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. As former in-house counsel to an academic medical center, 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. In addition, Dianne currently serves as a Vice Chair of AHLA's Health Care Reform Education Task Force.
She also counsels health care clients and other business entities on a broad range of privacy and data security issues, including the HIPAA Privacy Rule and Security Standards, including requirements under HITECH and the HIPAA Omnibus Rule, 42 CFR Part 2, and state-imposed medical privacy laws. She regularly assists clients with data breach response and mitigation, 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, 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.
Dianne was the first Suffolk University law student to graduate with a concentration in Health Care and Biomedical Law. She formerly served as an adjunct professor at Stonehill College, teaching an undergraduate Health Care Law course.
More Legal and Business Bylines From Dianne J. Bourque
- Medical Marijuana: Weeding Through the New Massachusetts Law - (Posted On Friday, November 09, 2012)
- MEEI Breach Notification Prompts OCR Investigation and Settlement - (Posted On Thursday, September 20, 2012)
- Office of Management and Budget "OMB" Extends Review Period for HIPAA/HITECH Omnibus Rule - (Posted On Wednesday, July 04, 2012)
- HIPAA Audit Protocols Now Public; Plus, Preliminary Insights from OCR - (Posted On Sunday, July 01, 2012)
- OCR Shares Preliminary HITECH Audit Results; What Regulated Entities Can Expect Next - (Posted On Sunday, June 17, 2012)
- HHS Office of Civil Rights Co-Hosts Security Conference and Announces New Educational Materials - (Posted On Saturday, June 09, 2012)
- HIPAA Omnibus Rule Expected Within 90 Days – Pending Review at OMB - (Posted On Friday, March 30, 2012)
- HHS OCR Announces First Settlement of a Self-Reported HIPAA Violation - (Posted On Sunday, March 18, 2012)
- New FDA Research Consent Form Requirements Now Effective - (Posted On Saturday, March 10, 2012)
- New FDA Research Consent Form Requirements – Effective Today - (Posted On Wednesday, March 07, 2012)