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
Shipping Firms Pilot Blockchain, New Crypto Payment Gateways and Products, Wyoming Announces Crypto Custody Rules
By Robert A. Musiala Jr., Simone O. Otenaike, Joanna F. Wasick
November 15, 2019
In this issue: • Shipping Firms, DHS and Wine Merchants Participate in Blockchain Pilots • Crypto Payment Gateways Announced, Multimillion-Dollar Property Sold for Bitcoin • Developments in Cryptocurrency Custody Providers, Banks and New...
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Blockchain Monitor
Blockchain Pilots Move Forward in Food Supply Chain, Land Registries and Buying Coffee with Crypto; Regulators Grant Approvals and Continue Enforcement
By Simone O. Otenaike, Jordan R. Silversmith, Diana J. Stern
November 1, 2019
In this issue: • Coffee Conglomerate Set to Accept Bitcoin in 2020 as Cryptocurrency Adoption Continues to Rise • Blockchain Capital Markets Firms Achieve New Approvals in US and Abroad • Blockchains Take Another Bite Into Food Tracking...
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Blockchain Monitor
UNICEF Launches Crypto Fund, Class Action Alleges Price Manipulation, US Enforcement Continues, More Ransomware and Hacks
By Robert A. Musiala Jr., Simone O. Otenaike, Joanna F. Wasick
October 11, 2019
In this issue: • Crypto and Blockchain Capital Markets News From UNICEF, Europe and Hong Kong • Blockchain and Cryptocurrency Payment Applications Introduced Across Jurisdictions • Class-Action Suit Filed Against Bitfinex/Tether, US...
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Blockchain Monitor
Blockchain Continues to Disrupt Across Industries, Cryptocurrency Services Expand, Malware Threats Identified
By Robert A. Musiala Jr., Simone O. Otenaike, Diana J. Stern
September 13, 2019
In this issue: • Blockchain Clearing, Settlement, Custody and Capital Markets Developments • Cryptocurrency Exchanges and Payment Applications Continue to Expand Services • Blockchain Pilots for Mortgages, Recycling, Supply Chain and...
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Blockchain Monitor
Blockchain Developments: Energy Grids, Automobiles, Stablecoins, International Regulations, SEC Enforcement
By Jonathan D. Blattmachr, Robert A. Musiala Jr., Simone O. Otenaike, Joanna F. Wasick
September 6, 2019
In this issue: • Blockchain Developments for Energy Grids, Automobiles, Enterprise Protocols • International Developments in Blockchain and Cryptocurrency Regulation • NY DFS Approves Gold-Backed Stablecoin, Financial Institutions Pursue...
Read More ->