Digital Health

Our team ably assists clients engaged in digital health enterprises, ranging from medical device and pharmaceutical companies to technology companies and health care providers—spanning from early-stage enterprises to Fortune 500 companies. Specifically, our practitioners:

• Assist companies and institutions in navigating Food and Drug Administration (FDA) regulatory requirements applicable to digital health solutions, including developing regulatory strategies and engaging with the agency.
• Advise developers of digital health products, including those that utilize machine learning, regarding early design considerations and clinical research strategy and compliance.
• Advise on state and federal telemedicine requirements, along with corporate practice of medicine laws.
• Counsel companies on the application of the Anti-Kickback Statute, including the “value-based” safe harbor protection for digital health technology, and other fraud and abuse laws.
• Help clients protect key digital health innovations through the pursuit of strategic intellectual property rights.
• Provide policy counsel concerning federal and state provisions for care coordination and digital data collection, including policy changes to address the current public health emergency.
• Address privacy and data security challenges presented by digital health solutions, including advising on data collection and use strategies, developing compliance programs, crafting privacy policies and consent forms, assisting with complex contracting issues and tailoring data breach response plans to accommodate new products and data streams.
• Assist clients interfacing with the Federal Trade Commission (FTC) regarding marketing and consumer protection for digital health technologies.
• Counsel clients on the impact of new interoperability and information blocking regulations.
• Develop federal coverage and reimbursement strategies for remote patient monitoring, clinical decision support and other digital tools.
• Complete due diligence and execute licensing, joint venture, and acquisition arrangements that mitigate transactional and compliance risks in the midst of evolving regulatory considerations while achieving business objectives.

The team—which features former high ranking government officials from the Department of Health and Human Services (HHS), including the FDA—has also represented numerous companies with software or machine learning-based algorithms in determining appropriate regulatory strategies to either enter the market as an exempt software tool, seek FDA marketing authorization or utilize a hybrid approach.

We harness decades of government and industry experience in health care and life sciences, privacy and data protection, intellectual property and antitrust to represent clients before a broad range of government stakeholders, including the:

• FDA
• Office for Human Research Protections (OHRP)
• Centers for Medicare & Medicaid Services (CMS)
• HHS Office for Civil Rights (OCR)
• HHS Office of the National Coordinator for Health Information Technology (ONC)
• FTC
• Federal Communications Commission (FCC)
• U.S. Patent and Trademark Office (USPTO)
• Patent Trial and Appeal Board (PTAB)
• State regulators
• State and federal courts.