Michelle Wilcox DeBarge

Partner

Michelle Wilcox DeBarge
Partner
offices New Haven
Hartford
New York
phone 203-498-4312
fax203-782-2889
emailmdebarge@wiggin.com
view LinkedIn profile


Biography

Michelle has spent nearly 25 years helping clients manage their legal risk so that they can focus on their mission and key business objectives.

A former executive in the nonprofit sector, Michelle chairs Wiggin and Dana’s HIPAA Practice Group and co-chairs the Cybersecurity and Privacy Practice Group. She also chairs the Clinical Research Regulation and Compliance Practice Group and is a member of the firm's Health Care and Biotechnology and Life Sciences Practice Groups.

Highly regarded for analytical and people skills that supplement her depth of experience, Michelle advises national and international organizations—both well-established enterprises and startups—on a wide range of privacy/security, health care, health information technology, and clinical research issues. These issues include state and federal privacy and security requirements; data breach and incident response; and health information exchange (including data management) in the context of integrations and affiliations. Michelle advises on the European Union's (EU's) General Data Protection Regulation (GDPR), as well as on HIPAA and other U.S. and state privacy laws. Michelle holds the certifications of CIPP/U.S. (Certified Information Privacy Professional / U.S.) and CIPP/E (Certified Information Privacy Professional / Europe), both granted by the International Association of Privacy Professionals. She is a dual citizen of the U.S. and Ireland/EU and is qualified to serve as a GDPR Data Protection Officer (DPO).

Michelle’s health care practice focuses on Medicare and Medicaid compliance and audits, HIPAA and related privacy requirements, patient-care matters; clinical research regulation and clinical research contracting; and general operational matters in the health care regulatory area. Michelle regularly applies her experience in data privacy, management, and security outside of health care, to businesses in a range of industries with the same concerns.

Michelle has been recognized by Chambers USA in the category of health care. As one client put it, "The length and breadth of her legal knowledge and understanding of complex organizational issues is rare for any professional." Michelle was also named by Best Lawyers as the Hartford legal community's "Health Care Law Lawyer of the Year" for 2012 and 2016. She has been listed in The Best Lawyers in America since 2006 and as a Connecticut Super Lawyer since 2007. She has also been recognized in Best Lawyers in New England.

Before practicing law, Michelle was a program director with the American Cancer Society, where she worked with physicians, nurses, and other health professionals to implement rehabilitation and educational programs for cancer patients, health professionals, and the general public. She also supervised the communications program of a community-based health and social service agency.

Michelle lectures frequently on both the state and national level. She is a co-author of the "HIPAA Handbook: Implementing the Federal Privacy Rule in a Long-Term Care Setting," published by The American Association of Homes and Services for the Aging and is the author of "HIV-infected Physicians: The Duty to Disclose under the Informed Consent Doctrine," published in the University of Connecticut Law Review.

Michelle is a member of the International Association of Privacy Professionals (IAPP), the Applied Research Ethics National Association, and the American Health Lawyers Association. She also is former chair of the Advisory Committee on Patient Privacy and Security to the State of Connecticut's Health Information and Technology Exchange.

Michelle received her J. D. with high honors from the University of Connecticut School of Law, where she was the editor-in-chief at the University of Connecticut Law Review. She received a B. A. from Williams College and studied at the University of Kent in Canterbury, England.

Recognitions

  • Editor-in-Chief, Connecticut Law Review
  • Chambers USA, "Leading Individual," health care, since 2012
  • The Best Lawyers in America, health care, since 2006
  • Super Lawyer, health care, since 2007
  • The Best Lawyers in America, "Health Care Lawyer of the Year," Hartford legal community, 2012 and 2016

Memberships

  • American Health Lawyers Association
  • Applied Research Ethics National Association
  • Connecticut Health Lawyers Association
  • Health Care Compliance Association
  • International Association of Privacy Professionals (IAPP)



Advisories

01.23.2018The Connecticut Supreme Court Recognizes a New Cause of Action for the Breach of a Health Care Provider's Duty of Confidentiality
01.06.2017Although Delayed, New York's Aggressive Cybersecurity Law Expected to Affect Financial Services and Insurance Firms
04.22.2016The General Data Protection Regulation: Its Time Has Come
02.18.2016CMS Issues Long-Awaited Final Rule on Reporting and Returning Overpayments
02.05.2016The New E.U.-U.S. Privacy Shield: What You Need to Know
01.29.2016Cybersecurity in Postmarket Medical Devices: New Guidance from the FDA
11.23.2015FTC Administrative Law Judge to FTC: "Not So Fast on Data Security Enforcement!"
10.06.2015European Union High Court Invalidates US/EU Safe Harbor for Data Transfers
07.20.2015Connecticut General Assembly Enacts Reforms to Medicaid Audit Statute
06.22.2015Five Tips from Wiggin and Dana's Health Care Compliance and Enforcement Roundtable
06.04.2015Doing Business in Connecticut? There's a New Data Security Law You Should Get to Know
05.01.2015Getting the Board on Board: The OIG Releases Practical Guidance for Health Care Governing Boards on Compliance Oversight
03.10.2015Higher Ed Legal Update, March 2015
02.09.2015Cybersecurity Updates Newsletter, Winter 2015
02.06.2015The Anthem Breach: What Affected Group Plans Should Be Thinking About
12.10.2014The Connecticut Supreme Court Opens Door for Expanded Negligence Liability Based on HIPAA Violations
10.28.2014Cybersecurity by Design: FDA's Final Guidance for the Medical Device Industry
04.14.2014HIPAA Enforcement Update
02.21.2014Cybersecurity Updates Newsletter, February 2014
12.09.2013Cyber Attacks: A Clear and Present Danger
09.30.2013Sizzling Summer of Settlements: HIPAA Enforcement is on the Rise
07.15.2013Hospice Payments to Nursing Homes
05.07.2013A Data Privacy and Security Checklist for Management
02.20.2013The Unusual Suspects: HIPAA's Applicability Broadly Expanded to Downstream Contractors
01.30.2013Keeping Up with HIPAA: OCR's New Omnibus Rule
01.22.2013Lessons from the Most Recent HHS HIPAA Settlement
01.16.2013Summary of Wiggin and Dana's Fifth Annual Health Care Compliance and Enforcement Roundtable on HIPAA Enforcement
12.08.2011OCR Begins HIPAA Audits
09.22.2011New Laws Add More Muscle to Connecticut False Claims Act
06.16.2011New Transparency Requirements for Drug, Device, Biological and Medical Supply Manufacturers: Begin Preparing Now
03.21.2011Clinical Trial Registration Requirements: Navigating the Landscape
01.18.2011Coming Soon to a Provider Near You: Medicaid Recovery Audit Contractors and Medicaid Integrity Contractors
12.21.2010Congress Curbs the Reach of the Red Flags Rule
08.19.2010HHS Proposes HIPAA Regulatory Changes to Address HITECH.
08.11.2010ONC Establishes Temporary EHR Certification Program
09.01.2009HIPAA Covered Entities and Business Associates Now Subject to New Breach Notification Requirements
08.14.2009Compliance with Red Flags Rule
06.16.2009The HITECH Act Makes Significant Changes to HIPAA Affecting Covered Entities, Business Associates and Personal Health Record Vendors
03.13.2009Final Federal Patient Safety Regulations Provide Broad Protection to Patient Safety Data
09.29.2008New Law Concerning the Protection of Personal Information Takes Effect on October 1, 2008
12.17.2007To Revise or Not to Revise, That is the Question:
CMS's Vacillation on the Medicare Clinical Trial Policy
12.11.2007New Registration Requirements for Clinical Trials:
FDA Amendments Act of 2007
12.10.2007FDA Amendments Act of 2007 Significantly Expands Clinical Trials Registry
01.21.2005New HIPAA Challenges: Implementing the HIPAA Security Rule
01.01.2005Special Advisory: Changes to Nursing Home Residents' Bill of Rights Effective October 1, 2004
09.14.2004Changes To Citation Law For Nursing Homes Effective July 1, 2004
08.13.2004Consolidated Billing Requirements For Service Arrangements Between Skilled Nursing Facilities And Outside Service Entities
07.13.2004HIPAA Security Rule Compliance Deadline Nine Months Away: Tips for Compliance
07.12.2004Phase II Stark II Regulations Effective July 26, 2004: Key Provisions and Important Compliance Steps
02.27.2004New EMTALA Final Rule Effective November 10, 2003; EMTALA Provisions Under The Medicare Modernization Act Of 2003
09.12.2000The Department of Health and Human Services Issues Proposed Rule Containing Federal Privacy Standards
02.01.2000Connecticut's Laws Governing HIV Testing and Confidentiality of HIV/AIDS Patients

Published Works

05.18.2018Keeping Compliance in the PictureThe Journal of American Academy of Clear Aligners
05.01.2018Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical ResearchTerraLex Connections Newsletter, 2018, Edition 2
04.18.2018Batter Up: The Starting 9 GDPR Takeaways for CROsLife Science Leader (April 2018)
01.30.2018Privacy Upheaval: Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical ResearchLife Science Compliance Update
12.06.2017HIPAA: Ignore at Your Own Peril The Journal of American Academy of Clear Aligners
03.06.2017Regulatory Oversight of Third-Party Arrangements: Who's Writing the Contract?New York Law Journal
07.14.2016What's Hot in HIPAA Enforcement: A Year in ReviewTerralex Connections
05.02.2016What's Hot in HIPAA Enforcement: A Year in ReviewConnecticut Law Tribune
03.16.2015US State Supreme Court Expands Potential Negligence Liability for HIPAA Violations TerraLex Connection
05.14.2012Feds Step up HIPAA Compliance AuditsConnecticut Law Tribune, Vol. 38, No. 20
01.27.2009Make Data Protection A High Priority
01.11.2008CMS's Question: To Revise Or Not To ReviseHealthLaw 360
06.29.2006Research Compliance Q&A: Focus on The Office of the Inspector General‘s Draft Model Compliance for Recipients of PHS Research AwardsReprinted with permission of the AHIA. New Perspectives, Spring 2006
06.21.2006Research Compliance Q&A: Investigator-Initiated Clinical Research StudiesAssociation of Healthcare Internal Auditors, New Perspectives
03.16.2006Research Compliance Q&A: Focus on HIPAAAssociation of Healthcare Internal Auditors, New Perspectives, Winter 2006
02.16.2006OIG Issues Draft Compliance Guidance for Recipients of PHS Research AwardsReprinted with permission from Compliance Today, the newsletter of the Health Care Compliance Association. This article originally appeared on pages 17–18, 36 of the January 2006 issue of Compliance Today
11.07.2005Managing and Auditing Conflicts of Interest in Clinical ResearchReprinted with permission of the AHIA. New Perspectives, Fall 2005
05.10.2005Fraud and Abuse in Clinical Research: Potential Pitfalls and Practical Measures for Avoiding ThemAssociation of Healthcare Internal Auditors, New Perspectives, Spring 2005
02.14.2005Connecting Research and Compliance: Developing a Research Compliance ProgramReproduced with the permission of AHIA. The Journal of the Association of Healthcare Internal Auditors, Winter 2005
01.01.2005HIPAA Handbook: Implementing the Federal Privacy Rule in a Long-Term Care Setting
01.01.2005HIV-Infected Physicians: The Duty to Disclose Under the Informed Consent DoctrineUniversity of Connecticut Law Review
11.29.2001Wiggin & Dana Develops HIPAA Privacy Handbook for Long-Term Care Providers

News

05.04.2018Chambers USA 2018 Recognizes Wiggin and Dana Practices and Lawyers
11.20.2017Super Lawyers Recognize 37 Wiggin and Dana Attorneys
10.27.2017Wiggin and Dana Hosts Another Successful Cyber and Privacy Forum
08.15.2017Best Lawyers in America Recognizes 30 Lawyers from Wiggin and Dana
06.05.2017Chambers USA 2017 Recognizes Wiggin and Dana Practices and Lawyers
10.28.2016Super Lawyers Recognizes 40 Wiggin and Dana Attorneys
08.15.2016Best Lawyers in America Recognizes 30 Lawyers from Wiggin and Dana
05.31.2016Chambers USA 2016 Recognizes Wiggin and Dana Practices and Lawyers
10.20.2015Super Lawyers Recognizes 38 Wiggin and Dana Attorneys
08.17.2015Best Lawyers in America Recognizes 31 Lawyers from Wiggin and Dana
08.07.2015Wiggin and Dana Files Appellate Amicus Brief on Medicaid Audits
05.21.2015Chambers USA 2015 Recognizes Wiggin and Dana Practices and Lawyers
05.21.2015Wiggin and Dana Health Care Department and its Lawyers Receive High Rankings in Chambers USA 2015
03.16.2015Attorneys Publish HIPAA Article in TerraLex Connections
10.29.2014Super Lawyers Recognizes Wiggin and Dana Lawyers
08.19.2014Best Lawyers in America Recognizes 33 Lawyers from Wiggin and Dana
05.27.2014Chambers USA Recognizes Wiggin and Dana Practices and Lawyers
05.27.2014Wiggin and Dana Health Care Department and its Lawyers Receive High Rankings in Chambers USA 2014
08.15.2013Best Lawyers in America Recognizes 35 Lawyers from Wiggin and Dana
06.07.2013Chambers USA Ranks Wiggin and Dana Practices and Lawyers in Connecticut and Nationwide Categories
06.19.2012Chambers USA Ranks Wiggin and Dana Practices and Lawyers in Connecticut, New York and Nationwide Categories
01.05.2012Wiggin and Dana Health Care Partner Appointed Chairperson of Advisory Committee on Patient Privacy and Security
12.14.2011Best Lawyers Names Three Wiggin and Dana Partners as "Lawyers of the Year"
10.21.2011Super Lawyers® Recognizes Wiggin and Dana Lawyers
09.13.2011Best Lawyers in America Recognizes 32 Lawyers from Wiggin and Dana
04.30.2010Wiggin and Dana Partner Appointed to The Health Information Technology and Exchange Advisory Committee
12.21.2009Michelle Wilcox DeBarge interviewed by Part B Insider
10.05.2009Doctors Win Fight to Keep Records Private
10.04.2005Twenty-Two Wiggin and Dana Attorneys Named in Best Lawyers 2006
03.10.2005Michelle DeBarge quoted in Best Practices Magazine
08.23.2002HIPAA attorney Michelle Wilcox DeBarge quoted in McKnight's Long Term Care News on HIPAA compliance

Events

07.26.2018Data Privacy Governance & GDPR Alignment
"Validating Compliance Through Mock GDPR Gap Analysis in the Life Science Industry"
03.28.2018TerraLex Webinar: Current Legal Trends Impacting the Life Sciences Industry
03.12.2018Life Sciences GDPR Prep Forum: Proactive Measures for U.S. Companies with a Global Reach
12.08.2017You Can Run (Swim or Fly) But You Can't Hide: The EU Data Protection (GDPR) On the U.S. Doorstep
09.14.20172017 Cyber and Privacy Forum
06.03.2016Healthcare Risk Management: Cybersecurity
05.19.2016Cyber Liability
04.08.2016Hacked: Implications for Privacy and Bioethics in an Era of Big Data
04.06.2016Social Media and Digital Communications in the Health Care Environment: The Good, the Bad and the Ugly
03.11.2016Protecting Privacy in Behavioral Health Practice
12.03.2015Lessons Learned from Recent Privacy and Security Cases and Settlements
07.22.2015Technology in Healthcare - How Personalized Health Data Will Save Medicine
07.13.2015HIPAA Compliance
06.23.2015HIPAA Security Rule: Implementing the Necessary Safeguards
05.14.2015The Seventh Annual Health Care Compliance and Enforcement Roundtable
04.23.20152015 Connecticut Cyber and Privacy Forum
03.25.2015Privacy and Security of Personal and Healthcare Information in the Workplace (Stamford)
03.18.2015Privacy and Security of Personal and Healthcare Information in the Workplace (New Haven)
10.08.2014CMS New Civil Monetary Penalties for Home Care
10.01.2014Overview of CMS Certification Survey Process
04.25.2014Fifth Annual Connecticut Privacy Forum
04.04.2014The Connecticut Medicaid Audit: A Survival Guide for Dental Practices
04.04.2014Legal Education
03.12.2014The Connecticut Medicaid Audit: A Survival Guide for Dental Practices
01.14.2014Keeping Up With HIPAA
09.19.2013Keeping Up with HIPAA: What Will the New Omnibus Rule Mean for Dentists
06.20.2013HITECH & Cyber Risk
06.13.2013HIPAA Omnibus Rule Update and Implementation Collaborative
05.23.2013HIPAA Omnibus Rule Update and Implementation Collaborative
04.01.2013New Dentist Roundtable Series Presents: The Legal Forum
03.06.2013HIPAA Updates - New Rule Protects Patient Privacy, Secures Health Information
03.01.2013Don't Miss the Omnibus!: How to Comply With the New HIPAA Provisions (Hartford)
02.27.2013Don't Miss the Omnibus!: How to Comply With the New HIPAA Provisions (New Haven)
11.08.2012Fifth Annual Health Care Compliance and Enforcement Roundtable
03.09.2012HIPAA & HITECH: What Litigators Should Know
11.15.2011Healthcare IT: Its Challenges and Opportunities
06.01.2011Auditing for Privacy Compliance, including HIPAA/HITECH, and Enforcement Update
05.12.2011Managed Care Contracting
06.24.2010The Nonprofit Conference: The Medicaid Audit and Recoupment Process
06.08.2010Highlights of the HITECH Act
04.29.2010The New HIPAA Rules & Regulations
01.14.2010Legal and Practical Implications of a Data Breach Incident
11.17.2009New Federal HITECH Regulation Briefing
11.17.2009HITECH Overview
11.05.2009Health Information Technology for Economic and Clinical Health Act (HITECH) Seminar
08.27.2009National Government Services Medical Review and Red Flags Implementation
01.27.2009Access to Public Records in the Probate Court - HIPAA, Freedom of Information Act and Beyond
12.16.2008Protecting Patient Information: Implementing Public Act 08-167 and Preparing for Federal 'Red Flag'
11.18.2008Anatomy of a Research Misconduct Investigation: The Regulations and the Reality
11.17.2008PRIM&R's 2008 Advancing Ethical Research Conference
09.23.2008Managing Legal Risks in Structuring & Conducting Clinical Trials
09.26.2007Managing Legal Risks in Structuring and Conducting Clinical Trials
09.26.2007Tips, Traps, and Trends in Informed Consent and Secondary Research
09.23.2007Emerging Trends in Informed Consent and Their Impact on Recruitment
04.19.2007Electronic Records and IT Issues: Update on Stark, Anti-kickback and E-discovery Issues
04.05.2007Critical Legal Issues for Nursing Home Administrators
04.27.2006Clinical Research Billing Compliance
03.28.2006CBI's 2nd Annual Forum on: Maximize Investigator - Initiated Studies
03.27.2006Legal Considerations in Investigator-Initiated Studies
04.07.2005Critical Legal Issues for Nursing Home Administrators
02.24.2005HIPAA Security Compliance
11.12.2004CT Counseling Directors Meeting
04.20.2004HIPAA: Overview and Impact
02.24.2004EMTALA Perspectives Program
02.19.2003HIPAA Overview and Impact, Access of Law Enforcement Officials to Protected Health Information
02.11.2003HIPAA Implementation For Long-Term Care Providers: The Time Is Now
02.06.2003HIPAA Audio Conferences
10.29.2002HIPAA Implementation: Challenges and Solutions
04.24.2002Auditing Research and IRB Activities
02.26.2002Getting A Handle on HIPAA: Focus on Long Term Care



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