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Requirements Analysis Technology & Vendor Evaluation Data-Architecture Design
Software Development Product Management Legal and Regulatory Expert Services

Requirements Analysis

We analyze and document end-user requirements and technical requirements for clinical information systems. Our combined knowledge of the medical domain and the software domain enable us to ascertain the requirements of clinician end-users and to effectively communicate these requirements to software developers. Our experience in clinical software development allows us to anticipate unstated requirements or areas of potential misunderstanding.

Representative Engagements:
A Technical Infrastructure for Health Information Exchange in California
Wide Area Network Requirements for Telemedicine and HIE
Sharable Web-Services Components for Personal Health Records

Technology & Vendor Evaluation

We help our clients assess whether specific software products, technologies, and standards are good fits for their business and technical needs. The first step is to fully understand our clients' goals. We then apply our technical knowledge of and experience with clinical information systems to assess the suitability of various options in furthering those goals. The key is asking the right questions so our clients can see beyond sales pitches and technology fashions to true capabilities and trade-offs.

Representative Engagements:
A Pilot Implementation of DIRECT Messaging
A Market Assessment of Open Source EHRs
A Practical Design for SNOMED-CT in Patient Problem Lists
Use of Retrospective Lab Data in P4P Measures: Problems and Solutions

Data-Architecture Design

Clinical data may be represented in many different ways within clinical information systems, ranging from documents to discrete data elements and free text to structured concepts. The choices that organizations make determine the ease with which data are captured, accessed, analyzed, and shared by their software. We help our clients make high-level decisions as well as create detailed designs for their data architectures. The designs include conceptual data models, logical data models, terminology models, and query models.

Representative Engagements:
ELINCS: A National Standards Project for Lab-to-EHR Interoperability
A Technical Infrastructure for Health Information Exchange
Sharable Web-Services Components for Personal Health Records

Software Development

We develop prototypes and sub-components of clinical information systems in areas where specific healthcare informatics knowledge is required. These areas include terminology management, clinical data integration, and decision-support logic. We also develop entire applications for our clients, in collaboration with larger software-engineering partners.

Representative Engagements:
A Pilot Implementation of DIRECT Messaging
Web-Services Components for PHRs: An Application of SOAP and WSDL
A GUI-Based Validation Tool for ELINCS HL7 Messages
An Extraction-Transformation-Load (ETL) Module for a Retinal Screening Application

Product Management

We help organizations manage the full product-development cycle on an outsourced basis, including requirements analysis, interim development review, change management, documentation, and beta testing. Effective management of these steps can critically influence the acceptability of a clinical information system to end users and healthcare organizations, as well as affect the overall cost and duration of product-development projects.

Representative Engagements:
The California Joint Replacement Registry
A GUI-Based Validation Tool for ELINCS HL7 Messaging

Legal and Regulatory Expert Services

We provide technical consulting and expert witness services for patent litigation and regulatory compliance cases related to EHRs and other health information technologies. We are familiar with patent law and the prosecution of IPRs and patent-infringement claims, and have experience in preparing claim charts, authoring legal declarations and providing sworn testimony. Our firm also has deep subject matter expertise regarding EHR certification under the Meaningful Use and Promoting Interoperability programs, including performing audits of EHR certification compliance.


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