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- About MMM
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.
Data privacy and security is pivotal. Data – client data, customer data, vendor data, patient data, personnel data – is core to operating a business, as such it must be properly protected and maintained. The number of data breach incidents has increased sharply over the past few years. Given the potential costs associated with a data breach or cyber-attack, companies need a law firm with significant regulatory, risk management and litigation experience. Morris, Manning & Martin’s Data Security, Privacy & Breach practice offers a wealth of experience guiding clients through such situations, managing them in the most effective way possible to optimize compliance, limit risk and minimize damages.
We provide a broad spectrum of specialized services which pull from several key practices including regulatory, litigation, insurance, financial services, healthcare, and technology. We recognize that the flow of information between businesses, consumers, and third-party vendors is becoming increasingly faster and more difficult to protect. While the vast array of data presents numerous opportunities and advantages, it also presents tremendous risks and exposure to potential cyber-liabilities.
Our specialized industry experience ensures we have the right lawyers in place to address regulatory compliance and breaches in a myriad of industries. We represent a diverse group of clients with respect to data security breaches, including financial institutions, payment processing vendors, retailers, health care providers, hospitality, travel & leisure, high-tech companies, and insurance issuers.
The means by which we communicate information has exploded in the past few decades and as each channel becomes available, the rules for protecting them must be created and the exposures they reveal must be examined. Clients need experienced, responsive counsel to help make sense of the opportunities and issues these channels present, as well as provide an understanding of the different rules associated with each, developing appropriate policies, and handling potential data breaches.
MMM’s Data Security, Privacy & Breach Practice assists businesses of all sizes and types with:
Our lawyers have a thorough knowledge of the state, federal and international data privacy and security laws which apply to data breaches. For instance, our team regularly analyzes and applies the following laws to data breaches across various industries and circumstances:
We also advise clients with regard to state security breach notification laws and other state laws dealing with the privacy and security of personal information.
In the event of a breach, our integrated approach ensures that the best privacy, internal investigations and securities legal counseling is provided in a coordinated manner at a time when companies feel the most vulnerable. We have extensive experience working on cyber security matters with federal officials, investigators, the FTC and other government agencies. In addition, our corporate and securities lawyers have counseled the leaders of many top companies and their boards of directors in disclosure requirements arising from data security breaches.
Areas in which MMM provides specific advice pertaining to data breaches & security include:
Privacy of Consumer Information
Businesses must be hyper-cognizant of regulations concerning the protection of consumers’ personally identifiable information (PII), particularly those within the healthcare and insurance industries. Those that collect, use, and store PII – such as names, addresses, phone numbers, account numbers, credit information, and social security numbers – are subject to an increasing number of state and federal laws and regulations that require privacy notices to consumers, patients, employees, and the rigorous protection of PII. Noncompliance with these requirements, as well as data breaches resulting in sensitive information being released to unauthorized persons, can result in substantial fines, penalties and other legal liability, as well as public relations concerns.
Businesses are also subject to a plethora of regulations concerning marketing practices. We regularly counsel clients on the CAN-SPAM Act, Do Not Call and Telemarketing Sales laws among others, analyzing whether existing and prospective advertising campaigns and promotions are fully compliant. MMM’s lawyers are also experienced with the unique issues presented by new media outlets such as social networking sites, blogs, and mobile advertising, and we advise businesses on how to protect themselves while taking advantage of powerful, new communication tools.
Privacy of Healthcare Information
We regularly counsel clients on healthcare-related privacy regulations, such as those mandated by the Health Insurance Portability and Accountability Act (HIPAA) and the HITECH provisions of the American Reinvestment and Recovery Act of 2009, which imposes civil and criminal penalties for mishandling medical records upon healthcare providers and the many businesses that support them.
Privacy of Financial Information
MMM counsels clients regarding the rapidly evolving body of regulations aimed at protecting financial information. Under FTC regulations adopted pursuant to the Gramm-Leach-Bliley Act, companies that offer financial products or services to individuals (consumer lending, tax preparation, financial advice or credit counseling, residential real estate settlement, and consumer debt collection) must comply with the Financial Privacy Rule, Safeguards Rule, and antipretexting provisions. The FTC’s “Red Flags Rule” requires virtually every business that extends credit to consumers to develop and implement written identity theft prevention programs. We are experienced in helping businesses understand their obligations and developing practical compliance methods.
Our Data Security, Privacy & Breach Practice is experienced with analyzing the internal practices of large and small employers, and the steps taken to maintain privacy compliance in the workplace. We advise employers on the development of systematic and consistent data protection policies across various company functions, such as the implementation of effective staff training to increase sensitivity to data privacy concerns and the maintenance of physical and technological safeguards for sensitive data, such as passwords, encryption, and data retention/destruction policies. Equally important, we advise employers regarding workplace monitoring and searches, the handling of medical records, employees’ personal use of office technology (e-mail, computers, phones), and social media.
Breach Management and Litigation
The evolution of privacy regulations has been paralleled by a significant increase in the penalties associated with breaches of privacy. The price of a compromise of confidential information is steep – it can result in fines reaching millions of dollars along with significant public relations and customer service challenges. The lawyers in our Data Security & Breach Practice offer a wealth of experience guiding clients through such situations, managing them in the most effective way possible to minimize damages, and correcting mistakes to ensure future compliance.
MMM lawyers have advised clients on a wide variety of data security and privacy matters, including the following:
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: