Publications

2016
Joshua C Mandel, David A Kreda, Kenneth D Mandl, Isaac S Kohane, and Rachel B Ramoni. 2016. “SMART on FHIR: a standards-based, interoperable apps platform for electronic health records.” J Am Med Inform Assoc.Abstract
OBJECTIVE: In early 2010, Harvard Medical School and Boston Children's Hospital began an interoperability project with the distinctive goal of developing a platform to enable medical applications to be written once and run unmodified across different healthcare IT systems. The project was called Substitutable Medical Applications and Reusable Technologies (SMART). METHODS: We adopted contemporary web standards for application programming interface transport, authorization, and user interface, and standard medical terminologies for coded data. In our initial design, we created our own openly licensed clinical data models to enforce consistency and simplicity. During the second half of 2013, we updated SMART to take advantage of the clinical data models and the application-programming interface described in a new, openly licensed Health Level Seven draft standard called Fast Health Interoperability Resources (FHIR). Signaling our adoption of the emerging FHIR standard, we called the new platform SMART on FHIR. RESULTS: We introduced the SMART on FHIR platform with a demonstration that included several commercial healthcare IT vendors and app developers showcasing prototypes at the Health Information Management Systems Society conference in February 2014. This established the feasibility of SMART on FHIR, while highlighting the need for commonly accepted pragmatic constraints on the base FHIR specification. CONCLUSION: In this paper, we describe the creation of SMART on FHIR, relate the experience of the vendors and developers who built SMART on FHIR prototypes, and discuss some challenges in going from early industry prototyping to industry-wide production use.
Jeremy L Warner, Matthew J Rioth, Kenneth D Mandl, Joshua C Mandel, David A Kreda, Isaac S Kohane, Daniel Carbone, Ross Oreto, Lucy Wang, Shilin Zhu, Heming Yao, and Gil Alterovitz. 2016. “SMART precision cancer medicine: a FHIR-based app to provide genomic information at the point of care.” J Am Med Inform Assoc.Abstract
BACKGROUND: Precision cancer medicine (PCM) will require ready access to genomic data within the clinical workflow and tools to assist clinical interpretation and enable decisions. Since most electronic health record (EHR) systems do not yet provide such functionality, we developed an EHR-agnostic, clinico-genomic mobile app to demonstrate several features that will be needed for point-of-care conversations. METHODS: Our prototype, called Substitutable Medical Applications and Reusable Technology (SMART)® PCM, visualizes genomic information in real time, comparing a patient's diagnosis-specific somatic gene mutations detected by PCR-based hotspot testing to a population-level set of comparable data. The initial prototype works for patient specimens with 0 or 1 detected mutation. Genomics extensions were created for the Health Level Seven® Fast Healthcare Interoperability Resources (FHIR)® standard; otherwise, the prototype is a normal SMART on FHIR app. RESULTS: The PCM prototype can rapidly present a visualization that compares a patient's somatic genomic alterations against a distribution built from more than 3000 patients, along with context-specific links to external knowledge bases. Initial evaluation by oncologists provided important feedback about the prototype's strengths and weaknesses. We added several requested enhancements and successfully demonstrated the app at the inaugural American Society of Clinical Oncology Interoperability Demonstration; we have also begun to expand visualization capabilities to include cancer specimens with multiple mutations. DISCUSSION: PCM is open-source software for clinicians to present the individual patient within the population-level spectrum of cancer somatic mutations. The app can be implemented on any SMART on FHIR-enabled EHRs, and future versions of PCM should be able to evolve in parallel with external knowledge bases.
2015
Kenneth D Mandl and Joshua C Mandel. 2015. “Building a self-measuring healthcare system with computable metrics, data fusion, and substitutable apps.” BMJ Outcomes, 2015, 1, Pp. 6-13.
Kenneth D Mandl, Joshua C Mandel, and Isaac S Kohane. 2015. “Driving Innovation in Health Systems through an Apps-Based Information Economy.” Cell Syst, 1, 1, Pp. 8-13.Abstract
Healthcare data will soon be accessible using standard, open software interfaces. Here, we describe how these interfaces could lead to improved healthcare by facilitating the development of software applications (apps) that can be shared across physicians, health care organizations, translational researchers, and patients. We provide recommendations for next steps and resources for the myriad stakeholders. If challenges related to efficacy, accuracy, utility, safety, privacy, and security can be met, this emerging apps model for health information technology will open up the point of care for innovation and connect patients at home to their healthcare data.
2014
John D D'Amore, Joshua C Mandel, David A Kreda, Ashley Swain, George A Koromia, Sumesh Sundareswaran, Liora Alschuler, Robert H Dolin, Kenneth D Mandl, Isaac S Kohane, and Rachel B Ramoni. 2014. “Are Meaningful Use Stage 2 certified EHRs ready for interoperability? Findings from the SMART C-CDA Collaborative.” J Am Med Inform Assoc, 21, 6, Pp. 1060-8.Abstract
BACKGROUND AND OBJECTIVE: Upgrades to electronic health record (EHR) systems scheduled to be introduced in the USA in 2014 will advance document interoperability between care providers. Specifically, the second stage of the federal incentive program for EHR adoption, known as Meaningful Use, requires use of the Consolidated Clinical Document Architecture (C-CDA) for document exchange. In an effort to examine and improve C-CDA based exchange, the SMART (Substitutable Medical Applications and Reusable Technology) C-CDA Collaborative brought together a group of certified EHR and other health information technology vendors. MATERIALS AND METHODS: We examined the machine-readable content of collected samples for semantic correctness and consistency. This included parsing with the open-source BlueButton.js tool, testing with a validator used in EHR certification, scoring with an automated open-source tool, and manual inspection. We also conducted group and individual review sessions with participating vendors to understand their interpretation of C-CDA specifications and requirements. RESULTS: We contacted 107 health information technology organizations and collected 91 C-CDA sample documents from 21 distinct technologies. Manual and automated document inspection led to 615 observations of errors and data expression variation across represented technologies. Based upon our analysis and vendor discussions, we identified 11 specific areas that represent relevant barriers to the interoperability of C-CDA documents. CONCLUSIONS: We identified errors and permissible heterogeneity in C-CDA documents that will limit semantic interoperability. Our findings also point to several practical opportunities to improve C-CDA document quality and exchange in the coming years.
Kenneth D Mandl, Isaac S Kohane, Douglas McFadden, Griffin M Weber, Marc Natter, Joshua Mandel, Sebastian Schneeweiss, Sarah Weiler, Jeffrey G Klann, Jonathan Bickel, William G Adams, Yaorong Ge, Xiaobo Zhou, James Perkins, Keith Marsolo, Elmer Bernstam, John Showalter, Alexander Quarshie, Elizabeth Ofili, George Hripcsak, and Shawn N Murphy. 2014. “Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS): architecture.” J Am Med Inform Assoc, 21, 4, Pp. 615-20.Abstract
We describe the architecture of the Patient Centered Outcomes Research Institute (PCORI) funded Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS, http://www.SCILHS.org) clinical data research network, which leverages the $48 billion dollar federal investment in health information technology (IT) to enable a queryable semantic data model across 10 health systems covering more than 8 million patients, plugging universally into the point of care, generating evidence and discovery, and thereby enabling clinician and patient participation in research during the patient encounter. Central to the success of SCILHS is development of innovative 'apps' to improve PCOR research methods and capacitate point of care functions such as consent, enrollment, randomization, and outreach for patient-reported outcomes. SCILHS adapts and extends an existing national research network formed on an advanced IT infrastructure built with open source, free, modular components.
2013
William Bosl, Joshua Mandel, Magdalena Jonikas, Rachel Badovinac Ramoni, Isaac S Kohane, and Kenneth D Mandl. 2013. “Scalable decision support at the point of care: a substitutable electronic health record app for monitoring medication adherence.” Interact J Med Res, 2, 2, Pp. e13.Abstract
BACKGROUND: Non-adherence to prescribed medications is a serious health problem in the United States, costing an estimated $100 billion per year. While poor adherence should be addressable with point of care health information technology, integrating new solutions with existing electronic health records (EHR) systems require customization within each organization, which is difficult because of the monolithic software design of most EHR products. OBJECTIVE: The objective of this study was to create a published algorithm for predicting medication adherence problems easily accessible at the point of care through a Web application that runs on the Substitutable Medical Apps, Reusuable Technologies (SMART) platform. The SMART platform is an emerging framework that enables EHR systems to behave as "iPhone like platforms" by exhibiting an application programming interface for easy addition and deletion of third party apps. The app is presented as a point of care solution to monitoring medication adherence as well as a sufficiently general, modular application that may serve as an example and template for other SMART apps. METHODS: The widely used, open source Django framework was used together with the SMART platform to create the interoperable components of this app. Django uses Python as its core programming language. This allows statistical and mathematical modules to be created from a large array of Python numerical libraries and assembled together with the core app to create flexible and sophisticated EHR functionality. Algorithms that predict individual adherence are derived from a retrospective study of dispensed medication claims from a large private insurance plan. Patients' prescription fill information is accessed through the SMART framework and the embedded algorithms compute adherence information, including predicted adherence one year after the first prescription fill. Open source graphing software is used to display patient medication information and the results of statistical prediction of future adherence on a clinician-facing Web interface. RESULTS: The user interface allows the physician to quickly review all medications in a patient record for potential non-adherence problems. A gap-check and current medication possession ratio (MPR) threshold test are applied to all medications in the record to test for current non-adherence. Predictions of 1-year non-adherence are made for certain drug classes for which external data was available. Information is presented graphically to indicate present non-adherence, or predicted non-adherence at one year, based on early prescription fulfillment patterns. The MPR Monitor app is installed in the SMART reference container as the "MPR Monitor", where it is publically available for use and testing. MPR is an acronym for Medication Possession Ratio, a commonly used measure of adherence to a prescribed medication regime. This app may be used as an example for creating additional functionality by replacing statistical and display algorithms with new code in a cycle of rapid prototyping and implementation or as a framework for a new SMART app. CONCLUSIONS: The MPR Monitor app is a useful pilot project for monitoring medication adherence. It also provides an example that integrates several open source software components, including the Python-based Django Web framework and python-based graphics, to build a SMART app that allows complex decision support methods to be encapsulated to enhance EHR functionality.
2012
Nich Wattanasin, Alyssa Porter, Stella Ubaha, Michael Mendis, Lori Phillips, Joshua Mandel, Rachel Ramoni, Kenneth Mandl, Isaac Kohane, and Shawn N Murphy. 2012. “Apps to display patient data, making SMART available in the i2b2 platform.” AMIA Annu Symp Proc, 2012, Pp. 960-9.Abstract
The Substitutable Medical Apps, Reusable Technologies (SMART) project provides a framework of core services to facilitate the use of substitutable health-related web applications. The platform offers a common interface used to "SMART-ready" health IT systems allowing any SMART application to be able to interact with those systems. At Partners Healthcare, we have SMART-enabled the Informatics for Integrating Biology and the Bedside (i2b2) open source analytical platform, enabling the use of SMART applications directly within the i2b2 web client. In i2b2, viewing the patient in an EMR-like view enables a natural-feeling medical review process for each patient.
Kenneth D Mandl, Joshua C Mandel, Shawn N Murphy, Elmer Victor Bernstam, Rachel L Ramoni, David A Kreda, Michael J McCoy, Ben Adida, and Isaac S Kohane. 2012. “The SMART Platform: early experience enabling substitutable applications for electronic health records.” J Am Med Inform Assoc, 19, 4, Pp. 597-603.Abstract
OBJECTIVE: The Substitutable Medical Applications, Reusable Technologies (SMART) Platforms project seeks to develop a health information technology platform with substitutable applications (apps) constructed around core services. The authors believe this is a promising approach to driving down healthcare costs, supporting standards evolution, accommodating differences in care workflow, fostering competition in the market, and accelerating innovation. MATERIALS AND METHODS: The Office of the National Coordinator for Health Information Technology, through the Strategic Health IT Advanced Research Projects (SHARP) Program, funds the project. The SMART team has focused on enabling the property of substitutability through an app programming interface leveraging web standards, presenting predictable data payloads, and abstracting away many details of enterprise health information technology systems. Containers--health information technology systems, such as electronic health records (EHR), personally controlled health records, and health information exchanges that use the SMART app programming interface or a portion of it--marshal data sources and present data simply, reliably, and consistently to apps. RESULTS: The SMART team has completed the first phase of the project (a) defining an app programming interface, (b) developing containers, and (c) producing a set of charter apps that showcase the system capabilities. A focal point of this phase was the SMART Apps Challenge, publicized by the White House, using http://www.challenge.gov website, and generating 15 app submissions with diverse functionality. CONCLUSION: Key strategic decisions must be made about the most effective market for further disseminating SMART: existing market-leading EHR vendors, new entrants into the EHR market, or other stakeholders such as health information exchanges.