Dianne advises a variety of health care clients on a broad range of issues, including licensure, regulatory, contractual, and risk management matters, and patient care. A large part of her practice involves counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, including patient consent, access to and use of tissue and associated patient information, and the Institutional Review Board process.
She also counsels health care clients and other business entities on the requirements of the HIPAA Privacy Rule and Security Standards, including new requirements under the HITECH provisions of the American Recovery and Reinvestment Act of 2009 (ARRA), and state-imposed medical privacy laws. She regularly assists clients with the implementation of HIPAA-mandated policies and procedures, privacy audits, third-party requests for information, and review of HIPAA-related contracts and forms. She has successfully defended clients in both civil and criminal HIPAA enforcement actions and regularly assists clients with the management of data breaches and other losses of protected health information.
Before joining Mintz Levin, Dianne was an associate staff attorney at the Lahey Clinic, where she provided general counsel services to medical, professional, and administrative staff. She also served as counsel to the Institutional Review Board, the Ethics Committee, the Intellectual Property and Technology Transfer Committee, and the Genetics Advisory Board. Before joining the Lahey Clinic’s legal staff, she worked in the research administration department. Her responsibilities included drafting a regulatory compliance manual detailing laws of concern in basic, clinical, and animal research, continually reviewing relevant regulations to ensure compliance for institutional programs, and researching and advising clients on a broad range of regulatory matters.
Before entering law school, Dianne was a freelance writer and editor for Compliance Engineering Magazine, and served as a special projects manager and a public information coordinator for the Massachusetts Water Resources Authority.
Dianne was the first Suffolk University law student to graduate with a concentration in Health Care and Biomedical Law. She continues to serve as an adjunct professor at Stonehill College, teaching an undergraduate Health Care Law course.
Dianne advises a variety of health care clients on a broad range of issues, including licensure, regulatory, contractual, and risk management matters, and patient care. A large part of her practice involves counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, including patient consent, access to and use of tissue and associated patient information, and the Institutional Review Board process.
She also counsels health care clients and other business entities on the requirements of the HIPAA Privacy Rule and Security Standards, including new requirements under the HITECH provisions of the American Recovery and Reinvestment Act of 2009 (ARRA), and state-imposed medical privacy laws. She regularly assists clients with the implementation of HIPAA-mandated policies and procedures, privacy audits, third-party requests for information, and review of HIPAA-related contracts and forms. She has successfully defended clients in both civil and criminal HIPAA enforcement actions and regularly assists clients with the management of data breaches and other losses of protected health information.
Before joining Mintz Levin, Dianne was an associate staff attorney at the Lahey Clinic, where she provided general counsel services to medical, professional, and administrative staff. She also served as counsel to the Institutional Review Board, the Ethics Committee, the Intellectual Property and Technology Transfer Committee, and the Genetics Advisory Board. Before joining the Lahey Clinic’s legal staff, she worked in the research administration department. Her responsibilities included drafting a regulatory compliance manual detailing laws of concern in basic, clinical, and animal research, continually reviewing relevant regulations to ensure compliance for institutional programs, and researching and advising clients on a broad range of regulatory matters.
Before entering law school, Dianne was a freelance writer and editor for Compliance Engineering Magazine, and served as a special projects manager and a public information coordinator for the Massachusetts Water Resources Authority.
Dianne was the first Suffolk University law student to graduate with a concentration in Health Care and Biomedical Law. She continues to serve as an adjunct professor at Stonehill College, teaching an undergraduate Health Care Law course.
Publications
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Co-author,
The New HIPAA Omnibus Rule & Your Liability, Advisory ()
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Co-author,
Finally! HHS Office for Civil Rights Releases HIPAA Omnibus Rule with Sweeping Changes to Compliance Requirements and Enforcement, Health Lawyers Weekly ()
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HIPAA Omnibus Rule Reference Chart, Health Law Alert ()
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Co-author,
Finally! HHS Office of Civil Rights Releases HIPAA Omnibus Rule With Sweeping Changes to Compliance Requirements and Enforcement, Privacy & Security HIPAA Compliance Alert ()
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Co-author,
Attorneys Detail BYOD Issues in Health Care, HealthData Management ()
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Author,
New FDA Research Consent Form Requirements Now Effective, Health Law Alert ()
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Author,
How ACOs Will Use and Disclose Protected Health Information While Complying with HIPAA, Health Care Reform Advisory ()
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Co-author,
FDA to Begin Revamping the 510(k) Medical Device Review Program, Life Sciences Advisory ()
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Co-author,
CMS Issues Proposed Rule Addressing Enhanced Program Integrity Requirements, Health Care Reform Advisory ()
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Co-author,
New Proposed HIPAA Rules May Benefit Researchers, Health Law Advisory ()
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Co-author,
New Proposed HIPAA Rules May Benefit Researchers, Life Sciences Advisory ()
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Author,
Finally! HHS Issues Proposed Rule Implementing Changes to the HIPAA Privacy, Security and Enforcement Rules under HITECH, Employment, Labor & Benefits | Health Law Advisory ()
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Co-author,
The HITECH Act: Is Your Organization Ready for Implementation?, G-2 Compliance Perspectives ()
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Co-author,
Comparative Effectiveness Research Proposals: Potential Implications for Stakeholders, Health Care Reform Advisory ()
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Co-author,
HHS Issues Interim Final Rule Implementing Civil Penalty Provisions of HITECH Act, Health Law | Employee Benefits | Executive Compensation Alert ()
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Co-author,
Department of Health and Human Services Issues Proposed Regulation Updating the HIPAA Privacy Rule for Changes under the Genetic Information Nondiscrimination Act of 2008, Employee Benefits | Executive Compensation | Health Law Advisory ()
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Co-author,
DOL, Treasury and HHS Issue Joint Interim Final Rule under Title I of the Genetic Information Nondiscrimination Act of 2008 (Relating to Group Health Plans and Health Insurance Issuers), Employee Benefits | Executive Compensation | Health Law Advisory ()
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Co-author,
HHS Issues Rules Relating to Breach Notification and Related Items under the HITECH Act, Employee Benefits | Executive Compensation | Health Law Advisory ()
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Co-author,
OHRP Publishes New Registration Requirements for IRBs, Health Law Alert ()
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Author,
Issues and Trends in the Regulation of Genetic Testing, Health Care Law Monthly ()
Speaking Engagements
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Speaker,
Business Associate Agreements and the New HIPAA Rule,
Strafford Publications, Webinar
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Speaker,
HIPAA – What You Should Know about the Final Rules,
Boston Bar Association, Boston, MA
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Speaker,
The New HIPAA Omnibus Rule & Your Liability,
Mintz Levin, Webinar
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Speaker,
Using Expert Determination and Safe Harbor Methods to De-Identify PHI,
De-Identifying Protected Health Information,
Strafford Publications, Webinar
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Speaker,
Portable Electronic Devices in Healthcare: Latest Legal Threat for Providers,
Strafford Publications, Webinar
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Speaker,
HIPAA and State-Imposed Privacy and Security Laws,
CableLabs,
Cable Television Laboratories, Inc., Louisville, CO
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Speaker,
HIT's ACO Developments,
American Health Lawyers Association, Webinar
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Speaker,
Privacy & Security Under HIPAA / HITECH in an Era of Heightened Enforcement,
Mintz Levin, Webinar
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Panelist,
Re-Evaluate Compliance Controls Applicable to Clinical Research Activities,
Medical Device and Diagnostic Compliance Congress,
CBI
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Speaker,
Legal Aspects of Medical Tourism,
Latin America Global Medicine and Wellness Congress
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Moderator,
Diseases of Aging,
MassBio Annual Meeting & Vendor Expo,
MassBio , Boston, MA
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Speaker,
Pardon Me, But Your Data Is Showing!,
Society for Health Care Risk Management Winter Conference
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Speaker,
Numbers You Should Know: 201 CMR 17.00 — Massachusetts Standards for the Protection of Personal Information of Residents of the Commonwealth,
Numbers You Should Know: 201 CMR 17.00 — Massachusetts Standards for the Protection of Personal Info,
New England Corporate Counsel Association, Boston, MA
Newsroom
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Quoted in
HIPAA Omnibus Rules Already Influencing Covered Entities, HealthITSecurity ()
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Quoted in
5 HIPAA Blunders to Avoid At All Costs, Law360 ()
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Quoted in
11th Circ. Ruling Charts HIPAA Preemption Road Map, Law360 ()
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Quoted in
7 Steps to Get HIPAA-Compliant Now, Law360 ()
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Quoted in
Will HIPAA Omnibus Subcontractor Rules Reduce Data Breaches?, Health IT Security ()
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Quoted in
Final HIPAA Final Rule Stricter than Interim Regulation on Data Protection, InsideHealthPolicy.com ()
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Quoted in
HIPPA Update will Shake up Marketing, Fundraising Efforts, Law360 ()
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Quoted in
Medical Privacy Rules Get an Update, Associated Press ()
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Quoted in
What 2013 Holds for the Healthcare Workforce, AMN Healthcare ()
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Quoted in
HHS Data-Scrubbing Guidance Backs Strict Privacy Definitions, Law360 ()
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Quoted in
Stage 2 Meaningful Use Success Rests on 3 Elements, American Medical News ()
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Quoted in
Hospitals Face Tougher Fraud Scrutiny Amid Shift to E-Records, Law360 ()
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Quoted in
Concerns Raised about Stage 2 Measures beyond Physicians’ Control, PhysBizTech ()
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Quoted in
Impact of Stage 2 Meaningful Use Rules to be Big, But Surprises are Few, Search HealthIT ()
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Quoted in
Docs Face Tricky Task in Patient Access E-Records Goals, Law360 ()
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Quoted in
Feds Give Break in Electronic Health Records, Computerworld ()
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Mintz Levin Attorney Dianne J. Bourque to Speak at Cable Television Laboratories, Inc. “Face to Face” Conference, ()
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Mintz Levin Elevates Seven Attorneys to Members of the Firm, ()
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Mintz Levin Attorney Dianne J. Bourque to Present at National HIPAA Summit West, ()
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Quoted in
Texas Law Gives More Privacy Than HIPAA, Law360 ()