Implementation of Clinical Artificial Intelligence in Radiology: Who Decides and How?

As the role of artificial intelligence (AI) in clinical practice evolves, governance structures oversee the implementation, maintenance, and monitoring of clinical AI algorithms to enhance quality, manage resources, and ensure patient safety. In this article, a framework is established for the infrastructure required for clinical AI implementation and presents a road map for governance. The road map answers four key questions: Who decides which tools to implement? What factors should be considered when assessing an application for implementation? How should applications be implemented in clinical practice? Finally, how should tools be monitored and maintained after clinical implementation? Among the many challenges for the implementation of AI in clinical practice, devising flexible governance structures that can quickly adapt to a changing environment will be essential to ensure quality patient care and practice improvement objectives.

How Image Exchange Breaks Down: the Image Library Perspective.

While in the last decade there has been significant technical infrastructure development to support standards-based image exchange through organizations like Integrating the Healthcare Enterprise, Carequality, DICOM, and HL7 FHIR, the human operationalization of such infrastructure using centralized, intuitive, standards-based applications remains the cornerstone of effective and reliable electronic image exchange. Image libraries managing the highly transactional and often uncertain inflows and outflows of images have a unique perspective on the challenges of image exchange. This manuscript will summarize frequent collaboration and communication, release of information, staffing, technology, information localization, and analytics difficulties for image exchange from the perspective of the image library staff managing the transactions.

Interactive Multimedia Reporting Technical Considerations: HIMSS-SIIM Collaborative White Paper.

Despite technological advances in the analysis of digital images for medical consultations, many health information systems lack the ability to correlate textual descriptions of image findings linked to the actual images. Images and reports often reside in separate silos in the medical record throughout the process of image viewing, report authoring, and report consumption. Forward-thinking centers and early adopters have created interactive reports with multimedia elements and embedded hyperlinks in reports that connect the narrative text with the related source images and measurements. Most of these solutions rely on proprietary single-vendor systems for viewing and reporting in the absence of any encompassing industry standards to facilitate interoperability with the electronic health record (EHR) and other systems. International standards have enabled the digitization of image acquisition, storage, viewing, and structured reporting. These provide the foundation to discuss enhanced reporting. Lessons learned in the digital transformation of radiology and pathology can serve as a basis for interactive multimedia reporting (IMR) across image-centric medical specialties. This paper describes the standard-based infrastructure and communications to fulfill recently defined clinical requirements through a consensus from an international workgroup of multidisciplinary medical specialists, informaticists, and industry participants. These efforts have led toward the development of an Integrating the Healthcare Enterprise (IHE) profile that will serve as a foundation for interoperable interactive multimedia reporting.

Multi-institutional Experience with Patient Image Access Through Electronic Health Record Patient Portals.

The objective is to determine patients' utilization rate of radiology image viewing through an online patient portal and to understand its impact on radiologists. IRB approval was waived. In this two-part, multi-institutional study, patients' image viewing rate was retrospectively assessed, and radiologists were anonymously surveyed for the impact of patient imaging access on their workflow. Patient access to web-based image viewing via electronic patient portals was enabled at 3 institutions (all had open radiology reports) within the past 5 years. The number of exams viewed online was compared against the total number of viewable imaging studies. An anonymized survey was distributed to radiologists at the 3 institutions, and responses were collected over 2 months. Patients viewed 14.2% of available exams - monthly open rate varied from 7.3 to 41.0%. A total of 254 radiologists responded to the survey (response rate 32.8%); 204 were aware that patients could view images. The majority (155/204; 76.0%) felt no impact on their role as radiologists; 11.8% felt negative and 9.3% positive. The majority (63.8%) were never approached by patients. Of the 86 who were contacted, 46.5% were contacted once or twice, 46.5% 3-4 times a year, and 4.7% 3-4 times a month. Free text comments included support for healthcare transparency (71), concern for patient confusion and anxiety (45), and need for attention to radiology reports and image annotations (15). A small proportion of patients viewed their radiology images. Overall, patients' image viewing had minimal impact on radiologists. Radiologists were seldom contacted by patients. While many radiologists feel supportive, some are concerned about causing patient confusion and suggest minor workflow modifications.

Data Sharing of Imaging in an Evolving Health Care World: Report of the ACR Data Sharing Workgroup, Part 2: Annotation, Curation, and Contracting.

A core principle of ethical data sharing is maintaining the security and anonymity of the data, and care must be taken to ensure medical records and images cannot be reidentified to be traced back to patients or misconstrued as a breach in the trust between health care providers and patients. Once those principles have been observed, those seeking to share data must take the appropriate steps to curate the data in a way that organizes the clinically relevant information so as to be useful to the data sharing party, assesses the ensuing value of the data set and its annotations, and informs the data sharing contracts that will govern use of the data. Embarking on a data sharing partnership engenders a host of ethical, practical, technical, legal, and commercial challenges that require a thoughtful, considered approach. In 2019 the ACR convened a Data Sharing Workgroup to develop philosophies around best practices in the sharing of health information. This is Part 2 of a Report on the workgroup's efforts in exploring these issues.

Data Sharing of Imaging in an Evolving Health Care World: Report of the ACR Data Sharing Workgroup, Part 1: Data Ethics of Privacy, Consent, and Anonymization.

Radiology is at the forefront of the artificial intelligence transformation of health care across multiple areas, from patient selection to study acquisition to image interpretation. Needing large data sets to develop and train these algorithms, developers enter contractual data sharing agreements involving data derived from health records, usually with postacquisition curation and annotation. In 2019 the ACR convened a Data Sharing Workgroup to develop philosophies around best practices in the sharing of health information. The workgroup identified five broad domains of activity important to collaboration using patient data: privacy, informed consent, standardization of data elements, vendor contracts, and data valuation. This is Part 1 of a Report on the workgroup's efforts in exploring these issues.

Electronic Health Record Closed-Loop Communication Program for Unexpected Nonemergent Findings.

Background Reliance on examination reporting of unexpected imaging findings does not ensure receipt of findings or appropriate follow-up. A closed-loop communication system should include provider and patient notifications and be auditable through the electronic health record (EHR). Purpose To report the initial design of and results from using an EHR-integrated unexpected findings navigator (UFN) program that ensures closed-loop communication of unexpected nonemergent findings. Materials and Methods An EHR-integrated UFN program was designed to enable identification and communication of unexpected findings and aid in next steps in findings management. Three navigators (with prior training as radiologic technologists and sonographers) facilitated communication and documentation of results to providers and patients. Twelve months (October 2019 to October 2020) of results were retrospectively reviewed to evaluate patient demographics and program metrics. Descriptive statistics and correlation analysis were performed by using commercially available software. Results A total of 3542 examinations were reported within 12 months, representing 0.5% of all examinations performed (total of 749 649); the median patient age was 62 years (range, 1 day to 98 years; interquartile range, 23 years). Most patients were female (2029 of 3542 [57%]). Almost half of the examinations submitted were from chest radiography and CT (1618 of 3542 [46%]), followed by MRI and CT of the abdomen and pelvis (1123 of 3542 [32%]). The most common unexpected findings were potential neoplasms (391 of 3542 [11%]). The median time between examination performance and patient notification was 12 days (range, 0-136 days; interquartile range, 13 days). A total of 2127 additional imaging studies were performed, and 1078 patients were referred to primary care providers and specialists. Most radiologists (89%, 63 of 71 respondents) and providers (65%, 28 of 43 respondents) found the system useful and used it most frequently during regular business hours. Conclusion An electronic health record-integrated, navigator-facilitated, closed-loop communication program for unexpected radiologic findings led to near-complete success in notification of providers and patients and facilitated the next steps in findings management. © RSNA, 2021 See also the editorial by Safdar in this issue.

Multispecialty Enterprise Imaging Workgroup Consensus on Interactive Multimedia Reporting Current State and Road to the Future: HIMSS-SIIM Collaborative White Paper.

Diagnostic and evidential static image, video clip, and sound multimedia are captured during routine clinical care in cardiology, dermatology, ophthalmology, pathology, physiatry, radiation oncology, radiology, endoscopic procedural specialties, and other medical disciplines. Providers typically describe the multimedia findings in contemporaneous electronic health record clinical notes or associate a textual interpretative report. Visual communication aids commonly used to connect, synthesize, and supplement multimedia and descriptive text outside medicine remain technically challenging to integrate into patient care. Such beneficial interactive elements may include hyperlinks between text, multimedia elements, alphanumeric and geometric annotations, tables, graphs, timelines, diagrams, anatomic maps, and hyperlinks to external educational references that patients or provider consumers may find valuable. This HIMSS-SIIM Enterprise Imaging Community workgroup white paper outlines the current and desired clinical future state of interactive multimedia reporting (IMR). The workgroup adopted a consensus definition of IMR as "interactive medical documentation that combines clinical images, videos, sound, imaging metadata, and/or image annotations with text, typographic emphases, tables, graphs, event timelines, anatomic maps, hyperlinks, and/or educational resources to optimize communication between medical professionals, and between medical professionals and their patients." This white paper also serves as a precursor for future efforts toward solving technical issues impeding routine interactive multimedia report creation and ingestion into electronic health records.

The Importance of Body Part Labeling to Enable Enterprise Imaging: A HIMSS-SIIM Enterprise Imaging Community Collaborative White Paper.

In order for enterprise imaging to be successful across a multitude of specialties, systems, and sites, standards are essential to categorize and classify imaging data. The HIMSS-SIIM Enterprise Imaging Community believes that the Digital Imaging Communications in Medicine (DICOM) Anatomic Region Sequence, or its equivalent in other data standards, is a vital data element for this role, when populated with standard coded values. We believe that labeling images with standard Anatomic Region Sequence codes will enhance the user's ability to consume data, facilitate interoperability, and allow greater control of privacy. Image consumption-when a user views a patient's images, he or she often wants to see relevant comparison images of the same lesion or anatomic region for the same patient automatically presented. Relevant comparison images may have been acquired from a variety of modalities and specialties. The Anatomic Region Sequence data element provides a basis to allow for efficient comparison in both instances. Interoperability-as patients move between health care systems, it is important to minimize friction for data transfer. Health care providers and facilities need to be able to consume and review the increasingly large and complex volume of data efficiently. The use of Anatomic Region Sequence, or its equivalent, populated with standard values enables seamless interoperability of imaging data regardless of whether images are used within a site or across different sites and systems. Privacy-as more visible light photographs are integrated into electronic systems, it becomes apparent that some images may need to be sequestered. Although additional work is needed to protect sensitive images, standard coded values in Anatomic Region Sequence support the identification of potentially sensitive images, enable facilities to create access control policies, and can be used as an interim surrogate for more sophisticated rule-based or attribute-based access control mechanisms. To satisfy such use cases, the HIMSS-SIIM Enterprise Imaging Community encourages the use of a pre-existing body part ontology. Through this white paper, we will identify potential challenges in employing this standard and provide potential solutions for these challenges.

Moving Radiology Workflow to the Electronic Health Record: Quantitative and Qualitative Experience From a Large Academic Medical Center.

RATIONALE AND OBJECTIVES: To objectively and subjectively evaluate a large, academic radiology department's transition to electronic health record (EHR) centered workflow. MATERIALS AND METHODS: Multiple metrics were compared from before and after the move to EHR-driven workflow. Examination ordering and reading priority data were obtained for 30 days both before and after the transition. Sixteen radiologists were observed opening a computed tomography (CT) examination, and time to open, mouse clicks, and keystrokes were recorded. Information available to the radiologist during interpretation was also compared. Additionally, a 12 question survey was sent out to the residents and faculty both before and after the transition. RESULTS: Implementation of an eight-level reading priority system increased worklist granularity and improved identification of more urgent studies to read. Radiologists opened CT studies in picture archiving and communications system-driven workflow in 52.4 ± 16.9 seconds using 9.5 ± 3.9 clicks and 6.3 ± 2.9 keystrokes, compared to 17.3 ± 9.5 seconds, 4.8 ± 1.5 clicks, and 0.1 ± 0.3 keystrokes in EHR-driven workflow (p < 0.001 for each measure). More information was available to the radiologist during examination interpretation, and 54.7% of radiologists rated the ease of use of the new system as good or very good (compared to 4.2% for the old system, p < 0.001). CONCLUSION: Transitioning to an EHR-driven workflow at a large academic medical center improved efficiency, was favorable to radiologists, and enhanced examination prioritization.

Image-Rich Radiology Reports: A Value-Based Model to Improve Clinical Workflow.

PURPOSE: To determine the value of image-rich radiology reports (IRRR) by evaluating the interest and preferences of referring physicians, potential impact on clinical workflow, and the willingness of radiologists to create them. METHODS: Referring physicians and radiologists were interviewed in this prospective, HIPAA-compliant study. Subject willingness to participate in the study was determined by an e-mail. A single investigator conducted all interviews using a standard questionnaire. All subjects reviewed a video mockup demonstration of IRRR and three methods for viewing embedded images, as follows: (1) clickable hyperlinks to access a scrollable stack of images, (2) scrollable and enlargeable small-image thumbnails, and (3) scrollable but not enlargeable medium-sized images. Questionnaire responses, free comments, and general impressions were captured and analyzed. RESULTS: Seventy-two physicians (36 clinicians, 36 radiologists) were interviewed. Thirty-one clinicians (86%) expressed interest in using IRRR. Seventy-seven percent of subjects believed IRRR would improve communication. Ten clinicians (28%) preferred method 1, 18 (50%) preferred method 2, and 8 (22%) preferred method 3 for embedding images. Thirty clinicians (83%) stated that IRRR would improve efficiency. Twenty-two radiologists (61%) preferred selecting a tool button with a mouse and right-clicking images to embed them, 13 (36%) preferred pressing a function key, and 11 (31%) preferred dictating series and image numbers. The average time radiologists were willing to expend for embedding images was 66.7 seconds. CONCLUSIONS: Referring physicians and radiologist both believe IRRR would add value by improving communication with the potential to improve the workflow efficiency of referring physicians.

Workflow Challenges of Enterprise Imaging: HIMSS-SIIM Collaborative White Paper.

With the advent of digital cameras, there has been an explosion in the number of medical specialties using images to diagnose or document disease and guide interventions. In many specialties, these images are not added to the patient's electronic medical record and are not distributed so that other providers caring for the patient can view them. As hospitals begin to develop enterprise imaging strategies, they have found that there are multiple challenges preventing the implementation of systems to manage image capture, image upload, and image management. This HIMSS-SIIM white paper will describe the key workflow challenges related to enterprise imaging and offer suggestions for potential solutions to these challenges.

Orders- Versus Encounters-Based Image Capture: Implications Pre- and Post-Procedure Workflow, Technical and Build Capabilities, Resulting, Analytics and Revenue Capture: HIMSS-SIIM Collaborative White Paper.

The decision to implement an orders-based versus an encounters-based imaging workflow poses various implications to image capture and storage. The impacts include workflows before and after an imaging procedure, electronic health record build, technical infrastructure, analytics, resulting, and revenue. Orders-based workflows tend to favor some imaging specialties while others require an encounters-based approach. The intent of this HIMSS-SIIM white paper is to offer lessons learned from early adopting institutions to physician champions and informatics leadership developing strategic planning and operational rollouts for specialties capturing clinical multimedia.

The Current State and Path Forward For Enterprise Image Viewing: HIMSS-SIIM Collaborative White Paper.

Clinical specialties have widely varied needs for diagnostic image interpretation, and clinical image and video image consumption. Enterprise viewers are being deployed as part of electronic health record implementations to present the broad spectrum of clinical imaging and multimedia content created in routine medical practice today. This white paper will describe the enterprise viewer use cases, drivers of recent growth, technical considerations, functionality differences between enterprise and specialty viewers, and likely future states. This white paper is aimed at CMIOs and CIOs interested in optimizing the image-enablement of their electronic health record or those who may be struggling with the many clinical image viewers their enterprises may employ today.

Enterprise Imaging Governance: HIMSS-SIIM Collaborative White Paper.

Enterprise imaging governance is an emerging need in health enterprises today. This white paper highlights the decision-making body, framework, and process for optimal enterprise imaging governance inclusive of five areas of focus: program governance, technology governance, information governance, clinical governance, and financial governance. It outlines relevant parallels and differences when forming or optimizing imaging governance as compared with other established broad horizontal governance groups, such as for the electronic health record. It is intended for CMIOs and health informatics leaders looking to grow and govern a program to optimally capture, store, index, distribute, view, exchange, and analyze the images of their enterprise.

ACR Appropriateness Criteria Head Trauma.

Neuroimaging plays an important role in the management of head trauma. Several guidelines have been published for identifying which patients can avoid neuroimaging. Noncontrast head CT is the most appropriate initial examination in patients with minor or mild acute closed head injury who require neuroimaging as well as patients with moderate to severe acute closed head injury. In short-term follow-up neuroimaging of acute traumatic brain injury, CT and MRI may have complementary roles. In subacute to chronic traumatic brain injury, MRI is the most appropriate initial examination, though CT may have a complementary role in select circumstances. Advanced neuroimaging techniques are areas of active research but are not considered routine clinical practice at this time. In suspected intracranial vascular injury, CT angiography or venography or MR angiography or venography is the most appropriate imaging study. In suspected posttraumatic cerebrospinal fluid leak, high-resolution noncontrast skull base CT is the most appropriate initial imaging study to identify the source, with cisternography reserved for problem solving. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every three years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

A Foundation for Enterprise Imaging: HIMSS-SIIM Collaborative White Paper.

Care providers today routinely obtain valuable clinical multimedia with mobile devices, scope cameras, ultrasound, and many other modalities at the point of care. Image capture and storage workflows may be heterogeneous across an enterprise, and as a result, they often are not well incorporated in the electronic health record. Enterprise Imaging refers to a set of strategies, initiatives, and workflows implemented across a healthcare enterprise to consistently and optimally capture, index, manage, store, distribute, view, exchange, and analyze all clinical imaging and multimedia content to enhance the electronic health record. This paper is intended to introduce Enterprise Imaging as an important initiative to clinical and informatics leadership, and outline its key elements of governance, strategy, infrastructure, common multimedia content, acquisition workflows, enterprise image viewers, and image exchange services.