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
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.
- "Is Big Pharma’s Antidote to the COVID-19 Waiver a Viable Alternative?" quoted in Life Sciences IP Review, August 2, 2021. Read here. – Roger Kuan
- "The Legal Landscape in Healthcare 3D Printing," speaker, 3DHEALS webinar, July 29, 2021. – Roger Kuan
- "Digital Health: Insights Into Today's Key Healthcare Data Issues," moderator, ICLG.com webinar, July 6, 2021. Watch video here. – Roger Kuan
- "The Business of Alt Protein: Intellectual Property for Alternative Protein Companies," speaker, Good Food Institute (GFI) webinar, June 16, 2021. – Roger Kuan, Jason Novak, Benjamin Pelletier and Roger Royse
- "Patenting Antibodies: The 4 Tactics To Use In 2021," author, BioProcess Online, June 4, 2021. Read here. – Benjamin Pelletier
- "Will Biden Backed Bills Boost Biosimilars Uptake in the U.S.?" speaker, The BioPharma Pod, May 7, 2021. Listen here. – Roger Kuan
- "Making Sense of Antibody Epitope Claims,” author, BioProcess Online, April 16, 2021. Read here. – Benjamin Pelletier
- "AI Patenting and Licensing," panelist, The University of Texas Technology Management Council Meeting, April 16, 2021. – Roger Kuan
- "The Uncertain Future of Antibody Claims," author, Life Sciences IP Review, April 1, 2021. Read here. – Benjamin Pelletier
- "Digital Health Innovations – What They Are, How to Protect Them, and Commercialization Strategies," speakers, Weill Digital Health Series webinar, March 12, 2021. – Roger Kuan and Jason Novak
- "Use of AI in Healthcare," speaker, AI Chats podcast, March 1, 2021. Listen here. – Roger Kuan
- "Initial Observations Regarding the USPTO's Patents 4 Partnerships Pilot Program," co-authors, IP & Technology Law Journal, Vol. 33 No. 3, March 2021. Read here. – Jason Novak and Daniel Kennedy
- "Qualifying for the USPTO's COVID-19 Prioritized Examination Pilot Program," co-author, IP & Technology Law Journal, Vol. 33 No. 2, February 2021. Read here. – Jason Novak
- "Navigating Legal Issues in Emerging Technologies in Healthcare & Life Sciences," contributors, UCSF Rosenman Institute Expert Consults, January 19, 2021. – Roger Kuan and Jason Novak
- "Digital Health 2021," contributors, International Comparative Legal Guides (ICLG), January 3, 2021. Read here. – Roger Kuan and Jason Novak
- "Life Sciences Considerations Regarding Compulsory Licensing, March-In Rights, and the Defense Production Act During COVID-19," co-author, Intellectual Property & Technology Law Journal, Volume 33, No. 1, January 2021. – Roger Kuan
- "The State of Artificial Intelligence in Healthcare," panelist, Harvard AI in Healthcare Group Panel, November 17, 2020. – Roger Kuan
- "Telehealth and Other Advancements in Healthcare Technology Spurred by COVID-19," speakers, DahShu Online Seminar, November 13, 2020. – Roger Kuan and Jason Novak
- "Biosimilars Caught in Crosshairs of Supreme Court ACA Fight," quoted in Law360, November 9, 2020. – Roger Kuan
- "IP Diligence Considerations," speakers, Idea-to-IPO webinar, September 17, 2020. – Jason Novak and Gary Edwards
- "How to Protect Your Intellectual Property," speakers, Idea-to-IPO webinar, June 30, 2020. – Jason Novak and Gary Edwards
- "Intellectual Property and 3D Printing Medical Devices and Bioprinting," speaker, 3DHEALS 2020, June 6, 2020. – Roger Kuan
- "Regulatory/Legal Challenges," speakers, 3DHEALS 2020, June 6, 2020. – Roger Kuan and Jason Novak
- "The Long Road to Health Care’s AI-Based Transformation," quoted in Trends Magazine, January 15, 2020. – Roger Kuan
- "Adopting AI no walk in the park for healthcare providers," quoted in MUUTAA, January 12, 2020. – Roger Kuan
- "Negotiating Term Sheets," Redefining Early Stage Investments (RESI) Conference, January 2020 (San Francisco). – Roger Kuan
- "Everything You Need to Know About Digital Health," Cedars-Sinai Accelerator, November 2019. – Roger Kuan
- "Adopting AI no walk in the park for healthcare providers," quoted in AI in Healthcare, October 18, 2019. – Roger Kuan
- "Adopting AI in Health Care Will be Slow and Difficult," Harvard Business Review (published on HBR.ORG), October 18, 2019. – Roger Kuan
- "Patent Protection for Medical 3D Printing & Bioprinting Technologies," 3DHeals (published on 3DHeals.com), September 2019. – Roger Kuan
- "Negotiating Term Sheets," Redefining Early Stage Investments (RESI) Conference, June 2019 (Philadelphia). – Roger Kuan
- "IP Protection Strategies for Personalized/Precision Medicine," BIOCOM, November 2018 (San Francisco). – Roger Kuan
- "Advanced Patent Prosecution Workshop 2018: Advanced Claim Drafting Issues (Personalized/Precision Medicine)," Practicing Law Institute (PLI), September 2018 (San Francisco). – Roger Kuan
- "Operation Valuation: Maximizing the Value of your Asset Portfolio," Redefining Early Stage Investments (RESI) Conference, June 2018 (Boston). – Roger Kuan
HR Magazine interviewed Haynes and Boone, LLP Associate Mini Kapoor about new COVID-19 safety protocols for California workers. Here is an excerpt: California state employees, health care workers and workers in high-risk settings must show proof of vaccination or adhere to weekly COVID-19 testing and other safety protocols, Gov. Gavin Newsom recently announced. Newsom issued this directive afte [...]