Lidia Niecko-Najjum is a senior counsel in Crowell & Moring’s Health Care Group and is part of the firm’s Digital Health Practice. With over 15 years of clinical, policy, and legal experience, Lidia provides strategic advice on health care regulatory and policy matters, with particular focus on artificial intelligence, machine learning, digital therapeutics, telehealth, interoperability, and privacy and security. Representative clients include health plans, health systems, academic medical centers, digital health companies, and long-term care facilities.
Lidia’s experience includes serving as a senior research and policy analyst at the Association of American Medical Colleges on the Policy, Strategy & Outreach team. Lidia also practiced as a nurse at Georgetown University Hospital in the general medicine with telemetry unit and the GI endoscopy suite, where she assisted with endoscopic procedures and administered conscious sedation.
Speeches & Presentations
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“How Rapidly Changing Data Policy Is Impacting Digital Health Innovation,” Healthcare Ounce of Prevention Seminar (HOOPS) 2023–Navigating the Rapid Developments in Health Care.
(March 16, 2023).
Presenters: Brandon Ge, Lidia Niecko-Najjum, Tara Singh, and Savanna Williams.
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"Aetna/CVS Health and Crowell & Moring Seminar: Hot Regulatory Issues in Health Care - Telehealth," Crowell & Moring Webinar, 2022.
(July 13, 2022).
Speakers: Jodi G. Daniel and Lidia Niecko-Najjum.
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“COVID-19 Vaccination for Health Care Workers: Review of CMS Emergency Regulation and Answering Common Questions," Crowell & Moring Webinar
(November 12, 2021).
Speakers: Troy A. Barsky, Janet C. Walker, Lidia Niecko-Najjum, and Tyler Brown.
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“Digital Health 2021: Telehealth and Remote Monitoring: Requirements, Reimbursement, and Risks under California and Federal Law,” Practising Law Institute
(July 22, 2021).
Presenters: Alice Hall-Partyka, Jodi Daniel, and Lidia Niecko-Najjum.
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"Health Information Privacy, Interoperability, and Patient Access to Data: Compliance and Opportunities Regarding Data Use and Data Protections," Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era
(February 25, 2021).
Presenters: Jodi G. Daniel, Brandon C. Ge, and Lidia Niecko-Najjum.
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"Telehealth and Remote Monitoring: Requirements, Reimbursement, FDA Oversight, and Risks," Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era
(February 22, 2021).
Presenters: Jodi G. Daniel, Lidia Niecko-Najjum, and Nicholas J. Diamond.
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"Telehealth has become essential during the pandemic; what are the current parameters and will that continue post-COVID?" Crowell & Moring Webinar
(December 11, 2020).
Presenters: Jodi G. Daniel and Lidia Niecko-Najjum.
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"Telemedicine: Regulatory Compliance Concerns in a Rapidly Changing Environment," Health Care Compliance Institute’s 22nd Annual Compliance Institute, Las Vegas, Nevada
(April 16, 2018).
Co-Presenter: Lidia Niecko-Najjum.
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"Pre-Summit Session C: Mini Course - Telehealth 101," Mid-Atlantic’s Telehealth Resource Center Telehealth Summit, Hershey, Pennsylvania
(April 15, 2018).
Co-Presenter: Lidia Niecko-Najjum.
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"Keeping Up with Technology & Compliance in Your Practice – Telemedicine, AI & Blockchains," 3rd Annual Healthcare Law & Compliance Boot Camp for Healthcare Providers, Washington D.C.
(February 24, 2018).
Presenter: Lidia Niecko-Najjum.
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"NOVA Lean Startups Presentations & Panel Discussion," Tysons Corner Health IT Roundtable
(June 29, 2017).
Panelist: Lidia Niecko-Najjum.
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"Hot Topics in Health Law: Perspectives on Where We Were and Where We Are," FDA and Telehealth, Women’s Bar Association of the District of Columbia, Health Law Forum
(March 23, 2017).
Panelist: Lidia Niecko-Najjum.
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"Telemedicine in the DMV – A Primer," 2nd Annual Healthcare Law & Compliance Boot Camp for Healthcare Providers, Washington, D.C.
(February 25, 2017).
Presenter: Lidia Niecko-Najjum.
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"Federal Stark Law and Anti-Kickback Statute: Key Concepts," 2nd Annual Healthcare Law & Compliance Boot Camp for Healthcare Providers, Washington, D.C.
(February 25, 2017).
Presenter: Lidia Niecko-Najjum.
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"HIPAA Breach Notification Rule," Periodontal and Implant Association of Greater Washington, Chevy Chase, Maryland
(February 7, 2017).
Co-Presenter: Lidia Niecko-Najjum.
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"Legal Issues Related to Telehealth and Mobile Health," Tysons Corner Health Information Technology Meetup, Tysons Corner, Virginia
(May 25, 2016).
Co-Presenter: Lidia Niecko-Najjum.
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"Telemedicine: What Is It and What Are Some Potential Legal Issues With It?" D.C. Bar Health Law Section, Washington, D.C.
(March 3, 2016).
Co-Presenter: Lidia Niecko-Najjum.
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"Medicare Rules on Telemedicine: How to Get Paid," Annual Healthcare Law & Compliance Boot Camp for Healthcare Providers, Washington, D.C.
(February 20, 2016).
Presenter: Lidia Niecko-Najjum.
Publications
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"OCR Issues Anti-Discrimination Guidance for Pharmacies Related to Reproductive Health Care Services," Crowell & Moring’s Health Law Blog
(July 25, 2022).
Authors: Jodi G. Daniel, Lidia Niecko-Najjum and Sarah Rippy.
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"CMS Issues First FAQs on the CMS Interoperability and Patient Access Rule," Crowell & Moring’s Health Law Blog
(May 24, 2021).
Authors: Jodi G. Daniel and Lidia Niecko-Najjum.
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"OIG Sends a Special Fraud Alert on Speaker Programs," Crowell & Moring’s Health Law Blog
(November 25, 2020).
Authors: Troy A. Barsky, Michael Shaheen and Lidia Niecko-Najjum.
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"HHS Approves Telecommunications for Providing Medicare Home Health Services, on a Permanent Basis, Effective January 1, 2021," Crowell & Moring’s Health Law Blog
(November 9, 2020).
Authors: Brian McGovern and Lidia Niecko-Najjum.
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"[U.S.] Digital Health and Health Care IT," Digital Health 2020, International Comparative Legal Guides
(March 2020).
Co-Author: Lidia Niecko-Najjum.
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"Telemedicine," American Bar Association/BNA Books, E-Health, Privacy and Security Law, Fourth Edition
(November 2018).
Chapter Co-Author: Lidia Niecko-Najjum.
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"Obligations in Response to a Health Care Data Security Breach," American Bar Association/BNA Books, E-Health, Privacy and Security Law, Third Edition
(November 2016).
Chapter Co-Author: Lidia Niecko-Najjum.
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"Postmarketing Obligations & REMS (Risk Evaluation and Mitigation Strategies) Programs," Bringing Your Pharmaceutical Drug to Market, The Food and Drug Law Institute
(May 2015).
Chapter Co-Author: Lidia Niecko-Najjum.
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"Primary Care Teams: Are We There Yet? Implications for Workforce Planning," Acad. Med. 2013 Dec; 88 (12):1827-9.
Authors: Grover A, Niecko-Najjum LM.
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"Building a Health Care Workforce for the Future: More Physicians, Professional Reforms, and Technological Advances," Health Aff (Millwood). 2013 Nov; 32(11):1922-27.
Authors: Grover A, Niecko-Najjum LM.
Client Alerts & Newsletters
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"CMS Issues a New “Advancing Interoperability and Improving Prior Authorization Processes” Proposed Rule,"
Health Care Alert
(December 22, 2022).
Contacts: Jodi G. Daniel, Lidia Niecko-Najjum, Tara Singh, Allison Kwon
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"FDA Issues Final Guidance on Clinical Decision Support Software,"
Mass Tort, Product, and Consumer Litigation Alert
(October 10, 2022).
Contacts: Jodi G. Daniel, Tara Singh, John Fuson, Robbie Rogart Jost, Rachael Padgett, Lidia Niecko-Najjum
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"CMS Releases Rule Requiring COVID-19 Vaccinations for Health Care Workers,"
Health Care Alert
(November 5, 2021).
Contacts: Troy A. Barsky, Lidia Niecko-Najjum, Janet C. Walker, Savanna Williams
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"Payers, Providers, and Patients – Oh My!: Business and Clinical Considerations for the Ketamine Industry,"
Podcast: Payers, Providers, and Patients – Oh My!
(October 25, 2021).
Contacts: Payal Nanavati, Joe Records, Lidia Niecko-Najjum, John T. Brennan Jr.
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"OIG Issues Final Rule to Update AKS Safe Harbors: Part II,"
Administrative Law Alert
(February 25, 2021).
Contacts: Troy A. Barsky, Jodi G. Daniel, Michael Shaheen, Lidia Niecko-Najjum, Joe Records, Matthew Vicinanzo
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"HHS Finalizes SUNSET Rule, Placing Thousands of Regulations at Risk of Invalidation,"
Health Care Alert
(January 15, 2021).
Contacts: Jodi G. Daniel, Lidia Niecko-Najjum, Samuel H. Ruddy
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"CMS Expands on Patient Access and Interoperability Requirements for Health Plans,"
Health Care Alert
(December 18, 2020).
Contacts: Jodi G. Daniel, Lidia Niecko-Najjum
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"HHS NPRM Could Invalidate Thousands of Regulations,"
Health Care Alert
(December 7, 2020).
Contacts: Jodi G. Daniel, Lidia Niecko-Najjum
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"CMS Issues Sweeping Reform to Modernize the Stark Law: Part I,"
Health Care Alert
(November 30, 2020).
Contacts: Troy A. Barsky, John T. Brennan Jr., Lidia Niecko-Najjum, Roma Sharma
Firm News & Announcements