Digital Health
- The convergence of traditional healthcare and digital technology increasingly blurs the lines between providers, product developers and digital service platforms. At Holland & Knight, we help prepare our clients for legal changes and business disruption in a quickly changing environment.
- Holland & Knight's Digital Health Group brings together a multidisciplinary team of lawyers in healthcare and life sciences, intellectual property (IP), cybersecurity and data privacy, transactions, litigation and public policy.
- Our team has experience with emerging technologies such as artificial intelligence (AI), machine learning, wearable devices and remote patient monitoring. We advise on the opportunities and risks posed by these technologies.
- Our Digital Health Group helps technology companies comply with U.S. Food and Drug Administration (FDA) regulations and works with clients to obtain approval for software, medical devices and other cutting-edge applications used in patient care.
Overview
Digital health is reshaping how care is delivered, financed and regulated. The convergence of healthcare, technology and data has created a dynamic environment where providers, payers, life sciences companies and technology platforms must navigate rapid innovation alongside increasing regulatory scrutiny.
Holland & Knight's Digital Health Group is built for this evolving landscape. We help clients anticipate legal and business risks, unlock opportunities and execute strategies at the intersection of healthcare delivery and digital innovation.
An Integrated Approach
Our team brings together attorneys and policy professionals across healthcare and life sciences, intellectual property (IP), data privacy and cybersecurity, regulatory compliance, transactions, litigation and public policy.
This integrated, multidisciplinary model reflects the reality of digital health, where legal issues rarely fall into a single category. Whether deploying new technologies, scaling digital platforms or responding to enforcement risk, our clients benefit from coordinated advice across disciplines.
Deep Experience Across the Digital Health Ecosystem
We represent a broad range of stakeholders who rely on us to navigate the increasingly complex relationships among technology platforms, clinical delivery models and regulatory frameworks.
- healthcare providers and health systems
- health plans, payers and insurers
- medical device and life sciences companies
- digital health and software developers
- investors and emerging growth companies
Focused on Innovation and Execution
Regulatory Strategy and Compliance. We advise on evolving federal and state requirements affecting digital health, including regulatory frameworks governing software, devices and data-driven healthcare solutions:
- U.S. Food and Drug Administration (FDA) compliance and product approvals for digital therapeutics, software and devices
- telehealth and virtual care regulatory frameworks
- healthcare fraud and abuse considerations
- licensing, reimbursement and cross-state regulatory issues
Data, Privacy and Cybersecurity. Digital health depends on data, and government scrutiny of data use continues to intensify:
- Health Insurance Portability and Accountability Act (HIPAA) and health data governance
- cybersecurity risk management and incident response
- cross-border data use and emerging artificial intelligence (AI) governance requirements
Technology Transactions and Commercialization. We help clients bring innovations to market and structure scalable partnerships:
- licensing, commercialization and IP protection
- strategic partnerships and joint ventures
- digital platform and vendor arrangements
Corporate, Investment and Growth Strategy. We support clients at every stage of the business life cycle:
- venture financing, private equity and digital health mergers and acquisitions (M&A)
- due diligence for technology-enabled healthcare transactions
- market entry and expansion strategies
Litigation, Investigations and Risk Management. As innovation outpaces regulation, disputes are increasing, and we are there to assist clients with:
- regulatory investigations and enforcement defense
- product liability and class action litigation
- risk assessments tied to AI-enabled and software-driven care
Emerging Technologies. Our team delivers forward-looking counsel on cutting-edge technologies transforming healthcare, adeptly guiding clients in evaluating the opportunities and legal risks associated with deploying these technologies at scale:
- AI and machine learning
- digital medicine and remote monitoring
- telemedicine and telebehavioral health
Why Holland & Knight?
Digital health requires more than traditional healthcare counsel. It demands insight into how technology, regulation and business models converge in real time.
Holland & Knight combines:
- one of the largest healthcare and life sciences practices in the U.S.
- a broad IP bench supporting commercialization
- nationwide regulatory and policy capabilities
- experience across the full life cycle of digital health innovation
This depth enables us to help clients operate confidently in a sector where technology is driving both clinical decision-making and business transformation.
