Computer Scientist

Brad Ulrich

VP of Health IT & Audits

Brad Ulrich has a 15+ 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 Experience

Masonicare Corporation v. Cerner Corporation | Apr 2022–Present
Jurisdiction: U.S. District Court
District of Connecticut
Counsel: Blank Rome LLP
Nature of Matter: 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 | Jan 2022–Present
Jurisdiction: U.S. District Court
District of Delaware
Counsel: Willkie Farr & Gallagher LLP
Nature of Matter: 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 et. al. v.
Dr. Shahrokh Dayyani et. al. | Nov 2021–Present
Jurisdiction: Superior Court, State of CA, County of Los Angeles
Counsel: Kennaday Leavitt PC
Nature of Matter: 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 | May 2021–Present
Jurisdiction: Circuit Court of Berkeley County West Virginia
Counsel: West Virginia United Health System
Nature of Matter: 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. et al. | Dec 2021–Present
Jurisdiction: U.S. District Court
District of Delaware
Counsel: Beus Gilbert McGroder PLLC
Nature of Matter: 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 et al. | Nov 2021–Present
Jurisdiction: U.S. District Court
District of Delaware
Counsel: Lock Lorde LLP
Nature of Matter: 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. et al. v. Mednax, Inc. et al. | Oct 2020 – July 2021
Jurisdiction: U.S. District Court
Eastern District of Pennsylvania
Counsel: Robbins, Russell, Englert, Orseck & Untereiner LLP
Nature of Matter: 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 | Oct 2020 – Present
Jurisdiction: District Court of Lancaster County, Nebraska
Counsel: Cline Williams Wright Johnson & Oldfather, LLP
Nature of Matter: 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 | May 2020 – Present
Jurisdiction: U.S. District Court
Middle District of Florida, Fort Myers Division
Counsel: Wicker Smith
Nature of Matter: 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 | Mar 2020 – May 2020
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 | July 2018 – May 2019
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. | Nov 2016 – Nov 2017
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 et. al. | May 2016 – April 2017
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 | Sept 2016 – June 2017
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. | Nov 2015–Present
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 | May 2015–Present
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. | Apr 2015–Present
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. | Mar 2015–Present
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. | Feb 2015–Mar 2015
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 | Jan 2015–Mar 2015
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. | Feb 2015–Present
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. | Feb 2015–Present
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. | Oct 2014–Mar 2015
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. | Oct 2014–Dec 2014
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. | June 2014–Mar 2015
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 | June 2014–Sep 2014
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. | Oct 2013–Present
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. | Oct 2013–Dec 2014
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 et. al. | Oct 2013–Jan 2014
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 | Dec 2013–Present
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 | Oct 2013–Present
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. | Oct 2013–Sept 2014
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. | Aug 2013–Present
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. | Aug 2013–Present
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 | Feb 2013–May 2013
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 | Mar 2013–Dec 2013
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 | Mar 2013–Mar 2014
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 | June 2013–Present
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 | Aug 2012–Present
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. | July 2012–Mar 2013
Jurisdiction: U.S. District Court for the Eastern District of Texas
Counsel: Desmarais LLP
Nature of Suit: Intellectual Property–Patent

Management, Audits, & Compliance Consulting

Technical Due Diligence–Artificial Intelligence in Healthcare
(CLIENT CONFIDENTIAL) | May 2022–Present
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.
Electronic Health Record Vendor
(CONFIDENTIAL) | Feb 2019–Jan 2020
Performing consultation regarding compliance and regulatory matters for Certified Health IT software.
Electronic Health Record Vendor
(CONFIDENTIAL) | Mar 2019–Present
Performing gap analysis and recommendations for improving compliance with CEHRT regulations for Certified Health IT software.
REMS–Data, Quality, Process and Systems Review
(CONFIDENTIAL) | Apr 2019–Present
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) | Nov 2017–Present
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 | Aug 2017–Dec 2018
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 | July 2017–Feb 2021
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 | Nov 2016–June 2017
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) | Mar 2016–Dec 2016
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

Location

Brad is working in our Nashville office.

Practice Areas

LitigationLitigationSenior Testifying Expert

Health ITFocus AreaSoftware & Standards

Due DiligenceArea of ExpertiseHealth IT & Standards

Download Brad’s CV

Brad served four years as project lead of the nation's first multi-disciplinary EHR Software Quality Oversight Organization under the purview of HHS-OIG and the ONC.

Brad is a software engineer specialized in assisting companies and government agencies in the Health IT and Life Sciences industries with software quality and regulatory compliance matters.