Michael DiMaio
Associate
Michael DiMaio is a member of the health care group. Michael advises health care industry clients, pharmaceutical and medical device manufacturers, and private equity firms and other investors regarding a broad range of transactional, regulatory, and privacy issues. Michael has written and presented regarding the implications of data privacy laws for research. He works alongside members of the firm’s private equity group in conducting regulatory diligence of private equity investments in health care.
Experience
- Counseled U.S.-based academic medical centers, universities, and life sciences companies on the application of the European Union’s General Data Protection Regulation (GDPR) to their research and health care operations.
- Advised a medical group regarding formation of a management services organization.
- Advised a hospital with regulatory considerations and drafted agreements for an affiliation with a university.
- Assisted with investigations related to health care compliance.
- Advised a durable medical equipment manufacturer and supplier regarding regulatory due diligence concerns in connection with a strategic acquisition of another supplier.
- Advised a private equity sponsor regarding regulatory matters in connection with acquisitions involving laboratory equipment manufacturers.
- Advised private equity sponsors regarding assessment of revenue cycle management companies.
- Advised a contract research organization regarding regulatory due diligence concerns in connection with a potential strategic acquisition of another contract research organization.
- Advised a private equity sponsor regarding its acquisition of a care coordination company.
- Counseled an academic medical center on a potential affiliation with a large health system and provided advice with respect to diligence matters.
- Assisted tax-exempt borrowers obtain tax-exempt financings.
Publications
- Cited, “Challenges of “Return to Work” in an Ongoing Pandemic,” The New England Journal of Medicine “Special Report” (June 18, 2020)
- Co-author, “Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data,” Nature publishing’s European Journal of Human Genetics (March 2, 2020)
- Co-author, “Guidance Regarding Interaction Between GDPR and EU Clinical Trials Regulation Leaves Several Questions Unanswered,” Bloomberg Law (February 14, 2019)
- Co-author, “Insights On Right To Try Act And 'Expanded Access' Concerns,” Law360 (December 18, 2018)
- Co-author, “INSIGHT: Kickbacks or Common Sense Business? Hurdles for Value-Based Care,” Bloomberg Law’s Health Law and Business (December 10, 2018)
- Co-author, “Delaware appraisal decisions,” International Law Office Corporate Finance/M&A Newsletter (December 5, 2018)
- Co-author, “Use of 'ticking fee' in Novartis-AveXis transactions,” International Law Office Corporate Finance/M&A Newsletter (November 14, 2018)
- Co-author, “Will Consent Be Disfavored as Basis for Processing Personal Data in Clinical Research Under EU Data Protection Law?” Bloomberg Law’s Medical Law & Research Policy Report (June 15, 2018)
- Co-author, “What To Know About HHS Revised 'Common Rule',” Law360 (Feb. 13, 2017)
Presentations
- Presenter, “European General Data Protection Regulation (GDPR),” PRIM&R 2019 Advancing Ethical Research Conference (November 19, 2019)
- Presenter, “The European General Data Protection Regulation (GDPR) – Oversight and Impact,” PRIM&R 2019 Social, Behavioral, and Educational Research Conference (November 17, 2019)
- Presenter, “Protecting Confidential Information in Summaries of Trial Results,” Global Clinical Trial Disclosure and Data Transparency Conference (September 20, 2019)
- Presenter, “Clinical Trials and Human Research,” Strafford Webinars (July 18, 2019)
- Presenter, “Implications of GDPR for Collection and Sharing of Clinical Trial Data,” 6th Annual Clinical Data Disclosure and Transparency Conference (January 29, 2019)
Education
- JD (Health Law Concentration), magna cum laude, Boston University School of Law, 2016; Boston University Law Review
- BA (Political Science & Economics), summa cum laude, University of Connecticut, 2013