Our Digital Health Team works with pharmaceutical, medical device and technology clients to achieve their strategic goals, while managing business and legal considerations arising from the sale and use of connected products, and the collection, processing and analysis of health data. Collectively, our global team across the United States, Europe, Asia, and the Middle East is engaged on all aspects of compliance, regulatory, litigation defense, technology, and contracting matters in the health care industry.

To help you achieve these goals, we meld industry knowledge, legal skills, and backgrounds in IT and telecommunications to provide more informed guidance on digital health. We will provide you with a team-based approach that crosses practice areas and reflects the multitude of legal and business considerations associated with these products and services.

You can ask our authorities for advice on the full spectrum of legal and regulatory issues arising from the use of technology improve the delivery of health care services, including:

• Advising you on the innovative arrangements and relationships created by these products and services across manufacturers, health care providers and facilities, payors, and patients/consumers, including compliance with federal and state fraud and abuse, licensing, and consumer protection laws and requirements.
• Helping you navigate the FDA regulatory pathways to determine whether and how the FDA will regulate a health app, platform or software, and if the product will be exempt from FDA’s oversight or fall with FDA’s enforcement discretion.
• Keeping you informed on evolving cyber and privacy laws and regulations globally, as well as on industry standards and developing market trends.
• Helping you synthesize these many laws, regulations, and standards to develop successful and manageable business plans and compliance programs that not only comply with legal requirements, but also increasingly provide a competitive advantage to successfully launch new products, win business and customers, and speed up the contracting timeline with customers who vet regulatory and cybersecurity practices at both the corporate and product levels.
• Advising on both corporate data systems and cloud services (information security) as well as products and industrial control systems (operational security).
• Engaging in technical discussions with cybersecurity professionals and product engineers to provide pragmatic, business-oriented solutions that are aligned with your technology.
• Helping you understand your risk profile for possible litigation through targeted risk assessments before during and after products are on the market.