Health care is among the most heavily regulated sectors in the United States and across the globe. Digital health is now integral and indispensable to efficient and effective care delivery and continues to challenge the boundaries between tech innovation and regulation.

The Dentons Digital Health team combines deep legal expertise with practical experience: our attorneys have been thought leaders and have represented digital health companies, as well as the federal healthcare agencies, academic institutions, and large payors and health systems critical to their success. We help our clients navigate the broad range of legal, regulatory, policy, operational, competitive, compliance and financial considerations underpinning the industry.

We have teams that specialize in all company stages of growth and funding—from pre-seed through exit. Every client works with a partner that serves, like an outside general counsel, as their go-to contact to deliver timely, coordinated and expert advice within budget expectations.

Typical areas of focus for our clients:

• Corporate and Transactional
  • Company formation, venture capital, private equity and growth financing
  • M&A, IPOs and securities and tax law matters
  • Strategic partnerships, joint ventures and deal diligence
  • Commercial and technology transactions
  • Capitalization and restructuring
• Healthcare Regulatory and Policy
  • Regulatory, including product and reimbursement strategy
  • Anti-kickback, Stark Law, and Fraud, Waste & Abuse counseling
  • Provider networks and contracting, including ACOs, value-based care and risk arrangements
  • Friendly PC Models
  • State managed care, insurance and provider licensure o Commercial (fully-insured and self-funded/ERISA) and Government Programs (Medicare/Medicaid managed care)
  • Internal and government investigations, compliance program design, implementation and training; regulatory gap analyses
  • FDA Medical Device and Software as Medical Device (SaMD)
  • Risk management and litigation; FCA and FCPA defense
  • Public policy and counseling
• Emerging Technology
  • Payment processing and transactions; revenue cycle management
  • Telehealth platforms
  • Blockchain and Cryptocurrency
  • Artificial Intelligence (AI), Generative AI (GenAI), Retrieval-Augmented Generation (RAG), Machine Learning (ML) and Large Language Models (LLM)
  • Intellectual Property (IP) commercialization, strategy, protection and enforcement
• Data Security and Privacy
  • Data privacy (HIPAA, GDPR, medical records, electronic health records and state law) and offshoring
  • Cybersecurity (HITRUST, SOC2 Type 2)