Brad Ulrich - Software Expert Witness
Computer Scientist

Brad Ulrich

VP of Health IT & Audits

Brad Ulrich has a 20+ year career as a computer scientist, tech entrepreneur, and expert consultant. He is trusted by federal agencies and leading software vendors to provide expert analysis and guidance on complex matters involving the safety and quality of software, regulations such as CEHRT and Meaningful Use, and industry best practices for quality and risk management in Health IT software.

His professional experience includes modern software architectures, safety-based product design, health IT software, FDA-regulated medical devices, distributed software, automation and DevOps, cellular devices, and more. He is adept at risk management, SDLCs and project management, software governance and compliance with SDO standards, CTO and strategic management, IP management and consulting, and litigation support and expert testimony as a computer scientist.

He is currently the Director of Quandary Peak’s Health IT and Audits division, where he oversees a team of software and health informatics experts in analyzing and audits of health IT software systems and companies, including reviews for private companies as well as the Department of Health and Human Services and United States Department of Justice.

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 in more than forty cases, including sixteen patent infringement cases.
  • 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

  • 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).
  • 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.
  • Risk Controls and Scalability in Software
    Robust software, failsafe design, usability controls, automated testing, microservices, distributed computing
  • Litigation Support
    Intellectual property and patent infringement, software design/source code audit and review, non-performance claims, expert witness and depositions
  • Modern Software Processes
    DevOps, continuous integration, risk-based agile development
  • Medical Standards and Vocabularies
    HL7, C-CDA, X12, DICOM, IDC-9/10, HIPAA, Meaningful Use, SNOMED, RxNorm, QRDA
  • 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
  • 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
  • Database and ERP
    MySQL, PostgreSQL, Oracle, Siebel, OFBiz, OpenERP, JDBC, ADO.NET, OLE, Microsoft SQL
  • 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
  • Analytics
    MATLAB. Statistical and numerical analysis, signal processing algorithms and systems, machine learning, financial trading indicators and systems.

Litigation Consulting

  • Kelly Albrecht v. Portland Adventist Medical Center; Women’s Healthcare Clinic of Oregon; Julie Crawford, MD; Kelli Andersen, MD; and Stephen R. Crook, MD |
    Jurisdiction: Oregon Circuit Court, Multnomah County
    Case Number: 20cv34636, 22cv00194
    Counsel: Hart Wagner, LLP
    Nature of Suit: Medical Malpractice
  • William J. Van Kirk v. West Virginia United Health System, WVU Medicine, and University Health Associates |
    Jurisdiction: Circuit Court of Monongalia County, West Virginia
    Case Number: 23-C-281
    Counsel: Thomas Combs & Spann, PLLC
    Nature of Suit: Medical Malpractice
  • Madelyn Hammock v. Hackensack Meridian Health |
    Jurisdiction: Superior Court of New Jersey
    Case Number: MON-L-003760-21 – 20510
    Counsel: Walsh Pizzi O’Reilly Falanga LLP
    Nature of Suit: Medical Malpractice
  • Kristen Dondero, et al. v. Yaakov Abdelhak, M.D. |
    Jurisdiction: Superior Court of New Jersey Bergen County
    Case Number: BER-L-3527-20
    Counsel: Walsh Pizzi O’Reilly Falanga LLP
    Nature of Suit: Medical Malpractice
  • Club Speed, LLC v. K1 Speed, Inc |
    Jurisdiction: Superior Court of California
    Case Number: 30-2022-01241507-CU-BC-CJC
    Counsel: Rutan & Tucker, LLP
    Nature of Suit: Breach of Contract
  • Avelardo Rivera and Yasmine Romero v. Amazon Web Services, Inc |
    Jurisdiction: Western District of Washington
    Case Number: 2:22-cv-00269-JHC
    Counsel: Edelson P.C.
    Nature of Suit: Class Action
  • AlmondNet Inc v. Amazon.com Inc |
    Jurisdiction: Western District of Texas
    Case Number: 6:21-cv-00898-ADA
    Counsel: Russ August & Kabat
    Nature of Suit: Patent
  • Pioneer Rx, LLC v. Danwins, LLC |
    Jurisdiction: Louisiana Western District
    Case Number: 5:21-cv-01738
    Counsel: Kirkland & Ellis, LLP
    Nature of Suit: Trade Secret
  • Richard Lasiw v. Hackensack University Medical Group |
    Jurisdiction: Superior Court of New Jersey, Appellate Division
    Counsel: Walsh Pizzi O’Reilly Falanga LLP
    Nature of Suit: Medical Malpractice
    Health IT System: Epic
  • Lifescience Technologies, LLC, v.
    Mercy Health, Mercy ACO Clinical Services, Inc and Myia Labs, Inc     |
    Jurisdiction: U.S. District Court, Eastern District of Missouri
    Counsel: Stinson LLP
    Nature of Suit: breach of contract, trade secret
    Providing analysis of trade secrets and trade secret misappropriation in health IT applications including virtual health and telehealth.
  • Kasandra Izquierdo v.
    The New York and Presbyterian Hospital     |
    Jurisdiction: Supreme Court of the State of New York County of Bronx
    Counsel: Heidell, Pittoni, Murphy & Bach, LLP
    Nature of Suit: Medical Malpractice
    Health IT System: Eclipsys (Now Allscripts/ Veradigm)
  • Jazmine Harris v. Public Broadcasting Service |
    Jurisdiction: US District Court for the Northern District of Georgia
    Case Number: 1:22-cv-02456-AT
    Counsel: Edelsberg Law, P.A.
    Nature of Suit: Class Action
  • Jabari Seller v. Bleacher Report, Inc (Warner Media) |
    Jurisdiction: US District Court for the Northern District of California
    Case Number: 3:2023cv00368
    Counsel: Edelsberg Law, P.A.
    Nature of Suit: Class Action
  • Zachary Rohlfs v. WGNTV (Nexstar Media Inc) |
    Jurisdiction: US District Court for the Central District of Illinois
    Case Number: 1:23-cv-01050
    Counsel: Edelsberg Law, P.A.
    Nature of Suit: Class Action
  • Jennifer Waller v. Tampa Bay Times |
    Jurisdiction: US District Court for the Middle District of Florida
    Case Number: 8:23-cv-00119
    Counsel: Edelsberg Law, P.A.
    Nature of Suit: Class Action
  • Greg Roland v. The Chive (Chive Media Group, LLC) |
    Jurisdiction: US District Court for the Western District of Texas
    Case Number: 1:2023cv00337
    Counsel: Edelsberg Law, P.A.
    Nature of Suit: Class Action
  • Emma Mendoza v. Newsweek Digital, LLC |
    Jurisdiction: US District Court for the Southern District of New York
    Case Number: 1:2023cv00643
    Counsel: Edelsberg Law, P.A.
    Nature of Suit: Class Action
  • Melanie Barber v. Eisenhower Medical Center, Inc |
    Jurisdiction: California Central District Court
    Case Number: 5:23-cv-00250
    Counsel: Edelsberg Law, P.A.
    Nature of Suit: Class Action, Breach of Contract
  • Emma Mendoza v. The Washington Post |
    Jurisdiction: U.S. District of Columbia Superior Court
    Case Number: 2023CAB001101
    Counsel: Edelsberg Law, P.A.
    Nature of Suit: Class Action
  • Estate of Alan Reyes-Landweer v.
    Advocate Health and Hospitals     |
    Jurisdiction: Circuit Court of Cook County, Illinois
    Case Number: 2020 L 003397
    Counsel: Barker, Castro & Steinback, LLC
    Nature of Suit: Medical Malpractice
  • K+S Potash Canada General Partnership v.
    Veolia Water Technologies Inc     |
    Jurisdiction: Court Of Queen’s Bench For Saskatchewan
    Case Number: QB No. 817 (filed 2018)
    Nature of Suit: Breach of Contract
    Counsel: Stikeman Elliott LLP
    Technology: Plant Design Management Systems (PDMS), Clash Detection, Database synchronization
    Role: Served as Testifying Expert
  • Brady and Macy Ingram v. Corporation |
    Jurisdiction: Circuit Court Of Jefferson County, Alabama
    Counsel: Hare, Wynn, Newell & Newton, LLP
    Nature of Suit: Medical Malpractice
    Health IT System: Cerner
    Review and analyze electronic health records, system configurations, and system generated artifacts along with internal development documents to determine the nature of microbiology laboratory results display.
  • Amy Fleschert v. Cedars-Sinai Medical Center |
    Jurisdiction: Superior Court of California, County of Los Angeles
    Counsel: Carpenter Law
    Nature of Suit: Class Action, Medical Billing
    Health IT System: Epic
    Assist in the review and analysis of billing information to aid in determination of system export capabilities regarding medical billing
  • James Barcz v. Mercy Hospital Cedar Rapids Iowa, |
    Jurisdiction: Iowa District Court for Linn County
    Counsel: Hayes Lorenzen Lawyers, PLC
    Nature of Suit: Medical Malpractice
    Health IT System: Epic
    Review and analyze electronic health records, audit logs, and automated vitals machine data.
  • RedVector.com, LLC v. Locality Media, Inc |
    Case Number: 21-CA-001419
    Filed in: Delaware District Court
    Retained by: Plaintiff
  • Ruth Elsie Sowder v. Louis Kattine, M.D., |
    Jurisdiction: Montana Fourth Judicial District Court Missoula County
    Counsel: Hall Booth Smith
    Nature of Suit: Medical Malpractice
    Health IT System: Epic
    Review and guide client on subpoena requests for audit trails across multiple Epic features such as InBasket messages and Sticky Notes. Review relevant audit trails and electronic health records.
  • Tony L. Sylvester v. University of S. Alabama Health Services Foundation (representing Laboratory Corporation of America Holdings) |
    Jurisdiction: Circuit Court, Mobile County Alabama
    Counsel: Lewis Rice, LLC
    Nature of Suit: Medical Malpractice
    Health IT System: LabCorp, NextGen, Cerner
    Review and analyze electronic health records, audit logs, interface messages (HL7) relevant to the case. Provide expert analysis on industry standard laboratory information system (LIS) integration with EHR systems.
  • Angela Prieto v. Rush University Medical Center |
    Jurisdiction: Circuit Court, Cook County Illinois
    Case Number: 18 L 003531
    Counsel: Swanson, Martin & Bell LLP
    Nature of Suit: Medical Malpractice
    Health IT System: Epic
    Review and provide affidavit and analysis of electronic health records, audit logs, and system configurations for the Epic EHR.
  • Byron Foxie v. Ann and Robert Lurie Children’s Hospital of Chicago and Almost Home |
    Jurisdiction: Circuit Court, Cook County Illinois
    Case Number: 19 L 7430
    Counsel: Barker, Castro & Steinbeck, LLC
    Nature of Suit: Medical Malpractice
    Health IT System: Epic
    Assist with the review and discovery production of electronic health record information relevant to the case. Provide analysis of electronic health records, audit logs, and system configurations for the Epic EHR.
  • Masonicare Corporation v. Cerner Corporation |
    Jurisdiction: U.S. District Court
    District of Connecticut
    Counsel: Blank Rome LLP
    Nature of Suit: breach of contract
    Description of Services: providing analysis of the attempted implementation of Cerner’s CommunityWorks EHR product and related software for use with Masonicare’s residential living, skilled nursing, long term care, acute care and home care services; work includes review of the health IT software and services and compliance with industry standards.
  • Roche Diabetes Care, Inc v. Insulet Corporation |
    Jurisdiction: U.S. District Court
    District of Delaware
    Counsel: Willkie Farr & Gallagher LLP
    Nature of Suit: patent infringement
    Description of Services: provided expert report and deposition testimony regarding design and function of medical device source code for use in insulin pumps and diabetes management.
  • People of the State of California; Aetna Health of California v. Dr. Shahrokh Dayyani |
    Jurisdiction: Superior Court, State of CA, County of Los Angeles
    Counsel: Kennaday Leavitt PC
    Nature of Suit: healthcare billing fraud
    Description of Services: assisting with the review and discovery production of electronic health record information relevant to the case and providing analysis regarding industry standards for electronic health record audit logs.
  • Ellen Turner, Estate of Kelly Turner v. University Health Care Physicians, Inc and Robert Cicchino |
    Jurisdiction: Circuit Court of Berkeley County West Virginia
    Counsel: West Virginia United Health System
    Nature of Suit: medical malpractice
    Description of Services: assisting with the review of electronic health record information relevant to the case and providing analysis regarding industry standards for electronic health record audit logs.
  • Truinject Corp. v. Nestle Skin Health, S.A. |
    Jurisdiction: U.S. District Court
    District of Delaware
    Counsel: Beus Gilbert McGroder PLLC
    Nature of Suit: breach of contract, fraud, patent infringement, trade secret misappropriation
    Description of Services: providing expert analysis including source code analysis for medical injection training software and patents; provided expert report.
  • Allscripts Healthcare, LLC v. Andor Health LLC |
    Jurisdiction: U.S. District Court
    District of Delaware
    Counsel: Lock Lorde LLP
    Nature of Suit: health IT software contract and trade secret dispute
    Description of Services: provided expert report, deposition testimony and expert analysis including source code comparison of configuration software for patient engagement applications.
  • Aetna Inc v. Mednax, Inc |
    Jurisdiction: U.S. District Court
    Eastern District of Pennsylvania
    Counsel: Robbins, Russell, Englert, Orseck & Untereiner LLP
    Nature of Suit: medical billing fraud claim
    Description of Services: provided expert analysis and authored expert report regarding the use of IT technology in medical records and billing software, including the use of artificial intelligence.
  • WIPRO Limited, LLC v. State of Nebraska |
    Jurisdiction: District Court of Lancaster County, Nebraska
    Counsel: Cline Williams Wright Johnson & Oldfather, LLP
    Nature of Suit: contract dispute
    Description of Services: providing expert services regarding the development of software and services for the State of Nebraska’s Medicaid Eligibility and Enrollment solution.
  • NCH Healthcare Systems Inc v. PaxeraHealth |
    Jurisdiction: U.S. District Court
    Middle District of Florida, Fort Myers Division
    Counsel: Wicker Smith
    Nature of Suit: contract dispute
    Description of Services: providing expert services regarding the installation and use of Health IT technology for radiology services, specifically a picture archiving (PACS) system in a hospital setting; provided expert report.
  • Lenovo Group Limited |
    Counsel: Sheppard Mullin Richter and Hampton LLP
    Nature of Suit: 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 v.
    Emerson Process Management LLP     |
    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 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 v.
    TCL Communication Technology Holdings, Ltd     |
    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 |
    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
  • Wasielewicz v.
    Southwestern Illinois Health Facilities, Inc     |
    Jurisdiction: Illinois State Court, Madison County
    Counsel: Thurman Law
    Nature of Suit: Defect Analysis
    Prepared for expert testimony re: medical records software defects
  • 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
    Intellectual Ventures, LLC v. T-Mobile USA, Inc
    Intellectual Ventures, LLC v. Nextel Operations, Inc
    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
    ROY-G-BIV Corporation v. Siemens Corporation
    ROY-G-BIV Corporation v. ABB, Ltd.     |
    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
  • 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
    Delivered code review and infringement analysis for three patents across a number of smartphone models running the Android operating system.
  • 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
    Provided source code review and analysis and authored expert report.
  • Anthony Dike, M.D. v. Kindred Healthcare Operating, Inc |
    Jurisdiction: Superior Court of the State of California, County of Los Angeles–East District
    Counsel: Giovanniello & Michels, LLP
    Nature of Suit: Loss of Property
    Valuation of medical software and best practices analysis.
  • 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
  • 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

Management, Audits, & Compliance Consulting

  • MAK-SYSTEM Group |
    Providing training to MAK-SYSTEM personnel to prepare for FDA audit including content, audit process, and preparedness strategies. Performin a mock audit utilizing the FDA’s Quality Systems Guide to Inspections of Quality Systems. Based on QSR and other applicable 21 CFR Part 800 and ISO 13485 requirements. Will incorporate applicable FDA guidance such as General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002) and the ISO 14971 and 62304 standards.
  • Technical Due Diligence–Artificial Intelligence in Healthcare
    (CLIENT CONFIDENTIAL)     |
    Performing consultation in the context of a sale/transfer of technology; analysis regarding industry best practices and compliance for artificial intelligence in Health IT. Applications are predictive care models for use in hospitals for detection of sepsis and other “early warning” signals. Analysis of source code in HL7, FHIR, Pytorch and Airflow; analysis of algorithm training, model selection and validation, and MLOps processes.
  • 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.
  • Greenway Health |
    Performing consultation regarding compliance and regulatory matters for Certified Health IT software.
  • Integra Connect |
    Performing gap analysis and recommendations for improving compliance with CEHRT regulations for Certified Health IT software.
  • 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.
Download Brad’s CV

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George Edwards, PhD
President & Principal Computer Scientist Los Angeles

Dr. George Edwards has more than twenty years of experience as a scientist, engineer, and technical consultant to academic research labs, government agencies, and technology companies, and he has served as a software expert in various litigation contexts, including more than fifty patent infringement cases.

LitigationLitigationSenior Testifying Expert
Vikas Sharma | Director of Patent Services
Vikas Sharma
Director of Patent Services Austin

Vikas is an IP expert with 15+ years of experience in source code review, patent portfolio analysis, and monetizing client patent portfolios. He leads teams of consultants to perform source code discovery, drafting expert witness reports, creating validity and non-infringement rebuttal reports, and assisting attorneys during technical depositions and trials.

LitigationLitigationSenior Consulting Expert
Ray Chiang | Software Consultant and Code Analyst
Ray Chiang
Senior Software Consultant Orange County

Ray Chiang is a software consultant and code analyst involved in technologies related to systems engineering, digital media, embedded system, consumer electronics, and industry-standard development. He is skilled in source code review and reverse-engineering.

LitigationLitigationConsulting Expert
Health ITFocus AreaSoftware Quality & Source Code
Due DiligenceArea of ExpertiseDigital Media & Code Analysis
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