Life Sciences & Healthcare Regulatory

Arnold & Porter's renowned Life Sciences and Healthcare Regulatory practice is unique in providing a fully integrated team focused on delivering comprehensive and sophisticated assistance to clients in all areas of life sciences product and healthcare regulation. Our clients include manufacturers of pharmaceutical, biotechnology, medical device, and diagnostic products; healthcare professionals; universities; and leading trade and professional organizations. We also represent companies in the food, dietary supplement, over-the-counter drug, and cosmetic fields. Our practice supports virtually every aspect of our clients' regulated business activities, including US FDA, EU, UK, and China regulatory strategies; clinical trials; inspections; promotion and advertising; exclusivities; fraud and abuse; pricing; contracting; coverage and reimbursement; domestic and global compliance programs; government investigations; transactional diligence and post-transaction integration; and public policy advocacy.

Decades of Experience: Our global team has handled the most challenging life sciences and healthcare regulatory matters, from high-profile global regulatory investigations to unprecedented strategies for obtaining approval.

Deep Knowledge of Government and Science: Our highly experienced lawyers and other professionals are thought leaders in the field; many have senior government, in-house and corporate professional experience, as well as advanced degrees in diverse scientific and medical fields.

Global in Scope: Our practitioners in the US, Europe, the UK, and Asia routinely handle global regulatory challenges for our clients, from compliance program development to simultaneous regulatory inspections.

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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.
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