Sheila Sokolowski

Shareholder

Sheila Sokolowski chairs the Firm’s Privacy and Data Protection Practice.  Her clients include Fortune 500 companies, health care data streaming and machine learning platforms, and institutions of higher education.  Sheila advises clients on data privacy and security risk mitigation and management strategies, including data breach and security incident responses.   She collaborates with in-house legal and technical professionals to develop scalable, risk-based data privacy and security legal compliance solutions, encompassing the FTC Act, HIPAA/HITECH, 42 C.F.R. Part 2, FERPA and GDPR.

Sheila counsels emerging life sciences companies on practical, business-focused legal compliance strategies to address the federal regulation of health care providers and clinical research, including the Stark Law, the federal Anti-Kickback Statute, state and federal false claims acts, HIPAA/HITECH, the Food, Drug, and Cosmetic Act, and the Federal Policy for the Protection of Human Subjects (the “Common Rule”).  She also counsels investors seeking to evaluate and understand the health care regulatory risks involved in transactions with emerging life sciences companies.

Sheila is the creator and host of  HIPAA Bytes, a series of podcasts addressing specific issues raised by the HIPAA privacy, security and breach notification regulations and providing practical guidance for compliance. She regularly speaks to national audiences about health care data privacy and security compliance, as well as the legal issues that arise in the context of clinical research arrangements.

 

Education

  • University of Texas, School of Law (J.D.)
  • Barnard College (B.A.)

Admissions

  • Illinois (2009)
  • Texas (2001)
  • American Bar Association
  • American Health Lawyers Association
  • Illinois Association of Healthcare Attorneys
  • International Association of Privacy Professionals

Events

  • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, New Orleans (September 27, 2018).
  • “CECU Cybersecurity Panel,” Career Education Colleges and Universities Annual Conference, Orlando (June 4, 2018).
  • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, Orlando (October 5, 2017).
  • “Mobile Devices and Healthcare: Navigating HIPAA and Other Legal Privacy Risks”, Clear Law Institute CLE Webinar (June 7, 2017).
  • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, Montreal (September 29, 2016).
  • “Stark Law Update: New Exceptions, Clarifications and Revisions,” National Constitution Center CLE Webinar (December 17, 2015).
  • “Privacy and Security for Colleges and Universities: Navigating the Legal Risks,” Career Education Colleges and Universities Webinar (November 4, 2015).
  • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, Denver (September 17, 2015).
  • “Phase 2 HIPAA Audits: Preparing for When the OCR Comes Knocking,” National Constitution Center CLE Webinar (August 6, 2015).
  • “Stark Law & OIG Activity Update: Changes, Challenges and Recent Litigation,” National Constitution Center CLE Webinar (December 11, 2014).
  • “Patient Engagement: Legal Risks and Practical Realities,” Chicago Bar Association, Health Law Committee (October 22, 2014).
  • “Access to Electronic Health Information: Navigating HIPAA & Meaningful Use Stage 2,” National Constitution Center CLE Webinar (August 6, 2014).
  • “HIPAA Audits: Issues & Answers for Privacy, Security and Breach Requirements,” National Constitution Center CLE Webinar (May 13, 2014).
  • “HIPAA Update: What You Need to Know,” Pincus Professional Education CLE Webinar (April 8, 2014).
  • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, New Orleans (September 26, 2013).
  • “The Final HIPAA Omnibus Rule: What You Need to Know Now,” National Constitution Center CLE Webinar (August 6, 2013; March 13, 2013).
  • “Business Associates Under the Final HIPAA Omnibus Rule,” National Constitution Center CLE Webinar (June 11, 2013).
  • “HIPAA Compliance Update: HITECH Rulemaking and Enforcement,” National Constitution Center CLE Webinar (October 26, 2011).
  • “HIPAA Compliance Update: Facebook, Twitter and Legal Liabilities,” National Constitution Center CLE Webinar (May 5, 2011).
  • Profile

    Sheila Sokolowski

    Shareholder

    Sheila Sokolowski chairs the Firm’s Privacy and Data Protection Practice.  Her clients include Fortune 500 companies, health care data streaming and machine learning platforms, and institutions of higher education.  Sheila advises clients on data privacy and security risk mitigation and management strategies, including data breach and security incident responses.   She collaborates with in-house legal and technical professionals to develop scalable, risk-based data privacy and security legal compliance solutions, encompassing the FTC Act, HIPAA/HITECH, 42 C.F.R. Part 2, FERPA and GDPR.

    Sheila counsels emerging life sciences companies on practical, business-focused legal compliance strategies to address the federal regulation of health care providers and clinical research, including the Stark Law, the federal Anti-Kickback Statute, state and federal false claims acts, HIPAA/HITECH, the Food, Drug, and Cosmetic Act, and the Federal Policy for the Protection of Human Subjects (the “Common Rule”).  She also counsels investors seeking to evaluate and understand the health care regulatory risks involved in transactions with emerging life sciences companies.

    Sheila is the creator and host of  HIPAA Bytes, a series of podcasts addressing specific issues raised by the HIPAA privacy, security and breach notification regulations and providing practical guidance for compliance. She regularly speaks to national audiences about health care data privacy and security compliance, as well as the legal issues that arise in the context of clinical research arrangements.

     

  • Education/Admissions

    Education

    • University of Texas, School of Law (J.D.)
    • Barnard College (B.A.)

    Admissions

    • Illinois (2009)
    • Texas (2001)
  • Memberships/Affiliations
    • American Bar Association
    • American Health Lawyers Association
    • Illinois Association of Healthcare Attorneys
    • International Association of Privacy Professionals
  • Publications/Events

    Events

    • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, New Orleans (September 27, 2018).
    • “CECU Cybersecurity Panel,” Career Education Colleges and Universities Annual Conference, Orlando (June 4, 2018).
    • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, Orlando (October 5, 2017).
    • “Mobile Devices and Healthcare: Navigating HIPAA and Other Legal Privacy Risks”, Clear Law Institute CLE Webinar (June 7, 2017).
    • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, Montreal (September 29, 2016).
    • “Stark Law Update: New Exceptions, Clarifications and Revisions,” National Constitution Center CLE Webinar (December 17, 2015).
    • “Privacy and Security for Colleges and Universities: Navigating the Legal Risks,” Career Education Colleges and Universities Webinar (November 4, 2015).
    • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, Denver (September 17, 2015).
    • “Phase 2 HIPAA Audits: Preparing for When the OCR Comes Knocking,” National Constitution Center CLE Webinar (August 6, 2015).
    • “Stark Law & OIG Activity Update: Changes, Challenges and Recent Litigation,” National Constitution Center CLE Webinar (December 11, 2014).
    • “Patient Engagement: Legal Risks and Practical Realities,” Chicago Bar Association, Health Law Committee (October 22, 2014).
    • “Access to Electronic Health Information: Navigating HIPAA & Meaningful Use Stage 2,” National Constitution Center CLE Webinar (August 6, 2014).
    • “HIPAA Audits: Issues & Answers for Privacy, Security and Breach Requirements,” National Constitution Center CLE Webinar (May 13, 2014).
    • “HIPAA Update: What You Need to Know,” Pincus Professional Education CLE Webinar (April 8, 2014).
    • “Legal Issues Involving Clinical Research, Including Scientific Misconduct,” Society of Clinical Research Associates, New Orleans (September 26, 2013).
    • “The Final HIPAA Omnibus Rule: What You Need to Know Now,” National Constitution Center CLE Webinar (August 6, 2013; March 13, 2013).
    • “Business Associates Under the Final HIPAA Omnibus Rule,” National Constitution Center CLE Webinar (June 11, 2013).
    • “HIPAA Compliance Update: HITECH Rulemaking and Enforcement,” National Constitution Center CLE Webinar (October 26, 2011).
    • “HIPAA Compliance Update: Facebook, Twitter and Legal Liabilities,” National Constitution Center CLE Webinar (May 5, 2011).
Sheila Sokolowski