EHRs to accomplish urgent and critical tasks, optimizing an EHR's usability is critical to its success. Historically, EHRs have been vulnerable to use errors that can directly or indirectly lead to patient harm. As such, EHR developers are well served to embrace a user-centered design process (also called a human factors engineering (HFE) process), and follow user interface design guidelines (see related Work Item Proposal). Implementing such a design process will (1) help prevent potentially harmful use errors, and (2) as a related benefit, increase EHR usability.

8 Revised NP (previously circulated as doc. HITN048) in response to public comments ATTACHMENT A EHR use errors can (and do) result in patient harm How could EHR use errors be harmful to patients? A data entry or reading error could lead to a patient receiving an inappropriate therapy, such as the wrong medication dose or type. A patient might receive suboptimal treatment because medical decisions were made on the basis of incorrect or incomplete information. As a final example, a patient might not receive the necessary follow-up care because an on-screen message is inconspicuous, or abnormal lab results might go unattended because an on-screen alert is unclear. Notably, a study published in the Journal of the American Medical Association found that a computerized physician order entry (CPOE) system facilitated a range of medication errors, such as those resulting from difficulties related to patient identification and selection (Koppel et al., 2005). Use errors associated with electronic health records have also been covered in the news, such a case in which a pharmacy technician entered an incorrect dose into infant s medical record, leading to fatal overdose of sodium chloride. 1 In another case, a patient s cervical cancer went undetected for several years because the electronic health record system incorrectly displayed an older normal test result. 2 The need for and benefit of EHR-specific user interface design process The application of HFE and user interface design guidelines has helped make many other types of systems and products safer, including automobiles, aircraft, power plants, and medical devices. Applying HFE during EHR development promises to reduce the chance of potentially harmful use errors. An advantageous and predictable byproduct is increased EHR usability, which benefits healthcare providers and an EHR developer s business, as well as increased task effectiveness, worker efficiency, and user satisfaction. Associated business benefits include reduced application development time and cost, lower customer support demands, extended marketability, reduced risk of liability claims, and increased customer loyalty. Existing resources may serve as a foundation for a new AAMI work item Recently, the widespread adoption of EHRs prompted NIST to engage UL, LLC to conduct a five-year research effort focused specifically on EHR usability, resulting in a report titled Technical Basis for User Interface Design of Health IT ( 2015). The goal of the research effort was to develop a tool for electronic health record developers and usability engineers that would help them develop usable, safe, and effective EHRs. The authors developed a high-level design process framework, including a summary of EHR design best practices based on interviews with EHR developers, and a detailed set of over 300 design guidelines. Notably, the authors believe that this document could serve as an appropriate foundation (i.e., starting point) for the development of the proposed EHR design process. Conclusion Mirroring the well-established approach to reducing risk that prevails in other industries where use errors involving hardware and software products has led to significant harms, developers should follow a user interface design process that seeks to identify potentially harmful use errors and decrease their likelihood of occurrence (i.e., reduce risk). The proposed standard, which may be developed from existing resources, seeks to be a comprehensive, practical guide for EHR developers to create and implement a user-centered design process for the creation of safe and usable EHRs

9 Revised NP (previously circulated as doc. HITN048) in response to public comments ATTACHMENT A Relevance to AAMI s mission: AAMI s mission is to provide global leadership to support the healthcare community in the development, management, and use of safe and effective healthcare technology. Providing EHR vendors with guidance on implementing a user-centered design approach to enhance EHR safety, effectiveness, and usability is well aligned with this mission. Moreover, publishing such guidance would position AAMI as the first standards organization to guide EHR vendors to this end. This guidance is also comparable to the guidance AAMI has already developed on the application of a user-centered approach to medical device development, particularly AAMI HE74 (now withdrawn due to issuance of IEC 62366, which is derived from AAMI HE74). Select relevant documentation: Existing Document (NIST GCR ) Reference/background materials: Wiklund, M.E., Kendler, J., Hochberg, L., & Weinger, M. B. (2015). NIST GCR : Technical Basis for User Interface Design of Health IT. ANSI/AAMI/IEC (2015). Medical devices Part 1: Application of usability engineering to medical devices. Geneva, Switzerland: International Electrotechnical Commission. ANSI/AAMI HE74 (withdrawn). Human Factors Design Process for Medical Devices. ANSI/AAMI HE Arlington, VA: Association for the Advancement of Medical Instrumentation. ANSI/AAMI HE75. (2009). Human Factors Engineering Design of Medical Devices. ANSI/AAMI HE Arlington, VA: Association for the Advancement of Medical Instrumentation. Koppel, R., Metlay, J. P., Cohen, A., Abaluck, B., Localio, A. R., Kimmel, S. E., & Strom, B. L. (2005). Role of computerized physician order entry systems in facilitating medication errors. Journal of the American Medical Association, 293(10), Lowry, S. Z., Ramaiah, M., Taylor, S., Patterson, E. S., Prettyman, S. S., Simmons, D.,... & Gibbons, M. C. (2015). NISTIR :Technical evaluation, testing, and validation of the usability of electronic health records: Empirically based use cases for validating safety-enhanced usability and guidelines for standardization. Ratwani, R. M., Fairbanks, R. J., Hettinger, A. Z., & Benda, N. C. (2015). Electronic health record usability: Analysis of the user-centered design processes of eleven electronic health record vendors. Journal of the American Medical Informatics Association, ocv050. Known patent issues: None Intended Audience: Industry/Manufacturing; Regulatory; Testing/Labs; Academia

10 Revised NP (previously circulated as doc. HITN048) in response to public comments ATTACHMENT A Section C: Consensus Body Considerations Committee considerations: Existing work group (Health IT Committee); New task group Additional committee/work group input: Human Factors Engineering Committee; Mobile Applications Working Group Stakeholder outreach: EHR vendors; Regulators; User experience and usability consultants and practitioners; Academic researchers focused on Health IT/EHRs; Clinicians from a variety of user environments (e.g., private clinics, hospital systems) International relevance: This work is not expected to affect existing standards. Resource considerations: N/A

11 Revised NP (previously circulated as doc. HITN049) in response to public comments ATTACHMENT B AAMI NEW WORK ITEM PROPOSAL FORM Section A: Project Information Proposed project title: EHR User Interface Design Guidance Type of project: AAMI Technical Information Report Anticipated use environment: Health IT industry use, particularly by Electronic Health Record (EHR) developers Scope: The proposed guidelines for designing user interfaces for electronic health records will help EHR developers create safe, effective, and usable EHRs. Specifically, the guidelines will help developers (1) ensure that clinicians and support staff are well-supported while using the EHR, and (2) avoid common user interface design flaws that could lead to potentially harmful use errors, impede healthcare worker tasks, and degrade an EHR s usability. The guidelines are not intended to have the power of requirements. They will primarily describe general and proven design practices rather than prescribe specific user interface design solutions. For example, design guidance pertaining to alerts might suggest that alerts be visually prominent so that they draw the user s attention, rather than specify a particular design solution (e.g., an alert must be displayed in red text). The guidance could cover the following topics: Accessibility; Affordances; Alerts; Buttons; Clinical decision support; Conceptual model; Content organization; Controls; Customizability; Data entry; Efficiency; Error prevention, detection and recovery; Feedback; Information density; Language; Metaphor; Navigation; Patient identification; Search; Security; Status indication; User support; Color; Graphics; General Visual Design; Typography; and Workflow. Proposed project contacts: Michael Wiklund, General Manager Human Factors Engineering, UL LLC; michael.wiklund@ul.com Limor Hochberg, Human Factors Specialist, UL LLC; limor.hochberg@ul.com Section B: Market/Stakeholder Relevance Purpose/justification: Introduction EHRs serve a critical function in healthcare delivery, facilitating high-quality, efficient, and affordable patient care. Considering the expansive content and complexity of EHRs, as well as the frequency with which healthcare providers use EHRs to accomplish urgent and critical tasks, optimizing an EHR's usability is critical to its success.

12 Revised NP (previously circulated as doc. HITN049) in response to public comments ATTACHMENT B Historically, EHRs have been vulnerable to use errors that can directly or indirectly lead to patient harm. As such, EHR developers are well served to follow user interface design guidelines within the framework of a user-centered design process (see related Work Item Proposal). Applying such user interface design guidelines will (1) help prevent potentially harmful use errors, and (2) increase EHR usability and thereby help vendors achieve Meaningful Use certification. Additionally, such design guidance could also help vendors and healthcare systems reduce the cost of training and supporting EHR users because the applications are easier to learn to use. EHR use errors can (and do) result in patient harm How could EHR use errors be harmful to patients? A data entry or reading error could lead to a patient receiving an inappropriate therapy, such as the wrong medication dose or type. A patient might receive suboptimal treatment because medical decisions were made on the basis of incorrect or incomplete information. As a final example, a patient might not receive the necessary follow-up care because an on-screen message is inconspicuous, or abnormal lab results might go unattended because an on-screen alert is unclear. Notably, a study published in the Journal of the American Medical Association found that a computerized physician order entry (CPOE) system facilitated a range of medication errors, such as those resulting from difficulties related to patient identification and selection (Koppel et al., 2005). Use errors associated with electronic health records have also been covered in the news, such as a case in which a pharmacy technician entered an incorrect dose into infant s medical record, leading to fatal overdose of sodium chloride. 1 In another case, a patient s cervical cancer went undetected for several years because the electronic health record system incorrectly displayed an older normal test result. 2 The need for and benefit of EHR-specific user interface design guidelines The application of HFE and user interface design guidelines has helped make many other types of systems and products safer, including automobiles, aircraft, power plants, and medical devices. However, existing user interface design guidelines do not necessarily address the challenges unique to EHR design and development, resulting from factors including that (a) individual patients electronic health records are accessed by variety of clinicians and medical support staff, (b) electronic health records often provide clinicians with clinical decision support, requiring an EHR to display the right subset of information at the right time, (c) EHRs are used over a period of many years, (d) clinicians often multi-task rapidly among patients, and (e) clinicians often use multiple EHR systems within and between health care facilities over the course of a single day or week. Given these challenges and use cases, careful consideration and application of EHR-specific UI design guidelines promises to reduce the chance of potentially harmful use errors. An advantageous and predictable by-product is increased EHR usability, which benefits healthcare providers and an EHR developer s business, as well as increased task effectiveness, worker efficiency, and user satisfaction. Associated business benefits include reduced application development time and cost, lower customer support demands, extended marketability, reduced risk of liability claims, and increased customer loyalty. Existing resources may serve as a foundation for a new AAMI work item Recently, the widespread adoption of EHRs prompted NIST to engage UL, LLC to conduct a five-year research effort focused specifically on EHR usability, resulting in a report titled Technical Basis for User Interface Design of Health IT ( 2015). The goal of the research effort

13 Revised NP (previously circulated as doc. HITN049) in response to public comments ATTACHMENT B was to develop a tool for electronic health record developers and usability engineers that would help them develop usable, safe, and effective EHRs. The resulting report includes a detailed set of over 300 design guidelines, derived from a range of user research activities, along categories including patient identification, navigation, workflow, and user support. Notably, the authors believe that this document could serve as an appropriate foundation (i.e., starting point) for the development of an EHR design guidance document, particularly due to the wide scope of the research conducted and because the design principles contained in the report are empirically driven. Relevance to AAMI s mission: AAMI s mission is to provide global leadership to support the healthcare community in the development, management, and use of safe and effective healthcare technology. Providing EHR vendors with user interface design guidance toward enhancing EHR safety, effectiveness, and usability is well aligned with this mission. Moreover, publishing such guidance would position AAMI as the first standards organization to guide EHR vendors in this manner. This guidance is also comparable to the guidance AAMI has already developed on the application of a user-centered approach to medical device development, particularly AAMI HE75. Select relevant documentation: Existing Document (NIST GCR ) Reference/background materials: Wiklund, M.E., Kendler, J., Hochberg, L., & Weinger, M. B. (2015). NIST GCR : Technical Basis for User Interface Design of Health IT. ANSI/AAMI/IEC (2015). Medical devices Part 1: Application of usability engineering to medical devices. Geneva, Switzerland: International Electrotechnical Commission. ANSI/AAMI HE74 (withdrawn). Human Factors Design Process for Medical Devices. ANSI/AAMI HE Arlington, VA: Association for the Advancement of Medical Instrumentation. ANSI/AAMI HE75. (2009). Human Factors Engineering Design of Medical Devices. ANSI/AAMI HE Arlington, VA: Association for the Advancement of Medical Instrumentation. ANSI/HFES 100 (2007). Human factors engineering of computer workstations. Santa Monica, CA: Human Factors and Ergonomics Society. Koppel, R., Metlay, J. P., Cohen, A., Abaluck, B., Localio, A. R., Kimmel, S. E., & Strom, B. L. (2005). Role of computerized physician order entry systems in facilitating medication errors. Journal of the American Medical Association, 293(10), Lowry, S. Z., Ramaiah, M., Taylor, S., Patterson, E. S., Prettyman, S. S., Simmons, D.,... & Gibbons, M. C. (2015). NISTIR :Technical evaluation, testing, and validation of the usability of electronic health records: Empirically based use cases for validating safety-enhanced usability and guidelines for standardization. Lowry, S. Z., Quinn, M. T., Ramaiah, M., Schumacher, R. M., Patterson, E. S., North, R.,... & Abbott, P. (2012). NIST 7804: Technical evaluation, testing, and validation of the usability of electronic health records. National Institute of Standards and Technology.

14 Revised NP (previously circulated as doc. HITN049) in response to public comments ATTACHMENT B Ratwani, R. M., Fairbanks, R. J., Hettinger, A. Z., & Benda, N. C. (2015). Electronic health record usability: Analysis of the user-centered design processes of eleven electronic health record vendors. Journal of the American Medical Informatics Association, ocv050. Zhang, J., & Walji, M. F. (2011). TURF: Toward a unified framework of EHR usability. Journal of Biomedical Informatics, 44(6), Known patent issues: None Intended Audience: Industry/Manufacturing; Regulatory; Testing/Labs; Academia Section C: Consensus Body Considerations Committee considerations: Existing work group (Health IT Committee); New task group Additional committee/work group input: Human Factors Engineering Committee; Mobile Applications Working Group Stakeholder outreach: EHR vendors; Regulators; User experience and usability consultants and practitioners; Academic researchers focused on Health IT/EHRs; Clinicians from a variety of user environments (e.g., private clinics, hospital systems) International relevance: This work is not expected to affect existing standards. Resource considerations: N/A