Digital Health

• Regulatory. We help clients navigate the myriad regulatory issues posed by digital health technologies and services, including regulatory classification of software, devices, and combination products; drug regulatory issues implicated by digital health products that are associated with pharmaceuticals or developed by or in collaboration with drug manufacturers; the application of market access rules; the regulation of healthcare and e-commerce services; wireless device regulation; and pricing and reimbursement. Our life sciences and technology teams are consistently recognized as premier practices by leading legal directories such as Chambers and Legal 500.
• Technology Transactions. Our technology transactions team has been at the cutting edge of cloud services and big data transactions, collaborating with clients efficiently and effectively to craft transactions that meet their business objectives and address the regulatory issues raised by greater industry-wide reliance on the cloud and big data. We also provide strategic and legal advice in structuring and negotiating all types of ICT agreements, including software licensing, support and maintenance, software and hardware development, SaaS agreements, and system procurement. We have extensive experience in related transactions, such as joint ventures, collaborations, and outsourcing arrangements as well as all aspects of social media and mobile commerce.
• Privacy and Data Security. Covington’s leading, global privacy and data security team has been at the forefront of privacy and security issues affecting life sciences, information technology, e-commerce and social media companies for decades. We are highly experienced in dealing with the privacy and security laws, regulations and guidance that govern the data collection, processing and usage at the heart of digital health solutions.
• Intellectual Property. Our IP lawyers can advise digital health stakeholders on the full range of IP issues, including the procurement, commercialization, defense, and enforcement of patent, trade secret, copyright, design and other IP rights in software, hardware and collections of data.
• Product Liability. Digital health products and services may, by reason of defective hardware or software, or incorrect input data, result in harm being caused to their users and recipients. Covington has a dynamic product liability practice, regularly serving as defense trial and appellate counsel in product liability and mass tort lawsuits, and as strategic advisors for clients with liability risks or actions.
• Government Contracts. Government purchasers are poised to be one of the largest consumers of digital health services. Covington’s government contracts practice is well situated to advise contractors who wish to compete to provide these services to government, advise on government grants for the use of electronic health record technology, and assist with corporate transactions involving divisions that are recipients of government grants or contracts.
• Antitrust/Competition. Ranked among the top antitrust and competition firms in the world, Covington can guide clients through the maze of antitrust and competition considerations raised by the access, interoperability, compatibility, exclusivity and other issues raised by in digital health platforms, apps and transactions. Our team understands the need for a holistic approach that manages these issues in the context of the overall business goals of the project.
• Public Policy. With technological developments outpacing the adoption of rules and regulations, governments around the world continue to address the need for policies and standards for digital health technologies. Our international Public Policy team includes professionals with established credentials in health and information technology policies and relationships with key governmental decision makers. We have experience guiding the drafting of legislation in the United States, Europe and elsewhere to ensure that it lends itself to regulatory implementation and advances industry goals, and we effectively manage regulatory and policy processes to advance our clients’ business objectives.

Our attorneys in these and other related practice areas collaborate seamlessly across practices, offices, and jurisdictions to develop creative and practical solutions for digital health products, solutions and services. We have represented a variety of different players in the digital health ecosystem, enabling us to understand the issues and imperatives of clients filling a variety of roles. As a result, we are well placed to advise our clients on what to expect, given current market trends and typical resolutions, and likely future developments. By coordinating across our offices in the United States, Europe, and Asia, we are able to advise clients on a global basis.