Simone O. Otenaike

Associate

Houston
T +1.713.646.1365
F +1.713.751.1717

Overview

A technology enthusiast with a background in cognitive science, clients rely on Simone Otenaike’s background and experience with regulatory and transactional matters, primarily in the healthcare and life sciences industries, to navigate the maze of healthcare laws and address general operational concerns. Simone has experience assisting pharmacy, outsourcing facility, drug manufacturer, drug wholesaler and third-party logistics provider clients in navigating state licensing and pharmacy practice act issues. Her background also includes counseling clients on data privacy and security matters, and fraud and abuse matters.

A member of the firm’s Blockchain Technologies and Digital Currencies team, Simone evaluates and develops ways for blockchains and smart contracts to enhance enterprise. She also assesses the potential risks and rewards of cutting-edge opportunities, and delivers a roadmap for clients to navigate the complex regulatory environment. She frequently contributes to workshop presentations on blockchain technology for enterprise solutions and advises founders, venture capital firms, and non-profit organizations on blockchain technology related issues. Her passion for blockchain expands to her community engagement, which includes serving as a member of the Hyperledger Healthcare Special Interest Group.

Select Experience

  • Advises pharmacy, wholesaler and third-party logistics provider clients on state licensing issues and compliance with state pharmacy practice laws.
  • Counsels human and veterinary pharmaceutical, medical device and food manufacturers on issues related to registration, compliance and import/export customs issues.
  • Counsels clients on post-closing compliance obligations, develops and implements compliance programs, and manages compliance through multi-state growth.
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Experience

  • Advises pharmacy, wholesaler and third-party logistics provider clients on state licensing issues and compliance with state pharmacy practice laws.
  • Counsels human and veterinary pharmaceutical, medical device and food manufacturers on issues related to registration, compliance and import/export customs issues.
  • Counsels clients on post-closing compliance obligations, develops and implements compliance programs, and manages compliance through multi-state growth.
  • Counsels clients on pharmaceutical issues, including drug pricing and drafting pharmacy benefit management and participation agreements.
  • Advises food and dietary supplement manufacturers on transactional and compliance matters, including registration, labeling, advertising, inspections and recalls.
  • Advises private equity groups and alternative lenders in the healthcare industry on the regulatory risks of potential investments, and negotiates transactional documents to minimize high-risk regulatory concerns.
  • Drafts documents related to the formation of hospital-physician business partnerships and healthcare joint ventures, hospital-physician recruitment agreements, physician employment agreements, business associate agreements, clinical affiliation agreements and technology service agreements.
  • Advises hospital executives and medical staff on compliance with HIPAA/HITECH, Stark Law, anti-kickback and other applicable fraud and abuse laws.
  • Advises healthcare payor and provider organizations with the investigation, response, legal obligations and risks that arise from data security incidents, including breach notification and regulatory response.
  • Counsels clients on various transactional matters, including labor and employment, HIPAA, consumer data breach and privacy issues, and general operational concerns. Provides legal analysis and opinions on research.

Recognitions and Memberships

Memberships

  • Houston Lawyers Association
  • Hyperledger Healthcare Special Interest Group
  • American Health Lawyers Association

Blog Posts

Community

  • Girls Empowerment Network: Volunteer
  • Amref Health Africa: Young Professionals Board Member

Pro Bono

  • In conjunction with the South Texas Civil Rights Project and Texas Rio Grand Legal Aid, drafted wills and assisted pro se petitioners with documents for the United States Citizenship and Immigration Services.
  • Developed materials for the University of Texas School of Law expunction clinic and School-to-Prison Pipeline Project, which helps eligible community members expunge their criminal members.

Admissions

  • Texas

Education

  • J.D., The University of Texas School of Law, Texas International Law Journal: Staff, Development Committee; National Black Law Students Association, National Convention Coordinator; Pro Bono Scholars Program
  • B.A., Cognitive Science, Rice University

Languages

  • Yoruba

Blog

In The Blogs

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Blockchain Monitor
New Blockchain Enterprise Initiatives in US, New Blockchain and Crypto Regulations in South Korea and France, Enforcement Actions Continue in US, Japan and Australia
By Simone O. Otenaike, Jordan R. Silversmith, Joanna F. Wasick
March 13, 2020
In this issue: • New Enterprise Initiatives for Ethereum, Hyperledger, Aviation and Clothing • New Blockchain and Cryptocurrency Regulations in South Korea and France • Cryptocurrency Enforcement Actions in U.S., Japan and Australia New...
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Blockchain Monitor
Blockchain Developments in Food Safety, Ethical Sourcing, Financial Services, Social Media and Trading Platforms; DOJ Continues Actions Against Crypto Crimes
By Brian P. Bartish, Simone O. Otenaike, Jordan R. Silversmith, Joanna F. Wasick
February 7, 2020
In this issue: • Blockchain Enterprise Solutions Aim to Improve Safety and Address Ethical Sourcing Concerns • Financial Services and Social Media Firms Integrate Blockchain and Cryptocurrencies, US Marshalls to Auction 4,040 Bitcoins • US...
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Blockchain Monitor
New Blockchain Solutions, Crypto Products, Regulations and Licenses; 51% Attack Hits, Insurer Traces Ransomware Payment, Crypto Crimes Report Published
By Robert A. Musiala Jr., Simone O. Otenaike, Veronica Reynolds, Joanna F. Wasick
January 31, 2020
In this issue: • Solutions Debut for Wine, Farming Data, Media Authenticity and Credentialing • Blockchain Platforms and Crypto Exchanges Launch Products, Announce Developments • Foreign Regulators Issue New Regulations and Licenses, WEF...
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Blockchain Monitor
Foreign Regulators Issue Approvals and Guidance, SEC Enforcement Continues, Blockchain Trade Groups File Amicus Briefs, Reports Detail Terrorist Financing Risks
By Teresa Goody Guillén, Simone O. Otenaike, Veronica Reynolds, Joanna F. Wasick
January 24, 2020
In this issue: • New Approvals From European and Thai Regulators, Canada and WEF Publish Guidance • SEC Targets ICOs, IRS Updates Crypto FAQs, UK Tax Agency Seeks Blockchain Analytics Tool • Chamber of Digital Commerce and Blockchain...
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Blockchain Monitor
New Blockchain Patents, Crypto Mining Expands in US and Russia, French ICO Approved Under New Law, DOJ and INTERPOL Enforcement Actions
By Simone O. Otenaike, Veronica Reynolds, Joanna F. Wasick
January 10, 2020
In this issue: • Patents Granted to Blockchain Payments Firms, Crypto Mining Expands in Texas and Russia • First ICO Is Approved Under New French Law, New Crypto Bill Is Introduced in US • DOJ Prosecutes Crypto Dark Markets, INTERPOL...
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