Digital health products increasingly blur the boundaries between consumer technology and medical devices. Innovators in this field face unique challenges in navigating the highly uncertain premarket regulatory terrain and evolving privacy rules. Our lawyers advise some of the most prominent consumer technology companies in the world, supporting their efforts to develop mobile apps, platform technologies, wearables, and other health IT to promote wellness and improve healthcare.
Sidley’s deep understanding of life sciences is based on more than 25 years of work for service providers, drug and medical device manufacturers, clinical laboratories, genetic testing firms and healthcare technology and health IT companies, as well as leaders in consumer technology. We harness that knowledge and experience to assist our clients in optimizing their digital health business models, while avoiding pitfalls.
We bring value to our clients in the following ways:
- Managing FDA regulation—Transformative digital health products and services challenge traditional regulatory models. Anticipating compliance issues can be a critical advantage for your business. We provide counseling to firms that have not yet been subject to U.S. Food and Drug Administration (FDA) regulation on whether, when and how to submit to oversight by the agency. Our lawyers also assist companies with regulatory compliance itself, which requires ongoing vigilance due to the fast-evolving laws. A number of lawyers on our team previously served with the FDA, affording us uncommon insight into how and why the agency pursues enforcement. This includes a former acting chief counsel, deputy chief counsel, and deputy director for policy, Center for Devices and Radiological Health.
- Advice on privacy and cybersecurity—As technology develops, our clients face new issues involving cloud computing and mobile applications, among others. Sidley advises on how to maximize opportunities presented by new methods of health information delivery while avoiding potential regulatory problems. Our team provides regulatory counseling and legislative services to a wide variety of companies that access and process health information. This includes advising on the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and amendments made to HIPAA by the Health Information Technology for Economic and Clinical Health Act (HITECH). We also counsel clients on the Genetic Information Nondiscrimination Act (GINA), as well as on various state healthcare privacy laws.
- Diversified services—Sidley has assisted clients in achieving revolutionary advances in healthcare for decades. Our team harnesses Sidley’s global network of lawyers across numerous disciplines and around the world, putting our global legal capabilities to work for companies leading transformative change in healthcare. We assist digital health clients on a variety of complex business matters, including mergers and acquisitions, private equity, funding, antitrust, dispute resolution, tax, intellectual property and products liability.
About the team
Our team features practitioners with diverse backgrounds, including in pharmaceutical development, engineering, clinical laboratories and academic and community-based medical practice. Many have served in government posts, including as acting chief counsel and deputy chief counsel of the FDA, senior FDA policymakers in the areas of medical devices and biotechnology, policy advisors to both Democratic and Republican secretaries of the U.S. Department of Health and Human Services (HHS) and legal counsel to the European Commission.