Precision Medicine and Digital Health

Emerging technologies are changing the way clients operate in the rapidly evolving healthcare industry. Haynes and Boone's Precision Medicine and Digital Health Practice Group understands where the industry has been and where it is going, and we are ready to help companies of all sizes navigate and excel in this growing market.

Our lawyers provide full-service counsel to the key players in precision medicine and digital health - from technology startups to established corporations, health insurers, pharmaceuticals, and investors supporting the industry. Our team draws on the firm's highly regarded healthcare, life sciences, technology and intellectual property experience to address trends in evolving markets, cutting-edge advances in technology, and legal and regulatory changes.

We advise clients across the precision medicine and digital health landscape, including companies focused on the following areas:

• AI/ML genomics and imaging based predictive health analytics
• Molecular diagnostics
• Companion diagnostics
• Cell and gene therapies
• Genomic sequencing systems and software
• Consumer genomics testing and analytics
• Clinical decision support software
• IVF pre-implantation genetic testing
• AI/ML genomics-based drug discovery platforms
• Health information technology
• Mobile healthcare applications
• 3D printing/bioprinting
• Health wearables
• AR/VR and computer vision for remote surgery and pre-op planning
• Telehealth/telemedicine

With a global team of more than 600 lawyers, Haynes and Boone has a cross-collaborative environment in which our practice groups work seamlessly to support each other. The broader team provides legal insights in many critical areas related to Precision Medicine and Digital Health, including IP strategy, freedom-to-operate analysis, portfolio management, data rights transactions and transactional IP due diligence as they pertain to precision medicine and digital health; litigation and enforcement; FDA regulatory; data privacy, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), the Federal Trade Commission (FTC) guidance, and state healthcare privacy and data security laws; corporate transactions, including mergers and acquisitions, joint ventures, and securities offerings.

Below, see some of our latest client representations:

• Built out a patent estate to protect the AI/ML imaging and genomic diagnostics test pipelines of a leading AI/ML diagnostics company.
• Negotiated and drafted master collaboration agreements for companies and healthcare systems involving the sharing of genomics data and protected health information. 
• Analyzed patent estates and performed freedom-to-operate clearances for digital health-related investments of a global pharmaceutical conglomerate.
• Developed IP protection strategy and 24-month IP-gated timelines for a biotech analytics company using multi-omic data from the human gut microbiome to discover biomarkers and novel therapeutics.
• Developed IP protection strategy, 24-month IP budgets, and associated IP-gated timelines for a health tech company using contactless sleep tracker technology and artificial intelligence (AI) to enable early detection of respiratory failure.
• Developed IP protection strategy, associated investor materials, and IP-gated timelines for a 3D printing company using proprietary software platforms to develop 3D printed anatomical models to improve pre-operative planning and corresponding patient outcomes.
• Built out an IP estate to protect the hardware and software features of an advanced single-sided MRI technology company.