Summary of Qualifications
- Trusted and respected health IT software analyst and auditor; selected by the federal government and guiding EHR vendors to lead ground-breaking projects
- Experience leading independent 3rd party audits in the healthcare IT sector, including serving at the request of Office of National Coordinator for Health IT (ONC) and Office of Inspector General (OIG) as a Software Quality Oversight Organization (SQOO) and Independant Consultative Expert (ICE).
- Well-versed in best practices for compliance and patient safety, with specialization in quality management systems, SDLC, risk management, high-quality software and software organizations, and software usability.
- A trusted litigation consultant and software expert witness.
- Served on dozens of contract dispute, regulatory, trade secret, and patent infringement cases.
- Has served as an expert in International Trade Commission (ITC) investigations and USPTO patent re-examinations and IPRs, in addition to federal and state court cases.
- Conveys technical subjects in a clear, logical style easily understood by a broader audience. Has a depth of experience in modern software architectures, software governance, and risk-based design controls in medical software.
- Known for root cause analysis and corrective and preventive actions (CAPA)
- Known for his fast and efficient code review and analysis in wide-array of software languages such as Java, Android, iOS, Objective C, C++, C#, Microsoft Windows, .NET, Python, Matlab, and more.
- Well versed in software design patterns, both classic, and cloud/devops, SDLC, Software standards (ISO 13485, 25010, etc.)
- Has expertise in usability and UI design, microservices, smartphones, mobile apps, medical devices, electronic health record systems (EHRs), embedded systems, cellular devices, web applications, and ERP systems.
- Formerly served as Chief Technology Officer for Genesis Health Technologies, LLC, where he managed the growth of the company’s technology department and the commercial launch of Genesis’ flagship products and technology services for diabetes healthcare.
- Member of the IEEE Computer Society.
- Received his B.S. in Computer Science and Mathematics with cum laude honors from Vanderbilt University
Areas of Expertise
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Software Development Standards
Medical Device Standards (ISO 13485, ISO 14971, ISO 62304), Software governance (disciplined agile, CMMI for Agile); code quality standards (CWE, ISO 25010 / 25012, CISQ); SDLCs (Scrum).
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Software Risk Management and Technology Mgmt
Risk classification, HAZOP analysis, agile and FDA-regulated SDLC processes, risk and requirements traceability systems, software governance, compliance and audits.
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Risk Controls and Scalability in Software
Robust software, failsafe design, usability controls, automated testing, microservices, distributed computing
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Litigation Support
Intellectual property and patent infringement, software design/source code audit and review, non-performance claims, expert witness and depositions
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Modern Software Processes
DevOps, continuous integration, risk-based agile development
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Medical Standards and Vocabularies
HL7, C-CDA, X12, DICOM, IDC-9/10, HIPAA, Meaningful Use, SNOMED, RxNorm, QRDA
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Languages and Technologies
Java, Google Android and APIs (Maps, Cloud Messaging), RESTful APIs, HTML5, CSS, jQuery, django, Python, Chef, Fabric, PostgreSQL, json, SOAP, PHP, Rackspace Cloud, Amazon AWS/EC2, Apache, Ruby, Gunicorn, nginx, ZeroMQ, RabbitMQ, Perl, monitoring (Nagios, daemontools/supervise), Apple iOS and iPhone SDK, Objective C, Sencha, Appcelerator Titanium
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Microsoft Platforms
.NET, C#, VB.NET, Windows Phone SDK, IIS, Visual C++, Win32 applications and DLLs, WinCE applications, MFC 6.0, Visual Basic 6.0, Windows Phone OS
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Database and ERP
MySQL, PostgreSQL, Oracle, Siebel, OFBiz, OpenERP, JDBC, ADO.NET, OLE, Microsoft SQL
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Project Development and Management
Eclipse, Visual Studio 6, 8, 2005-2010, Visual Studio .NET, Siebel Tools, Visual Paradigm, UML, Github, JIRA, COCOMO, CASE tools, Microsoft Project, wrike, Visual SourceSafe
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Analytics
MATLAB. Statistical and numerical analysis, signal processing algorithms and systems, machine learning, financial trading indicators and systems.
Litigation Experience
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Lenovo Group Limited
Counsel: Sheppard Mullin Richter and Hampton LLP
Nature of Matter: patent analysis
Providing analysis regarding patent invalidity of Nokia-owned patents related to Android smartphone software -
Private Parties v CONFIDENTIAL
Jurisdiction: U.S. District Court
Counsel: Schlichter Bogard & Denton LLP
Nature of Suit: False Claims Act
Providing expert analysis regarding potential false claims related to Meaningful Use and CEHRT regulations in the Health IT industry -
North Brevard County Hospital District v McKesson Technologies, Inc.
Jurisdiction: U.S. District Court, Middle District of Florida
Counsel: GrayRobinson, P.A.
Nature of Suit: contract dispute
Provided expert report and analysis of the implementation of McKesson’s Horizon and Paragon systems at a community hospital, including a review of the EHR software and services and their compliance with industry standards. -
Automation Middleware Solutions vs. Emerson Process Management LLP et. al.
Jurisdiction: U.S. District Court, Eastern District of Texas
Counsel: Bragalone Conroy PC
Nature of Suit: patent infringement
Performed code review and infringement analysis for middleware components in industrial motion control software. -
CWI, Inc. v SmartDog Services LLC
Jurisdiction: U.S. District Court, Western District of Kentucky
Counsel: Broderick and Davenport LLP
Nature of Suit: contract dispute
Reviewed and provided expert report covering Oracle eBusiness Suite and WMS installation for a large outdoor products retail and distribution company. -
AliphCom, Inc. et. al. v Fitbit, Inc.
Jurisdiction: International Trade Commission, U.S. District Court, Northern Dist. of California
Counsel: Gibson Dunn and Crutcher LLP
Nature of Suit: Patent Infringement -
Walmart-Stores, Inc. v Cuker Interactive, LLC
Jurisdiction: U.S. District Court, Western District of Arkanas
Counsel: Kutak Rock LLP
Nature of Suit: Contract Dispute -
Ericsson, Inc. et al. v. TCL Communication Technology Holdings, Ltd, et al.
Jurisdiction: U.S. District Court, Eastern District of Texas
Counsel: Sheppard Mullin Richter and Hampton LLP
Nature of Suit: Intellectual Property – Patent -
Justin Hull and Amy Sweigard v. Marriott International, Inc.
Jurisdiction: U.S. District Court for the Southern District of Maryland
Counsel: Conn Maciel Carey PLLC
Nature of Suit: Americans with Disabilities Act (ADA) Compliance -
Mary Rutan Hospital v. Nextgen Healthcare Information Systems, Inc.
Jurisdiction: U.S. District Court for the Southern District of Ohio
Counsel: Reminger Co., L.P.A.
Nature of Suit: EMR Contract Dispute -
Computer Programs and Systems, Inc. v. Mad River Community Hospital and American Hospital Management Corporation
Jurisdiction: Circuit Court, Mobile County Alabama
Counsel: Janssen Malloy LLP
Nature of Suit: EMR Contract Dispute -
Core Wireless Licensing S.a.r.l. v. LG Electronics, Inc. & LG Electronics MobileComm USA, Inc.
Jurisdiction: U.S. District Court for the Eastern District of Texas
Counsel: Bunsow De Mory Smith & Allison LLP
Nature of Suit: Intellectual Property – Patent -
Core Wireless Licensing S.a.r.l. v. Apple Computer, Inc.
Jurisdiction: U.S. District Court for the Eastern District of Texas
Counsel: Bunsow De Mory Smith & Allison LLP
Nature of Suit: Intellectual Property – Patent -
Packet Intelligence, LLC v. Cisco Systems, Inc.
Jurisdiction: U.S. District Court for the Eastern District of Texas
Counsel: Heim, Payne and Chorush LLP
Nature of Suit: Intellectual Property – Patent -
Denise C. Tullock and Sandra M. Fry v. Success Health Corp.
Jurisdiction: Circuit Court, City of St. Louis, Missouri
Counsel: Thurman Howald Weber Senkel & Norrik LLC
Nature of Suit: Medical Malpractice -
Bridgetree, Inc. v. Red F Marketing LLC et al.
Jurisdiction: U.S. District Court – Western District of North Carolina Charlotte Division
Counsel: Harwell Howard Hyne Gabbert & Manner
Nature of Suit: Intellectual Property – Trade Secret -
YPPI v. SuperMedia LLC
Jurisdiction: U.S. Bankruptcy Court – District of Delaware
Counsel: Kirkland and Ellis
Nature of Suit: Intellectual Property – Copyright Infringement -
Guitar Apprentice, Inc. v. Ubisoft, Inc.
Jurisdiction: U.S. District Court – Western District of Tennessee Western Division
Counsel: Waddey Patterson
Nature of Suit: Intellectual Property – Patent -
Special Learning, Inc. v. Step-By-Step Academy, Inc.
Jurisdiction: U.S. District Court – Southern District of Ohio Eastern Division
Counsel: Cooke Demers and Gleason LLP
Nature of Suit: Contract Dispute -
Mediware Information Systems, Inc. v. Hematerra Technologies, LLC
Jurisdiction: U.S. District Court, Middle District of Florida Jacksonville Division
Counsel: Barack Ferrazzano Kirschbaum & Nagelberg LLP
Nature of Suit: Intellectual Property – Trade Secret -
Intellectual Ventures, LLC v. AT&T Mobility, LLC, et al.
Intellectual Ventures, LLC v. T-Mobile USA, Inc., et al.
Intellectual Ventures, LLC v. Nextel Operations, Inc., et al.
Intellectual Ventures, LLC v. United States Cellular Corporation
Jurisdiction: U.S. District Court for the District of Delaware
Counsel: Dechert LLP
Nature of Suit: Intellectual Property – Patent -
ROY-G-BIV Corporation v. Honeywell International, Inc., et al.
ROY-G-BIV Corporation v. Siemens Corporation, et al.
ROY-G-BIV Corporation v. ABB, Ltd., et al.
Jurisdiction: U.S. District Court for the Eastern District of Texas
Counsel: Boies, Schiller & Flexner LLP
Nature of Suit: Intellectual Property – Patent -
Motion Games, LLC v. Nintendo Co., Ltd., Nintendo of America Inc., Retro Studios, Inc., Rent-a-Center, Inc., and
Gamestop Corp.
Jurisdiction: U.S. District Court for the Eastern District of Texas
Counsel: Boies Schiller & Flexner LLP
Nature of Suit: Intellectual Property – Patent -
Nokia Corporation and Nokia Inc. v. HTC Corporation and HTC America, Inc.
Jurisdiction: United States International Trade Commission
Counsel: Desmarais LLP
Nature of Suit: Intellectual Property – Patent -
N5 Technologies, LLC v. Capital One, N.A., Capital One Bank (USA), and Capital One Services, LLC
Jurisdiction: U.S. District Court for the Eastern District of Virginia
Counsel: Panovia Group, LLP
Nature of Suit: Intellectual Property – Patent -
Anthony Dike, M.D. v. Kindred Healthcare Operating, Inc.
Jurisdiction: Superior Court of the State of Califoria, County of Los Angeles – East District
Counsel: Giovanniello & Michels, LLP
Nature of Suit: Loss of Property -
Wisconsin Technology Venture, LLC v. Fatwallet, Inc.
Jurisdiction: U.S. District Court for the Western District of Wisconsin
Counsel: Newman Du Wors LLP
Nature of Suit: Intellectual Property – Patent -
Nokia Corp. and Intellisync Corp. v. HTC, HTC America, Inc., and Exedea, Inc.
Jurisdiction: United States International Trade Commission
Counsel: Desmarais LLP
Nature of Suit: Intellectual Property – Patent -
Yazmin Reyazuddin v. Montgomery County, Maryland
Jurisdiction: U.S. District Court for the District of Maryland (Southern Division)
Counsel: Office of the Montgomery County Attorney
Nature of Suit: Reasonable Accommodations Dispute Re: Section 508 of the Rehabilitation Act -
MobileMedia Ideas, LLC v. HTC Corporation and HTC America, Inc.
Jurisdiction: U.S. District Court for the Eastern District of Texas
Counsel: Desmarais LLP
Nature of Suit: Intellectual Property – Patent
Audits and Compliance Consulting
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Electronic Health Record Vendor (CONFIDENTIAL)
Performing consultation regarding compliance and regulatory matters for Certified Health IT software. -
Electronic Health Record Vendor (CONFIDENTIAL)
Performing gap analysis and recommendations for improving compliance with CEHRT regulations for Certified Health IT software. -
REMS – Data, Quality, Process and Systems Review (CONFIDENTIAL)
Performing independent, internal data, quality, process and systems review for a major FDA-regulated REMS (Risk Evaluation and Mitigation Strategies) program and for a popular generic medication with serious side effects. Includes 21 CFR Part 11 compliance review, review of software development, architecture, requirements, documentation, testing and validation; review of annual report data and assisting with responses to FDA inquiries. -
Major Electronic Health Record Vendor (CONFIDENTIAL)
Developing guidance to meet CEHRT regulations with a focus on software governance and quality management systems; drafting policies and procedures that combine agile processes with regulatory governance requirements. Reviewing source code and issue tracking records to identify regulatory issues. -
Office of National Coordinator for Health IT
ONC Health IT Safety Evaluation Technical Analysis
Currently engaged as the leading software engineer on a small team led by NORC at the University of Chicago and selected under a federal contract and open solicitation (Solicitation # 17-233-SOL-00329) issued by the ONC. The project is expected to include technical reviews of known or expected patient safety issues in ONC-certified EHR systems, including software process and source code review, including review of past issues, recommendations for risk and quality management systems, design controls, improvements to software development and testing processes, code review and manual and automated code quality analysis. -
eClinicalWorks, LLC and the Office of the Inspector General of HHS
Software Quality Oversight Organization
Leading a team of seven serving as the Software Quality and Oversight Organization (SQOO) under the Corporate Integrity Agreement between eClinicalWorks LLC and the Office of the Inspector General of the United States Department of Health and Human Services dated May 30, 2017. Serving as an independent audit and oversight organization covering a technical review of EHR software and development processes as it relates to patient safety. The project includes software process and source code review, including review of past issues, recommendations for risk and quality management systems, design controls, improvements to software development and testing processes, code review and manual and automated code quality analysis. -
Office of National Coordinator for Health IT
Led a team of four serving as an Independent Consultative Expert (ICE), and issued a formal ICE report covering a technical review and audit of a major EHR software product as it relates to patient safety. The project included software process and source code review, review of past issues, and development of recommendations for risk and quality management systems, design controls, improvements to software development and testing processes, code review
and manual and automated code quality analysis. -
Consumer Financial Protections Bureau (CFPB)
Leading a team of three from Quandary Peak Research in providing technical review and audit for the CFPB in an ongoing investigation of a large mortgage servicing company. The review covers software process and code review, including a review of internal software development processes, documentation and communication practices, data storage and access practices, and source code review. The project includes assessing the integrity and reliability of key data and identifying potential data integrity and validation remedies.
