Nicholas Wallace

Associate

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  • JD, Yale Law School, 2015; editor,Yale Journal on Regulation
  • BA, with highest distinction, Phi Beta Kappa, Indiana University, 2011

Qualifications

  • California, 2015
  • Spanish

Nicholas Wallace

Associate

Nick Wallace provides regulatory, investigative and corporate governance advice to heath care clients—predominantly not-for-profit universities, hospitals and academic medical centers. Nick has particularly deep experience in the areas of conflict of interest, research, privacy, data and technology licensing, and fraud and abuse analysis.

Nick enjoys combining intensive legal research with creative analysis to meet the needs of clients in a variety of postures—advocacy and defense, internal investigation, and prospective compliance.

In his writing and speaking, Nick has been particularly active in exploring the application of the European Union General Data Protection Regulation in the research space.

Nick also works with individual pro bono clients. He represents immigration clients in asylum hearings, both before the immigration court and the asylum office, and U Visa clients in their petitions. Nick has also represented a veteran in a successful discharge status upgrade and in a pending disability benefits application.

Experience

Investigations

  • Investigating for multiple institutions the implications of cutting-edge technology spin-off arrangements under a host of state non-profit related party transaction and federal tax-exempt organization disqualified person requirements as well as under sponsored research and human subjects conflict-of-interest regimes.
  • Assisting clients subject to intense media scrutiny in navigating their response to questions as to compliance with a host of laws.
  • Assisting recipients of federal research funding in investigating and responding to funding agencies’ inquiries into “foreign influence.”
  • Representing provider in billing dispute responding to state Medicaid authorities’ demand for repayment.

Regulatory

  • Drafting request for advisory opinion to the HHS Office of the Inspector General.
  • Advising clients on privacy regulations, particularly questions concerning implementation of the EU General Data Protection Regulation.
  • Advising clinical trial sponsors and research sites on informed consent matters, privacy regulations, and good clinical practice requirements.
  • Advising boutique health care providers on challenges of applying reimbursement and privacy models to their businesses.
  • Helping 340B covered entities navigate options for use of 340B income deemed “program income” under a grant that qualified them for 340B participation.

Governance

  • Assisting client in navigating tax-exempt conversion of taxable physician groups into tax-exempt entities.
  • Revising Bylaws of not-for-profit entities to incorporate statutory updates and reflect developments in governance practice.
  • Advising Boards on duties and sundry governance questions.

Transactions

  • Acting as transaction counsel to academic medical centers in drafting an operating agreement for a joint venture.
  • Representing universities and hospitals in bond issuances, both tax-exempt and taxable.
  • Contracting with dispensing pharmacies for 340B covered entities.

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.

Publications

Presentations

  • “Tissue Repositories and Data Banks in the Era of the Revised Common Rule,” PRIM&R Social, Behavioral and Educational Research Conference (November 19-20, 2019)  
  • “Foreign Influence in Research: Foreign Research Support, ‘Foreign Components,’ and Personal Income from Foreign Entities,” PRIM&R Social, Behavioral and Educational Research Conference (November 18, 2019) 
  • “European Union, Japan, and U.S. Privacy Law: Implications for Data Sharing,” 16th DIA Japan Annual Meeting, Tokyo, Japan (November 11, 2019)  
  • “Risk Based Approaches to Handle and Protect Clinical Trial Data,” Q1 Life Science Data Privacy Governance & GDPR Alignment Conference, Philadelphia (July 27, 2018)   
  • “The EU General Data Protection Regulation: Implications for Research,” ADVARRA Webinar (June 13, 2018)  
  • “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) 
  • JD, Yale Law School, 2015; editor,Yale Journal on Regulation
  • BA, with highest distinction, Phi Beta Kappa, Indiana University, 2011
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