Digital Health

GT’s lawyers are at the forefront of shaping policy and are deeply engaged in the challenges facing the global digital health industry. With deep experience in navigating regulatory frameworks, we are well-positioned to guide clients through this period of rapid growth and evolving oversight.

GT provides counsel on corporate compliance, licensure and accreditation, coverage and reimbursement, fraud and abuse, data privacy, health reform counseling, and regulatory due diligences. We represent both public and private entities before federal and state administrative and regulatory agencies.

Our lawyers have a broad spectrum of experience supporting digital health companies with product level regulatory matters in the U.S. and major international markets. We support digital health companies with regulatory assessments for products that may be regulated as a medical device by the U.S. Food and Drug Administration (FDA) or equivalent ex-U.S. regulators (e.g., device versus non device clinical decision support). We also support digital health companies with regulated products (e.g., SaMD, SiMD), guiding them through all phases of the commercialization process with FDA or equivalent ex-US regulators, from submission through postmarket compliance. We routinely support digital health companies in navigating enforcement actions by the FDA (e.g., Warning Letters).

We help clients develop compliance program manuals and draft policies and procedures for the development, implementation, and maintenance of a compliance plan, including the following general categories: (i) state licensure and registration; (ii) government and commercial payor enrollment and credentialing; (iii) health care fraud and abuse; (iv) billing and reimbursement; (v) complaint reporting and corrective action mechanisms; (vi) retaliation and disciplinary actions; (vii) employee training and education; and (viii) government audits and investigations.

GT’s lawyers have a deep understanding of the rules and policies governing various third-party payors, including Medicare and Medicaid reimbursement and innovative payment systems to drive technology adoption.

We advise clients on the development of consumer-initiated (or direct-to-consumer) models that offer access to health services through an e-commerce platform, including laboratory tests, pharmaceuticals, and durable medical equipment. These models utilize professional telemedicine services and remote patient monitoring, which requires the development of strategic workflows for care delivery and revenue streams. This work also involves issues that vary state-by-state related to licensure and credentialing; corporate practice of medicine (CPOM); telemedicine modalities and practice standards; pharmacy and distributor laws; and privacy and security rules.

GT’s Intellectual Property and Technology Practice advises clients on matters ranging from licensing, consulting, and research agreements to Hatch-Waxman and FDA patent challenges. Our litigators enforce IP rights and defend patents against infringement claims. Our global team includes patent lawyers and agents who help clients execute global IP strategies, including building strong global patent and trademark portfolios in a myriad of digital health technologies, including:

• AI-based drug discoveries
• AI-based optimization of clinical studies, and medical devices incorporating innovative AI-based processing
• Software as FDA-approved medical devices to support disease detection, medical diagnostics, treatments and surgeries; and biological molecule manufacturing
• Remote health services and monitoring
• AI-based optimization of HIPAA-compliant electronic record keeping, and health services and claim reimbursement
• HIPAA-compliant medical data modeling via synthetic data and visualization

GT’s Data Privacy & Cybersecurity Practice counsels health care, biotech, and life sciences clients on data use and privacy laws and rules in the U.S. and abroad. We work with clients on compliance with CAN-SPAM, CCPA, CFAA, CPA, CPRA, CalOPPA, COPPA, GDPR, GLBA, ECPA, ePrivacy Directive, FCRA, FERPA, HIPAA, LGPD, PCI DSS, SOPIPA, TCPA, VCDPA, VPPA, WMHMDA, and UK GDPR.

We provide counsel on compliance with Common Rule, 21st Century Cures Act, Information Blocking Rules, and FDA cybersecurity guidance. We advise organizations on the use of technologies to facilitate communications among providers and patients, as well as privacy, cybersecurity, telehealth, medical device, and other legal considerations related to such use. Our team advises on privacy, informed consent, information blocking, security and data handling requirements, and good clinical practices. We can help build innovative products, devices, and systems that allow clients to collect, use, and process data in ways that best meet their needs, and support and accelerate innovation in health care delivery and payment biomedical research and discovery. We represent the institutions before the relevant funding or regulatory agency (e.g., National Institutes of Health, National Science Foundation, FDA) with respect to privacy and data integrity issues. 

GT’s Data Privacy Dish blog offers news and insights to stay current on important data privacy and cybersecurity developments. Our global team’s experience and knowledge of the latest data protection developments enables us to provide e-commerce, technology, health care, and financial companies with practical, business-sensitive options in the morass of data protection laws.

GT’s Technology Transactions Group advises digital health clients on the resolution of legal and business issues related to the development, commercialization, sourcing, licensing, and distribution of technology and data assets tailored to meet each client’s unique needs and stage of development.

We advise our clients on ways to protect software, data, and technology assets by structuring, drafting, and negotiating efficient technology licensing agreements and distribution programs across a wide range of products and services, including:

• Electronic medical records
• Mobile health
• Software development
• Scheduling solutions and workflows
• Patient/physician interactions
• Wearable technologies
• Cloud computing
• Online fitness solutions

With health care innovation occurring regularly within universities and research entities, GT offers deep experience to help university spin-outs and pre-venture companies efficiently transition innovative health care technologies from research to commercial success. We routinely collaborate with universities and research entities to structure and negotiate licensing agreements with the goal of maximizing the value and impact of these emerging technologies.

With GT’s multidisciplinary Corporate Practice, our business and health care lawyers advise clients in all stages of the business lifecycle, including company formation, venture capital financings, corporate governance, mergers & acquisitions, tech transactions, licensing agreements, strategic collaborations, and initial public offerings. We help clients develop an overall compliance program charter and code of conduct, establish committees and functionality at the management level, establish compliance and privacy officer roles and responsibilities, develop the compliance monitoring and investigative mechanisms, and establish documentation criteria.

GT’s Products Liability & Mass Torts Practice is well known for high-stakes litigation ranging from complex mass and toxic torts to class action consumer product liability matters across a broad spectrum of industries. Our team is comprised of more than 130 experienced litigators, many of whom are nationally recognized as trailblazers for some of the most high-profile litigations in the country.

GT is at the forefront of product liability issues emerging from the digital health revolution. As software, mobile apps, and AI-enabled medical devices become increasingly central to the health care ecosystem, courts are more frequently treating these digital tools as “products” under state law, exposing developers, manufacturers, and providers to strict liability claims for alleged design or manufacturing defects and failure to warn. Our lawyers have deep experience navigating these types of claims and the rapidly shifting regulatory landscape.

We provide comprehensive risk assessment and litigation avoidance counseling for digital health clients, assisting with new product development, acquisitions, and crisis response to adverse events or regulatory actions. Our team develops pre-litigation strategies, interfaces with relevant agencies, retains key experts, and utilizes mock trials and focus groups to help clients evaluate and mitigate potential exposure before disputes escalate.

Our deep bench of award-winning trial lawyers leverages decades of courtroom experience, vast geographic reach, and jurisdictional knowledge to design strategic approaches that dismantle plaintiffs’ claims. We routinely collaborate on a national scale, offering clients a consistent litigation approach with the ability to scale our operations swiftly when necessary, and have managed some of the largest mass tort, multi-jurisdiction litigations in history. We are uniquely equipped to handle the magnitude and complexity of cases that demand creative strategies and agile execution.