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The US Food and Drug Administration (FDA) Sentinel System uses a distributed data network, a common data model, curated real-world data, and distributed analytic tools to generate evidence for FDA decision-making. Sentinel system needs include analytic flexibility, transparency, and reproducibility while protecting patient privacy. Based on over a decade of experience, a critical system limitation is the inability to identify enough medical conditions of interest in observational data to a satisfactory level of accuracy. Improving the system's ability to use computable phenotypes will require an "all of the above" approach that improves use of electronic health data while incorporating the growing array of complementary electronic health record data sources. FDA recently funded a Sentinel System Innovation Center and a Community Building and Outreach Center that will provide a platform for collaboration across disciplines to promote better use of real-world data for decision-making., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: The study sought to design, pilot, and evaluate a federated data completeness tracking system (CTX) for assessing completeness in research data extracted from electronic health record data across the Accessible Research Commons for Health (ARCH) Clinical Data Research Network., Materials and Methods: The CTX applies a systems-based approach to design workflow and technology for assessing completeness across distributed electronic health record data repositories participating in a queryable, federated network. The CTX invokes 2 positive feedback loops that utilize open source tools (DQe-c and Vue) to integrate technology and human actors in a system geared for increasing capacity and taking action. A pilot implementation of the system involved 6 ARCH partner sites between January 2017 and May 2018., Results: The ARCH CTX has enabled the network to monitor and, if needed, adjust its data management processes to maintain complete datasets for secondary use. The system allows the network and its partner sites to profile data completeness both at the network and partner site levels. Interactive visualizations presenting the current state of completeness in the context of the entire network as well as changes in completeness across time were valued among the CTX user base., Discussion: Distributed clinical data networks are complex systems. Top-down approaches that solely rely on technology to report data completeness may be necessary but not sufficient for improving completeness (and quality) of data in large-scale clinical data networks. Improving and maintaining complete (high-quality) data in such complex environments entails sociotechnical systems that exploit technology and empower human actors to engage in the process of high-quality data curating., Conclusions: The CTX has increased the network's capacity to rapidly identify data completeness issues and empowered ARCH partner sites to get involved in improving the completeness of respective data in their repositories., (© The Author(s) 2019. Published by Oxford University Press on behalf of the American Medical Informatics Association.)

Objective: This paper describes Health Level 7 (HL7) V.3 Care Transfer, Care Record Query, and Care Record messages. This is the core of the Care Provision Domain in the HL7 standard which became normative at the end of 2012 and is an American National Standards Institute (ANSI)-approved HL7 standard., Background and Significance: Using a message is somewhat different from the approach offered in the current HL7 Clinical Document Architecture (CDA). The overall advantage is human-to-human communication and system-to-system processing of structured data through electronic messages, supporting continuity of care and interactive structured data exchange through querying., Materials and Methods: The Care Provision Domain Model in HL7 was developed based on use cases from several projects internationally. Use case and information analysis, model building, HL7 consensus methods (eg, working group meetings), conference calls, balloting, a draft standard for trial use, pilot implementations, and subsequent evaluation were applied., Results: The membership and pilot implementers gave feedback to improve the draft standard. After the formal ballot process, HL7 membership accepted it as a normative standard and it is now ANSI approved. The Care Provision Domain Model defines the structure (data exchanged) and dynamics (workflow and communications) of the Care Record, Care Record Query, and Care Transfer., Discussion and Conclusions: The HL7 V3 Care Provision Domain differs from the HL7 CDA regarding support of the dynamics of care (eg, for continuity of care) as provided through a series of interactions and queries, but is similar with respect to the data and their organization., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objective: The Cross-Institutional Clinical Translational Research project explored a federated query tool and looked at how this tool can facilitate clinical trial cohort discovery by managing access to aggregate patient data located within unaffiliated academic medical centers., Methods: The project adapted software from the Informatics for Integrating Biology and the Bedside (i2b2) program to connect three Clinical Translational Research Award sites: University of Washington, Seattle, University of California, Davis, and University of California, San Francisco. The project developed an iterative spiral software development model to support the implementation and coordination of this multisite data resource., Results: By standardizing technical infrastructures, policies, and semantics, the project enabled federated querying of deidentified clinical datasets stored in separate institutional environments and identified barriers to engaging users for measuring utility., Discussion: The authors discuss the iterative development and evaluation phases of the project and highlight the challenges identified and the lessons learned., Conclusion: The common system architecture and translational processes provide high-level (aggregate) deidentified access to a large patient population (>5 million patients), and represent a novel and extensible resource. Enhancing the network for more focused disease areas will require research-driven partnerships represented across all partner sites.

Electronic laboratory interfaces can significantly increase the value of ambulatory electronic health record (EHR) systems by providing laboratory result data automatically and in a computable form. However, many ambulatory EHRs cannot implement electronic laboratory interfaces despite the existence of messaging standards, such as Health Level 7, version 2 (HL7). Among several barriers to implementing laboratory interfaces is the extensive optionality within the HL7 message standard. This paper describes the rationale for and development of an HL7 implementation guide that seeks to eliminate most of the optionality inherent in HL7, but retain the information content required for reporting outpatient laboratory results. A work group of heterogeneous stakeholders developed the implementation guide based on a set of design principles that emphasized parsimony, practical requirements, and near-term adoption. The resulting implementation guide contains 93% fewer optional data elements than HL7. This guide was successfully implemented by 15 organizations during an initial testing phase and has been approved by the HL7 standards body as an implementation guide for outpatient laboratory reporting. Further testing is required to determine whether widespread adoption of the implementation guide by laboratories and EHR systems can facilitate the implementation of electronic laboratory interfaces.

Complete patient health information that is available where and when it is needed is essential to providers and patients and improves healthcare quality and patient safety. VA and DoD have built on their previous experience in patient data exchange to establish data standards and terminology services to enable real-time bi-directional computable (i.e., encoded) data exchange and achieve semantic interoperability in compliance with recommended national standards and the eGov initiative. The project uses RxNorm, UMLS, and SNOMED CT terminology standards to mediate codified pharmacy and allergy data with greater than 92 and 60 percent success rates respectively. Implementation of the project has been well received by users and is being expanded to multiple joint care sites. Stable and mature standards, mediation strategies, and a close relationship between healthcare institutions and Standards Development Organizations are recommended to achieve and maintain semantic interoperability in a clinical setting.

Objective: This study sought to define a scalable architecture to support the National Health Information Network (NHIN). This architecture must concurrently support a wide range of public health, research, and clinical care activities., Study Design: The architecture fulfils five desiderata: (1) adopt a distributed approach to data storage to protect privacy, (2) enable strong institutional autonomy to engender participation, (3) provide oversight and transparency to ensure patient trust, (4) allow variable levels of access according to investigator needs and institutional policies, (5) define a self-scaling architecture that encourages voluntary regional collaborations that coalesce to form a nationwide network., Results: Our model has been validated by a large-scale, multi-institution study involving seven medical centers for cancer research. It is the basis of one of four open architectures developed under funding from the Office of the National Coordinator of Health Information Technology, fulfilling the biosurveillance use case defined by the American Health Information Community. The model supports broad applicability for regional and national clinical information exchanges., Conclusions: This model shows the feasibility of an architecture wherein the requirements of care providers, investigators, and public health authorities are served by a distributed model that grants autonomy, protects privacy, and promotes participation.

Health care provides many opportunities in which the sharing of data between independent sites is highly desirable. Several standards are required to produce the functional and semantic interoperability necessary to support the exchange of such data: a common reference information model, a common set of data elements, a common terminology, common data structures, and a common transport standard. This paper addresses one component of that set of standards: the ability to create a document that supports the exchange of structured data components. Unfortunately, two different standards development organizations have produced similar standards for that purpose based on different information models: Health Level 7 (HL7)'s Clinical Document Architecture (CDA) and The American Society for Testing and Materials (ASTM International) Continuity of Care Record (CCR). The coexistence of both standards might require mapping from one standard to the other, which could be accompanied by a loss of information and functionality. This paper examines and compares the two standards, emphasizes the strengths and weaknesses of each, and proposes a strategy of harmonization to enhance future progress. While some of the authors are members of HL7 and/or ASTM International, the authors stress that the viewpoints represented in this paper are those of the authors and do not represent the official viewpoints of either HL7 or of ASTM International.

Clinical Document Architecture, Release One (CDA R1), became an American National Standards Institute (ANSI)-approved HL7 Standard in November 2000, representing the first specification derived from the Health Level 7 (HL7) Reference Information Model (RIM). CDA, Release Two (CDA R2), became an ANSI-approved HL7 Standard in May 2005 and is the subject of this article, where the focus is primarily on how the standard has evolved since CDA R1, particularly in the area of semantic representation of clinical events. CDA is a document markup standard that specifies the structure and semantics of a clinical document (such as a discharge summary or progress note) for the purpose of exchange. A CDA document is a defined and complete information object that can include text, images, sounds, and other multimedia content. It can be transferred within a message and can exist independently, outside the transferring message. CDA documents are encoded in Extensible Markup Language (XML), and they derive their machine processable meaning from the RIM, coupled with terminology. The CDA R2 model is richly expressive, enabling the formal representation of clinical statements (such as observations, medication administrations, and adverse events) such that they can be interpreted and acted upon by a computer. On the other hand, CDA R2 offers a low bar for adoption, providing a mechanism for simply wrapping a non-XML document with the CDA header or for creating a document with a structured header and sections containing only narrative content. The intent is to facilitate widespread adoption, while providing a mechanism for incremental semantic interoperability.

In this paper, the authors describe a methodology to transform programmatically structured reporting (SR) templates defined by the Digital Imaging and Communications for Medicine (DICOM) standard into an XML schema representation. Such schemas can be used in the creation and validation of XML-encoded SR documents that use templates. Templates are a means to put additional constraints on an SR document to promote common formats for specific reporting applications or domains. As the use of templates becomes more widespread in the production of SR documents, it is important to ensure validity of such documents. The work described in this paper is an extension of the authors' previous work on XML schema representation for DICOM SR. Therefore, this paper inherits and partially modifies the structure defined in the earlier work.

This case study describes a project that explores issues of quality of service (QoS) relevant to the next-generation Internet (NGI), using the PathMaster application in a testbed environment. PathMaster is a prototype computer system that analyzes digitized cell images from cytology specimens and compares those images against an image database, returning a ranked set of "similar" cell images from the database. To perform NGI testbed evaluations, we used a cluster of nine parallel computation workstations configured as three subclusters using Cisco routers. This architecture provides a local "simulated Internet" in which we explored the following QoS strategies: (1) first-in-first-out queuing, (2) priority queuing, (3) weighted fair queuing, (4) weighted random early detection, and (5) traffic shaping. The study describes the results of using these strategies with a distributed version of the PathMaster system in the presence of different amounts of competing network traffic and discusses certain of the issues that arise. The goal of the study is to help introduce NGI QoS issues to the Medical Informatics community and to use the PathMaster NGI testbed to illustrate concretely certain of the QoS issues that arise.

Electronic communication among clinicians and patients is becoming an essential part of medical practice. Evaluation and selection of these electronic systems, called personal clinical electronic communication (PCEC) systems, can be a difficult task in institutions that have no prior experience with such systems. It is particularly difficult in the clinical context. To directly address this point, the authors consulted a group of potential users affiliated with a nationally recognized telemedicine project, to determine important characteristics of a hypothetical PCEC system. They compiled a list of these characteristics and produced a desiderata, or list of desired features, for PCEC systems. Two conventional e-mail implementations and three Web-based PCEC systems were evaluated with respect to the features. The Web-based systems all scored higher than conventional e-mail. It is the hope of the authors that this paper will initiate further discussions about the features of PCEC systems and how to evaluate them.

Supplement 23 to DICOM (Digital Imaging and Communications for Medicine), Structured Reporting, is a specification that supports a semantically rich representation of image and waveform content, enabling experts to share image and related patient information. DICOM SR supports the representation of textual and coded data linked to images and waveforms. Nevertheless, the medical information technology community needs models that work as bridges between the DICOM relational model and open object-oriented technologies. The authors assert that representations of the DICOM Structured Reporting standard, using object-oriented modeling languages such as the Unified Modeling Language, can provide a high-level reference view of the semantically rich framework of DICOM and its complex structures. They have produced an object-oriented model to represent the DICOM SR standard and have derived XML-exchangeable representations of this model using World Wide Web Consortium specifications. They expect the model to benefit developers and system architects who are interested in developing applications that are compliant with the DICOM SR specification.

Many people know of Health Level 7 (HL7) as an organization that creates health care messaging standards. Health Level 7 is also developing standards for the representation of clinical documents (such as discharge summaries and progress notes). These document standards make up the HL7 Clinical Document Architecture (CDA). The HL7 CDA Framework, release 1.0, became an ANSI-approved HL7 standard in November 2000. This article presents the approach and objectives of the CDA, along with a technical overview of the standard. The CDA is a document markup standard that specifies the structure and semantics of clinical documents. A CDA document is a defined and complete information object that can include text, images, sounds, and other multimedia content. The document can be sent inside an HL7 message and can exist independently, outside a transferring message. The first release of the standard has attempted to fill an important gap by addressing common and largely narrative clinical notes. It deliberately leaves out certain advanced and complex semantics, both to foster broad implementation and to give time for these complex semantics to be fleshed out within HL7. Being a part of the emerging HL7 version 3 family of standards, the CDA derives its semantic content from the shared HL7 Reference Information Model and is implemented in Extensible Markup Language. The HL7 mission is to develop standards that enable semantic interoperability across all platforms. The HL7 version 3 family of standards, including the CDA, are moving us closer to the realization of this vision.

This study was conducted to examine how health counselling via electronic mail (e-mail health counselling) was used in the workplace. The definition of health counselling employed in this study was 'any assistance to an individual seeking to solve any health problem'. A total of 2119 health counsellings conducted at a Japanese company's head office (700 employees) in 1997 and 1998 was used for the analysis, which compared four health counselling methods: e-mail, face-to-face, telephone and ordinary mail. This study distinguished four main characteristics of e-mail health counselling. First, the most and second most frequently used counselling methods were face-to-face and telephone counselling, at 70 and 15%, respectively, with e-mail health counselling ranked third at 13%. e-mail counselling was the second most frequently used method for employees in their 20s and 30s, while it ranked third among those over 40. Only 6% of employees in their 50s used e-mail counselling. Secondly, the proportion of mental health issues treated via e-mail counselling was significantly higher, at 26%, than for other counselling methods, which was at or below 10% for each of the other methods. Thirty-two per cent of all mental health counselling was conducted via e-mail. Thirdly, compared with face-to-face counselling, e-mail counselling dealt with more health issues related to primary prevention than with those related to secondary or tertiary prevention. Fourthly, compared with face-to-face counselling, e-mail counselling dealt more with health issues of third parties. These results suggest that e-mail health counselling may be useful in reaching people other than those targeted by the remaining counselling methods.

In 1998, the American Medical Informatics Association (AMIA) published a white paper entitled "Guidelines for the Clinical Use of Electronic Mail with Patients," which outlined a practical framework for this interaction. Interest in the use of other Internet-based tools, such as the World Wide Web, to enhance clinical communication is increasing. In such systems, static information can be made centrally available to patients and interactive tools such as messaging systems, schedules, and individualized care regimens can be integrated within the site. Site-specific guidelines are needed to address potential problems inherent in the particular services being offered. This article presents advice on developing site-specific guidelines, with examples, based on experience gained in developing and refining guidelines for the use of PatientWeb at the Massachusetts General Hospital Department of Neurology.

Objective: Generalizing the data models underlying two prototype neurophysiology databases, the authors describe and propose the Common Data Model (CDM) as a framework for federating a broad spectrum of disparate neuroscience information resources., Design: Each component of the CDM derives from one of five superclasses-data, site, method, model, and reference-or from relations defined between them. A hierarchic attribute-value scheme for metadata enables interoperability with variable tree depth to serve specific intra- or broad inter-domain queries. To mediate data exchange between disparate systems, the authors propose a set of XML-derived schema for describing not only data sets but data models. These include biophysical description markup language (BDML), which mediates interoperability between data resources by providing a meta-description for the CDM., Results: The set of superclasses potentially spans data needs of contemporary neuroscience. Data elements abstracted from neurophysiology time series and histogram data represent data sets that differ in dimension and concordance. Site elements transcend neurons to describe subcellular compartments, circuits, regions, or slices; non-neuroanatomic sites include sequences to patients. Methods and models are highly domain-dependent., Conclusions: True federation of data resources requires explicit public description, in a metalanguage, of the contents, query methods, data formats, and data models of each data resource. Any data model that can be derived from the defined superclasses is potentially conformant and interoperability can be enabled by recognition of BDML-described compatibilities. Such metadescriptions can buffer technologic changes.

The "vocabulary problem" has long plagued the developers, implementers, and users of computer-based systems. The authors review selected activities of the Health Level 7 (HL7) Vocabulary Technical Committee that are related to vocabulary domain specification for HL7 coded data elements. These activities include: 1) the development of two sets of principles to provide guidance to terminology stakeholders, including organizations seeking to deploy HL7-compliant systems, terminology developers, and terminology integrators; 2) the completion of a survey of terminology developers; 3) the development of a process for HL7 registration of terminologies; and 4) the maintenance of vocabulary domain specification tables. As background, vocabulary domain specification is defined and the relationship between the HL7 Reference Information Model and vocabulary domain specification is described. The activities of the Vocabulary Technical Committee complement the efforts of terminology developers and other stakeholders. These activities are aimed at realizing semantic interoperability in the context of the HL7 Message Development Framework, so that information exchange and use among disparate systems can occur for the delivery and management of direct clinical care as well as for purposes such as clinical research, outcome research, and population health management.

Clinical laboratories and clinicians transmit certain laboratory test results to public health agencies as required by state or local law. Most of these surveillance data are currently received by conventional mail or facsimile transmission. The Centers for Disease Control and Prevention (CDC), Council of State and Territorial Epidemiologists, and Association of Public Health Laboratories are preparing to implement surveillance systems that will use existing laboratory information systems to transmit electronic laboratory results to appropriate public health agencies. The authors anticipate that this will improve the reporting efficiency for these laboratories, reduce manual data entry, and greatly increase the timeliness and utility of the data. The vocabulary and messaging standards used should encourage participation in these new electronic reporting systems by minimizing the cost and inconvenience to laboratories while providing for accurate and complete communication of needed data. This article describes public health data requirements and the influence of vocabulary and messaging standards on implementation.

Guidelines regarding patient-provider electronic mail are presented. The intent is to provide guidance concerning computer-based communications between clinicians and patients within a contractual relationship in which the health-care provider has taken on an explicit measure of responsibility for the client's care. The guidelines address two interrelated aspects: effective interaction between the clinician and patient, and observance of medicolegal prudence. Recommendations for site-specific policy formulation are included.

The Digital Imaging and Communications in Medicine (DICOM) Standard specifies a non-proprietary data interchange protocol, digital image format, and file structure for biomedical images and image-related information. The fundamental concepts of the DICOM message protocol, services, and information objects are reviewed as background for a detailed discussion of the functionality of DICOM; the innovations and limitations of the Standard; and the impact of various DICOM features on information system users. DICOM addresses five general application areas: (1) network image management, (2) network image interpretation management, (3) network print management, (4) imaging procedure management, (5) off-line storage media management. DICOM is a complete specification of the elements required to achieve a practical level of automatic interoperability between biomedical imaging computer systems--from application layer to bit-stream encoding. The Standard is being extended and expanded in modular fashion to support new applications and incorporate new technology. An interface to other Information Systems provides for shared management of patient, procedure, and results information related to images. A Conformance Statement template enables a knowledgeable user to determine if interoperability between two implementations is possible. Knowledge of DICOM's benefits and realistic understanding of its limitations enable one to use the Standard effectively as the basis for a long term implementation strategy for image management and communications systems.

Java, a new object-oriented computing language related to C++, is receiving considerable attention due to its use in creating network-sharable, platform-independent software modules (known as "applets") that can be used with the World Wide Web. The Web has rapidly become the most commonly used information-retrieval tool associated with the global computer network known as the Internet, and Java has the potential to further accelerate the Web's application to medical problems. Java's potentially wide acceptance due to its Web association and its own technical merits also suggests that it may become a popular language for non-Web-based, object-oriented computing.

Objective: Predict the behavior and estimate the telecommunication cost of a wide-area message store-and-forward network for health care providers that uses the telephone system., Design: A tool with which to perform large-scale discrete-event simulations was developed. Network models for star and mesh topologies were constructed to analyze the differences in performances and telecommunication costs. The distribution of nodes in the network models approximates the distribution of physicians, hospitals, medical labs, and insurers in the Province of Saskatchewan, Canada. Modeling parameters were based on measurements taken from a prototype telephone network and a survey conducted at two medical clinics. Simulation studies were conducted for both topologies., Results: For either topology, the telecommunication cost of a network in Saskatchewan is projected to be less than $100 (Canadian) per month per node. The estimated telecommunication cost of the star topology is approximately half that of the mesh. Simulations predict that a mean end-to-end message delivery time of two hours or less is achievable at this cost. A doubling of the data volume results in an increase of less than 50% in the mean end-to-end message transfer time., Conclusion: The simulation models provided an estimate of network performance and telecommunication cost in a specific Canadian province. At the expected operating point, network performance appeared to be relatively insensitive to increases in data volume. Similar results might be anticipated in other rural states and provinces in North America where a telephone-based network is desired.

The decentralization of laboratory testing provides distinct advantages for clinicians and patients, such as the reduction of test turnaround time, but also promotes the development of scattered caches of results. This problem could be ameliorated by the creation of an integrated laboratory data base. Such an approach would provide clinicians with a patient view of laboratory information in addition to the functional view of it that is offered currently. Impressive technologic advances are being made in the development of a distributed computer architecture in which processing tasks and information are shared across multiple hardware platforms attached to a network. Such architecture could be used to create a regional value-added laboratory network to integrate test information generated in decentralized testing sites. Independent reference laboratories and tertiary-care referral hospitals are the most likely candidates to create distributed value-added networks. Pathologists should view themselves as health-care professionals responsible for the processing, storage, and transmission of information, as well as for its generation. In time, the partition of information along hospital geopolitical boundaries will appear archaic and will be replaced by an emphasis on local and regional integration of medical information similar to that advocated here.