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. 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 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 formally served as an adjunct professor at Stonehill College, teaching an undergraduate Health Care Law course.