Digital Health
-
Cutting-Edge Client Base
At Wilson Sonsini, we focus on representing emerging and high-growth digital health companies that are transforming healthcare through technology, data, and AI-powered solutions.
-
Comprehensive Health Tech Expertise
Our expertise covers a broad spectrum of health tech, from telehealth and wellness apps to medical devices and AI-driven drug discovery.
-
Leading Advisor to Digital Health Innovators
Wilson Sonsini has more than 400 digital health clients, including 21 unicorns collectively valued at $47 billion.
-
More than $30 Billion in Venture Financings
Since 2000, we’ve assisted U.S.-based digital health clients in raising more than $30 billion in aggregate seed and venture funding.
Wilson Sonsini represents digital health companies and their venture investors in nearly all areas of health tech, including telehealth and telemedicine, mobile health and wellness apps and platforms, healthcare data analytics, wearables, medical devices, wellness products, digital therapeutics, data/AI drug discovery, and precision medicine.
Our multidisciplinary team provides comprehensive support in all areas critical to digital health companies’ growth and success, including:
- Company formation
- Healthcare regulatory advising and corporate practice of medicine structuring
- FDA pre- and post-approval counseling
- Venture capital financings
- Commercial transactions
- AI development and utilization
- Patents, trademarks, and intellectual property protections
- HIPAA compliance and healthcare data privacy
- Litigation and enforcement
- Mergers & acquisitions
- Initial public offerings (IPOs)
With a focus on emerging companies, Wilson Sonsini has robust experience navigating legal risks associated with the use of the most cutting-edge technology in healthcare. These technologies often outpace the legislatures and courts tasked with regulating them, requiring advice that balances legal, ethical, and business needs. Our team offers creative solutions to compliance obstacles tailored to the company’s stage, size, and risk tolerance, with rapid turnaround times and cost-effective advising, including fixed-fee pricing options.
Overview
Wilson Sonsini represents digital health companies and their venture investors in nearly all areas of health tech, including telehealth and telemedicine, mobile health and wellness apps and platforms, healthcare data analytics, wearables, medical devices, wellness products, digital therapeutics, data/AI drug discovery, and precision medicine.
Our multidisciplinary team provides comprehensive support in all areas critical to digital health companies’ growth and success, including:
- Company formation
- Healthcare regulatory advising and corporate practice of medicine structuring
- FDA pre- and post-approval counseling
- Venture capital financings
- Commercial transactions
- AI development and utilization
- Patents, trademarks, and intellectual property protections
- HIPAA compliance and healthcare data privacy
- Litigation and enforcement
- Mergers & acquisitions
- Initial public offerings (IPOs)
With a focus on emerging companies, Wilson Sonsini has robust experience navigating legal risks associated with the use of the most cutting-edge technology in healthcare. These technologies often outpace the legislatures and courts tasked with regulating them, requiring advice that balances legal, ethical, and business needs. Our team offers creative solutions to compliance obstacles tailored to the company’s stage, size, and risk tolerance, with rapid turnaround times and cost-effective advising, including fixed-fee pricing options.
Alerts
DEA and HHS Extend COVID-19 Telemedicine Prescribing Flexibilities Again
The federal Drug Enforcement Agency (DEA) and the U.S. Department of Health and Human Services (HHS) have extended COVID-19 telemedicine flexibilities for prescribing controlled substances. Until December 31, 2025, a DEA-registered practitioner can prescribe schedule II-V controlled substances via telemedicine without having conducted an in-person medical evaluation of the patient if specific requirements are met. This will likely be the DEA’s last extension of such flexibilities, as a final rule regarding prescribing controlled substances via telemedicine is expected sometime in 2025.
Alerts
California Governor Gavin Newsom Vetoes Law Requiring Attorney General Approval for Certain Healthcare Investments
Last weekend, California Governor Gavin Newsom vetoed Assembly Bill (AB) 3129, which would have required healthcare investors to notify and obtain written consent from the California Attorney General (AG) before investing in certain healthcare facilities and providers. In a letter to the California State Assembly, Governor Newsom reasoned that California’s existing Office of Health Care Affordability (OHCA) is the more appropriate entity for healthcare transaction reviews:
Alerts
FDA Issues Multiple Guidances Supporting Clinical Trial Innovation
In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical trial approaches, including trials that implement decentralized elements, trials that allow integration of research into routine clinical practice, and multiregional oncology clinical trials. These guidances may assist sponsors and investigators design and conduct efficient clinical trials to support medical product development.
Alerts
California Passes Law Requiring Attorney General Approval for Certain Healthcare Investments and Emphasizes Requirements for MSO-PC Models
Pre-Closing Notice or Consent: Assembly Bill 3129 (AB 3129) mandates that certain healthcare investors must provide a 90-day written notice to, or obtain consent from, the California Attorney General (AG) before proceeding with transactions involving specific healthcare facilities and providers.
Client Highlights
Wilson Sonsini Advises Regard on $61 Million Series B Financing
On July 11, 2024, Regard, an AI-powered clinical insights platform, announced the close of a $61 million Series B financing round, led by Oak HC/FT, with participation from Cedars-Sinai Health Ventures, as well as existing investors TenOneTen Ventures, Calibrate Ventures, and Techstars. The investment will enable the company to accelerate product development with their core clinical insights platform, invest in fundamental research in large language models (LLMs), and expand beyond inpatient facilities. Wilson Sonsini Goodrich & Rosati represented Regard in the financing.
Client Highlights
Wilson Sonsini Advises a16z on Talkiatry's $130 Million Series C
On June 18, 2024, Talkiatry, a leading provider of high-quality, in-network psychiatric care, announced the completion of a $130 million Series C funding. The equity round was led by Andreessen Horowitz (a16z) with participation from Perceptive Advisors. Wilson Sonsini Goodrich & Rosati advised a16z on the transaction.
Insights
Alerts
DEA and HHS Extend COVID-19 Telemedicine Prescribing Flexibilities Again
The federal Drug Enforcement Agency (DEA) and the U.S. Department of Health and Human Services (HHS) have extended COVID-19 telemedicine flexibilities for prescribing controlled substances. Until December 31, 2025, a DEA-registered practitioner can prescribe schedule II-V controlled substances via telemedicine without having conducted an in-person medical evaluation of the patient if specific requirements are met. This will likely be the DEA’s last extension of such flexibilities, as a final rule regarding prescribing controlled substances via telemedicine is expected sometime in 2025.
Alerts
California Governor Gavin Newsom Vetoes Law Requiring Attorney General Approval for Certain Healthcare Investments
Last weekend, California Governor Gavin Newsom vetoed Assembly Bill (AB) 3129, which would have required healthcare investors to notify and obtain written consent from the California Attorney General (AG) before investing in certain healthcare facilities and providers. In a letter to the California State Assembly, Governor Newsom reasoned that California’s existing Office of Health Care Affordability (OHCA) is the more appropriate entity for healthcare transaction reviews:
Alerts
FDA Issues Multiple Guidances Supporting Clinical Trial Innovation
In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical trial approaches, including trials that implement decentralized elements, trials that allow integration of research into routine clinical practice, and multiregional oncology clinical trials. These guidances may assist sponsors and investigators design and conduct efficient clinical trials to support medical product development.
Alerts
California Passes Law Requiring Attorney General Approval for Certain Healthcare Investments and Emphasizes Requirements for MSO-PC Models
Pre-Closing Notice or Consent: Assembly Bill 3129 (AB 3129) mandates that certain healthcare investors must provide a 90-day written notice to, or obtain consent from, the California Attorney General (AG) before proceeding with transactions involving specific healthcare facilities and providers.
Client Highlights
Wilson Sonsini Advises Regard on $61 Million Series B Financing
On July 11, 2024, Regard, an AI-powered clinical insights platform, announced the close of a $61 million Series B financing round, led by Oak HC/FT, with participation from Cedars-Sinai Health Ventures, as well as existing investors TenOneTen Ventures, Calibrate Ventures, and Techstars. The investment will enable the company to accelerate product development with their core clinical insights platform, invest in fundamental research in large language models (LLMs), and expand beyond inpatient facilities. Wilson Sonsini Goodrich & Rosati represented Regard in the financing.
Client Highlights
Wilson Sonsini Advises a16z on Talkiatry's $130 Million Series C
On June 18, 2024, Talkiatry, a leading provider of high-quality, in-network psychiatric care, announced the completion of a $130 million Series C funding. The equity round was led by Andreessen Horowitz (a16z) with participation from Perceptive Advisors. Wilson Sonsini Goodrich & Rosati advised a16z on the transaction.
WSGR Events
Wilson Sonsini Biotech Summit
We invite you to join us for Wilson Sonsini's inaugural Biotech Summit on October 9-10, 2024. This unique event will bring together leaders from across the biotech industry, including esteemed researchers, policymakers, prominent investors, and CEOs. Over two impactful days, we will host an intimate CEO dinner, as well as expert panel discussions covering key topics such as antitrust issues, FDA insights, and venture capital trends. Be a part of enriching conversations about strategic collaborations designed to foster innovation in treatments, advancements for patients, and value for companies within the biotech sector.
Speaking Engagements
State Bar of Michigan: Health Care Law Section 2024 Annual Meeting
On Thursday, September 19, 2024 at 1:30 p.m. ET, Andrea Linna, Wilson Sonsini partner and member of the firm's digital health industry group, will speak on navigating AI in healthcare at the State Bar of Michigan's Health Care Law Section Annual Meeting
Affiliated Programs
DHNY Summit
Wilson Sonsini is proud to sponsor DHNY. On Wednesday, September 18 at 8:15 a.m., partners Megan Baier and Maneesha Mithal will join industry leaders in a panel discussion exploring the impact of the 2024 election on key regulatory areas and implications for Private Equity (PE) and Venture Capital (VC) backed digital health companies.
Affiliated Programs
TechChicago Week Healthcare Innovation Breakfast Panel
Join Architect Health, Drive Capital, Lightbank and Wilson Sonsini for the 2024 TechChicago Week premier healthcare event. We are thrilled to host Chicago healthcare innovation leaders: Rushil Desai, CEO of Aetna Better Health of Illinois; Ryan Fukushima, COO of Tempus; Brian Whorley, CEO of Paytient; and Anil Saldanha, CINO of Rush University Medical Center.
Events
WSGR Events
Wilson Sonsini Biotech Summit
We invite you to join us for Wilson Sonsini's inaugural Biotech Summit on October 9-10, 2024. This unique event will bring together leaders from across the biotech industry, including esteemed researchers, policymakers, prominent investors, and CEOs. Over two impactful days, we will host an intimate CEO dinner, as well as expert panel discussions covering key topics such as antitrust issues, FDA insights, and venture capital trends. Be a part of enriching conversations about strategic collaborations designed to foster innovation in treatments, advancements for patients, and value for companies within the biotech sector.
Speaking Engagements
State Bar of Michigan: Health Care Law Section 2024 Annual Meeting
On Thursday, September 19, 2024 at 1:30 p.m. ET, Andrea Linna, Wilson Sonsini partner and member of the firm's digital health industry group, will speak on navigating AI in healthcare at the State Bar of Michigan's Health Care Law Section Annual Meeting
Affiliated Programs
DHNY Summit
Wilson Sonsini is proud to sponsor DHNY. On Wednesday, September 18 at 8:15 a.m., partners Megan Baier and Maneesha Mithal will join industry leaders in a panel discussion exploring the impact of the 2024 election on key regulatory areas and implications for Private Equity (PE) and Venture Capital (VC) backed digital health companies.
Affiliated Programs
TechChicago Week Healthcare Innovation Breakfast Panel
Join Architect Health, Drive Capital, Lightbank and Wilson Sonsini for the 2024 TechChicago Week premier healthcare event. We are thrilled to host Chicago healthcare innovation leaders: Rushil Desai, CEO of Aetna Better Health of Illinois; Ryan Fukushima, COO of Tempus; Brian Whorley, CEO of Paytient; and Anil Saldanha, CINO of Rush University Medical Center.
Haley N. Bavasi
Partner
Haley Bavasi is a partner in the Seattle office of Wilson Sonsini Goodrich & Rosati, where she focuses primarily on advising digital health companies across a range of privacy, transactional, research, and healthcare regulatory issues. In particular, Haley leverages her expertise in the Health Insurance Portability and Accountability Act (HIPAA), the U.S. federal health-privacy law, to provide early-stage companies with practical day-to-day counseling, as well advise as in the context of complex commercial transactions, M&A, and go-to-market strategy. Haley’s extensive experience with a wide range of cutting-edge digital health companies provides her with valuable market insights she leverages for her clients.
Andrea Linna
Partner
Andrea Linna is a partner at Wilson Sonsini Goodrich & Rosati, where she is a member of the firm’s digital health industry group and its healthcare practice. With more than a decade dedicated to healthcare law, Andrea exclusively represents digital health and healthcare IT clients, from emerging companies to established industry players, investors, and healthcare systems. Andrea guides her clients through the patchwork of federal and state laws that apply to digital health companies, addressing issues such as corporate practice of medicine, Stark Law compliance, Anti-Kickback Statute considerations, fee splitting, billing Medicare and Medicaid, contracting with commercial payors, value-based care arrangements, artificial intelligence, remote patient monitoring, online prescribing, scope of practice, and licensing requirements.
Eva F. Yin
Partner
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.
Rob Parr
Partner
Rob Parr is a partner in the Boston office of Wilson Sonsini Goodrich & Rosati, where he leads the office’s information technology transactions practice. He represents companies in transactions focused on the exploitation of intellectual property rights and technology in a variety of industries. Rob represents many companies in the digital health industry in particular and plays a key role in the firm’s digital health initiative. He regularly drafts and negotiates a wide variety of complex commercial agreements, including services, distribution, strategic alliance and joint venture, supply, asset transfer, and intellectual property license agreements. Rob also represents clients with the intellectual property and commercial issues arising from financings, mergers, acquisitions, and initial public offerings. The International Association of Privacy Professionals has designated Rob as a Certified Information Privacy Professional (CIPP/US).
Lang Liu
Partner
Lang represents public and private companies, investment banks and venture capital firms.
Megan J. Baier
Partner
Megan represents technology and life sciences clients in corporate transactional matters.
Mark B. Baudler
Partner
Mark is a corporate law veteran, having advised start-ups and mature public companies for more than 25 years.
Farah B. Gerdes
Partner
Farah focuses on the representation of pharmaceutical, biotechnology, medical device, and diagnostic companies in complex collaboration and partnering transactions.
Ali R. Alemozafar
Partner
Ali counsels clients on patent strategy, prosecution, and diligence for financings, M&A, and IPOs.
People
Haley N. Bavasi
Partner
Haley Bavasi is a partner in the Seattle office of Wilson Sonsini Goodrich & Rosati, where she focuses primarily on advising digital health companies across a range of privacy, transactional, research, and healthcare regulatory issues. In particular, Haley leverages her expertise in the Health Insurance Portability and Accountability Act (HIPAA), the U.S. federal health-privacy law, to provide early-stage companies with practical day-to-day counseling, as well advise as in the context of complex commercial transactions, M&A, and go-to-market strategy. Haley’s extensive experience with a wide range of cutting-edge digital health companies provides her with valuable market insights she leverages for her clients.
Andrea Linna
Partner
Andrea Linna is a partner at Wilson Sonsini Goodrich & Rosati, where she is a member of the firm’s digital health industry group and its healthcare practice. With more than a decade dedicated to healthcare law, Andrea exclusively represents digital health and healthcare IT clients, from emerging companies to established industry players, investors, and healthcare systems. Andrea guides her clients through the patchwork of federal and state laws that apply to digital health companies, addressing issues such as corporate practice of medicine, Stark Law compliance, Anti-Kickback Statute considerations, fee splitting, billing Medicare and Medicaid, contracting with commercial payors, value-based care arrangements, artificial intelligence, remote patient monitoring, online prescribing, scope of practice, and licensing requirements.
Eva F. Yin
Partner
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.
Rob Parr
Partner
Rob Parr is a partner in the Boston office of Wilson Sonsini Goodrich & Rosati, where he leads the office’s information technology transactions practice. He represents companies in transactions focused on the exploitation of intellectual property rights and technology in a variety of industries. Rob represents many companies in the digital health industry in particular and plays a key role in the firm’s digital health initiative. He regularly drafts and negotiates a wide variety of complex commercial agreements, including services, distribution, strategic alliance and joint venture, supply, asset transfer, and intellectual property license agreements. Rob also represents clients with the intellectual property and commercial issues arising from financings, mergers, acquisitions, and initial public offerings. The International Association of Privacy Professionals has designated Rob as a Certified Information Privacy Professional (CIPP/US).
Lang Liu
Partner
Lang represents public and private companies, investment banks and venture capital firms.
Megan J. Baier
Partner
Megan represents technology and life sciences clients in corporate transactional matters.
Mark B. Baudler
Partner
Mark is a corporate law veteran, having advised start-ups and mature public companies for more than 25 years.
Farah B. Gerdes
Partner
Farah focuses on the representation of pharmaceutical, biotechnology, medical device, and diagnostic companies in complex collaboration and partnering transactions.
Ali R. Alemozafar
Partner
Ali counsels clients on patent strategy, prosecution, and diligence for financings, M&A, and IPOs.
WSGR On-Demand Learning
- Digital Health Webinar Series - Session 1: Navigating the Legal Complexities of Digital Healthcare Regulations
- Digital Health Webinar Series - Session 2: Corporate Practice of Medicine
- Digital Health Webinar Series - Session 3: Value Based Care
- Digital Health Webinar Series - Session 4: Interoperability and Information Blocking Regulations
- Digital Health Webinar Series - Session 5: Marketing and Advertising for Digital Health Companies
- Digital Health Webinar Series - Session 6: AI in the Digital Health Industry: Key Regulatory, IP, and Commercial Topics
- Digital Health Webinar Series - Session 7: Privacy & Artificial Intelligence
Credit for online viewing with checkpoints is available in California (participatory), New York (experienced attorneys only), and Texas (accredited). For questions regarding any other states, please contact Wilson Sonsini’s MCLE Manager. Please note that you may be prompted to create an account the first time you access the site.
Webinars
WSGR On-Demand Learning
- Digital Health Webinar Series - Session 1: Navigating the Legal Complexities of Digital Healthcare Regulations
- Digital Health Webinar Series - Session 2: Corporate Practice of Medicine
- Digital Health Webinar Series - Session 3: Value Based Care
- Digital Health Webinar Series - Session 4: Interoperability and Information Blocking Regulations
- Digital Health Webinar Series - Session 5: Marketing and Advertising for Digital Health Companies
- Digital Health Webinar Series - Session 6: AI in the Digital Health Industry: Key Regulatory, IP, and Commercial Topics
- Digital Health Webinar Series - Session 7: Privacy & Artificial Intelligence
Credit for online viewing with checkpoints is available in California (participatory), New York (experienced attorneys only), and Texas (accredited). For questions regarding any other states, please contact Wilson Sonsini’s MCLE Manager. Please note that you may be prompted to create an account the first time you access the site.
Related Practices
- Capital Markets
- Corporate
- Corporate Governance
- Corporate Life Sciences
- Data, Privacy, and Cybersecurity
- FDA Regulatory, Healthcare, and Consumer Products
- Federal Trade Commission
- Government Investigations
- Internet Strategy and Litigation
- Life Sciences Business Advisory Practice
- Mergers & Acquisitions
- Patents and Innovations
- Public Company Representation
- Regulatory
- Technology Transactions
- Trademark and Advertising
- U.S. Expansion
Recent Insights
Alerts
DEA and HHS Extend COVID-19 Telemedicine Prescribing Flexibilities Again
The federal Drug Enforcement Agency (DEA) and the U.S. Department of Health and Human Services (HHS) have extended COVID-19 telemedicine flexibilities for prescribing controlled substances. Until December 31, 2025, a DEA-registered practitioner can prescribe schedule II-V controlled substances via telemedicine without having conducted an in-person medical evaluation of the patient if specific requirements are met. This will likely be the DEA’s last extension of such flexibilities, as a final rule regarding prescribing controlled substances via telemedicine is expected sometime in 2025.
Learn More
Alerts
California Governor Gavin Newsom Vetoes Law Requiring Attorney General Approval for Certain Healthcare Investments
Last weekend, California Governor Gavin Newsom vetoed Assembly Bill (AB) 3129, which would have required healthcare investors to notify and obtain written consent from the California Attorney General (AG) before investing in certain healthcare facilities and providers. In a letter to the California State Assembly, Governor Newsom reasoned that California’s existing Office of Health Care Affordability (OHCA) is the more appropriate entity for healthcare transaction reviews:
Learn More
Recent Events
WSGR Events
Wilson Sonsini Biotech Summit
We invite you to join us for Wilson Sonsini's inaugural Biotech Summit on October 9-10, 2024. This unique event will bring together leaders from across the biotech industry, including esteemed researchers, policymakers, prominent investors, and CEOs. Over two impactful days, we will host an intimate CEO dinner, as well as expert panel discussions covering key topics such as antitrust issues, FDA insights, and venture capital trends. Be a part of enriching conversations about strategic collaborations designed to foster innovation in treatments, advancements for patients, and value for companies within the biotech sector.
Learn More
- Privacy Policy
- Terms of Use
- Accessibility
Copyright © 2024 Wilson Sonsini Goodrich & Rosati. All Rights Reserved.