McDermott Will & Schulte, a global law firm

Drawing on the combined resources, experience and record of our top-ranked health law and antitrust practices, McDermott Will & Schulte’s health antitrust lawyers provide clients with sophisticated, practical legal counsel where one of the most highly regulated, rapidly evolving industries meets one of the most complex area of law. We help hospitals, health systems and other providers identify antitrust risks and implement solutions that achieve business objectives and improve the delivery of services.

We regularly advise clients regarding the antitrust implications of provider mergers, acquisitions, joint ventures and joint operating agreements and defend those transactions before state and federal antitrust enforcement agencies. We assist clients in the development of clinical integration programs, accountable care organizations (ACOs) and other provider managed care contracting networks such as IPAs and PHOs, and the structuring of co-marketing arrangements, Medicaid collaboratives, trade associations and joint-purchasing arrangements.

We provide legal counsel on a broad range of day-to-day operations that may expose healthcare organizations to antitrust risks, including managed care contracts, economic credentialing, physician conflicts of interest, exclusive services agreements, purchase and use of discounted pharmaceuticals under the Non-Profit Institutions Act, integrated delivery systems, vertical integration and participation in information exchanges.

Our primary goal is to help clients avoid antitrust investigations and litigation. In so doing, we regularly develop and implement antitrust compliance plans, protocols, firewalls and training on appropriate policies and procedures. We also help clients identify and mount potential defenses and immunities, such as certificates of public advantage and joint actions to influence government policy (Noerr immunity). When investigations, civil litigation or class actions arise, our health antitrust litigators draw on their prior successes to mount a solid defense in court and before regulatory agencies.

Healthcare organizations face increasing government scrutiny and private whistleblower activity, and frequent regulatory and policy changes—all of which pose greater financial and reputational costs than ever before. We offer unmatched guidance in navigating this complex legal environment to help our clients minimize risk while reaching their goals.

If an investigation or litigation is unavoidable, our healthcare defense team efficiently and effectively achieves the best possible result for our clients, so they can focus on what they do best—innovating and revolutionizing the healthcare industry.

We anticipate problems and proactively develop solutions.

We understand you have a business to run, and we can help by minimizing the distraction that comes with subpoenas, investigations and litigation. Our healthcare litigation, regulatory, compliance and transactional practitioners work together to address every aspect of a legal problem in a layered approach that includes leveraging our industry-leading experience, following trends and staying on top of ever-changing laws, rules and guidance.

Our unrivaled understanding of the business of operating hospitals, health systems, healthcare providers, life sciences and technology companies—down to the complicated reimbursement structure and rules, at both the federal and state level—is critical in a world where billing government payors is a source of constant scrutiny. And our skilled team works tirelessly to help clients on many fronts, including identifying and avoiding unnecessary risks, responding quickly and effectively in a crisis, efficiently defending any investigation or qui tam complaint, and negotiating the best possible outcomes with the government and private parties. We routinely handle matters under the False Claims Act, the Stark Law, the Anti-Kickback Statute, HIPAA, corporate governance, cybersecurity, pharmaceutical marketing and pricing, and disputes among payers and providers.

Made up of well-respected and nationally renowned lawyers across the United States and around the world, our team includes:

• Several former Assistant United States Attorneys and healthcare fraud lawyers from the US Department of Justice
• Former senior advisors, lawyers and professionals from the HHS Office of Inspector General and the Centers for Medicare and Medicaid Services
• A best-in-class regulatory and compliance team that wrote a leading treatise on the Stark Law and includes nationally recognized authorities on the Anti-Kickback Statute and its safe harbor regulations
• Transactional lawyers experienced in negotiating healthcare transactions involving complex regulatory and compliance issues

Our team’s robust experience helps us deliver optimal results in healthcare litigation and investigations, and provide the necessary compliance guidance to help clients operate smoothly and avoid running into new issues.

While we are—and will continue to be—on the front lines of some of the largest and most important cases shaping the healthcare industry, our goal is to prevent problems from ever reaching the courtroom. Our clients come to us because they know they will get the best possible advice to minimize the likelihood of investigation or litigation. The comprehensive breadth and depth of our knowledge and experience enables us to spot issues before they become problems. Working as partners with our industry-leading healthcare regulatory and transactional lawyers, we help clients avoid investigations, litigations and crises. Yet, if litigation is unavoidable, our team of seasoned, first-chair trial lawyers is experienced in aggressively and effectively defending healthcare litigation.

As the only law firm to receive national Tier 1 rankings in healthcare from all of the industry’s top legal directories—Chambers USA, The Legal 500 USA and U.S. News – Best Lawyers—we’ve earned our reputation by leading the legal strategies on some of the most important cases in the healthcare industry and stand ready to help you take on yours.

The physician practice management (PPM) and ambulatory surgery center (ASC) industries have experienced explosive growth and unprecedented consolidation and capital investment within the past 10 years, yet continue to be highly fragmented and competitive. As physicians, management companies, private equity and other investors join forces to strengthen their positions in this dynamic environment, they face reimbursement, regulatory, compliance, billing and transactional implementation issues that can cause roadblocks to their success.

We’ll expand your field of vision so you can execute your objectives.

With unparalleled experience and industry knowledge, we’re uniquely equipped to help you identify and mitigate risk, uncover new opportunities and develop winning strategies that maximize long-term value.

Our dedicated, multidisciplinary team has helped shape the ASC and PPM industries over the past three decades and offers clients practical and operational approaches to addressing their unique legal, transactional and regulatory needs. We provide clients with innovative, business-oriented legal solutions tailored to their competitive and operational challenges, such as syndicating start-ups, transactions with management companies and health systems, and joint venture arrangements.

Transactions within the ASC/PPM sectors involve complex legal, regulatory and compliance issues and are closely watched by state regulators and payors to ensure that patient care remains guided by professional judgment, not profit motivations. Our cross-functional legal team has a deep understanding of local and regional issues and licensing requirements, strong relationships with regulatory authorities and extensive experience in all regulatory aspects of the PPM/ASC industries, from structuring transactions and antitrust enforcement, to reimbursement rules and managed care contracting. We even provide lobbying assistance to national and state-based associations dedicated to the PPM/ASC industries through our office in Washington, DC.

We also host an annual ASC/PPM Symposium, considered the premier national conference addressing the industry’s key business, transactional and regulatory issues, attended each year by hundreds of executives and decision makers from across the United States.

How can we help you transform healthcare?

Today’s health market has entered a new age of collaboration, innovation and disruption.  With the shift to value-based care turning the healthcare industry on its head, forward thinking leaders are looking toward innovative alliances through mergers and acquisitions to improve quality of care and delivery, financial outcomes, and operational efficiencies.

Making these innovative and transformative business ventures a reality comes with significant regulatory and transactional challenges, and there are many opportunities for a deal to go off course.

That’s why you need the full weight of the industry’s leading healthcare law firm behind you.

As the industry’s top-ranked law firm for health and life sciences ventures, we’re passionate about our role in shaping the alliances that will lead to superior healthcare delivery. With more than 400 major hospital and health system transactions under our belts in the past five years, we are deeply experienced with helping clients find creative and unexpected solutions in the most complex healthcare and life sciences markets.
Whether they’re forming partnerships across industries or across the world, our unparalleled experience enables us to champion our clients’ visions. Our team’s cross-functional, cross-border capabilities, practical and operational approach, and extensive experience fostering game-changing collaborations give us unique insight into the relationship-building nuances that help healthcare leaders make these vital alliances a reality. Our transaction leaders bring highly focused skills and broad industry experience to bear on all elements of a transaction, earned from decades of fostering game-changing alliances in the healthcare space through merger and acquisitions, private equity and venture capital investment, joint ventures, and strategic investments and alliances.

Our transaction leaders bring highly focused skills and broad industry experience to bear on all elements of a transaction. We seamlessly integrate technical specialties with transactional, regulatory and controversy-contextual knowledge (e.g., Medicare reimbursement, the Stark Law) and have significant daily experience advising on these matters at operational and strategic levels. This cross-functional approach enables our team to anticipate change and craft creative solutions that avoid redundancy and delay, so that transactions are executed in a timely, cost-effective manner. Our deep regulatory bench and broad transactional backgrounds give us insight into the regulatory, reimbursement and operational issues that, in less experienced hands, can derail transactions and destroy value.

Because we have counseled hospitals and health systems across the United States and around the globe, our dedicated healthcare M&A teams have a complete understanding of the federal and state regulatory landscape and can quickly identify the local regulatory matters that, in conjunction with federal laws and regulations, will influence the outcome of a transaction.

Together, we’re pushing boundaries and knocking down barriers to usher in a new age of healthcare collaboration.

Regulation in the healthcare industry is pervasive and extraordinarily complex. To stay ahead of emerging regulations and minimize the risks associated with non-compliance, health industry leaders need experienced legal counsel who are well-versed in existing laws and have a finger on the pulse of new legal and regulatory developments.

We’ll be your guide on the road to innovation.

Almost every aspect of healthcare is overseen at the federal, state or local levels, and often by a range of private organizations as well, creating a regulatory maze of transactional structuring and due diligence, operations, compliance plan implementation, self-disclosure and defense. With centuries of combined experience providing counsel to some of the world’s most important healthcare organizations, we have the diverse and expansive capabilities necessary to clear your path to success.

With our team of former prosecutors and Office of Inspector General officials, Health and Human Services and US Food and Drug Administration (FDA) regulators, and compliance leaders, we are able to provide clients with real-world, practical approaches to managing the most complex regulatory challenges. As a result, our client base extends across all facets of the healthcare industry.

Our healthcare regulatory lawyers have unrivaled experience in all key areas of healthcare, including anti-kickback and self-referral laws, False Claims Act defense, reimbursement counseling, patient data privacy under HIPAA and the HITECH Act, health reform initiatives and tax issues, especially in these key areas:

• Affordable Care Act
  The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively, the Affordable Care Act) has expanded access to health insurance for tens of millions of US citizens and generated a complete overhaul of the nation’s health system. We help clients understand and navigate these changes, advising on industry best practices and the development of educational programs. Drawing on the knowledge and resources of lawyers in our highly regarded health, employee benefits, life sciences, executive compensation, government strategies and tax groups, we offer comprehensive service to help clients meet the challenges of the new healthcare landscape.
• Clinical and Database Research
  Adherence to good clinical practices is fundamental to research. We represent academic medical centers, pharmaceutical companies and research institutions on all aspects of FDA, National Institutes of Health, National Cancer Institute, and Animal and Plant Health Inspection Service regulatory matters. Our experience includes advising on procedures and other compliance matters, preparation for and representation during inspections and audits of device and drug trials, representation in enforcement actions, and advising on establishing organizations to conduct clinical research.
• Fraud and Abuse/Stark Law
  Healthcare fraud and abuse costs the industry billions. Without adequate processes in place to prevent fraudulent activities, providers may be subject to costly investigations. We advise clients in all areas of Medicare and Medicaid fraud and abuse statutes, the Stark Law, and other federal and state self-referral prohibitions, and provide guidance regarding safe harbor regulations. Our fraud and abuse consultation includes planning and structuring transactions to minimize fraud and abuse implications, and providing advisory opinions on potential concerns. We conduct audits and represent clients targeted in inspector general and grand jury investigations, often working with our white-collar defense team to provide effective, multifaceted representation.
• FDA/Product Regulation
  Members of our FDA and health industry advisory practices are nationally recognized by U.S. News – Best Lawyers and LMG Life Sciences. We provide comprehensive advice on all aspects of the development, clinical research, product application and review, manufacture, distribution, marketing and reimbursement of drug, biologic, device and other products regulated by the FDA.
• Tax-Exempt Organizations
  Tax-exempt healthcare organizations are subject to intense regulatory scrutiny by Congress, the Internal Revenue Service and state attorneys general. As the industry’s top-ranked healthcare law firm, and one of the largest and most-respected tax practices, we provide comprehensive tax planning, compliance and advocacy services to nonprofit hospitals and other tax-exempt healthcare organizations. We regularly advise healthcare clients on the special tax issues that arise in the context of joint operating arrangements, horizontal integrations, conversions and sales of assets and the resulting foundations, joint ventures, physician practice acquisitions, academic medical center relationships with physicians, and captive insurance and other risk-management arrangements.

Dealmakers need deal lawyers. Everything we do—from thinking creatively to acting with agility—is designed to help you secure the best possible outcome in every transaction.

Our first priority is to manage and assess your risks and opportunities, all while looking for the most efficient way to get the deal done. That begins with developing a strong thesis for the transaction, outlining exactly how you’ll benefit. We align our strategy and advice with your objectives to guide you through each step of the private equity lifecycle. When we spot a complex issue, we tackle it and move on, so your deal won’t get caught in the weeds. With our business-focused team working to anticipate the unknown and deliver actionable solutions, we help you stay ahead of the curve from fund formation to exit.

Deals are complex and require mastery of multiple disciplines. That’s why cross-practice collaboration is an integral part of our unique model. You have direct access to all of our experienced lawyers in any area you need. Our integrated team includes lawyers focused on a wide variety of practices, including:

Learn more about our Private Equity Practice.

Healthcare delivery and reimbursement is shifting toward value-based care and vertical consolidation at a rapid pace, while the boom of health plan mega-mergers shows no signs of stopping. Those who want to grow and innovate within this disrupted healthcare environment face difficult regulatory and transactional legal obstacles. In order to thrive despite these challenges, you must be willing to take calculated business risks and adapt to a shifting landscape.

Creative legal solutions in the most complex markets

Our experienced team anticipates change and crafts creative, strategic solutions in even the most complex markets. Clients turn to us for our depth of knowledge on key issues and our unmatched skill in navigating the complicated industry issues they face, including numerous types of managed care arrangements and integrated delivery systems for health insurers, hospitals, academic medical centers, other institutional inpatient and outpatient facilities, medical groups and independent practice associations, physicians, medical discount programs and employers, as well as for investment bankers, venture capitalists and individual entrepreneurs. Our Firm also works closely with health insurers and their pharmacy benefit managers (PBMs) on prescription drug plans and pricing issues. Amidst uncertainty we offer a level-headed approach, fostering collaboration across industries and borders.

We work tirelessly to facilitate connections through mergers, acquisitions, affiliations and joint ventures, conducting full due diligence while identifying and negotiating arrangements built with regulatory and technological assessments and solutions in mind.

Our team provides guidance to Accountable Care Organizations (ACOs) on the Medicare Shared Savings Program requirements for their organizational and contractual arrangements. We also advise trade associations on communications to their membership regarding legal developments, draft comments on proposed regulations and subregulatory guidance, and offer strategic counseling in dealing with state and federal agencies.

With an impressive depth of national and international regulatory knowledge, we’re at the forefront of health industry innovation. And as the United States’ top-ranked healthcare law firm, we offer unmatched experience addressing the legal obstacles facing health plans, managed care arrangements and ACOs, including providing counsel on:

• Administrative services only arrangements
• Requirements under the Affordable Care Act, such as tax issues and risk management
• Antitrust and trade regulation
• Bankruptcy and workout plans
• Consumer-directed health plans
• Prescription drug pricing
• Conversions and tax-exempt issues
• Corporate integrity agreements and compliance programs
• ERISA
• The Federal Employees Health Benefits Program
• HIPAA privacy and security
• Tiered-benefit arrangements and disease management programs
• Medical discount programs
• The Medicare Advantage Program and Medicare Part D
• Federal and state licensure of plans and insurers

Drawing on our robust, cross-functional, cross-border team, we provide cutting-edge solutions and creative counsel to our health plan clients to navigate the changing healthcare landscape.

Spurred by the shift to value-based care, the healthcare market is transforming at a rapid pace as systems join forces to tackle some of the industry’s biggest challenges. We counsel provider organizations across the United States and around the world on all aspects of healthcare investments, operations and regulatory matters. The results are operational efficiencies and reduced costs, optimized investments in technology and innovation, and improved patient care and safety.

Moving swiftly to capitalize on opportunities

Clients—including nonprofit, for-profit, faith-based and governmental hospitals; healthcare systems; and physician groups of all sizes—frequently turn to us to serve as outside general counsel. We work to seamlessly supplement in-house general counsel by providing responsive, accurate and forward-thinking legal advice on a variety of issues:

• Corporate governance
• Labor and employment needs for medical staff
• Employee benefits
• Professional services
• Provider and physician satisfaction
• Compliance with Medicare reimbursement regulations, fraud and abuse laws, Stark Law, HIPAA and data privacy laws
• Licensing and accreditation for the institution and its professionals
• Tax-exemption matters

As the top-ranked healthcare law firm, we advise clients on all elements of the health industry, whether by offering counsel through detailed and efficient due diligence; evaluating sophisticated and nuanced tax benefits, antitrust and health regulatory issues; or negotiating strong, practical transaction documents. Applying our wealth of experience and understanding of the rapidly changing business, legal and regulatory terrain, we help clients develop winning strategies and seize opportunities.

We create connection through mergers, acquisitions, affiliations and joint ventures, all while identifying solutions that minimize risk and maximize success for patients, providers and investors. Our extensive experience and practical approach to facilitating collaboration across industries and borders gives us unique insight into the relationship-building nuances that help healthcare leaders make these vital alliances a reality.

And with highly experienced lawyers throughout the Firm, we provide clients coordinated, cross-functional, cross-border counsel in key areas beyond healthcare as well, including tax, labor, employment and employee benefits, litigation and intellectual property.

Healthcare organizations face increasing government scrutiny and private whistleblower activity, and frequent regulatory and policy changes—all of which pose greater financial and reputational costs than ever before. We offer unmatched guidance in navigating this complex legal environment to help our clients minimize risk while reaching their goals.

If an investigation or litigation is unavoidable, our healthcare defense team efficiently and effectively achieves the best possible result for our clients, so they can focus on what they do best—innovating and revolutionizing the healthcare industry.

We anticipate problems and proactively develop solutions.

We understand you have a business to run, and we can help by minimizing the distraction that comes with subpoenas, investigations and litigation. Our healthcare litigation, regulatory, compliance and transactional practitioners work together to address every aspect of a legal problem in a layered approach that includes leveraging our industry-leading experience, following trends and staying on top of ever-changing laws, rules and guidance.

Our unrivaled understanding of the business of operating hospitals, health systems, healthcare providers, life sciences and technology companies—down to the complicated reimbursement structure and rules, at both the federal and state level—is critical in a world where billing government payors is a source of constant scrutiny. And our skilled team works tirelessly to help clients on many fronts, including identifying and avoiding unnecessary risks, responding quickly and effectively in a crisis, efficiently defending any investigation or qui tam complaint, and negotiating the best possible outcomes with the government and private parties. We routinely handle matters under the False Claims Act, the Stark Law, the Anti-Kickback Statute, HIPAA, corporate governance, cybersecurity, pharmaceutical marketing and pricing, and disputes among payers and providers.

Made up of well-respected and nationally renowned lawyers across the United States and around the world, our team includes:

• Several former Assistant United States Attorneys and healthcare fraud lawyers from the US Department of Justice
• Former senior advisors, lawyers and professionals from the HHS Office of Inspector General and the Centers for Medicare and Medicaid Services
• A best-in-class regulatory and compliance team that wrote a leading treatise on the Stark Law and includes nationally recognized authorities on the Anti-Kickback Statute and its safe harbor regulations
• Transactional lawyers experienced in negotiating healthcare transactions involving complex regulatory and compliance issues

Our team’s robust experience helps us deliver optimal results in healthcare litigation and investigations, and provide the necessary compliance guidance to help clients operate smoothly and avoid running into new issues.

While we are—and will continue to be—on the front lines of some of the largest and most important cases shaping the healthcare industry, our goal is to prevent problems from ever reaching the courtroom. Our clients come to us because they know they will get the best possible advice to minimize the likelihood of investigation or litigation. The comprehensive breadth and depth of our knowledge and experience enables us to spot issues before they become problems. Working as partners with our industry-leading healthcare regulatory and transactional lawyers, we help clients avoid investigations, litigations and crises. Yet, if litigation is unavoidable, our team of seasoned, first-chair trial lawyers is experienced in aggressively and effectively defending healthcare litigation.

As the only law firm to receive national Tier 1 rankings in healthcare from all of the industry’s top legal directories—Chambers USA, The Legal 500 USA and U.S. News – Best Lawyers—we’ve earned our reputation by leading the legal strategies on some of the most important cases in the healthcare industry and stand ready to help you take on yours.

Whether you’re a global biopharma leader in medical devices and drugs, a cutting-edge digital health innovator, a clinical research organization or something completely new, our Food and Drug Administration (FDA) practice will help fuel your mission by guiding you through the complex regulatory and compliance landscape.

As the top-ranked law firm for health and a leader in life sciences, we are dedicated to our clients and passionate about the work we do together. We counsel clients on the development, manufacture, marketing and promotion, and reimbursement of drugs, biologics, devices and other products regulated by the FDA.

Led by a former US Food and Drug Administration (FDA) Associate Chief Counsel and a former senior executive in-house counsel to leading biopharmaceutical companies, our FDA regulatory lawyers offer deep industry experience, strategic legal advice, diverse perspectives and practical solutions that address the full scope of regulatory and compliance issues life sciences companies face.

Our cross-border, cross-practice team will work collaboratively to help you clear your path to success on issues such as intellectual property, data privacy and security, litigation, pricing, reimbursement and healthcare compliance. We advise clients on the following:

• Current Good Manufacturing Practice (cGMP), Medical Device Quality System Regulation (QSR), Good Clinical Practice (GCP), internal compliance programs, internal and external audits, and standard operating procedures (SOPs)
• Marketing applications and other regulatory submissions, product labeling, advertising and promotions, and post-market surveillance
• Product regulatory status determinations, import-export compliance, and other pre- and post-market regulatory programs
• FDA inspection preparedness and responses to FDA Inspectional Observations (483s), warning letters and other regulatory communications
• FDA investigations, FDA consent decrees and other enforcement actions involving the FDA, the US Department of Justice (DOJ), state attorneys general, other federal and state agencies, the US Congress, and False Claims Act qui tam and other litigants
• Compliance program implementation, auditing and monitoring in accordance with OIG’s Seven Elements of an Effective Compliance Program and applicable PhRMA Code/ADVAMED industry standards and applicable laws and regulations
• Development and submission of citizen petitions, trade complaints and comments on FDA proposed rules and guidance
• Entry into the United States of non-US companies through clinical-study, approval, prelaunch, compliance-program and other initiatives

Innovative solutions for an ever-evolving industry

Digital health solutions are fundamentally transforming the quality and delivery of healthcare. As the doctor-patient relationship evolves beyond the in-person encounter, digitized data and technology have converged with healthcare delivery and payment. Our digital health team works with clients to create solutions that improve access to medical services and engage patients in managing their healthcare, with an eye toward the complex and ever-evolving regulatory considerations affecting healthcare innovation.

We offer guidance on all aspects of digital health, including the formation, financing and governance of business entities, joint venture arrangements, and mergers and acquisitions. Drawing on our vast institutional knowledge and the creativity to drive forward-looking solutions, we counsel clients in a wide range of areas, including development, reseller marketing and distribution arrangements, intellectual property protection and licensing agreements, systems integration agreements, internet and new technology issues, product liability matters, and employment and noncompetition agreements, as well as related personnel issues.

Our team leads emerging and established organizations through the unique—and often unanticipated—transactional, regulatory and compliance challenges they face. Uniting our depth of experience and our ability to anticipate change, we help clients develop creative solutions to the obstacles that slow adoption and growth so they can keep moving forward in an ever-changing industry.

How can we help you transform healthcare?

Our areas of focus

• Health Information Technology
• Mobile Health
• Big Data and Data Strategies
• Data Privacy/Security HIPAA and State Laws
• Telehealth/Telemedicine

Health information technology

Complex legal and compliance issues surround the acquisition, implementation, use and management of health information technology (HIT). Our team offers advice on key matters in a quickly changing landscape, including patient consent issues involved with health information exchanges; electronic communication issues among and between providers, payers and patients; and matters involving electronic health records (EHRs), health information exchanges (HIEs), and the use and disclosure of protected health information (PHI). We also counsel our clients on compliance with the Health Insurance Portability and Accountability Act, state breach notification laws, Medicare and Medicaid EHR Incentive Program requirements, the False Claims Act, the Anti-Kickback Statute, and other federal and state healthcare regulatory laws.

For clients ranging from physicians, hospitals and health systems to practice management companies, HIT vendors and medical billing companies, we offer skillful support with software and hardware procurement, implementation, service level agreements and warranties, and associated contract and regulatory compliance aspects.

mHealth

Mobile healthcare devices, including wearables and medical apps, empower patients to better understand their health. These devices capture consumer-generated health data, analyze it and provide mobile feedback to consumers. These mHealth applications may also deliver healthcare information to providers and researchers in order to facilitate efficient coordination of care. Our team assists clients with the transactional and regulatory issues that arise when businesses engage with patients, consumers, providers or researchers about their health needs, whether through mobile devices or other connected devices outside of traditional healthcare provider settings. We also offer counsel on issues arising from emerging digital health tools, such as mobile medical apps, that the US Food and Drug Administration (FDA) may consider regulated devices.

Big data and data strategies

We assist clients with the design and deployment of big data strategies. Supported by a flexible, yet sustainable, privacy and security protection infrastructure, big data strategies can capture, aggregate, transform and analyze key data. Businesses use these sophisticated analytics to effectively implement improvements in healthcare quality, coordination, accessibility and affordability for the benefit of payers, employers and healthcare consumers. Our team helps identify, manage and resolve legal issues associated with high-volume analytics and data mapping, privacy and security protections, data licensing and clinical research activities, including federal and privately sourced data. We also assist in forging collaborations between industry stakeholders to leverage strengths and accelerate initiatives.

Data privacy/security HIPAA and state laws

The Health Insurance Portability and Accountability Act (HIPAA) governs the use and disclosure of identifiable health information. Using our industry-leading best practices, we counsel a diverse range of clients in navigating these complex rules. We conduct audits, develop customized plans, policies and procedures for privacy and security compliance, and even facilitate HIPAA-related training sessions.

If a crisis does arise, we also advise clients regarding security breaches, risk assessment, mitigation and remediation, and negotiate settlements and resolution agreements with the US Department of Health and Human Services Office for Civil Rights. Together with lawyers in our privacy and data protection practice, our digital health team has guided companies through the successful resolution of many privacy and security incidents, including hundreds of incident responses and breach remediation efforts involving PHI. From cyber attacks and malicious insiders, to lost laptops, unsecured data and mailing mishaps, we have handled the full spectrum of information incidents.

We draw on this experience to bring calm to the storm and provide guidance from beginning to end, including developing and implementing effective audits, protection and loss-prevention programs, and simplifying the notification process across jurisdictions.

Telehealth/telemedicine

Bringing the doctor-patient relationship out of the confines of an in-person encounter, telehealth integrates information technology with traditional healthcare and wellness practices. Remote healthcare, also called telemedicine, is changing the way medical services are delivered. Thanks to advances in technology and information systems, these new diagnostic tools and methodologies can improve access to and consistency of medical services—an important benefit to consumers and providers alike. Our clients turn to us for guidance regarding licensure, patient consent and recordkeeping, data privacy, risk mitigation, and navigating the varied state-based regulations and regulatory definitions associated with telehealth. We help assess business strategies and advise on government and commercial reimbursement standards so clients can succeed in this rapidly changing, highly regulated industry.

Protect. Grow. Flourish.

As a life sciences company, your intellectual property is your most valuable asset—it’s what propels your growth, drives your success and sets you apart from competitors. But it may also be your most vulnerable asset.

How you commercialize your innovation and gain compliance is crucial for the success of your business. As competitors constantly work to capture your share of the market, it is imperative that your IP is protected to maximize its value.

Our more than 135 multidisciplinary life sciences lawyers are here to help. In addition to legal experience spanning the world’s foremost life sciences companies to its most innovative startups, the majority of our IP lawyers hold advanced degrees in the life sciences fields. Our institutional qualifications, coupled with real-world experience on almost 1,000 patent and trademarks annually, uniquely position the firm to anticipate change and adapt quickly to take advantage of opportunity, so you can focus on achieving your mission.

We provide the full array of services to protect and leverage your IP assets:

• Patent and trademark protection
  • Patentability analysis
  • Trademark clearance
• Infringement, validity and freedom-to-operate opinions
• IP transactions
  • Licensing and collaboration
  • M&A and finance
  • Outsourcing and licensing agreements
• Litigation
  • “Bet the company” litigation
  • Patent litigation
  • Hatch-Waxman Act cases
  • Medical device infringement

Let us help you go further.

The strategy behind your business growth

Pushing boundaries and moving forward, you’re always looking for what’s next. Be ready to take advantage of merger and acquisition opportunities with a hand-selected team of legal advisors by your side. We’ll navigate the complex and highly regulated life sciences landscape and help prevent challenges from holding you back. So you can keep moving at the pace of innovation.

It’s what we do: we fuel missions and knock down barriers to successfully negotiate and close deals on behalf of life sciences businesses large and small, worldwide.

No matter what your growth looks like, our cross-border team can help with your collaborative transformations, including:

• Traditional M&A deals
• Strategic acquisition of distressed assets
• Spin-offs, carve-outs and divestitures
• Private-equity-funded buyouts
• Venture capital funding
• Deals with universities, academic medical centers and research institutions

We offer comprehensive and holistic advice from an integrated team of Tier 1 health lawyers along with our deep bench of IP, regulatory, litigation, corporate, tax and employee benefits lawyers from more than 20 offices around the globe.

Learn how we can help you go further.