FDA Regulatory Approvals and Compliance
The process of obtaining approvals for new medical devices, pharmaceuticals and technology from the Food and Drug Administration (FDA) and complying with current regulatory schemes for other regulated industries can be both challenging and time-consuming. We understand the depth of the regulatory landscape and advise clients through the stages of a product’s lifecycle. We provide counsel on federal regulatory issues involving the FDA, ranging from advising on FDA submissions, to providing guidance on issues surrounding product advertising and marketing to counseling on post-market obligations. Additionally, we advise clients on compliance with good manufacturing practices, as well as on matters involving inspections, untitled letters, warning letters and enforcement actions.
Healthcare Regulatory Compliance
Healthcare and life sciences companies must carefully structure relationships between providers, referral sources, and other parties to avoid violations of the Stark Law, the Anti-Kickback Statute, and other similar federal and state laws. Our lawyers have extensive experience navigating these legal requirements while preserving the underlying goals of the desired business arrangements. We work closely with our clients to understand their business drivers, help them navigate the complex legal requirements of the environment in which they operate, and develop creative solutions to ultimately achieve their business objectives.
Healthcare Data Privacy and Information Management
Many of our clients are subject to healthcare data regulations and protections. We understand the importance of making deliberate decisions to manage the collection, storage and use of sensitive healthcare information and related technology throughout its useful life. Healthcare providers, health plans, healthcare clearinghouses and business associates are well aware of their obligations to comply with the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health (HITECH) Act, the HIPAA Omnibus Rule, and state privacy and security laws. Nevertheless, given the constantly evolving nature of health information technology, electronic medical records, health information exchanges (HIEs) and cloud computing, determining how to comply with these laws can prove challenging. As more health data is created and stored, it becomes an attractive target for cyber-criminals and others who want to use this valuable health data for nefarious purposes. We advise clients on their increasing cyber-security responsibilities in respect to protecting digital health data.
We view HIPAA privacy and security issues as just one facet of our larger focus on information management. We also provide clients with transactional guidance, regulatory compliance counseling, intellectual property protection and enforcement, and dispute resolution services. We regularly counsel clients in connection with reviewing, evaluating and developing HIPAA-compliant policies and procedures, investigating possible privacy and security breaches, evaluating and implementing the appropriate response, and facilitating HIPAA training for employees.
Since the creation of the Medicare program in the 1960’s, the U.S. federal government has used payment rules to drive and enforce national health policy. This makes knowledge of reimbursement rules and regulations an essential competency for anyone involved in the healthcare industry. Our healthcare lawyers deliver comprehensive guidance on third party payer reimbursement requirements while also providing targeted counsel on matters related to structuring deals or transactions. Healthcare reimbursement matters can be extraordinarily complicated in the diagnostic market and the applicable Medicare and Medicaid rules have far-reaching effects on the financial and business operations of healthcare-related providers. We work closely with a client’s internal claims processing and payment monitoring infrastructure, as well as with any consulting firms providing services related to these activities. We partner with our clients and these third party entities to focus on the legal, compliance and policy implications of reimbursement and claims processing.
Technology continues to transform every aspect of healthcare. From the bedside to the boardroom, healthcare organizations must address complex legal and regulatory issues related to digital health. We have deep experience negotiating complex IT contracts, navigating federal “safe harbors” for donation of electronic medical records (EMRs) and other Health IT, and investigating and responding to healthcare data breaches. Our lawyers are at the leading edge of developing initiatives to safely and securely exchange health information to improve quality and lower costs. We have worked with diverse stakeholder groups at the national, regional, state and local levels to successfully develop the legal governance infrastructure necessary to support local data sharing networks for providers and payers. We also serve as counsel to one of the country’s leading accelerator programs for digital health companies developing cutting edge IT solutions.
The 21st Century Cures Act, passed by Congress in the last days of the 2016 session, created significant new initiatives to support the expansion of “precision medicine” programs. The National Institute of Health, the FDA and the Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) are each expected to take major steps in 2017 to enhance precision medicine. Our healthcare lawyers are very familiar with all aspects of this groundbreaking legislation and how it will impact the life sciences and healthcare industries.