Health

In the health sector, regulation never stands still. We help you anticipate change, adapt with confidence, and seize opportunity.

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We know how overwhelming it can be trying to effectively navigate today's regulatory environment and capitalize on opportunities. Our role is to help you thrive through change – removing unnecessary complexity, anticipating what’s next, and unlocking opportunities for growth. Because we have an in-depth understanding of how commercial dynamics and legislative direction intersect, we provide legal solutions that are aligned with business strategy.

We are uniquely positioned to serve providers and suppliers of health care services and products and all other players in the health care sector. We work with them as regulatory lawyers, and also as their strategic advisers, lobbyists, litigators, and dealmakers. From start-ups to multinational enterprises to trade associations, our clients come from every part of the health care sector of the worldwide economy.

One thing that makes us so effective is that our team includes an exceptionally high number of lawyers who are former senior government officials. This means we have insider insight into institutional thinking and decision-making processes at regulatory agencies so that we can better persuade them to take a certain view or course of action. We activate our influence across industries and institutions to give you the edge.

We also collaborate across our firm to provide seamless cross-border regulatory counseling and representation in the United States, the European Union, Asia, Latin America, Australia, and other major markets. By breaking through regulatory silos and working across borders, we deliver practical, business-focused solutions wherever you operate.

The broad array of organizations we represent in the health care sector, and our ability to meet all of their regulatory and other legal needs make us your one-stop resource for anticipating and responding to health care legal issues. We take you beyond compliance – shaping regulation to create opportunity and long-term advantage.

Health Privacy and Cybersecurity

Government Price Reporting

Fraud and Abuse

Health Legislation and Policy

AI and Digital Health

Inflation Reduction Act

Increasingly, health care services are conducted via telehealth technologies rather than only through face-to-face interactions. Providers, third-party payers, and manufacturers of health technologies need to understand the complex and evolving federal and state legal issues that could arise when services are delivered through telehealth interactions and across state and national borders. Our comprehensive health regulatory practice advises health care providers, payers, telehealth companies, and others in navigating the maze of federal and state rules, and evolving licensure, coverage and reimbursement policies, that may apply to telehealth devices, services, and providers.

Our global health privacy and cybersecurity team, part of the Hogan Lovells Privacy and Cybersecurity practice, advises health care organizations around the world on health data protection and privacy compliance issues. Whether it is preparing for or responding to cyberattacks and data breaches; advising on transactional work; developing policies, procedures, and training; strengthening incident response protocols; or counseling on regulatory compliance; our team has a vast range of experiences to share on health privacy and security issues.

Our government pricing team is the unquestioned industry leader and serves as a trusted advisor to many of the nation’s leading pharma and biotech companies. We assist manufacturers with applying price reporting and compliance requirements under the Medicaid Drug Rebate Program, Medicare Part B, and the 340B drug pricing program to their particular business models and commercial approaches. In cooperation with the health group, our government contracts team supports manufacturers with drug price computation reporting and compliance obligations associated with the VA Federal Supply Schedule and DOD Tricare retail rebate programs.

We regularly advise pharmaceutical manufacturers and other life sciences companies on a range of issues, including adherence to federal and state anti-kickback and false claims law, and compliance in connection with a variety of sales and marketing programs or arrangements with customers. We’ve been doing so since before most companies had “fraud and abuse” concerns on their radar. As the government has increased its focus on health care, aggressive enforcement actions have followed.

Lawyers in our Health practice are conversant with existing laws and policies and closely monitor proposed changes that could affect our clients’ businesses. With a practice that includes many former government officials, we can help you construct and implement strategies to better protect your interests. We are often called upon to advocate before government agencies at the cutting edge of new policy development. We also assist with issues ranging from medical research to patient privacy.

Our lawyers regularly assist clients with issues related to the scope of regulation for digital health products, including health IT technology such as electronic health records and hospital information systems, mobile health products such as mobile medical applications and wearable sensors, and the intersection between traditional medical devices and digital health services. We advise on all aspects of regulation involving the FDA, the EU, and other local, national, and international regulatory entities. We regularly counsel clients regarding strategic plans that not only comply with government regulations, but also achieve their business objectives on the complex process governing related patent information exchanges.

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The Inflation Reduction Act (IRA) introduces sweeping changes to Medicare drug pricing, including the Drug Price Negotiation Program, Part D benefit redesign, and inflation rebates for Part B and Part D drugs. These reforms significantly impact how life sciences and health care companies commercialize existing therapies and plan for future products. Our interdisciplinary team – spanning CMS, FDA, and IP insight – guides clients through the IRA’s complexities, helping them adapt strategies from clinical trials to market launch and generic entry. We also support administrative and legislative advocacy as the IRA evolves. Whether you're navigating early-stage development or managing a mature portfolio, we help you align with the new regulatory landscape and seize emerging opportunities.

Hogan Lovells has deep, substantive experience and access to regulators. The firm is very plugged in to the industry and evolving."

Chambers & Partners, USA Guide, 2025

The Hogan team not only have several former FDA staff members, but also possess significant scientific and technical expertise. They are always responsive and get the job done quickly and efficiently."

Chambers & Partners, USA Guide, 2025

Key contacts

Ronald L. Wisor, Jr.

Partner

Ronald L. Wisor, Jr.

Partner

Washington, D.C.

Dr. Jörg Schickert

Partner

Dr. Jörg Schickert

Partner

Munich

Meet the Health team

Representative experience

Assisting a major Health IT company in conducting a complete regulatory assessment of all portfolio and pipeline products to determine which products may be subject to regulation and assisting with bringing products into compliance where needed.

Successfully obtaining clearance for standalone software products in the imaging, anesthesia, and remote patient monitoring space.

Assisting pharmaceutical manufacturers in evaluating discount strategies, including value-and outcomes-based contracting strategies, to determine their impact on price points required to be reported to the federal government, namely Average Manufacturer Price (AMP), Best Price (BP), Average Sales Price (ASP), and Nonfederal Average Manufacturer Price (NFAMP), which can impact reimbursement rates, Medicaid rebate liability, and the 340B ceiling price, and to ensure compliance with fraud and abuse laws.

Assisting multiple manufacturers in designing and proposing demonstration projects to CMMI and Administration testing various value-based arrangements involving various types of drugs and biologics and, in the course of doing so, identifying innovative solutions to government price reporting and other concerns attendant to such arrangements.

Counsel various pharmaceutical and biological trade associations and individual manufacturers on a myriad of cutting-edge issues, including those concerning the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, fraud and abuse, and health information privacy.

Provided comprehensive incident response counsel to numerous health services companies and health plans with breaches involving tens of millions of records, including advising on forensic investigation, breach notification, and communications and interactions with consumers and customers. We also handled the investigations by federal and state health and insurance regulators, state attorneys general, and law enforcement.

Serving as primary outside privacy counsel for Fortune 500 pharmaceutical companies regarding a range of data privacy and security matters, including providing advice regarding international data protection, data use agreements, and privacy policies and procedures, as well as performing comprehensive website reviews.

Our thinking

Talking the Cure Podcast

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover cutting-edge topics such as AI, digital health, diversity in clinical trials, supply chains, the Inflation Reduction Act, and more.

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Guide

Horizons 2025 Life Sciences and Health Care Edition

Our Horizons edition brings together insights from across our global Life Sciences and Health Care team, exploring the issues and developments shaping the future of the industry.

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