Virtual and Digital Health
Digital health technologies and virtual healthcare are revolutionizing the healthcare and life science industries, and Arnold & Porter is at the forefront in helping our clients to navigate the myriad of complex, ever-evolving legal and regulatory issues in this arena. From telehealth platforms to innovative healthcare apps to artificial intelligence to remote monitoring and diagnosis, digital healthcare technology is rapidly changing established biomedical product development and clinical delivery models. This technological innovation is also challenging traditional regulatory frameworks, which have been slow to adapt, creating a patchwork of domestic and international regulations impacting both deployment of the technology and investments in the field. Our cross-functional team of transactional and regulatory attorneys (including many former governmental regulators) combines diverse subject-matter experience, deep industry knowledge, international perspectives, and creative problem solving to help our clients transform the delivery of healthcare solutions.
-
Supporting Innovation: We regularly assist clients in the US, Europe and Asia in the execution of virtual and digital health strategies, investment in digital and data capabilities, intellectual property portfolio management, and commercialization of digital health products, data and other services.
-
Seamless Collaboration: Our team is comprised of leading attorneys with unmatched experience in the areas of life sciences and healthcare regulatory, compliance, coverage and reimbursement, advertising and promotion, privacy and data security, IP, litigation, and risk management issues.
-
Strategic Advice: Our cross-functional team provides holistic, integrated, efficient advice to a broad range of global clients including healthcare providers, investors and companies in the digital health and virtual healthcare space.
Experience Highlights
-
Sanofi U.S., an innovative, global healthcare company, in its $30M strategic promotion and development agreement with DarioHealth Corp.
-
PE firm in connection with their investment in a technology company focused on infant monitoring including FDA SaMD requirements in current and protyped tech.
-
Onex Corporation in advising its portfolio company, Carestream Health, in the sale of its healthcare information systems (HCIS) business to Royal Philips, a global leader in health technology.
-
Pharmaceutical, medical device and telecommunications manufacturers on the complex and interlocking regulation in the US and UK/EU applicable to healthcare IT products, mobile medical apps, disease management software, and clinical decision support tools.
-
Zimmer Biomet, a global medical device company, in conducting HIPAA Security Rule risk assessment, overseeing penetration test and implementing data security requirements for robotic surgery devices, mobile health app, artificial intelligence for surgery applications, and software services.
-
Zimmer Biomet in developing privacy and security product guidance for digital health and remote rehab app (mymobility), which is paired with commercial wearable, including counsel on data-driven analysis and data combination, use of AI and biometrics, use in clinical trials and commercially, compliant privacy sales and distribution structure, contracting with wearable provider, data transfer and data localization, and other data protection counseling.
-
Innovations team of a leading healthcare provider in strategic technology and intellectual property investments and transactions, including transactions involving novel SaMD, AI/ML and data analytic tools to improve healthcare delivery and outcomes.
-
Several major medical device companies in the US and UK/EU in obtaining coverage/pricing and reimbursement of digital technologies, advising on procurement strategy for medical devices and digital solutions, and assisting with government price reporting compliance.
-
Antitrust advice on a number of transactions in digital health technologies, including Fitbit Inc. on its $2.1 billion sale to Google, Boston Scientific in its $27 billion acquisition of Guidant and GE Healthcare in the $1.05 billion sale of its healthcare management software unit to Veritas Capital.
-
International imaging technology company in a False Claims Act investigation focused on bundled discount sales programs.
Related Services
