Safeguarding Data Security in the Era of Imaging mHealth.

Mobile health (mHealth) technologies stand poised to find broad application in the radiology space. They hold considerable promise for millions of patients in the United States, enabling at-home imaging and augmenting clinical decision-making. However, they often lie outside the ambit of FDA regulation and process vast quantities of data largely unprotected by HIPAA. This article explores features of federal mHealth policy relevant to imaging practice and advocates for greater regulatory clarity to assist radiologists, developers, and ultimately, patients.

Clinical applications of AI in MSK imaging: a liability perspective.

Artificial intelligence (AI) applications have been gaining traction across the radiology space, promising to redefine its workflow and delivery. However, they enter into an uncertain legal environment. This piece examines the nature, exposure, and theories of liability relevant to musculoskeletal radiologist practice. More specifically, it explores the negligence, vicarious liability, and product liability frameworks by way of illustrative vignettes.

Critical access hospital ED to quaternary medical center: successful implementation of an integrated Picture Archiving and Communications System for patient transfers by air and sea.

PURPOSE: The purpose of this study was to investigate the role of imaging in transfers between an island Critical Access Hospital (CAH) emergency department (ED) and a quaternary care hospital. METHODS: Electronic medical records were reviewed to identify all patients who were transferred from an island CAH to our quaternary care hospital in 2012 and 2013. Medical history, transfer diagnosis, and the type of imaging performed at the CAH prior to transfer were reviewed. RESULTS: During the study period, a total of 22075 ED visits were made to the CAH and 696 (3.2%) of these patients were transferred for higher level of care, with 424 (60.9%) of the patients transferred to our quaternary care hospital. The most common reasons for transfer were cardiac (121; 28.5%), trauma (82; 19.3%), gastrointestinal (63; 14.9%), and neurologic conditions (54; 12.7%). 349 patients (82.3%) had imaging prior to transfer (56.4% radiograph, 33.5% computed tomography, 4.7% magnetic resonance imaging, 8.0% ultrasound). Of patients that had imaging, 53.6% had positive imaging findings related to the transfer diagnosis, and patients transferred for noncardiac etiologies were significantly more likely to have imaging findings related to their transfer diagnosis compared with patients transferred for cardiac etiologies (72.9% vs 6.9%, respectively; P< .0001). CONCLUSION: Approximately 3 of every 100 ED visits to the rural CAH required transfer for higher level of care, with nearly three-quarters of noncardiac transferred patients having a positive imaging finding related to the reason for transfer.

Diagnostic yield of recommendations for chest CT examination prompted by outpatient chest radiographic findings.

PURPOSE: To evaluate the diagnostic yield of recommended chest computed tomography (CT) prompted by abnormalities detected on outpatient chest radiographic images. MATERIALS AND METHODS: This HIPAA-compliant study had institutional review board approval; informed consent was waived. Reports of all outpatient chest radiographic examinations performed at a large academic center during 2008 (n = 29 138) were queried to identify studies that included a recommendation for a chest CT imaging. The radiology information system was queried for these patients to determine if a chest CT examination was obtained within 1 year of the index radiographic examination that contained the recommendation. For chest CT examinations obtained within 1 year of the index chest radiographic examination and that met inclusion criteria, chest CT images were reviewed to determine if there was an abnormality that corresponded to the chest radiographic finding that prompted the recommendation. All corresponding abnormalities were categorized as clinically relevant or not clinically relevant, based on whether further work-up or treatment was warranted. Groups were compared by using t test and Fisher exact test with a Bonferroni correction applied for multiple comparisons. RESULTS: There were 4.5% (1316 of 29138 [95% confidence interval {CI}: 4.3%, 4.8%]) of outpatient chest radiographic examinations that contained a recommendation for chest CT examination, and increasing patient age (P < .001) and positive smoking history (P = .001) were associated with increased likelihood of a recommendation for chest CT examination. Of patients within this subset who met inclusion criteria, 65.4% (691 of 1057 [95% CI: 62.4%, 68.2%) underwent a chest CT examination within the year after the index chest radiographic examination. Clinically relevant corresponding abnormalities were present on chest CT images in 41.4% (286 of 691 [95% CI: 37.7%, 45.2%]) of cases, nonclinically relevant corresponding abnormalities in 20.6% (142 of 691 [95% CI: 17.6%, 23.8%]) of cases, and no corresponding abnormalities in 38.1% (263 of 691 [95% CI: 34.4%, 41.8%]) of cases. Newly diagnosed, biopsy-proven malignancies were detected in 8.1% (56 of 691 [95% CI: 6.2%, 10.4%]) of cases. CONCLUSION: A radiologist recommendation for chest CT to evaluate an abnormal finding on an outpatient chest radiographic examination has a high yield of clinically relevant findings.

Imaging utilization from the ED: no difference between observation and admitted patients.

OBJECTIVES: This study aims to determine the use of diagnostic imaging in emergency department (ED) observation units, particularly relative to inpatients admitted from the ED. STUDY DESIGN: Retrospective, descriptive analysis. METHODS: Our database of ED patients was retrospectively reviewed to identify patients managed in the observation unit or admitted to inpatient services. In February 2014, we randomly selected 105 ED observation patients and 108 patients admitted to inpatient services from the ED. Electronic medical records were reviewed to assess diagnosis as well as type and quantity of imaging tests obtained. RESULTS: Eighty (76%) ED observation patients underwent imaging tests (radiographs, 39%; computed tomography, 25%; magnetic resonance imaging (MRI), 24%; ultrasound, 8%; other, 4%); 85 inpatients (79%) underwent imaging tests while in the ED (radiographs, 52%; computed tomography, 30%; MRI, 8%; ultrasound, 9%; other, 1%). There was no significant difference in overall imaging use between ED observation patients and inpatients, but ED observation patients were more likely to undergo MRI (P=.0243). The most common presenting diagnoses to the ED observation unit were neurologic complaints (25%), abdominal pain (17%), and cardiac symptoms (16%). CONCLUSION: There is no difference in the overall use of imaging in patients transferred to the ED observation unit vs those directly admitted from the ED. However, because ED observation unit patients tend to be accountable for a higher proportion of their health care bill, the impact of imaging in these patients is likely substantive.

Innovating for the developing world: meeting the affordability challenge.

OBJECTIVE: Ultrasound technologies have gained increasing prominence and accessibility in the developing world as manufacturers focus on this region as an emerging market. More extensive ultrasound use holds promise for addressing the disproportionate morbidity and mortality that continues to plague the developing world, particularly in the area of obstetrics. CONCLUSION: In this article, we describe the challenge of making ultrasound technologies affordable to health care providers in resource-limited regions vis-à-vis an innovative group of midwives in Nairobi.

Journal club: How radiation exposure histories influence physician imaging decisions: a multicenter radiologist survey study.

OBJECTIVE: The purpose of this article is to evaluate the influence of patient radiation exposure histories on radiologists' imaging decisions. MATERIALS AND METHODS: We conducted a physician survey study in three academic medical centers. Radiologists were asked to make an imaging recommendation for a hypothetical patient with a history of multiple CT scans. We queried radiologists' decision making, evaluating whether they incorporated cancer risks from previous imaging, reported acceptance (or rejection) of the linear no-threshold model, and understood linear no-threshold model implications in this setting. Consistency between radiologists' decisions and their linear no-threshold model beliefs was evaluated; those acting in accordance with the linear no-threshold model were expected to disregard previously incurred cancer risks. A Fisher exact test was used to verify the generalizability of results across institutions and training levels (residents, fellows, and attending physicians). RESULTS: Fifty-six percent (322/578) of radiologists completed the survey. Most (92% [295/322]) incorporated risks from the patient's exposure history during decision making. Most (61% [196/322]) also reported acceptance of the linear no-threshold model. Fewer (25% [79/322]) rejected the linear no-threshold model; 15% (47/322) could not judge. Among radiologists reporting linear no-threshold model acceptance or rejection, the minority (36% [98/275]) made decisions that were consistent with their linear no-threshold model beliefs. This finding was not statistically different across institutions (p = 0.070) or training levels (p = 0.183). Few radiologists (4% [13/322]) had an accurate understanding of linear no-threshold model implications. CONCLUSION: Most radiologists, when faced with patient exposure histories, make decisions that contradict their self-reported acceptance of the linear no-threshold model and the linear no-threshold model itself. These findings underscore a need for educational initiatives.

How the FDA Regulates AI.

Recent years have seen digital technologies increasingly leveraged to multiply conventional imaging modalities' diagnostic power. Artificial intelligence (AI) is most prominent among these in the radiology space, touted as the "stethoscope of the 21st century" for its potential to revolutionize diagnostic precision, provider workflow, and healthcare expenditure. Partially owing to AI's unique characteristics, and partially due to its novelty, existing regulatory paradigms are not well suited to balancing patient safety with furthering the growth of this new sector. The current review examines the historic, current, and proposed regulatory treatment of AI-empowered medical devices by the US Food and Drug Administration (FDA). An innovative framework proposed by the FDA seeks to address these issues by looking to current good manufacturing practices (cGMP) and adopting a total product lifecycle (TPLC) approach. If brought into force, this may reduce the regulatory burden incumbent on developers, while holding them to rigorous quality standards, maximizing safety, and permitting the field to mature.

Gadolinium Deposition Disease: A New Risk Management Threat.

Gadolinium-based contrast agents (GBCAs) have enjoyed wide use since their introduction some 30 years ago. Used in as many as 30% of MRIs performed in the United States, GBCAs have generally been associated with low rates of adverse events. However, the safety profile and attendant medicolegal liability associated with GBCAs changed in 2016 with the description of gadolinium deposition disease (GDD). Despite being unproven scientifically, a groundswell of GDD-related litigation and personal injury advertising targeting potential GDD patients has occurred. In this article, we describe what GDD is, why GDD has created medicolegal risk, and how this risk might be mitigated. This article advocates using a risk mitigation strategy focused on reducing brain gadolinium retention during the period of purported GDD development. As such, based on the currently available data, the authors recommend the preferential use of gadoteridol as the default GBCA for MRI imaging.

Characteristics of Paid Malpractice Claims Among Resident Physicians From 2001 to 2015 in the United States.

PURPOSE: Limited information exists about medical malpractice claims against physicians-in-training. Data on residents' involvement in malpractice actions may inform perceptions about medicolegal liability and influence clinical decision-making at a formative stage. This study aimed to characterize rates and payment amounts of paid malpractice claims on behalf of resident physicians in the United States. METHOD: Using data from the National Practitioner Data Bank, 1,248 paid malpractice claims against resident physicians (interns, residents, and fellows) from 2001 to 2015, representing 1,632,471 residents-years, were analyzed. Temporal trends in overall and specialty-specific paid claim rates, payment amounts, catastrophic (> $1 million) and small (< $100,000) payments, and other claim characteristics were assessed. Payment amounts were compared with attending physicians during the same time period. RESULTS: The overall paid malpractice claim rate was 0.76 per 1,000 resident-years from 2001 to 2015. Among 1,194 unique residents with paid claims, 95.7% had exactly 1 claim, while 4.3% had 2-4 claims during training. Specialty-specific paid claim rates ranged from 0.12 per 1,000 resident-years (pathology) to 2.96 (obstetrics and gynecology). Overall paid claim rates decreased by 52% from 2001-2005 to 2011-2015 (95% confidence interval [CI]: 0.45, 0.59). Median inflation-adjusted payment amount was $199,024 (2015 dollars), not significantly different from payments made on behalf of attending physicians during the same period. Proportions of catastrophic (11.2%) and small (33.1%) claims did not significantly change over the study period. CONCLUSIONS: From 2001 to 2015, paid malpractice claim rates on behalf of resident physicians decreased by 52%, while median payment amounts were stable. Resident paid claim rates were lower than attending physicians, while payment amounts were similar.

ACR Appropriateness Criteria® Movement Disorders and Neurodegenerative Diseases.

Movement disorders and neurodegenerative diseases are a variety of conditions that involve progressive neuronal degeneration, injury, or death. Establishing the correct diagnosis of a movement disorder or neurodegenerative process can be difficult due to the variable features of these conditions, unusual clinical presentations, and overlapping symptoms and characteristics. MRI has an important role in the initial assessment of these patients, although a combination of imaging and laboratory and genetic tests is often needed for complete evaluation and management. This document summarizes the imaging appropriateness data for rapidly progressive dementia, chorea, Parkinsonian syndromes, suspected neurodegeneration with brain iron accumulation, and suspected motor neuron disease. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Impact of Primary Care Physician Interaction on Longitudinal Adherence to Screening Mammography Across Different Racial/Ethnic Groups.

PURPOSE: Regular contact with a primary care physician (PCP) is associated with increased participation in screening mammography. Older studies suggested that PCP interaction may have a smaller effect on screening mammography uptake among racial and ethnic minorities compared with whites, but there is limited contemporary evidence about the effect of PCP interaction on screening mammography uptake across different racial and ethnic groups. The purpose of this study was to evaluate the association between PCP contact and longitudinal adherence with screening mammography guidelines over a 10-year period across different racial/ethnic groups. METHODS: This HIPAA-compliant and institutional review board-approved retrospective single-institution study included women between the ages of 50 and 64 years who underwent screening mammography in the calendar year of 2005. The primary outcome of interest was adherence to recommended screening mammography guidelines (yes or no) at each 2-year interval from their index screening mammographic examination in 2005 until 2015. Patients were defined as having a high level of PCP interaction if their PCPs were listed in the electronic medical record within the top three providers with whom the patients had the most visits during the study period. Generalized estimating equation models were used to estimate the effect of high PCP interaction on screening mammography adherence while adjusting for correlated observations and patient characteristics. RESULTS: Patients in the high PCP interaction group had increased longitudinal adherence to recommended screening mammography (adjusted odds ratio [OR], 1.51; 95% confidence interval [CI], 1.42-1.73; P < .001). This was observed in stratified analyses for all self-reported racial groups, including white (adjusted OR, 1.51; 95% CI, 1.36-1.68; P < .001), black (adjusted OR, 1.93; 95% CI, 1.31-2.86; P = .001), Hispanic (adjusted OR, 1.92; 95% CI, 1.27-2.87; P = .002), Asian (adjusted OR, 1.55; 95% CI, 1.01-2.39; P = .045), and other (adjusted OR, 2.18; 95% CI, 1.32-3.56; P = .002), with no evidence of effect modification by race/ethnicity (P = .342). Medicaid (adjusted OR, 0.41; 95% CI, 0.31-0.53) and self-pay or other (adjusted OR, 0.39; 95% CI, 0.27-0.56) insurance categories were associated with decreased longitudinal adherence to recommended screening mammography (P < .001 for both). CONCLUSIONS: High levels of PCP interaction result in similar improvements in longitudinal screening mammography adherence for all racial/ethnic minority groups. Future efforts will require targeted outreach to assist Medicaid and uninsured patient populations overcome barriers to screening mammography adherence.

Chronic Medical Illness as a Risk Factor for Poor Mammography Screening Adherence.

Objective: The aim of this study was to determine the association between the presence of chronic medical disease and mammography screening adherence. Materials and Methods: We performed a retrospective study on women between the ages of 50 and 64 who received screening mammography in 2005 and had at least 8 years of follow-up. Demographic and clinical information was obtained from our centralized patient data registry. Women diagnosed with one or more of the following diseases for at least 3 months before their index mammogram were considered to have a chronic disease, including atrial fibrillation, congestive heart failure, Chronic Obstructive Pulmonary Disease (COPD), diabetes mellitus type II, heart disease, and/or peripheral vascular disease. Generalized estimating equations were used to evaluate for correlated observations. Multivariable regression analyses were used to evaluate the effects of selected chronic medical diseases on longitudinal engagement with routine mammography. Results: Of 9575 women identified, 1669 (17.7%) had one or more of the selected chronic medical diseases. The presence of one or more of these diseases was associated with reduced mammography screening (-0.29; confidence interval [CI] = -0.36 to -0.14; p < 0.01) compared with women without these diseases over the study period. Within this group, the presence of congestive heart failure (-0.88; CI = -0.84 to -0.45; p ≤ 0.01), COPD (-0.39; CI = -0.57 to -0.21; p ≤ 0.01), or diabetes mellitus type II (-0.37; CI = -0.57 to -0.17; p ≤ 0.01) was individually associated with reduced screening compared with women without the respective disease. Compared with women without chronic medical disease, women with multiple chronic medical diseases (-0.62; CI = -0.93 to -0.30; p ≤ 0.01) were significantly (p ≤ 0.05) less likely to receive routine screening, while no significant difference was seen in women with only one chronic medical disease (-0.18; CI = -0.39 to -0.02; p ≤ 0.08). Conclusion: Despite experiencing longer life expectancies, women with specific chronic diseases may experience additional barriers to uptake of mammography screening, which is likely compounded by the comorbidity burden of being simultaneously treated for multiple chronic conditions. Increased health care interactions seen in this group may represent missed opportunities to improve screening adherence.

Curbing Inappropriate Usage of STAT Imaging at a Large Academic Medical Center.

PURPOSE: To evaluate a new system for processing and performing inpatient STAT diagnostic imaging with respect to utilization and time-based performance metrics. MATERIALS AND METHODS: This HIPAA-compliant study had institutional review board approval; informed consent was not required. The radiology information system of a large academic medical center was queried for all inpatient diagnostic imaging exams performed and interpreted from August 1, 2010, to October 31, 2012. Using customized software, data were evaluated based on order priority (non-STAT or STAT) and exam modality with respect to exam volume and time-based performance metrics (time-to-performance and preliminary interpretation time). Data were compared over 3 periods: August 1, 2010, to October 31, 2010 (preimplementation period); November 1, 2010, to October 31, 2011 (year 1 postimplementation); and November 1, 2011, to October 31, 2012 (year 2 postimplementation). RESULTS: In the first year after implementation of the new STAT policy, the percentage of inpatient exams ordered STAT significantly decreased from 22.1% to 5.4% (P < 0.001). This represented a proportional decrease of 26% (CT), 16% (MRI), 20% (US), and 24% (radiographs) relative to pre-STAT policy levels. The median time-to-performance and median preliminary interpretation time significantly decreased for all modalities after implementation of the policy (P < 0.05 for all modalities), decreasing by an average of 104 and 162 minutes, respectively. These changes persisted throughout year 2 postimplementation. CONCLUSION: A new institutional system for handling inpatient STAT diagnostic imaging results in a decreased number of STAT exams ordered and improved time-based performance metrics, thereby increasing workflow efficiency.