HIPAA Research Articles

Training undergraduate students in HIPAA compliance

ABSTRACT The Health Insurance Portability and Accountability Act (HIPAA) has radically changed the way healthcare is conducted, and its relevance continues to expand as healthcare technology evolves. This article describes a method for training inexperienced undergraduate students to become HIPAA-compliant clinical research volunteers in a pediatric traumatic brain injury (TBI) study. Volunteers are trained to use the hospital’s electronic health records (EHR) system to identify potential study candidates for approach, and they develop this skill set through google classroom modules/quizzes along with routine zoom calls to solidify their consenting approach. Since the inception of this study in 2018, there have been over one hundred different undergraduate research volunteers involved, and there has not been a single HIPAA violation to date. This compliance success rate is indicative of the efficacy of this training protocol. This paper serves as a guide to implementing HIPAA compliance training and ensuring accountability in new and existing clinical research studies.

The cell phone quandary

Cell phones are used by almost everyone and have become an integral part of our daily life. They are an almost universal instrument for gathering and transmitting information. The amount of bacteria crawling on a typical cell phone has been a point of contention, although studies show that they contain at least 10 times the amount of bacteria found on most toilet seats. As medical workers in hospital and clinic settings, we use our cell phones extensively, for paging, texting, calling, and recreational activities; thus, the risk of contamination by pathogens is a legitimate issue. Cell phones in the operating room may give patients the impression that they are not the main priority or the center of care, in addition to being a potential source of infection. Cell phones also have been found to be the number-one productivity killer in workplaces, amongst a long list of other distractions. All workers must be fully aware of their Health Insurance Portability and Accountability Act (HIPAA) compliance responsibilities and obligations, including the protection of health information, while using their cell phones at workplaces. On clinic or hospital grounds, reasonable diligence and strict adherence to cell phone policies may help us maintain greater safety, productivity, and professionalism, resulting in better service for our patients.

Patient Perspectives on the Development of a Novel Mobile Health (mHealth) Application for Dietary Supplement Tracking and Reconciliation-A Qualitative Focus Group Study.

BackgroundMore than 170 million adults use dietary supplements (DS) in the United States, which can have both benefit and harm to patient health. DS use is often poorly documented in the medical record and can pose health risks if not properly communicated with providers. Reasons for poor DS documentation include low disclosure rates, time constraints of clinical encounters, and providers’ failure to inquire about DS use. This study was conducted to assess patients’ views on the facilitators and barriers to using a mobile health (mHealth) application (app) to collect and share DS information with their healthcare providers.MethodsUtilizing a theory-based conceptual model, we conducted 7 patient focus groups (FGs) to assess opinions on DS safety, provider communication, comfort with technology use, and our proposed mHealth app. Participants were recruited from the general public and through patient advisory groups. Patient views will inform the creation of an mHealth app to improve DS patient-provider communication and tracking and reconciliation in the electronic medical record (EMR).ResultsOverall, participants believe their DS information is inaccurately represented in the EMR, leading to safety concerns and negatively impacting overall quality of care. Participants desired an app designed with (1) Health Insurance Portability and Accountability Act (HIPAA) compliance; (2) ease of use for a variety of technical efficacy levels; (3) access to reliable DS information, including a DS-drug interaction checker; and (4) integration with the EMR.ConclusionAn app to simplify and improve DS entry and reconciliation was of interest to patients, as long as it maintained health autonomy and privacy and possessed key valuable features.

User Control of Personal mHealth Data Using a Mobile Blockchain App: Design Science Perspective.

BackgroundIntegrating pervasive computing with blockchain’s ability to store privacy-protected mobile health (mHealth) data while providing Health Insurance Portability and Accountability Act (HIPAA) compliance is a challenge. Patients use a multitude of devices, apps, and services to collect and store mHealth data. We present the design of an internet of things (IoT)–based configurable blockchain with different mHealth apps on iOS and Android, which collect the same user’s data. We discuss the advantages of using such a blockchain architecture and demonstrate 2 things: the ease with which users can retain full control of their pervasive mHealth data and the ease with which HIPAA compliance can be accomplished by providers who choose to access user data.ObjectiveThe purpose of this paper is to design, evaluate, and test IoT-based mHealth data using wearable devices and an efficient, configurable blockchain, which has been designed and implemented from the first principles to store such data. The purpose of this paper is also to demonstrate the privacy-preserving and HIPAA-compliant nature of pervasive computing-based personalized health care systems that provide users with total control of their own data.MethodsThis paper followed the methodical design science approach adapted in information systems, wherein we evaluated prior designs, proposed enhancements with a blockchain design pattern published by the same authors, and used the design to support IoT transactions. We prototyped both the blockchain and IoT-based mHealth apps in different devices and tested all use cases that formed the design goals for such a system. Specifically, we validated the design goals for our system using the HIPAA checklist for businesses and proved the compliance of our architecture for mHealth data on pervasive computing devices.ResultsBlockchain-based personalized health care systems provide several advantages over traditional systems. They provide and support extreme privacy protection, provide the ability to share personalized data and delete data upon request, and support the ability to analyze such data.ConclusionsWe conclude that blockchains, specifically the consensus, hasher, storer, miner architecture presented in this paper, with configurable modules and software as a service model, provide many advantages for patients using pervasive devices that store mHealth data on the blockchain. Among them is the ability to store, retrieve, and modify ones generated health care data with a single private key across devices. These data are transparent, stored perennially, and provide patients with privacy and pseudoanonymity, in addition to very strong encryption for data access. Firms and device manufacturers would benefit from such an approach wherein they relinquish user data control while giving users the ability to select and offer their own mHealth data on data marketplaces. We show that such an architecture complies with the stringent requirements of HIPAA for patient data access.

Regionalization with Self-Organizing Maps for Sharing Higher Resolution Protected Health Information

This article addresses the challenge of sharing finer scale protected health information (PHI) while maintaining patient privacy by using regionalization to create higher resolution Health Insurance Portability and Accountability Act (HIPAA)-compliant geographical aggregations. We compare four regionalization approaches in terms of their fitness for analysis and display: max-p-regions, regionalization with dynamically constrained agglomerative clustering and partitioning (REDCAP), and self-organizing map (SOM) variants of each. Each method is used to create a configuration of regions that aligns with census boundaries, optimizes intraunit homogeneity, and maximizes the number of spatial units while meeting the minimum population threshold required for sharing PHI under HIPAA guidelines. The relative utility of each configuration was assessed with measures of model fit, compactness, homogeneity, and resolution. Adding the SOM procedure to max-p-regions resulted in statistically significant improvements for nearly all assessment measures, whereas the addition of SOM to REDCAP primarily degraded these measures. These differences can be attributed to the different impacts of SOM on top-down and bottom-up regionalization procedures. Overall, we recommend REDCAP, which outperformed on most measures. The SOM variant of max-p-regions (MSOM) could also be recommended, because it provided the highest resolution while maintaining suitable performance on all other measures.

Use of Patients' Protected Health Information to Solicit Hospital Funds: How did This Practice Come About?

Modifications to Health Insurance Portability and Accountability Act (HIPAA) have allowed for the disclosure of patient protected health information (PHI) for the purpose of hospital fundraising. The public has recently raised ethical concerns regarding these practices. We examined the forces that brought about these HIPAA modifications. We first examined 304 comments submitted to the proposed rule for the HIPPA regulation modifications. We additionally queried the OpenSecrets repository for lobbying activity by these commenters. We found that 57 out of the 304 comments pertained specifically to fundraising practices. The majority of comments were from hospital developmental (fundraising) offices (51%, 29 of 57 comments), and the majority (96%, 24 of 25 hospital comments; 83%, 34 of 41 total comments discussing PHI disclosure) supported additional PHI disclosure. There was a paucity of comments from physician organizations (1 of 57) and patient advocates (2 of 57). The majority of lobbying dollars (95% of over $81 million) were from commenters who favored the modifications. The lack of physician and patient representation in the rule-making process likely contributed to the creation of regulations that elicit ethical concerns in physicians, and potential harm for patients.

The health equity mandate.

ABSTRACTPeople of color and the poor die younger than the White and prosperous. And when they are alive, they are sicker. Health inequity is morally tragic. But it is also economically inefficient, raising the nation’s healthcare bill and lowering productivity. The COVID pandemic only, albeit dramatically, highlights these pre-existing inequities. COVID sufferers of color die at twice the rate of Whites. The cause, in large part, is structural inequality and racism. Neither the popular nor the scholarly discussion of healthcare inequity, while robust, has translated into palpable and rapid progress. This article describes why health inequity has so far proven intractable. In the healthcare system, no one actor has both adequate incentive and adequate wherewithal to create progress. The healthcare system cannot solve the problem alone. To jumpstart reform, the article suggests a new regulatory approach, grounded in principles of democratic experimentalism and cooperative federalism. It draws inspiration from the examples that the Health Insurance Portability and Accountability Act (HIPAA) and the Clean Air Act provide. A federal health equity mandate, with funding and penalties for state non-compliance, will spur collaboration between federal, state, local, public, and private entities and start the USA on the path to remediating healthcare’s inequities.

The Implementation of a State-wide Rapid Initiation of Antiretroviral Therapy as a Best Practice in Primary Care Practices Using an Academic Detailing Approach: Lessons Learned from NewYork State, United States

Background:New York State Department of Health AIDS Institute policy recommends that primary care clinicians should initiate same-day-antiretroviral treatment (ART) of a new HIV diagnosis or at the next clinical visit as the standard of care. However, non-HIV-specialized primary care clinicians might not be sufficiently trained to initiate a specialized ART with a newly HIV diagnosed patient. We assessed clinicians’ knowledge and attitudes toward the rapid initiation of ART and provided academic sessions as a training method to guide clinicians through the implementation of a new standard of care.Methods:A Research Electronic Data Capture (REDCap), Health Insurance Portability and Accountability Act (HIPAA)-compliant, online survey was sent to primary care clinicians to assess their knowledge and attitudes towards Rapid Initiation of ART (RIA). We provided personalized academic detailing sessions, addressing questions and concerns gathered from both the initial survey and the individual pre-assessment questionnaire completed prior to the sessions.Results:The survey was initially distributed in February 2019, followed by 4 weekly reminders. Approximately 585 providers completed the survey. Subsequently, 552 health care providers from 25 out of 62 counties in NY State were detailed between March 2019 and March 2021. Lessons learned from the sessions included the identification of pragmatic strategies that could be used in the design of effective detailing sessions, followed by enhanced clinical knowledge, which improved patient care.Conclusion and Global Health Implications:Inconsistencies in the current testing practices result in missed HIV diagnoses and an increased risk of HIV transmission. Academic detailing-training techniques can be used to respond to clinician-identified key issues/attitudes that may result in a new intervention, suggesting a promising approach in addressing the implementation barriers of of rapid-treatment initiation as the standard of care. The academic detailing approach can be easily adapted and can be beneficial in global public health, HIV/ AIDS control, and other conditions that require a medical practice change.

ECONOMIC POLICY OF THE STATE IN CONDITIONS OF INFORMATIZATION OF HEALTH CARE IN UKRAINE AS AN INTEGRAL PART OF THE SOCIAL SPHERE

The purpose of the article is to analyze domestic and international legal norms on the protection of medical information in order to improve the system of national legislation in the field of health care. The methodological basis of this study is a system of methods, the set of which is determined by the purpose and features of the study: dialectical, systemic, system-structural, analytical-synthetic, comparative-legal methods of analysis of domestic and international legal regulation of economic policy of the state in the conditions of informatization of health care of Ukraine. It argues that Ukraine, seeking to integrate into the European space and building its own strategy of economic development, must be clearly aware of both its capabilities and external factors of influence. The choice of possible alternatives is too complex a task, but the leading idea of socio-economic policy should remain the desire to ensure sustainable economic development of the country. In particular, the following is analyzed: recent international and domestic normative acts regulating state economic policy activities in the field of health care informatization in Ukraine: in particular, General Data Protection Regulation of the European Union (GDPR), CMS Interoperability and Patient Access Final Rule, ONC's Cure Act Final Rule, Order of functioning of the electronic health care system of Ukraine; materials of judicial practice, including materials of cases of the European Court of Human Rights, the results of sociological research. A comparative analysis of the GDPR and the Health Insurance Portability and Accountability Act (HIPAA) was conducted. The main problematic issues of state economic policy in the context of health informatization in Ukraine are highlighted. Compared to previous regulations governing medical data, the GDPR pays much more attention to the implementation of new requirements that have arisen due to the growing digitalization of healthcare, and therefore may contribute to strengthening their protection. Results. It is theoretically substantiated that quality medical reform is possible only with the introduction of modern methods of informatization and, consequently, information protection. As the analysis has shown, currently in Ukraine the legal system providing information protection in the medical sphere needs immediate improvement. This requires: systematizing and codifying national legislation in accordance with European legal norms and international law; developing a comprehensive legislative act, which would regulate the collection, protection and transition of medical information at the legislative level, following the example of GDPR (for structuring the medical information system, ensuring mandatory certification for information protection, development of cryptography/encryption technologies, delimitation of rights of access to information for medical workers, ensuring access to information with mandatory use of electronic signature, medical workers need to take short courses and register with information security specialists (defined access rights and the ability to change the level of access, provide input for identification and authentication), correcting data and entering new information is carried out with a confirmation of electronic signature, develop an algorithm for transferring information between medical institutions).

The Potential Role of the Fat-Glandular Interface (FGI) in Breast Carcinogenesis: Results from an Ultrasound Tomography (UST) Study.

This study explored the relationship between the extent of the fat–glandular interface (FGI) and the presence of malignant vs. benign lesions. Two hundred and eight patients were scanned with ultrasound tomography (UST) as part of a Health Insurance Portability and Accountability Act (HIPAA)-compliant study. Segmentation of the sound speed images, employing the k-means clustering method, was used to help define the extent of the FGI for each patient. The metric, α, was defined as the surface area to volume ratio of the segmented fibroglandular volume and its mean value across patients was determined for cancers, fibroadenomas and cysts. ANOVA tests were used to assess significance. The means and standard deviations of α for cancers, fibroadenomas and cysts were found to be 4.0 ± 2.0 cm−1, 3.1 ± 1.7 cm−1 and 2.3 ± 0.9 cm−1, respectively. The differences were statistically significant (p < 0.001). The separation between the groups increased when α was measured on only the image slice where the finding was most prominent, with values for cancers, fibroadenomas and cysts of 5.4 ± 3.6 cm−1, 3.6 ± 2.3 cm−1 and 2.4 ± 1.5 cm−1, respectively. Of the three types of masses studied, cancer was associated with the most extensive FGIs, suggesting a potential role for the FGI in carcinogenesis, a subject for future studies.

Surgery-Associated Bleeding Risk in Patients with Platelet Function Disorders - a Cross Sectional Study with the American Thrombosis and Hemostasis Network Dataset (ATHNdataset)

▪Introduction: Platelet function disorders (PFDs) are a group of heterogenous bleeding disorders with varying bleeding phenotype. Intraoperative and post-operative bleeding are serious complications among patients with PFDs undergoing surgery. There are very few studies in literature that have specifically investigated surgery associated bleeding complications in PFDs. The aim of this study was to utilize a large national dataset to describe surgeries performed in patients with PFD, characterize the bleeding associated with these surgical procedures and outline the therapeutic approaches adopted.Methods: In this retrospective study, the ATHNdataset was queried for demographic data, PFD diagnosis, surgeries among patients with PFD, intraoperative and post-operative bleeding episodes and treatment. Descriptive statistics were used. The ATHNdataset captures information from patients with bleeding and clotting disorders from over 140 federally funded hemophilia and thrombosis treatment centers (HTCs) in the US. Patients authorize inclusion of their demographic and clinical information in this de-identified Health Insurance Portability and Accountability Act (HIPAA)-compliant data set.Results: From January 2010 to March 2020, the ATHNdataset captured 2767 patients with PFDs, of which 1769 (63.93%) were female and 998 (36.1%) were male, with 1393 patients between 0-18 years (50%) and 1374 (50%) adults >18 years. PFDs identified include 32 patients with Bernard Soulier syndrome (1.16%), 131 patients with Glanzmann thrombasthenia (4.7%), 4 patients with Gray platelet syndrome (0.14%), 29 patients with Hermansky Pudlak syndrome (1%), 1548 patients with storage pool deficiency (55.9%), and 1023 patients diagnosed as PFD (36.9%). A total of 3252 procedures were reported between 2010 and 2020; 1271 patients (46%) patients with at least one documented procedure. Figure 1 shows common procedures among patients with PFDs.Surgery-associated bleeding episodes (includes intraoperative and post-operative bleeds) were reported with 69 procedures (2.1%), which included intraoperative bleeds reported for 18 procedures (0.5%) and post-operative bleeds reported for 51 procedures (1.6%). Of the 60 procedures in patients with Glanzmann thrombasthenia, surgery-associated bleeding episodes were reported after 9 dental procedures (41%), 1 circumcision (25%) and 11 other surgeries/procedures (18.3%). Of the 6 procedures in patients with Bernard Soulier syndrome, no intraoperative or post-operative bleeding episodes were reported. Of 1688 procedures in patients with storage pool deficiency, surgery-associated bleeding episodes were reported after 26 dental procedures (1.5%) and 62 other surgeries/procedures (3.67%). No intraoperative or post-operative mortality was reported among these patients.Of 1272 patients who underwent at least 1 procedure, 646 patients (50.7%) received some form of treatment before/during/after a procedure. Among these 646 patients, 2794 exposure days of hemostasis medications were used before/during/after procedures. Among these, 49% were prior to the procedure, 0.7 % during the procedure and 49.5% after the procedure. Treatments used are shown in figure 2.Conclusion: Our study shows that patients with PFDs have a substantial risk of bleeding associated with surgery. Identifying the risk of bleeding by type and providing appropriate pre-surgical prophylaxis can decrease rates of surgery-associated bleeding in PFDs. [Display omitted] DisclosuresSidonio: Sanofi, Takeda, Octapharma, Bayer, Biomain, Grifols, Kedrion, Genentech. Catalyst, Guardian Therapeutics, Novo Nordisk, Hema Biologics, Uniqure.: Consultancy, Honoraria. Ahuja: Genentech: Membership on an entity's Board of Directors or advisory committees; Takeda: Other: DSMB member ; XaTek, Inc: Patents & Royalties; Sanofi: Membership on an entity's Board of Directors or advisory committees.

Evaluation of Functional and Cytogenetic High-Risk Multiple Myeloma Using Real-World Data

Introduction: Multiple myeloma (MM) is a heterogeneous disease with wide variability in outcomes. The presence of cytogenetic abnormalities in MM is of critical importance for prognosis and risk stratification. However, patients who may or may not have sufficient cytogenetic abnormalities to classify as high-risk can still experience rapid disease progression despite therapy, or functional high risk (FHR) disease. These two high risk cohorts comprise vulnerable subpopulations who have a significant burden of disease, and it is critical that we understand the underlying patient characteristics and optimal treatment sequence. We sought to investigate these two high risk patient populations treated in the contemporary real-world practice setting.Methods: A total of 1719 patients were identified in the COTA real-world database as having been diagnosed with active MM on or after January 1, 2015 and classified as either FHR, cytogenetic high risk (CHR), or both. The COTA real-world database is a USA-based real-world evidence database comprised of longitudinal, Health Insurance Portability and Accountability Act (HIPAA)-compliant, data on the diagnosis, clinical management, and outcomes of patients with cancer. Of the 1719 patients, 1260 were identified to be FHR, defined as relapse <18 months from initial active MM diagnosis. A total of 459 patients were identified as CHR, among which 347 were both FHR and CHR. CHR was defined as a patient having at least one of the following abnormalities: t(4;14), t(14;16), t(14;20), del(17p), 1q gain, or hypoploid. Line of therapy was applied programmatically using an algorithm based on International Myeloma Working Group criteria and clinical guidance. The primary outcome was time to next treatment (TTNT) calculated using the Kaplain Meier method. Univariate and multivariate analyses were conducted to understand predictors of rapid disease progression among high-risk patients.Results: In our real-world population, FHR patients tended to be slightly younger, African American, and treated predominantly in the academic setting (Table 1). First-line (1L) and second-line (2L) treatment patterns by category are shown in Table 2. A lower proportion of FHR patients received 1L immunomodulators as compared to the other high-risk groups, while almost half of the CHR patients received 1L stem cell transplant (SCT). In 2L, among patients not receiving 2L SCT, a higher proportion of CHR patients received a daratumamab-based treatment as compared to FHR (23.2% vs. 12.0%, respectively). We observed a longer median (95% CI) TTNT for high-risk patients receiving 2L daratumamab-based treatment as compared to patients who did not: 8.5 months (6.4-13.0) vs. 6.0 months (5.3-6.9), p=0.07 (Figure 1). Univariate and multivariate analyses showed age at diagnosis (HR: 0.98, CI: 0.97, 0.99), normal cytogenetics (HR: 0.78, CI: 0.63, 0.97), 1L immunomodulator (HR: 0.39, CI: 0.22, 0.69), 1L proteasome inhibitor (HR: 1.4, CI: 1.1, 1.8), and 1L SCT (HR: 0.22, CI: 0.15, 0.32) as significant predictors of rapid disease progression.Conclusions: Our study provides important insights comparing high risk populations with MM treated in the real-world setting. A higher proportion of CHR patients received 1L SCT and this provided the longest 1L TTNT as compared to other treatments. In 2L, among patients not receiving 2L SCT, we observed a trend towards significantly longer TTNT provided by dara-based treatment as compared to non-dara based treatment; however, our TTNT is lower than progression-free survival results observed in pivotal trials. We identified potential underlying differences in our patient populations that may be driving the predictors of rapid disease progression, including 1L SCT eligibility and renal disease, and these will be further investigated in propensity score matched populations. Future research will continue to explore optimal treatment sequences in high-risk populations with multiple myeloma to improve patient outcomes. These data highlight an urgent need to better predict FHR patients at diagnosis and develop clinical trials incorporating novel compounds in high risk patients. [Display omitted] DisclosuresHansen: COTA, Inc.: Current Employment. Belli: COTA, Inc.: Current Employment, Other: Equity ownership. Goran: COTA, Inc.: Current Employment. Wang: COTA, Inc.: Current Employment, Other: Equity ownership.

Frontline Venetoclax (ven) Based Combination Therapy in Older Adults with Acute Myeloid Leukemia Treated in the Real-World Setting; A Multi-Institutional Retrospective Study

Introduction: Acute myeloid leukemia (AML) is a disease of the older population, with a median age at diagnosis of 68 years. Outcomes remain poor for patients (pts) older than 60 years of age who are unfit to receive intensive chemotherapy. Ven based combination therapy has become the standard of care based on the results of the Viale-A and Viale-C in combination with hypomethylating agents (HMA) or low dose cytarabine (LDAC), respectively. This combination therapy is myelosuppressive leading to multiple dose adjustments in the real-world setting, which may impact the validity of the trial responses and overall survival (OS) in a community-based practice. We therefore sought to investigate the outcomes of pts treated with ven based combination therapy in the real-world setting to better understand efficacy and patterns of adverse events.Methods: Pts 65 years of age or older, diagnosed with AML on or after January 1, 2019, and who received frontline ven based combination therapy with azacitidine (aza), decitabine (dac) or LDAC were identified in the COTA real-world database. The COTA database is a USA-based dataset comprised of longitudinal, Health Insurance Portability and Accountability Act (HIPAA)-compliant data on the diagnosis, clinical management, and outcomes of pts with cancer. Clinical outcomes, including real-world overall response rate (rwORR), OS and adverse events were calculated by treatment group. Responses were defined per treating physician as complete response (CR) or partial (PR) or progressive disease (PD). Categorical variables and rwORR were compared using Fisher's exact test. Survival outcomes were calculated using the Kaplan-Meier method and compared amongst groups using log-rank test.Results: A cohort of 112 pts were treated with ven based combination: ven/aza (n=54), ven/dac (n=52) and ven/LDAC (n=6). Across all treatment groups, the majority (91.1%) of pts were treated in the community setting. The median age at diagnosis was 77 yrs (IQR: 71-81 yrs). Per ELN risk, 6.2% had favorable, 19.6% had intermediate and 62.5% had high-risk AML. Five of the 6 pts receiving ven/LDAC had secondary AML (Table 1). The most common molecular abnormalities across the cohort were TP53 (38.4%), TET2 (26.8%), ASXL1 (27.7%), and DNMT3A (20.5%). The rwORR by treatment was 57.7% for ven/dac, 55.6% for ven/aza and 33.3% for ven/LDAC (ven/dac vs. ven/aza, p=0.85). Median OS (mOS) was similar for ven/dac with a longest mOS of 13.9 mo, followed by ven/aza with a mOS of 11.3 mo, and ven/LDAC mOS of 6.5 mo (ven/dac vs. ven/aza, p=0.77). The most common reasons for treatment discontinuation were toxicity (32.1%) followed by progression/inadequate response (10.7%). The most common toxicities were related to myelosuppression/cytopenias (Table 3). In this cohort, only 6 pts underwent an allogeneic stem cell transplant in first remission and no pts underwent an allogeneic transplant in second remission.Conclusions: To our knowledge, this dataset represents the largest cohort of pts treated with ven based combination therapy in the real world setting across multiple community practices. As less intense regimens are used to treat AML, more pts are receiving induction in the community setting, making these findings relevant in clinical practice. Although ven/dac combination had the longest OS, this was not significantly different from ven/aza. The ven/HMA response rates were lower and survival outcomes were shorter than those reported in the Viale-A trial, which raises concerns about early discontinuation of therapy in the real world setting due to myelosuppression. Ven/LDAC combination had the shortest OS, though most of these patients had sAML. Despite this enriched population for targeted therapies, the outcomes remained poor overall.There are drawbacks to interpreting retrospective outcomes data. First, there were no treatment related AML cases in this dataset, which would be highly unusual in an elderly population of 112 cases of AML. It is more plausible that the diagnosis of treatment related AML was not utilized in the patient's chart. Other data points that were not adequately captured were cause of death and International Working Group response criteria. Mutational panel testing remains underutilized for AML patients in a community-based practice setting. However, this dataset highlights the need for larger datasets to compare the outcomes of AML therapy by practice setting. [Display omitted] DisclosuresMadanat: Blue Print Pharmaceutical: Honoraria; Stem line pharmaceutical: Honoraria; Onc Live: Honoraria; Geron Pharmaceutical: Consultancy. Belli: COTA, Inc.: Current Employment, Other: Equity ownership. Hansen: COTA, Inc.: Current Employment. Foss: COTA, Inc.: Current Employment. Schulte: COTA, Inc.: Current Employment. Wang: COTA, Inc.: Current Employment, Other: Equity ownership.

REALM (OP-RW001): Comparing the Characteristics and Clinical Outcomes of Patients with Relapsed/Refractory Multiple Myeloma in the Real World to Patients Receiving Melflufen in the Horizon Study

REALM (OP-RW001): Comparing the Characteristics and Clinical Outcomes of Patients with Relapsed/Refractory Multiple Myeloma in the Real World to Patients Receiving Melflufen in the Horizon Study

How to Handle Online Harassment, Cyberstalking by Patients

Back to table of contents Previous article Next article Government & LegalFull AccessHow to Handle Online Harassment, Cyberstalking by PatientsAllison M. Funicelli, M.P.A., C.C.L.A., A.R.M.Allison M. FunicelliSearch for more papers by this author, M.P.A., C.C.L.A., A.R.M.Published Online:27 Oct 2021https://doi.org/10.1176/appi.pn.2021.11.31AbstractDon’t hesitate to take action if a patient engages in harassing online behavior.Several studies have concluded that as many as 75% of workplace assaults and violent attacks occur in health care settings. Furthermore, as many as 20% of physicians surveyed reported being the victim of at least one instance of stalking or harassment by a patient.Unfortunately, predicting who may exhibit this type of behavior is difficult. In addition, the internet allows perpetrators to harass their victims, such as health care professionals, more frequently, easily, and anonymously than ever before. Both male and female physicians report stalking events with almost the same frequency. Mental illness and fear are two of the top reasons cited as why patients act out against their health care professionals. Transference is another potential cause for cyberstalking and harassing behavior; a patient may redirect some of his/her feelings for others onto the psychiatrist, enhancing their need to interact with his/her psychiatrist in unhealthy ways.Online harassment is defined as using online media (such as social media platforms, websites, apps, emails, and text) to cause emotional distress to an intended victim. Cyberstalking is the repeated use of electronic communications to harass or frighten someone, for example, by sending threatening emails. APA has a resource document that addresses stalking, intrusive behaviors, and related phenomena by patients (see link below). It provides key information related to personal safety, prevention, and intervention. Depending on the level of threat, psychiatrists may need to seek personal counseling to deal with the stress of being harassed or intimidated by a patient and determine if the patient requires hospitalization or transfer of care to another psychiatrist. Moreover, consider if there is a duty to warn others who may be in danger. It may be important to inform staff members if there is a credible threat to their safety as well.Maintain clear boundaries with patients. Do not accept friend requests on social media platforms.Maintain professionalism to avoid blurred lines in the doctor/patient relationship.Report threatening behavior to law enforcement; consider filing a civil protection order for stalking behavior.Provide the minimum necessary information to law enforcement/court to comply with the Health Insurance Portability and Accountability Act (HIPAA).Document the details of the event both in the patient’s medical record and in your personal records.Block the telephone number of the harasser and/or change your personal telephone number if necessary.Contact patients through HIPAA-compliant privacy apps or a patient portal that encrypts your telephone number and email address.Use separate cell phone numbers and email addresses for work and personal use.Dismiss the patient from the practice if necessary. Follow proper termination procedures.Consider safety precautions such as panic buttons installed in the office, protective barriers where possible (patient session rooms, waiting areas, private staff areas), and other security measures.Consult your risk management professional or practice attorney for guidance. ■This information is provided as a risk management resource for Allied World policyholders and should not be construed as legal or clinical advice. This material may not be reproduced or distributed without the express, written permission of Allied World Assurance Company Holdings Ltd, a Fairfax company (“Allied World”). Risk management services are provided by or arranged through AWAC Services Company, a member company of Allied World. © 2021 Allied World Assurance Company Holdings, Ltd. All Rights Reserved.APA’s “Resource Document on Stalking, Intrusive Behaviors, and Related Phenomena by Patients” is posted here.Allison M. Funicelli, M.P.A., C.C.L.A., A.R.M., is a risk management consultant in the Risk Management Group of AWAC Services Company, a member company of Allied World. Risk management services are provided as an exclusive benefit to insureds of the APA-endorsed American Professional Agency Inc. liability insurance program. ISSUES NewArchived

Raspberry Pi-Based Data Archival System for Electroencephalogram Signals From the SedLine Root Device.

The retrospective analysis of electroencephalogram (EEG) signals acquired from patients under general anesthesia is crucial in understanding the patient's unconscious brain's state. However, the creation of such database is often tedious and cumbersome and involves human labor. Hence, we developed a Raspberry Pi-based system for archiving EEG signals recorded from patients under anesthesia in operating rooms (ORs) with minimal human involvement. Using this system, we archived patient EEG signals from over 500 unique surgeries at the Emory University Orthopaedics and Spine Hospital, Atlanta, for about 18 months. For this, we developed a software package that runs on a Raspberry Pi and archives patient EEG signals from a SedLine Root EEG Monitor (Masimo) to a secure Health Insurance Portability and Accountability Act (HIPAA) compliant cloud storage. The OR number corresponding to each surgery was archived along with the EEG signal to facilitate retrospective EEG analysis. We retrospectively processed the archived EEG signals and performed signal quality checks. We also proposed a formula to compute the proportion of true EEG signal and calculated the corresponding statistics. Further, we curated and interleaved patient medical record information with the corresponding EEG signals. We retrospectively processed the EEG signals to demonstrate a statistically significant negative correlation between the relative alpha power (8-12 Hz) of the EEG signal captured under anesthesia and the patient's age. Our system is a standalone EEG archiver developed using low cost and readily available hardware. We demonstrated that one could create a large-scale EEG database with minimal human involvement. Moreover, we showed that the captured EEG signal is of good quality for retrospective analysis and combined the EEG signal with the patient medical records. This project's software has been released under an open-source license to enable others to use and contribute.

An atomic approach to the design and implementation of a research data warehouse.

ObjectiveAs a long-standing Clinical and Translational Science Awards (CTSA) Program hub, the University of Pittsburgh and the University of Pittsburgh Medical Center (UPMC) developed and implemented a modern research data warehouse (RDW) to efficiently provision electronic patient data for clinical and translational research.Materials and MethodsWe designed and implemented an RDW named Neptune to serve the specific needs of our CTSA. Neptune uses an atomic design where data are stored at a high level of granularity as represented in source systems. Neptune contains robust patient identity management tailored for research; integrates patient data from multiple sources, including electronic health records (EHRs), health plans, and research studies; and includes knowledge for mapping to standard terminologies.ResultsNeptune contains data for more than 5 million patients longitudinally organized as Health Insurance Portability and Accountability Act (HIPAA) Limited Data with dates and includes structured EHR data, clinical documents, health insurance claims, and research data. Neptune is used as a source for patient data for hundreds of institutional review board-approved research projects by local investigators and for national projects.DiscussionThe design of Neptune was heavily influenced by the large size of UPMC, the varied data sources, and the rich partnership between the University and the healthcare system. It includes several unique aspects, including the physical warehouse straddling the University and UPMC networks and management under an HIPAA Business Associates Agreement.ConclusionWe describe the design and implementation of an RDW at a large academic healthcare system that uses a distinctive atomic design where data are stored at a high level of granularity.

APA App Advisor: Working With Patients to Use Apps

APA App Advisor: Working With Patients to Use Apps

Predicting clinical outcomes in COVID-19 using radiomics on chest radiographs.

ObjectivesFor optimal utilization of healthcare resources, there is a critical need for early identification of COVID-19 patients at risk of poor prognosis as defined by the need for intensive unit care and mechanical ventilation. We tested the feasibility of chest X-ray (CXR)-based radiomics metrics to develop machine-learning algorithms for predicting patients with poor outcomes.MethodsIn this Institutional Review Board (IRB) approved, Health Insurance Portability and Accountability Act (HIPAA) compliant, retrospective study, we evaluated CXRs performed around the time of admission from 167 COVID-19 patients. Of the 167 patients, 68 (40.72%) required intensive care during their stay, 45 (26.95%) required intubation, and 25 (14.97%) died. Lung opacities were manually segmented using ITK-SNAP (open-source software). CaPTk (open-source software) was used to perform 2D radiomics analysis.ResultsOf all the algorithms considered, the AdaBoost classifier performed the best with AUC = 0.72 to predict the need for intubation, AUC = 0.71 to predict death, and AUC = 0.61 to predict the need for admission to the intensive care unit (ICU). AdaBoost had similar performance with ElasticNet in predicting the need for admission to ICU. Analysis of the key radiomic metrics that drive model prediction and performance showed the importance of first-order texture metrics compared to other radiomics panel metrics. Using a Venn-diagram analysis, two first-order texture metrics and one second-order texture metric that consistently played an important role in driving model performance in all three outcome predictions were identified.Conclusions:Considering the quantitative nature and reliability of radiomic metrics, they can be used prospectively as prognostic markers to individualize treatment plans for COVID-19 patients and also assist with healthcare resource management.Advances in knowledgeWe report on the performance of CXR-based imaging metrics extracted from RT-PCR positive COVID-19 patients at admission to develop machine-learning algorithms for predicting the need for ICU, the need for intubation, and mortality, respectively.

Impact of the COVID-19 Pandemic on Child and Adolescent Mental Health Policy and Practice Implementation.

Background: The impact of the 2019 coronavirus pandemic on the mental health of millions worldwide has been well documented, but its impact on prevention and treatment of mental and behavioral health conditions is less clear. The COVID-19 pandemic also created numerous challenges and opportunities to implement health care policies and programs under conditions that are fundamentally different from what has been considered to be usual care. Methods: We conducted a qualitative study to determine the impact of the COVID-19 pandemic on implementation of evidence-based policy and practice by State Mental Health Authorities (SMHA) for prevention and treatment of mental health problems in children and adolescents. Semi-structured interviews were conducted with 29 SMHA representatives of 21 randomly selected states stratified by coronavirus positivity rate and rate of unmet services need. Data analysis with SMHA stakeholders used procedures embedded in the Rapid Assessment Procedure—Informed Community Ethnography methodology. Results: The need for services increased during the pandemic due primarily to family stress and separation from peers. States reporting an increase in demand had high coronavirus positivity and high unmet services need. The greatest impacts were reduced out-of-home services and increased use of telehealth. Barriers to telehealth services included limited access to internet and technology, family preference for face-to-face services, lack of privacy, difficulty using with young children and youth in need of substance use treatment, finding a Health Insurance Portability and Accountability Act (HIPAA)-compliant platform, training providers and clients, and reimbursement challenges. Policy changes to enable reimbursement, internet access, training, and provider licensing resulted in substantially fewer appointment cancellations or no-shows, greater family engagement, reduction in travel time, increased access for people living in remote locations, and increased provider communication and collaboration. States with high rates of coronavirus positivity and high rates of unmet need were most likely to continue use of telehealth post-pandemic. Despite these challenges, states reported successful implementation of policies designed to facilitate virtual services delivery with likely long-term changes in practice. Conclusions: Policy implementation during the pandemic provided important lessons for planning and preparedness for future public health emergencies. Successful policy implementation requires ongoing collaboration among policy makers and with providers.