We are a specialized law firm dedicated to protecting and advancing healthcare technology. From regulatory compliance to intellectual property, we provide comprehensive legal solutions that empower healthtech pioneers to transform patient care.
Founded in 2001, Legal Litigation has grown to become the nation's premier law firm specializing exclusively in healthcare technology law. Our unique focus allows us to provide unparalleled expertise in this rapidly evolving intersection of healthcare, technology, and regulatory compliance.
Our attorneys combine deep legal knowledge with genuine understanding of healthcare technology systems, from electronic health records and telemedicine platforms to AI-driven diagnostics and medical IoT devices. This dual expertise enables us to anticipate challenges and craft solutions that protect our clients while advancing their innovative missions.
We believe that healthcare technology has the power to save lives and improve outcomes for millions. Our role is to ensure that legal complexities never stand in the way of that progress. We serve as trusted partners to startups and Fortune 500 companies alike, navigating the complex regulatory landscape so our clients can focus on what they do best: innovating for better health.
Comprehensive HIPAA, FDA, and state-level compliance protection for your technology.
Healthcare never stops, and neither do we. Round-the-clock support for urgent matters.
Specialized practice groups ensuring deep expertise in every healthcare tech domain.
Track record of successful outcomes in complex healthcare technology litigation.
From inception to IPO and beyond, we provide end-to-end legal support tailored to the unique needs of healthcare technology organizations.
Navigate the complexities of healthcare data privacy with confidence. We help you develop robust compliance programs, conduct risk assessments, and respond to potential breaches with speed and precision.
Software as a Medical Device (SaMD), AI/ML algorithms, and digital therapeutics face unique FDA oversight. Our regulatory team guides you through 510(k) submissions, De Novo pathways, and ongoing compliance obligations.
Protect your innovations with comprehensive IP strategies. From patent prosecution for novel algorithms to trademark protection for your brand, we safeguard the assets that define your competitive advantage.
Whether you're acquiring a competitor, merging with a health system, or seeking venture funding, our transactional team structures deals that protect your interests and facilitate growth.
When disputes arise, our seasoned litigators bring deep healthcare technology knowledge to the courtroom. We handle everything from contract disputes to complex regulatory enforcement actions.
The rapid expansion of telemedicine brings complex multi-state licensing, reimbursement, and prescribing challenges. We help digital health platforms operate confidently across jurisdictions.
Our attorneys don't just understand law; they understand technology. Many of our team members hold advanced degrees in computer science, biomedical engineering, and healthcare administration, giving us unique insight into the technical challenges our clients face.
Interoperability, data portability, and information blocking compliance
Algorithm validation, bias mitigation, and explainability requirements
Device connectivity, data security, and medical device regulations
Clinical validation pathways and prescription digital therapeutic frameworks
Credential verification, supply chain tracking, and health data exchange
Privacy Rule, Security Rule, and Breach Notification requirements
SaMD classifications, Pre-Cert program, and real-world evidence
ONC regulations, exceptions, and compliance strategies
CCPA, state health privacy laws, and emerging state AI regulations
GDPR, EU MDR, and cross-border data transfer frameworks
Our partners bring decades of combined experience in healthcare law, technology, and regulatory affairs. Each leader has been recognized for excellence in their field.
Former FDA Chief Counsel with 20+ years in healthcare regulatory law. Sarah founded Legal Litigation with a vision to bridge the gap between legal expertise and technology innovation.
A former federal prosecutor, James leads our litigation practice with extensive experience in healthcare fraud defense and complex commercial disputes. He has successfully defended clients in over 100 government investigations.
A physician-attorney with deep expertise in AI/ML medical devices, Dr. Rahman advises healthcare technology companies on FDA strategy and has guided over 50 successful device clearances.
Michael leads our corporate practice, having structured billions in healthcare technology transactions. His client roster includes leading EHR vendors, telehealth platforms, and digital health startups.
Stay informed with analysis and commentary from our attorneys on the latest developments in healthcare technology regulation and law.
The FDA's recently released guidance on predetermined change control plans represents a significant shift in how AI/ML-based medical devices will be regulated. Our regulatory team breaks down the key implications for healthcare technology developers.
With new state privacy laws emerging across the country, healthcare technology companies face an increasingly complex compliance landscape. We provide a practical framework for navigating these requirements.
Acquiring an AI-powered healthcare company requires examining not just the technology, but the training data, validation studies, and regulatory pathway. Here's what sophisticated buyers are looking for.
Band 1 - Healthcare Technology
"Law Firm of the Year" 2025
Top Tier - Health Tech
Top 100 Law Firms
Headquarters
100 Federal StreetWest Coast Hub
555 California StreetRegulatory Office
1200 New Hampshire Ave NWFinancial District
One World Trade Center