Nick Wallace joined Ropes & Gray in 2015 as an associate in the firm’s health care practice group.
During law school, Nick participated in the Transnational Development Clinic and was an editor of the Yale Journal on Regulation. He was also a Teaching Fellow for Yale College classes in the History and Economics departments.
- Investigations. Advising research institution in connection with internal investigation involving allegations of research misconduct. Representing non-profit research organization in financial conflict of interest internal investigation and conflict management plan development. Determining provenance and history of research database and compliance with applicable laws.
- Regulatory. Advising clients on privacy regulations, particularly questions concerning implementation of the EU General Data Protection Regulation (GDPR). Advising health care providers on Medicare and Medicaid billing requirements and potential repayment obligations, federal and state anti-kickback statutes, and self-referral laws. Advising research organizations on federal grant funding requirements, research misconduct policies, and financial conflict of interest disclosure policies and practices. Advising clinical trial sponsors and research sites on informed consent matters, privacy regulations, and good clinical practice requirements.
- Litigation. Representing health care company in federal False Claims Act qui tam action involving alleged breaches of Medicaid regulatory requirements, Affordable Care Act marketplace regulatory requirements, and billing standards. Advising client on response to subpoena.
- Transactions. Representing universities and hospitals in bond issuances, both tax-exempt and taxable. Representing faculty practice plan regarding affiliation with academic medical center.
- Pro Bono Matters. Representing pro bono client in challenge to state referendum initiative. Representing clients in immigration matters, including U Visa petitions and asylum applications. Representing veteran in claim for disability benefits and records correction.
- Co-author, “GDPR Complicates Admissions Applications for U.S. Universities,” Bloomberg BNA’s Privacy Law Watch (June 27, 2018)
- Co-author, “Final Guidelines on Consent Requirements Under the EU General Data Protection Regulation: Implications for Scientific Research,” Bloomberg BNA’s Life Sciences Law & Industry Report (April 30, 2018)
- Co-author, “New Draft Guidelines on GDPR Consent Requirement’s Application to Scientific Research,” Bloomberg BNA’s Medical Law & Research Policy Report (January 17, 2018)
- Co-author, “Extraterritorial Effect of the GDPR and Implications for U.S. Academic Medical Centers Treating EU Patients,” Bloomberg BNA’s Medical Law & Research Policy Report (November 1, 2017)
- Co-author, “Laws and Ethics Affecting Clinical Trials in Africa,” Journal of Health Care Law and Policy (2017)
- Co-author, “Reconciling Personal Data Consent Practices in Clinical Trials with the EU General Data Protection Regulation,” Bloomberg BNA’s Medical Research Law & Policy Report (September 20, 2017)
- Co-author, “OIG’s Warranty Safe Harbor Opinion and Value-Based Care,” Law360 (September 14, 2017)
- Presenter, “Risk Based Approaches to Handle and Protect Clinical Trial Data,” Q1 Life Science Data Privacy Governance & GDPR Alignment Conference, Philadelphia (July 27, 2018)
- Speaker, “The EU General Data Protection Regulation: Implications for Research,” ADVARRA Webinar (June 13, 2018)
- Speaker, “EU General Data Protection Regulation: What U.S. Research Institutions Need to Know,” Public Responsibility in Medicine and Research (PRIM&R) Webinar (April 25, 2018)