Regulatory
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An Elite Antitrust and Competition Practice
Hailed by Global Competition Review as “perhaps the best antitrust and competition practice for high-tech matters in the world,” Wilson Sonsini’s exceptional antitrust and competition practice group represents clients in high-stakes antitrust litigation, mergers, and criminal and civil investigation, in addition to providing valuable counseling on business strategy.
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Expanded FDA, Healthcare, and Consumer Products Practice
Wilson Sonsini's newly expanded regulatory practice includes attorneys experienced in helping clients with FDA, healthcare, and consumer product compliance.
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CFIUS and Export Controls Teams Anchored by Former Government Officials
Wilson Sonsini’s CFIUS and export controls teams include attorneys who have served in the U.S. government on CFIUS and the constituent agencies that enforce national security laws, including the Departments of Commerce, Defense, Homeland Security, Justice, and State; the CIA; and the White House.
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A Highly Ranked Privacy and Cybersecurity PracticeWilson Sonsini's privacy and cybersecurity practice is consistently recognized by well-known ranking authorities such as Law360, Chambers USA, Chambers Global, Chambers Europe, and Legal 500.
Wilson Sonsini is the premier legal advisor to technology, life sciences, and growth enterprises worldwide, as well as the venture firms, private equity firms, and investment banks that finance them. We represent companies from entrepreneurial start-ups to multibillion-dollar global corporations at every stage of development. The firm's attorneys collaborate across a comprehensive range of practice areas and industry groups to help the management, boards of directors, shareholders, and in-house counsel of our clients address their most pressing challenges and pursue their most promising opportunities.
The firm has expanded its regulatory services to address the ongoing need clients have for advice concerning enforcement and oversight agencies, both in the U.S. and certain international markets. Our services include antitrust and competition; privacy and cybersecurity; FDA, healthcare, and consumer products; national security (export trade; CFIUS; and FCPA); and advising on other regulatory issues.
In this area, the firm's clients include companies and other entities that compete in rapidly developing and innovative industries, including the biotech, communications, digital media, energy, financial services, medical devices, software and other sectors.
Overview
Wilson Sonsini is the premier legal advisor to technology, life sciences, and growth enterprises worldwide, as well as the venture firms, private equity firms, and investment banks that finance them. We represent companies from entrepreneurial start-ups to multibillion-dollar global corporations at every stage of development. The firm's attorneys collaborate across a comprehensive range of practice areas and industry groups to help the management, boards of directors, shareholders, and in-house counsel of our clients address their most pressing challenges and pursue their most promising opportunities.
The firm has expanded its regulatory services to address the ongoing need clients have for advice concerning enforcement and oversight agencies, both in the U.S. and certain international markets. Our services include antitrust and competition; privacy and cybersecurity; FDA, healthcare, and consumer products; national security (export trade; CFIUS; and FCPA); and advising on other regulatory issues.
In this area, the firm's clients include companies and other entities that compete in rapidly developing and innovative industries, including the biotech, communications, digital media, energy, financial services, medical devices, software and other sectors.
Alerts
Proposed Rulemaking Issued by the DOJ Covering Data Export Transactions with Entities from Countries of Concern
On October 21, 2024, the U.S. Department of Justice (DOJ) issued a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117, which authorizes the Attorney General to prohibit or restrict transactions by U.S. persons that could result in the transfer of government-affiliated or bulk U.S. sensitive data to countries of concern or covered persons, and to provide safeguards around other activities that may otherwise provide access to such data.
Newsletters
Sustainability and ESG Advisory Practice Update, October 2024
We are pleased to share the October 2024 issue of Wilson Sonsini's Sustainability and ESG Advisory Practice Update. Each issue combines news, key legal developments, and resources related to sustainability and environmental, social, and governance (ESG) matters relevant to public and private companies internationally.
Bylined Articles
The Blake Brief: Navigating Foreign Investments for U.S. Space Companies
SatMagazine’s latest Blake Brief article, titled "Navigating Foreign Investments for U.S. Space Companies," and authored by Nimit Dhir, Curt Blake, and Peter Bratton, highlights the importance of careful consideration of investment for U.S. space-focused companies. Navigating foreign investment requires an in-depth understanding of several regulatory authorities, as each have unique triggers for reporting changes in foreign investment or ownership. Understanding and addressing these requirements is crucial, particularly given the potential national security implications associated with these industries. A comprehensive approach to regulatory compliance is advised for ensuring seamless operations.
Alerts
FTC Passes Overhaul of HSR Filing Regime
On October 10, 2024, the Federal Trade Commission (FTC) announced that it unanimously approved a much-anticipated final rulemaking that will radically change the form and substance of Hart-Scott-Rodino (HSR) filings.1 The new rules, which represent the most significant changes to the HSR filing regime since the HSR Act was enacted over 45 years ago, will significantly increase the burden on parties submitting HSR filings to the FTC and Antitrust Division of the Department of Justice (DOJ). Unless challenged in federal court and enjoined, the new rules will go into effect 90 days after they are published in the Federal Register.
Alerts
California Governor Gavin Newsom Vetoes Law Requiring Attorney General Approval for Certain Healthcare Investments
Last weekend, California Governor Gavin Newsom vetoed Assembly Bill (AB) 3129, which would have required healthcare investors to notify and obtain written consent from the California Attorney General (AG) before investing in certain healthcare facilities and providers. In a letter to the California State Assembly, Governor Newsom reasoned that California’s existing Office of Health Care Affordability (OHCA) is the more appropriate entity for healthcare transaction reviews:
Alerts
Colorado Department of Law Proposes Amendments to the Colorado Privacy Act Regulations Regarding Biometric and Minors’ Data
On September 13, 2024, the Colorado Attorney General’s office (the Colorado Department of Law) proposed draft amendments (draft regulations) to its Colorado Privacy Act (CPA) regulations, which took effect in 2023. The draft regulations implement two new Colorado laws on biometric data (HB 24-1130) and minors’ data (SB 24-041) passed earlier this year, both of which amend the CPA. This alert provides an overview of these laws and key related draft regulations.
Insights
Alerts
Proposed Rulemaking Issued by the DOJ Covering Data Export Transactions with Entities from Countries of Concern
On October 21, 2024, the U.S. Department of Justice (DOJ) issued a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117, which authorizes the Attorney General to prohibit or restrict transactions by U.S. persons that could result in the transfer of government-affiliated or bulk U.S. sensitive data to countries of concern or covered persons, and to provide safeguards around other activities that may otherwise provide access to such data.
Newsletters
Sustainability and ESG Advisory Practice Update, October 2024
We are pleased to share the October 2024 issue of Wilson Sonsini's Sustainability and ESG Advisory Practice Update. Each issue combines news, key legal developments, and resources related to sustainability and environmental, social, and governance (ESG) matters relevant to public and private companies internationally.
Bylined Articles
The Blake Brief: Navigating Foreign Investments for U.S. Space Companies
SatMagazine’s latest Blake Brief article, titled "Navigating Foreign Investments for U.S. Space Companies," and authored by Nimit Dhir, Curt Blake, and Peter Bratton, highlights the importance of careful consideration of investment for U.S. space-focused companies. Navigating foreign investment requires an in-depth understanding of several regulatory authorities, as each have unique triggers for reporting changes in foreign investment or ownership. Understanding and addressing these requirements is crucial, particularly given the potential national security implications associated with these industries. A comprehensive approach to regulatory compliance is advised for ensuring seamless operations.
Alerts
FTC Passes Overhaul of HSR Filing Regime
On October 10, 2024, the Federal Trade Commission (FTC) announced that it unanimously approved a much-anticipated final rulemaking that will radically change the form and substance of Hart-Scott-Rodino (HSR) filings.1 The new rules, which represent the most significant changes to the HSR filing regime since the HSR Act was enacted over 45 years ago, will significantly increase the burden on parties submitting HSR filings to the FTC and Antitrust Division of the Department of Justice (DOJ). Unless challenged in federal court and enjoined, the new rules will go into effect 90 days after they are published in the Federal Register.
Alerts
California Governor Gavin Newsom Vetoes Law Requiring Attorney General Approval for Certain Healthcare Investments
Last weekend, California Governor Gavin Newsom vetoed Assembly Bill (AB) 3129, which would have required healthcare investors to notify and obtain written consent from the California Attorney General (AG) before investing in certain healthcare facilities and providers. In a letter to the California State Assembly, Governor Newsom reasoned that California’s existing Office of Health Care Affordability (OHCA) is the more appropriate entity for healthcare transaction reviews:
Alerts
Colorado Department of Law Proposes Amendments to the Colorado Privacy Act Regulations Regarding Biometric and Minors’ Data
On September 13, 2024, the Colorado Attorney General’s office (the Colorado Department of Law) proposed draft amendments (draft regulations) to its Colorado Privacy Act (CPA) regulations, which took effect in 2023. The draft regulations implement two new Colorado laws on biometric data (HB 24-1130) and minors’ data (SB 24-041) passed earlier this year, both of which amend the CPA. This alert provides an overview of these laws and key related draft regulations.
WSGR Events
Preparing For Incident Response Under The EU’s Digital Operational Resilience Act
The Digital Operational Resilience Act (DORA) will take effect on January 17, 2025. As implementation approaches, financial entities and their ICT service providers are preparing for these new regulatory expectations in managing ICT risk.
Speaking Engagements
Balancing Parenting and Professional Goals
On December 4, Wilson Sonsini partner Brendan Coffman will join panelists from private practice and the government for a discussion hosted by the American Bar Association, titled "Balancing Parenting and Professional Goals." Panelists will explore the challenges faced by parents managing busy careers and offer strategies for thriving both as a parent and a professional. This timely conversation is particularly relevant in light of the recent advisory issued by the U.S. Surgeon General, which addresses the mental and physical health challenges faced by parents, particularly those juggling work and family responsibilities.
Speaking Engagements
Navigating the Nexus: Competition Law, Arbitration, and Global Trade Dynamics
On Tuesday, November 19, Wilson Sonsini partners Brent Snyder, Mike Casey, and Jindrich Kloub will join esteemed practitioners from the Hong Kong International Arbitration Centre, Des Voeux Chambers, and Monckton Chambers for a seminar exploring the complex interplay between competition law and arbitration, with insights on sanctions, export controls, and foreign direct investment (FDI).
Speaking Engagements
IAPP Europe Data Protection Congress 2024
IAPP Europe Data Protection Congress, Europe’s must-attend data protection event, is returning for its 13th year in Brussels. Learn from subject matter experts and gain working knowledge to assess ways to improve your current data protection operations and safely integrate new technologies.
Speaking Engagements
2024 ABA Antitrust Fall Forum
Wilson Sonsini partner Taylor Owings will co-chair the 2024 Antitrust Fall Forum in Washington, D.C. one week after the election, on Thursday, November 14. This year’s program will feature an engaging debate-style format, focusing on the future of antitrust policy in light of the forthcoming change in Administration.
Events
WSGR Events
Preparing For Incident Response Under The EU’s Digital Operational Resilience Act
The Digital Operational Resilience Act (DORA) will take effect on January 17, 2025. As implementation approaches, financial entities and their ICT service providers are preparing for these new regulatory expectations in managing ICT risk.
Speaking Engagements
Balancing Parenting and Professional Goals
On December 4, Wilson Sonsini partner Brendan Coffman will join panelists from private practice and the government for a discussion hosted by the American Bar Association, titled "Balancing Parenting and Professional Goals." Panelists will explore the challenges faced by parents managing busy careers and offer strategies for thriving both as a parent and a professional. This timely conversation is particularly relevant in light of the recent advisory issued by the U.S. Surgeon General, which addresses the mental and physical health challenges faced by parents, particularly those juggling work and family responsibilities.
Speaking Engagements
Navigating the Nexus: Competition Law, Arbitration, and Global Trade Dynamics
On Tuesday, November 19, Wilson Sonsini partners Brent Snyder, Mike Casey, and Jindrich Kloub will join esteemed practitioners from the Hong Kong International Arbitration Centre, Des Voeux Chambers, and Monckton Chambers for a seminar exploring the complex interplay between competition law and arbitration, with insights on sanctions, export controls, and foreign direct investment (FDI).
Speaking Engagements
IAPP Europe Data Protection Congress 2024
IAPP Europe Data Protection Congress, Europe’s must-attend data protection event, is returning for its 13th year in Brussels. Learn from subject matter experts and gain working knowledge to assess ways to improve your current data protection operations and safely integrate new technologies.
Speaking Engagements
2024 ABA Antitrust Fall Forum
Wilson Sonsini partner Taylor Owings will co-chair the 2024 Antitrust Fall Forum in Washington, D.C. one week after the election, on Thursday, November 14. This year’s program will feature an engaging debate-style format, focusing on the future of antitrust policy in light of the forthcoming change in Administration.
Josephine Aiello LeBeau
Partner
Josephine focuses on matters related to compliance and enforcement of U.S. export control and sanctions.
Mark Bass
Partner
Mark Bass is a partner in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where he works with public and private technology companies at all stages of growth. He also represents venture capital funds, private equity firms, and investment banks in financings and public offerings.
Michael S. Casey
Partner
Mike Casey is a dual-qualified, Chambers-ranked partner in the London office of Wilson Sonsini Goodrich & Rosati. His practice focuses on investigations and regulatory compliance matters related to economic sanctions, export controls, money laundering, corruption, and white-collar fraud. In addition, he regularly acts as a specialist in mergers, acquisitions, venture financings, lending arrangements, and other types of corporate transactions. He also frequently advises clients on the UK’s National Security and Investment Act and other foreign direct investment review regimes.
Mark R. Fitzgerald
Partner
Mark is a veteran attorney who advises technology and life sciences companies on corporate law and transactional matters.
Joshua F. Gruenspecht
Partner
Joshua advises domestic and foreign investors, funds, established companies and startups in regulatory, investigative, and enforcement matters.
Stephen R. Heifetz
Partner
Stephen advises clients on laws and policies at the intersection of international business and national security. He previously served in the U.S. government on the Committee on Foreign Investment in the U.S.
Andrea Linna
Partner
Andrea Linna is a partner at Wilson Sonsini Goodrich & Rosati, where she is a member of the firm’s digital health industry group and its healthcare practice. With more than a decade dedicated to healthcare law, Andrea exclusively represents digital health and healthcare IT clients, from emerging companies to established industry players, investors, and healthcare systems. Andrea guides her clients through the patchwork of federal and state laws that apply to digital health companies, addressing issues such as corporate practice of medicine, Stark Law compliance, Anti-Kickback Statute considerations, fee splitting, billing Medicare and Medicaid, contracting with commercial payors, value-based care arrangements, artificial intelligence, remote patient monitoring, online prescribing, scope of practice, and licensing requirements.
Eva F. Yin
Partner
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.
Jahna Hartwig
Of Counsel
Jahna Hartwig is Of Counsel at Wilson Sonsini Goodrich & Rosati, where she advises domestic and foreign companies on compliance with international trade laws.
Brett Weinstein
Of Counsel
Brett Weinstein is Of Counsel in the New York City office of Wilson Sonsini Goodrich & Rosati, where his practice focuses on advising technology companies regarding privacy, data security, and consumer protection.
People
Josephine Aiello LeBeau
Partner
Josephine focuses on matters related to compliance and enforcement of U.S. export control and sanctions.
Mark Bass
Partner
Mark Bass is a partner in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where he works with public and private technology companies at all stages of growth. He also represents venture capital funds, private equity firms, and investment banks in financings and public offerings.
Michael S. Casey
Partner
Mike Casey is a dual-qualified, Chambers-ranked partner in the London office of Wilson Sonsini Goodrich & Rosati. His practice focuses on investigations and regulatory compliance matters related to economic sanctions, export controls, money laundering, corruption, and white-collar fraud. In addition, he regularly acts as a specialist in mergers, acquisitions, venture financings, lending arrangements, and other types of corporate transactions. He also frequently advises clients on the UK’s National Security and Investment Act and other foreign direct investment review regimes.
Mark R. Fitzgerald
Partner
Mark is a veteran attorney who advises technology and life sciences companies on corporate law and transactional matters.
Joshua F. Gruenspecht
Partner
Joshua advises domestic and foreign investors, funds, established companies and startups in regulatory, investigative, and enforcement matters.
Stephen R. Heifetz
Partner
Stephen advises clients on laws and policies at the intersection of international business and national security. He previously served in the U.S. government on the Committee on Foreign Investment in the U.S.
Andrea Linna
Partner
Andrea Linna is a partner at Wilson Sonsini Goodrich & Rosati, where she is a member of the firm’s digital health industry group and its healthcare practice. With more than a decade dedicated to healthcare law, Andrea exclusively represents digital health and healthcare IT clients, from emerging companies to established industry players, investors, and healthcare systems. Andrea guides her clients through the patchwork of federal and state laws that apply to digital health companies, addressing issues such as corporate practice of medicine, Stark Law compliance, Anti-Kickback Statute considerations, fee splitting, billing Medicare and Medicaid, contracting with commercial payors, value-based care arrangements, artificial intelligence, remote patient monitoring, online prescribing, scope of practice, and licensing requirements.
Eva F. Yin
Partner
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.
Jahna Hartwig
Of Counsel
Jahna Hartwig is Of Counsel at Wilson Sonsini Goodrich & Rosati, where she advises domestic and foreign companies on compliance with international trade laws.
Brett Weinstein
Of Counsel
Brett Weinstein is Of Counsel in the New York City office of Wilson Sonsini Goodrich & Rosati, where his practice focuses on advising technology companies regarding privacy, data security, and consumer protection.
Related Practices
- Advertising, Promotions, and Marketing
- Antitrust and Competition
- Committee on Foreign Investment in the United States (CFIUS)
- Export Control and Sanctions
- FCPA and Anti-Corruption
- FDA Regulatory, Healthcare, and Consumer Products
- Federal Trade Commission
- Fintech and Financial Services
- National Security
- Payments
- Data, Privacy, and Cybersecurity
- Strategic Risk and Crisis Management
Recent Insights
Alerts
Proposed Rulemaking Issued by the DOJ Covering Data Export Transactions with Entities from Countries of Concern
On October 21, 2024, the U.S. Department of Justice (DOJ) issued a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117, which authorizes the Attorney General to prohibit or restrict transactions by U.S. persons that could result in the transfer of government-affiliated or bulk U.S. sensitive data to countries of concern or covered persons, and to provide safeguards around other activities that may otherwise provide access to such data.
Learn More
Newsletters
Sustainability and ESG Advisory Practice Update, October 2024
We are pleased to share the October 2024 issue of Wilson Sonsini's Sustainability and ESG Advisory Practice Update. Each issue combines news, key legal developments, and resources related to sustainability and environmental, social, and governance (ESG) matters relevant to public and private companies internationally.
Learn More
Recent Events
WSGR Events
Preparing For Incident Response Under The EU’s Digital Operational Resilience Act
The Digital Operational Resilience Act (DORA) will take effect on January 17, 2025. As implementation approaches, financial entities and their ICT service providers are preparing for these new regulatory expectations in managing ICT risk.
Learn More
Speaking Engagements
Balancing Parenting and Professional Goals
On December 4, Wilson Sonsini partner Brendan Coffman will join panelists from private practice and the government for a discussion hosted by the American Bar Association, titled "Balancing Parenting and Professional Goals." Panelists will explore the challenges faced by parents managing busy careers and offer strategies for thriving both as a parent and a professional. This timely conversation is particularly relevant in light of the recent advisory issued by the U.S. Surgeon General, which addresses the mental and physical health challenges faced by parents, particularly those juggling work and family responsibilities.
Learn More
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