William J. Gordon

Background: The digitization of medical data and advances in interoperability have opened opportunities for research studies to use more comprehensive, longitudinal patient data from multiple sources. As patients often interact with many providers and payers over time, collecting data across organizations may have critical implications for accuracy and bias in study results. US policy has promoted exchanging health information among providers, payers, and patients, but less attention has focused on facilitating data collection for research, which presents unique challenges. Objective: This study aimed to identify and evaluate existing and emerging approaches for collecting comprehensive provider and payer data for research in the United States, with the goals of informing researchers of possible methods and generating evidence to inform policy initiatives. Our focus was on electronic approaches to data aggregation for studies requiring patient consent. Methods: We conducted a landscape analysis through interviews with subject matter experts (SMEs). SMEs were selected based on expertise. We created a list of evaluation criteria, identified existing and emerging approaches, and described the benefits and limitations of each approach by applying the evaluation criteria. We interviewed SMEs until saturation was achieved. Data collection was limited to the United States. Results: A total of 20 SMEs helped identify 8 distinct approaches: (1) general-purpose smartphone app, (2) commercial app, (3) research community app, (4) structured data export, (5) Trust Exchange Framework and Common Agreement Individual Access Service, (6) regional study query, (7) national study query, and (8) aggregated data source. Participant-mediated exchange approaches (1-5) leveraged patients’ right of access. Three approaches leveraged existing data exchange services (5-7). To evaluate these approaches, we identified 12 criteria, including perspectives of participants, research teams, and broader stakeholders. Each approach had benefits and limitations; no single approach emerged as superior for all use cases. While currently available approaches for participant-mediated exchange bypass the need for complex governance arrangements, they are limited by participant burden, effort needed by research teams, and data gaps, especially from payers. Some regional health information exchanges and aggregated data sources address governance challenges and can provide services such as preparing analytic datasets but are restricted to specific locations and/or data-source coverage. National networks currently do not allow queries for research and confront challenges in establishing trust and enforcing compliance with data-sharing requirements among network sites. Conclusions: Collecting comprehensive health data from multiple providers and payers in the United States is a complex and evolving process. The suitability of an approach may vary based on the needs of a study. Given the numerous barriers and the lack of a clear dominant method, further exploration and benchmark comparisons of all identified approaches are necessary. Ongoing public policy efforts will likely play an important role in progress.

Background: The COVID‐19 pandemic disrupted traditional health care; one fallout was a drastic decrease in blood pressure (BP) assessment. We analyzed the pandemic's impact on our existing remote hypertension management program's effectiveness and adaptability. Methods and Results: This retrospective observational analysis evaluated BP control in an entirely remote management program before and during the pandemic. A team of pharmacists, nurse practitioners, physicians, and nonlicensed navigators used an evidence‐based clinical algorithm to optimize hypertensive treatment. The algorithm was adapted during the pandemic to simplify BP control. Overall, 1256 patients (605 enrolled in the 6 months before the pandemic shutdown in March 2020 and 651 in the 6 months after) were a median age of 63 years old, 57% female, and 38.2% non‐White. Among enrolled patients with sustained hypertension, 51.1% reached BP goals. Within this group, rates of achieving goal BP improved to 94.6% during the pandemic from 75.8% prepandemic ( P P P P P <0.0001), compared with the prepandemic period. Conclusions: A remote clinical management program was successfully adapted and delivered significant improvements in BP control and increased home BP monitoring despite a nationally observed disruption of traditional hypertension care. Such programs have the potential to transform hypertension management and care delivery.

Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered on ClinicalTrials.gov for four chronic neurological disorders: epilepsy, multiple sclerosis, Alzheimer’s, and Parkinson’s disease. We document growth in the collection of both more established digital measures (e.g., motor function) and more novel digital measures (e.g., speech) over recent years, highlighting contexts of use and key trends.

Cybersecurity is an increasingly important concern for reliable healthcare delivery and is particularly salient for robotic surgery. Surgical robots are complex systems with numerous points of vulnerability, and there have been real-world demonstrations of successful cyberattacks on surgical robots. There are several ways to improve the risk profile of robotic surgery, including recognizing system complexity, investing in regular software updates, following cybersecurity best-practices, and increasing transparency for all stakeholders. As robotic surgery continues to technologically advance, ensuring overall system safety from a cybersecurity perspective is paramount.

Objective: Improving health data interoperability through application programming interfaces (APIs) is a focus of US policy initiatives and could have tremendous impact on many aspects of care delivery, such as innovation, operational efficiency, and patient-centered care. To better understand the landscape of API use cases, we interviewed US thought leaders involved in developing and implementing standard-based APIs. Materials and Methods: We conducted semi-structured virtual interviews with US subject matter experts (SMEs) on APIs. SMEs were asked to describe API use cases along with value and barriers for each use case. Written summaries were checked by the SME and analyzed by the study team to identify findings and themes. Results: We interviewed 12 SMEs representing diverse sectors of the US healthcare system, including academia, industry, public health agencies, electronic health record vendors, government, and standards organizations. Use cases for standards-based APIs fell into six categories: patient-facing, clinician-facing, population health and value-based care, public health, administrative, and social services. The value across use cases was viewed as unrealized to date, and barriers to the use of APIs varied by use case. Conclusions: SMEs identified a diverse set of API use cases where standard-based APIs had the potential to generate value. As policy efforts seek to increase API adoption, our work provides an early look at the landscape of API use cases, value propositions, and barriers. Additional effort is needed to better understand the barriers and how to overcome them to create value, such as through demonstration projects and rigorous evaluations for specific use cases.

Objectives Hypertension is a modifiable risk factor for numerous comorbidities and treating hypertension can greatly improve health outcomes. We sought to increase the efficiency of a virtual hypertension management program through workflow automation processes. Methods We developed a customer relationship management (CRM) solution at our institution for the purpose of improving processes and workflow for a virtual hypertension management program and describe here the development, implementation, and initial experience of this CRM system. Results Notable system features include task automation, patient data capture, multi-channel communication, integration with our electronic health record (EHR), and device integration (for blood pressure cuffs). In the five stages of our program (intake and eligibility screening, enrollment, device configuration/setup, medication titration, and maintenance), we describe some of the key process improvements and workflow automations that are enabled using our CRM platform, like automatic reminders to capture blood pressure data and present these data to our clinical team when ready for clinical decision making. We also describe key limitations of CRM, like balancing out-of-the-box functionality with development flexibility. Among our first group of referred patients, 76% (39/51) preferred email as their communication method, 26/51 (51%) were able to enroll electronically, and 63% of those enrolled (32/51) were able to transmit blood pressure data without phone support. Conclusion A CRM platform could improve clinical processes through multiple pathways, including workflow automation, multi-channel communication, and device integration. Future work will examine the operational improvements of this health information technology solution as well as assess clinical outcomes. This work is a quality improvement project at Mass General Brigham whose sole purpose is quality measurement and thus under institution guidelines the work was not reviewed by the Mass General Brigham Human Research Committee. ^* These authors contributed equally to this manuscript. Received: 03 June 2021 Accepted: 23 September 2021 Article published online: 10 November 2021 © 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/) Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

The 21st Century Cures Act, passed in 2016, and the Final Rules it called for create a roadmap for enabling patient access to their electronic health information. The set of data to be made available, as determined by the Office of the National Coordinator for Health IT through the US Core Data for Interoperability expansion process, will impact the value creation of this improved data liquidity. In this commentary, we look at the potential for significant value creation from USCDI in the context of clinical bioinformatics research and advocate for the research community’s involvement in the USCDI process to propel this value creation forward. We also describe 1 mechanism—using existing required APIs for full data export capabilities—that could pragmatically enable this value creation at minimal additional technical lift beyond the current regulatory requirements.