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The Healthcare Practice is highly regulated and rapidly changing. Individuals and companies that do business in this arena require legal counsel with a hands-on understanding of the unique issues of the healthcare environment and constructive solutions to their problems. Our Healthcare lawyers practice exclusively in this area and, consequently, have in-depth expertise helping clients properly structure their business relationships and transactions, comply with laws and regulations, and achieve successful resolutions in civil, criminal and administrative proceedings. Our excellent service and skills are evidenced by the practice’s ranking in Chambers USA, a leading legal services ranking publication.
Our industry knowledge uniquely positions us to assist clients in structuring transactions and relationships that meet their business goals and comply with state and federal healthcare laws. Our Healthcare lawyers have extensive experience in assisting clients in selecting and forming the appropriate business entity(ies); putting into place effective corporate governance and financial mechanisms; documenting contractual and other legal relationships; implementing tax-efficient business arrangements; and developing, documenting and executing joint ventures, mergers and acquisitions, and other business relationships. We provide our clients with advice and creative solutions to ensure compliance with the myriad of complex healthcare laws and regulations, including the Anti-Kickback Statute, federal and state self-referral laws, Certificate of Need matters, HIPAA’s Privacy and Security Standards, and the Georgia Medical Practice Act.
Our experienced Healthcare litigators regularly represent clients in litigation in federal and state courts and in administrative proceedings. This representation includes matters ranging from complex business litigation to employment issues to whistleblower actions to provider reimbursement issues to medical staff disputes. Additionally, our attorneys have represented clients in civil and criminal disputes involving allegations of fraud and abuse and false claims. In administrative matters, we regularly represent healthcare providers in Certificate of Need appeals; licensure investigations and disciplinary actions; credentialing matters; Medical staff investigations, adverse actions and hearings; and Medicare/Medicaid audits, investigations, and appeals.
Our lawyers' experience in these areas of business transactions, statutory and regulatory guidance, and litigation extends to all components of the healthcare industry, including hospitals and healthcare systems, physician practices (both single and multispecialty), home health agencies, skilled nursing facilities, assisted living facilities, ambulatory surgery centers, and diagnostic imaging centers. This comprehensive knowledge and experience allows us to anticipate and address concerns throughout the healthcare industry.
We practice daily at the intersection of legal, policy, and technical cutting-edge cybersecurity and privacy issues. We offer solution-oriented guidance tailored to your industry and your data collection and use practices, leveraging years of experience and strategic partnerships to swiftly deliver direct, practical advice.
Our Cybersecurity & Privacy team covers compliance assessments under privilege to decrease corporate risk, working with in-house legal departments, information technology and security teams, C-suites, and boards of directors on proactive measures to improve preparedness and to effectively manage cyber-risk.
We serve as crisis managers in the event of a data breach, guiding you during the first hours of a data security incident investigation through post-breach litigation matters.
Our experience across a broad range of industries allows for integrated advice, incorporation diverse perspectives from our attorneys in related practice areas such as technology, insurance, litigation, and corporate matters. We scale the solution based on client needs. Components of your customized roadmap can include:
Cyberattack and Data Breach Response
Even the most secure organizations will experience a data security event. We have deep experience responding to cybersecurity incidents across industry sectors, threat actors and threat vectors.
Our cyberattack and data security incident response practice is here to work with you in those first minutes and hours of becoming aware of a breach to mitigate harm, risk and liability. We direct physical and IT forensics investigations, coordinate with law enforcement agencies, provide guidance on how to manage business and reputational risks, internal investigations, and board-level and consumer communications, advise on regulatory and contractual data breach notification requirements in the United States and abroad, direct public relations and media strategy, represent clients in government investigations before state and federal regulators and non-U.S. data protection authorities, and defend clients in parallel proceedings, including civil class actions and arbitrations, and shareholder derivative litigation.
Clients have exclusive access to our cybersecurity incident hotline. As soon as a client discovers an incident, our team is available 24/7, whenever a breach occurs.
Global Compliance Programs and EU General Data Protection Regulation (GDPR)
With business objectives in mind, we assist emerging and public companies in mitigating reputational, regulatory and litigation risks by creating global compliance programs. We advise companies on how privacy and data protection laws impact business operations, including customer service, HR functions, big data analytics, and product and service development.
We regularly counsel on compliance with numerous federal and state privacy laws, regulations and industry standards, including the Gramm-Leach-Bliley Act (GLBA), Fair Credit Reporting Act (FCRA), Payment Card Industry Security Standards, the CAN-SPAM Act, Health Insurance Portability and Accountability Act (HIPAA), Telephone Consumer Protection Act (TCPA), Children’s Online Privacy Protection Act (COPPA), California Online Privacy Protection Act (CalOPPA), Canadian Personal Information Protection and Electronic Documents Act (PIPEDA), Canada Anti-Spam Legislation (CASL), and others.
Determining the applicability of the EU General Data Protection Regulation (GDPR) to your operations is a critical business decision. Penalties for violations of the GDPR can amount to 4% of annual worldwide turnover. We can help you navigate this complex and strict privacy framework. Our team constantly advises clients on the right strategy to GDPR compliance and collaborates with clients to address accountability obligations, stronger rights and ongoing restrictions on international data flows. We have extensive experience evaluating the GDPR’s impact on our client’s data processing agreements, embedding privacy-by-design principles, selecting the appropriate mechanism for international data transfers, and crafting clear comprehensive privacy notices. We leverage relationships with strategic partners to offer our clients ready access to data protection officer and EU representative services.
Data-Driven Transactions and Data Management
Data drives the digital economy. Our team is at the forefront of critical issues, such as Big Data, Artificial Intelligence, Blockchain, Internet of Things, and the application of these technologies to our clients’ businesses. We assist clients in maximizing their rights to data, while addressing global data privacy requirements and proactively reducing security risk. We have represented more than 1,000 companies in their corporate transactions valued from a few million to many billions of dollars, throughout the U.S. and abroad. We are generally recognized as the leading M&A law firm in the Southeast in representing high-growth and middle market companies.
Today’s healthcare, pharmaceutical, life sciences and medical device companies face ever expanding state and federal regulations, and are often targeted in parallel civil, criminal and administrative proceedings at the federal and state level. Additional collateral proceedings such as product liability suits, third-party payor suits and employment issues are frequent by products of civil and criminal investigations. Morris, Manning & Martin’s deep expertise in the healthcare sector, along with its collaborative approach of teaming with appropriate substantive and regulatory experts, provides clients with full-service, multidisciplinary representation when confronted with such issues. In addition, the firm utilizes a broad array of mobile resources and technology to respond quickly and efficiently to pressing client needs.
A Diverse Team of Specialists
Attorneys in the Healthcare Fraud and Abuse Practice have extensive training and experience in the healthcare industry and with various federal healthcare compliance and regulatory matters. Two of the Healthcare Fraud and Abuse Practice’s members have served as in-house counsel at large Georgia hospitals, providing unique insight into the challenges faced by many of our clients. Additionally, one of our practice members is a former Assistant United States Attorney who served as the federal Criminal Healthcare Coordinator, in which capacity she oversaw all healthcare investigations and prosecutions in her office’s district, including investigations into and prosecutions of federal providers and pharmaceutical companies. These combined prior experiences provide a unique understanding of the investigative and prosecutorial process, as well as an appreciation for the consequences of the findings that may arise from such inquiries.
Should the need arise, we provide clients with a creative, hardworking litigation team equipped to deal efficiently, effectively and responsively with the most sensitive and challenging legal issues. Each case is engaged with our aggressive, hands-on approach and, always conscious of the cost of litigation, we strive to formulate a strategy to obtain the best possible result, carried out in a practical, cost-effective manner that best applies our resources to meet each client’s objectives.
Our Healthcare Information Technology Practice provides legal and compliance services to information technology companies and healthcare providers by providing regulatory advice, drafting and negotiating contracts, counseling, and litigation defense in all aspects of the data security, privacy, and use and transmission of data on both a state and federal level. Our lawyers work collaboratively with our clients to address regulatory compliance with software or product modifications, enhancements and upgrades. We continually provide information technology companies with regulatory analysis of strategic business plans, products and offerings and daily operational activities. In addition to regulatory compliance, our lawyers have specific expertise in intellectual property rights and assist clients in proactively protecting intellectual property assets.
Our firm has significant experience in data privacy and security, both on state and federal levels. Our lawyers have unique experience and expertise in not only healthcare regulations, including HIPAA, but also the impact and application of healthcare regulations to information technology organizations.
Our lawyers have counseled numerous clients on issues related to electronic exchange of health information, personal health records, pay for performance and payer programs, discovery, document preservation issues, document retention policies, and data breach issues. We advise our clients regarding the electronic exchange of health information and when security breaches, theft, or loss of electronic storage media or health records occurs, including how to prevent such breaches and thefts in the future. We also work with our clients to address regulatory compliance and best practices in the changing electronic medical record industry.
Our industry knowledge and experience uniquely positions us to assist clients in structuring compliant transactions, addressing the regulations to establish relationships that meet their business goals and comply with the state and federal healthcare laws.
The Healthcare Practice is highly regulated and rapidly changing. Individuals and companies that do business in this arena require legal counsel with a hands-on understanding of the unique issues of the healthcare environment and constructive solutions to their problems. Our Healthcare litigators practice exclusively in this area and, consequently, have in-depth expertise helping clients achieve successful resolutions in civil, criminal and administrative proceedings. Our excellent service and skills are evidenced by the practice’s ranking in Chambers USA, a leading legal services ranking publication.
Our experienced Healthcare litigators offer deep healthcare expertise and significant experience with sensitive and high-pressure matters. Our clients span the healthcare industry, including for-profit and nonprofit healthcare providers, rural and community hospitals, pharmaceutical companies, managed care organizations and physician practice groups. We regularly represent these clients in litigation in federal and state courts and in administrative proceedings, ranging from complex business litigation to employment issues to whistleblower actions to provider reimbursement issues to medical staff disputes. Our team represents clients in civil and criminal disputes involving allegations of fraud and abuse and false claims. We also represents healthcare providers in administrative matters such as Certificate of Need appeals; licensure investigations and disciplinary actions; credentialing matters; Medical staff investigations, adverse actions and hearings; and Medicare/Medicaid audits, investigations, and appeals.
Morris, Manning & Martin’s Medical Device Practice enables successful development of new medical device and life science technologies by providing legal and business guidance on formation, financing and operation of leading medical device companies.
The Medical Device Practice of Morris, Manning & Martin has built its reputation by assisting medical device entrepreneurs grow their businesses. We have consistently focused on representing companies that are developing and commercializing new technologies and engaged in fundamental scientific research. From our inception over 30 years ago, we have grown into one of the leading law firms in the Southeast and, in the words of the Atlanta Business Chronicle, are “generally regarded as having the city’s top technology group.” We understand the promise of medical device and life sciences technology, and we bring the full scope of our expertise to help our clients succeed.
From emerging companies to large public enterprises, Morris, Manning & Martin has become a leader in technology related venture capital deals, M&A transactions and IPOs for medical device companies. We have also developed leading practices in the intellectual property and regulatory areas related to the medical device industry. As such, our lawyers have the industry experience and business acumen to work with companies in all stages of development, from idea generation and initial patent filings, to clinical trials and venture financings, through to an M&A transaction or an IPO and beyond. We maintain extensive ties with venture capital firms and other investors who are active in the medical device field. We were leaders in the formation and operation of the Southeastern Medical Device Association (SEMDA), a networking community that helps inventors and entrepreneurs locate sources of financing, navigate complex licensing and regulatory issues and grow their medical device businesses. Through SEMDA and other organizations, our Medical Device Practice has an extended reach into resources and contacts and has established crucial business relationships within the medical device community.
Medical device and related life science companies need capital to grow. We have been recognized as the Southeast’s leading law firm in representing companies in venture capital transactions. In the recent past, we have acted as counsel in well over 200 venture capital transactions that have raised approximately $2 billion. Due to our active practice in this area, we have strong relationships with many venture capitalists throughout the country. We assist our clients in identifying funding sources, creating the appropriate investment structure and negotiating both the term sheet and final investment documents. More importantly, our experience helps our clients avoid strategic errors that may hinder further growth or complicate exit strategies. We understand that as our clients succeed, we succeed. Therefore, our philosophy is to add value, not expense.
As our clients grow, we assist them in raising capital in the public securities markets, where we have been ranked among the top firms in the nation in initial public offerings. In the recent past, our clients have raised approximately $6 billion from sales of equity in initial public offerings. As company counsel, we help our clients through every stage of the offering process, from identifying and selecting the underwriters to preparing the prospectus and closing the transaction.
For companies with an interest in debt financing, we are very active in the public and private debt markets. In addition to acting as counsel with respect to offerings of debt securities, such as senior subordinated notes and convertible subordinated notes, we are regularly involved in asset-based financings, acquisition financings, mezzanine financings, syndicated financings and sale/leaseback transactions.
Achieving Corporate Goals
Many of our clients engage in joint ventures or mergers and acquisitions as an integral part of their corporate strategies. Due to our reputation for providing creative, efficient and effective solutions to our clients’ business and legal challenges, we have one of the leading merger, acquisition and joint venture practice groups in the Southeast. In the recent past, we have acted as counsel in more than $15 billion of merger, acquisition and joint venture transactions. We represent companies at all stages of their growth. We are able to efficiently staff transactions from small private company acquisitions to multibillion-dollar public company acquisitions and joint ventures.
We have particular experience in complicated domestic and international licensing, distribution and joint venture transactions. These types of transactions often require expertise in many legal disciplines, such as tax, securities, intellectual property, litigation, employee benefits, environmental and real estate. To address the complexities of these transactions, we create multidisciplinary client teams that work together seamlessly and efficiently to complete the transactions.
Protecting and Managing Intellectual Property
Most of our clients create and depend upon intellectual property as their core asset. Our practice group that deals with protecting, developing, selling, licensing and granting rights in intellectual property is among the most prominent in the Southeast. Patent filings and transactions involving critical technologies require not only solid legal drafting and negotiation skills, but also comprehensive technical knowledge and business acumen. Patens and technology contracts are as diverse as the technologies they address, and the law governing patenting and licensing intellectual property evolves almost daily. Accordingly, we actively focus our practice on understanding and applying the most recent industry and legal developments for the benefit of our clients.
We provide guidance on key regulatory issues faced by a medical device concern. Clients count on our thorough understanding of HIPAA privacy and security rules to keep them in compliance with the evolving nuances of this recent law. Operational hurdles are surmounted, from FDA compliance issues through clinical trials to product approval. We also focus on reimbursement issues, fraud and abuse laws and product liability concerns, allowing our clients to keep their attention fixed on creating innovative medical products. Together with Morris, Manning & Martin’s Healthcare Regulatory lawyers, we provide the sound advice our clients need to successfully navigate the many laws and regulations imposed upon them, both in the U.S. and internationally.
Practicing a team approach to legal service, we work closely with other relevant practices, such as our Licensing, Intellectual Property and Healthcare Regulatory Practices, to assist medical device and related life science companies in all stages of their lifecycles. Our Medical Device lawyers also draw upon the experience of our corporate and technology practices, who have built their reputations on helping entrepreneurs grow their businesses and by representing companies that are developing and commercializing new technologies, particularly in scientific research. We advise and assist our Medical Device clients on matters involving equity and debt financings, mergers and acquisitions, intellectual property, technology licensing and protection, strategic joint ventures and general corporate governance. For a sound legal approach with sophisticated deal-making experience, Medical Device clients rely on Morris, Manning & Martin.
Representative Clients and Transactions
Morris, Manning & Martin’s Medical Device lawyers represent clients and organizations of all types across the medical device industry, including clients engaged in the development of products in the cardiovascular, orthopedic, endoscopic, bioinformatics, nanotechnology and related fields, as well as other biotechnology and healthcare companies, including therapeutics companies, clinical research organizations, pharmaceutical manufacturers, pharmaceutical distributors, healthcare IT companies and venture capital and private equity investors. Several recent representations include: