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Lidia Niecko-Najjum
Of Counsel
Regulatory
Washington, D.C.
lnieckonajjum@wsgr.com

D202-791-8007

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  • Experienced Healthcare Regulatory Attorney

    Well-versed in health data use and exchange laws, Lidia provides strategic counseling to a broad range of technology companies, payers, and healthcare providers.

  • Strategic Counsel on Health Data Use and Exchange

    Lidia has extensive experience advising on complex regulatory issues related to compliance with HIPAA, privacy, information blocking, interoperability, and AI laws, as well as TEFCA.

  • Other Roles

    Lidia draws on her clinical nursing and health policy analyst experience to provide uniquely informed legal counsel to clients.

Lidia Niecko-Najjum is Of Counsel in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where she provides strategic counseling on health care regulatory and policy matters. Lidia is a seasoned attorney and former nurse with over 15 years of legal and policy experience. Her practice is focused on data use, interoperability, information blocking, privacy and security, artificial intelligence, machine learning, digital therapeutics, and telehealth. Her representative clients include digital health companies, health information networks, health plans, health systems, and academic medical centers.

Lidia provides strategic counseling for the development of digital health products and services. She advises clients on best practices to reduce regulatory risk, including compliance, training, tracking, and monitoring of regulatory developments. She also advises on digital health delivery models, addressing issues related to privacy and security, interoperability and information blocking, and telehealth.

Lidia regularly engages with regulators regarding governmental inquiries and investigations, as well as the implementation of rules and regulations related to data use and protection. She has also advised on the developing Trusted Exchange Framework and Common Agreement (TEFCA) requirements, particularly as it relates to information exchange for “treatment” purposes.

Lidia has also led healthcare regulatory due diligence for both sellers and buyers in anticipation of transactions, which includes revising purchase agreements and master service agreements related to regulatory compliance.

Prior to practicing law, Lidia served as a senior research and policy analyst at the Association of American Medical Colleges as part of the Policy, Strategy & Outreach team. Before law school, Lidia practiced as a nurse at Georgetown University Hospital in the general medicine with telemetry unit and the GI endoscopy suite.

Lidia is fluent in Polish.

Experience

Lidia Niecko-Najjum is Of Counsel in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where she provides strategic counseling on health care regulatory and policy matters. Lidia is a seasoned attorney and former nurse with over 15 years of legal and policy experience. Her practice is focused on data use, interoperability, information blocking, privacy and security, artificial intelligence, machine learning, digital therapeutics, and telehealth. Her representative clients include digital health companies, health information networks, health plans, health systems, and academic medical centers.

Lidia provides strategic counseling for the development of digital health products and services. She advises clients on best practices to reduce regulatory risk, including compliance, training, tracking, and monitoring of regulatory developments. She also advises on digital health delivery models, addressing issues related to privacy and security, interoperability and information blocking, and telehealth.

Lidia regularly engages with regulators regarding governmental inquiries and investigations, as well as the implementation of rules and regulations related to data use and protection. She has also advised on the developing Trusted Exchange Framework and Common Agreement (TEFCA) requirements, particularly as it relates to information exchange for “treatment” purposes.

Lidia has also led healthcare regulatory due diligence for both sellers and buyers in anticipation of transactions, which includes revising purchase agreements and master service agreements related to regulatory compliance.

Prior to practicing law, Lidia served as a senior research and policy analyst at the Association of American Medical Colleges as part of the Policy, Strategy & Outreach team. Before law school, Lidia practiced as a nurse at Georgetown University Hospital in the general medicine with telemetry unit and the GI endoscopy suite.

Lidia is fluent in Polish.

Education
  • Graduate Certificate in Health Care Corporate Compliance, The George Washington University, 2011
  • J.D., University of Richmond School of Law, 2010
  • B.S., Nursing with a Double Major in Economics, University of Virginia, 2003
Admissions
  • Bar of the District of Columbia
Credentials
Education
  • Graduate Certificate in Health Care Corporate Compliance, The George Washington University, 2011
  • J.D., University of Richmond School of Law, 2010
  • B.S., Nursing with a Double Major in Economics, University of Virginia, 2003
Admissions
  • Bar of the District of Columbia

Select Publications

  • Co-author, “Health Data—Promoting Interoperability and Prohibiting Information Blocking,” Health Law Handbook, 2021 Edition, Thomson Reuters, 2021
  • Co-author, “Telemedicine,” E-Health, Privacy and Security Law, 4th Edition, American Bar Association/BNA Books, 2018
  • Co-author, “Obligations in Response to a Health Care Data Security Breach,” E-Health, Privacy and Security Law, 3rd Edition, American Bar Association/BNA Books, 2016
  • Co-author, “Building a healthcare workforce for the future: more physicians, professional reforms, and technological advances,” 32(11) Health Aff (Millwood) 1922-27, 2013

Select Speaking Engagements

  • Co-presenter, “Health Data Regulations – Privacy and Interoperability,” AHLA at the Department of Labor, September 13, 2024
  • Co-presenter, “California Data Exchange Framework: Legal and Compliance Consideration for Health Plans,” California Association of Health Plans, December 12, 2023
Insights

Select Publications

  • Co-author, “Health Data—Promoting Interoperability and Prohibiting Information Blocking,” Health Law Handbook, 2021 Edition, Thomson Reuters, 2021
  • Co-author, “Telemedicine,” E-Health, Privacy and Security Law, 4th Edition, American Bar Association/BNA Books, 2018
  • Co-author, “Obligations in Response to a Health Care Data Security Breach,” E-Health, Privacy and Security Law, 3rd Edition, American Bar Association/BNA Books, 2016
  • Co-author, “Building a healthcare workforce for the future: more physicians, professional reforms, and technological advances,” 32(11) Health Aff (Millwood) 1922-27, 2013

Select Speaking Engagements

  • Co-presenter, “Health Data Regulations – Privacy and Interoperability,” AHLA at the Department of Labor, September 13, 2024
  • Co-presenter, “California Data Exchange Framework: Legal and Compliance Consideration for Health Plans,” California Association of Health Plans, December 12, 2023
Focus Areas
  • AI in Healthcare
  • Biotech
  • Digital Health
  • FDA Regulatory, Healthcare, and Consumer Products
  • Life Sciences
  • Medical Devices
  • Regulatory
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