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.
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.
- Suffolk University Law School (JD)
- Suffolk University (MPA)
- Boston College (BA)
- Provided strategic counsel to a start-up medical application company that has devised a method to detect mild cognitive impairment as a precursor to more significant cognitive diseases.
- Counseled a publically traded medical device company on risk management advice and helped them manage multiple significant adverse events following suspension of trial by the FDA.
- Assisted our client, a manufacturer of smart, wireless prescription bottles, with structuring their patient interface to be consistent with privacy and data security laws and other regulatory issues.
Recognition & Awards
- Chambers USA: Massachusetts – Healthcare (2015 – 2017)
- Best Lawyers in America: Health Care Law (2020-2021)
- Regular guest lecturer, Cybersecurity Policy & Governance Program, Boston College Woods College of Advancing Studies
News & Press
HHS’ OCR Announces Enforcement Discretion for HIPAA Noncompliance Relating to Online COVID-19 Vaccination Appointment Scheduling Applications
February 25, 2021 | Blog
Fifth Circuit Vacates $4.3M HIPAA Penalty and Potentially Opens the Door for Future HIPAA Enforcement Challenges
January 25, 2021 | Blog | By Dianne Bourque
Beyond its harsh words for HHS, this opinion is notable for calling into question some longstanding HHS enforcement practices and interpretations of the HIPAA regulations. The opinion also makes clear that regulated entities should check the math when HHS levies a fine. Although limited in its precedential authority, the Fifth Circuit’s opinion, at the very least, gives HIPAA-regulated entities some new food for thought if faced with an HHS enforcement action.
January 21, 2021 | Blog | By Dianne Bourque, Cassandra Paolillo
December 28, 2020 | Blog | By Dianne Bourque, Ellen Janos
December 14, 2020 | Blog | By Dianne Bourque
December 3, 2020 | Podcast | By Nili Yolin
October 30, 2020 | Blog | By Dianne Bourque
HHS Further Amends 42 CFR Part 2, Easing Some, But Not All, Burdens on Substance Use Disorder Treatment Providers
July 17, 2020 | Blog | By Sarah Beth Kuyers, Dianne Bourque
Providers May Contact Recovered COVID-19 Patients About Blood and Plasma Donation, According to OCR Guidance
June 17, 2020 | Blog
March 21, 2020 | Blog | By Dianne Bourque, Benjamin Zegarelli
News & Press
January 8, 2021
November 30, 2020
November 4, 2020
October 14, 2020
September 24, 2020
April 08, 2020
Trump Keeps Touting an Unproven Coronavirus Treatment. It’s Now Being Tested on Thousands in New York
March 31, 2020
February 24, 2020
On Bloomberg Television, Mintz Member Dianne Bourque Discusses Google’s Deal with Ascension Hospitals
November 19, 2019
The full show is available here, and the segment featuring Ms. Bourque runs from 29:47 - 35:15.