United States
HealthTech
Agile solutions for success in healthcare innovation
Advances in technology continue to push the boundaries of healthcare delivery and offer exciting solutions to some of the industry’s greatest challenges. We understand the digital health environment, its complexities and opportunities. And we provide innovative, integrated advice that helps you achieve your goals.
Rapid advancements in technology, including the development and adoption of AI and data analytics, are dramatically transforming the healthcare industry – and the pace of innovation has outstripped traditional regulatory and risk frameworks. Companies operating in this environment require a team that understands healthcare, technology and AI at an engineering, regulatory, and operational level.
Our cross-practice, integrated healthtech Team combines globally recognized strengths in medical devices, digital health, AI governance, product engineering, data strategy, IP protection, and global regulatory frameworks to deliver pragmatic and commercial solutions that seamlessly integrate with the manner in which cutting edge healthtech businesses operate.
Our ability to think creatively, look around corners, and truly partner with our clients, is why so many of the world’s leading pharmaceutical, medical device, technology, and healthcare companies look to DLA as their law firm of choice in healthtech.
Defining healthtech
Healthtech is the broad umbrella term for the use of any technology to improve health and to facilitate healthcare delivery, encompassing everything from software to wearable sensors to physical devices, hardware, and artificial intelligence. While healthtech and Digital Health are often used interchangeably, Digital Health is a subset of healthtech, specifically focusing on digital tools (software, apps, wearables, telehealth, electronic health records) to improve health and wellness and streamline healthcare delivery for both patients and providers of care. While all Digital Health is healthtech, not all healthtech is Digital Health (e.g., a surgical robot).
The DLA Piper difference
Implementing healthcare technologies requires practical experience and bold thinking. We understand the healthtech regulatory environment and competitive market, its nuances and its complexities. We have deep knowledge not only of the applicable laws and regulations addressing these technologies but also of the technologies themselves. Many of our team members are former policymakers, agency representatives, entrepreneurs, and/or hold advanced degrees in scientific and technological fields of study, allowing us to truly understand our clients’ products and strategic goals. We bring life sciences and technology lawyers together into one healthtech practice; you get sound, integrated advice, on a global scale.
Whether you're a healthtech startup, a global medical device company, big pharma or a traditional tech company, we advise all players in the healthtech ecosystem and at all stages of the product or service lifecycle.
You may be optimizing R&D or improving screening and diagnosis with AI. You may be enhancing care delivery with telehealth or digital pharmacies, or supporting health and wellness with wearable sensors. Or you may improving clinical management with electronic records systems and tools, increasing operational efficiency.
Whatever your objective, our industry knowledge and experience will help you succeed.
Healthcare industry expertise and sector approach
DLA’s sector-focus ensures that you have the right legal specialists – from regulatory, to IP, to employment, corporate, litigation, and government advocacy – with a specific focus and understanding of the healthcare industry.
Our healthtech team brings together various practices across jurisdictions to deliver cohesive and comprehensive advice and strategic direction to efficiently advance and support your initiatives, keeping you head of the curve. Our team is well-versed in the regulation of AI/ML tools, including Software as a Medical Device (SaMD), clinical decision support (CDS) tools, and cybersecurity issues, digital platforms, and the protection of company-critical IP.
Members of our team co-founded the Health AI Partnership with Duke Health, Mayo Clinic, and UC Berkeley; advised the American Medical Association on its AI liability policy; and serve as lead AI, Digital Health, and healthtech counsel to several major life sciences and tech companies.
Experience in medical devices and digital health
Across the United States, Europe, Canada, China, Australia and the Asia-Pacific (APAC), as well as in emerging markets, our team assists clients in navigating classification, design, testing, commercialization, privacy/security, safety, compliance, and product lifecycle risks – all through a coordinated, global platform.
Our combination of experience with United States Food and Drug Administration (FDA), the European Union Medical Device Regulation (MDR) and Artificial Intelligence Act (AI Act), Health Canada, and Australian Therapeutic Goods Administration (TGA) regulatory requirements, and China and Asia-Pacific (APAC) market entry pathways, provides clients with coordinated classification, testing, engagement, and compliance strategies across jurisdictions.
AI governance, safety, and lifecycle strategy
Our team includes lawyer–data scientists, lawyers with medical qualifications, PhDs, former regulators and policy makers, and compliance professionals who work on Artificial Intelligence/Machine Learning (AI/ML) platforms, Software as a Medical Device (SaMD), Clinical Decision Support (CDS) tools, cybersecurity, algorithm transparency, validation, monitoring, and post-market compliance. We help companies adopt and scale Artificial Intelligence (AI) safely, aligning product development with regulatory expectations and emerging global AI frameworks.
We bring an exceptional understanding of life sciences and healthcare—built on decades of experience. This combination of scientific, technical, and regulatory knowledge means we understand the science behind your products, as well as the legal, regulatory and commercialization landscape. That critical crossover of deep tech, life sciences and healthcare experience enables us to guide clients from concept through development, testing and trial, to market launch, with confidence.
Engineering-level understanding of tech infrastructure
We advise companies designing products that rely on cloud, Kubernetes, containerized environments, sensor technologies, device-to-cloud communication, and cross-platform software architectures. This allows us to advise on risk, classification, and regulatory strategy with technical precision.
Coverage, Reimbursement and Compliance
We help clients assess the available coverage and payment options and pathways for their innovative technologies early in the development process, understanding that the design of a clinical trial and the resulting approvals could have a significant impact on potential government and commercial payor coverage. Members of our healthtech team include former health policymakers, health agency representatives, and healthcare regulatory attorneys with decades of experience in achieving CPT codes and product coverage under existing and new payment pathways. We also ensure that our clients’ financial relationships with business partners, vendors, and healthcare providers comply with applicable fraud and abuse laws and when necessary, defend against government investigations and enforcement actions.
Our litigators represent clients in all manner of disputes, from tort and contract claims to regulatory and patent cases.
Intellectual property
We help clients develop IP asset management and protection strategies designed to manage risk, continue growth and protect market share. We advise on how to best leverage IP assets into revenue streams through licensing agreements, royalty structures and other dispositions. We also undertake IP due diligence and IP audits for clients looking to make acquisitions or venture capital investments.
Cybersecurity and privacy
Our Privacy team advises extensively on the collection and use of individuals’ data, including for marketing, research, AI development and testing, and data analytics. We routinely advise on cybersecurity and privacy requirements under HIPAA, GDPR, state law (e.g. CCPA) and laws pertaining to email, text messaging and telemarketing, such as the CAN-SPAM Act, the Telemarketing Sales Rule and the Telephone Consumer Protection Act, as well as laws pertaining to the cybersecurity of medical devices. We help clients facilitate data transfer and data sharing arrangements in compliance with applicable laws.
Medical products and life sciences regulatory
Our FDA Regulatory and Global Life Sciences teams advise medical device, pharmaceutical and global tech companies on U.S. and global regulatory frameworks that govern the development and commercialization of digital health tools for medical uses. We routinely advise companies on FDA regulatory and global regulatory premarket and postmark requirements for SaMD, CDS, AI-enabled medical devices and the use of AI and other digital health tools for GxP, clinical trials and product development. We have assisted companies in obtaining market licenses for breakthrough AI-enabled devices and helped companies implement compliance processes to support the use and integration of digital health tools in compliance with applicable laws.
Our cross-practice, integrated healthtech Team combines globally recognized strengths in medical devices, digital health, AI governance, product engineering, data strategy, IP protection, and global regulatory frameworks to deliver pragmatic and commercial solutions that seamlessly integrate with the manner in which cutting edge healthtech businesses operate.
Our ability to think creatively, look around corners, and truly partner with our clients, is why so many of the world’s leading pharmaceutical, medical device, technology, and healthcare companies look to DLA as their law firm of choice in healthtech.
Defining healthtech
Healthtech is the broad umbrella term for the use of any technology to improve health and to facilitate healthcare delivery, encompassing everything from software to wearable sensors to physical devices, hardware, and artificial intelligence. While healthtech and Digital Health are often used interchangeably, Digital Health is a subset of healthtech, specifically focusing on digital tools (software, apps, wearables, telehealth, electronic health records) to improve health and wellness and streamline healthcare delivery for both patients and providers of care. While all Digital Health is healthtech, not all healthtech is Digital Health (e.g., a surgical robot).
The DLA Piper difference
Implementing healthcare technologies requires practical experience and bold thinking. We understand the healthtech regulatory environment and competitive market, its nuances and its complexities. We have deep knowledge not only of the applicable laws and regulations addressing these technologies but also of the technologies themselves. Many of our team members are former policymakers, agency representatives, entrepreneurs, and/or hold advanced degrees in scientific and technological fields of study, allowing us to truly understand our clients’ products and strategic goals. We bring life sciences and technology lawyers together into one healthtech practice; you get sound, integrated advice, on a global scale.
Whether you're a healthtech startup, a global medical device company, big pharma or a traditional tech company, we advise all players in the healthtech ecosystem and at all stages of the product or service lifecycle.
You may be optimizing R&D or improving screening and diagnosis with AI. You may be enhancing care delivery with telehealth or digital pharmacies, or supporting health and wellness with wearable sensors. Or you may improving clinical management with electronic records systems and tools, increasing operational efficiency.
Whatever your objective, our industry knowledge and experience will help you succeed.
Healthcare industry expertise and sector approach
DLA’s sector-focus ensures that you have the right legal specialists – from regulatory, to IP, to employment, corporate, litigation, and government advocacy – with a specific focus and understanding of the healthcare industry.
Our healthtech team brings together various practices across jurisdictions to deliver cohesive and comprehensive advice and strategic direction to efficiently advance and support your initiatives, keeping you head of the curve. Our team is well-versed in the regulation of AI/ML tools, including Software as a Medical Device (SaMD), clinical decision support (CDS) tools, and cybersecurity issues, digital platforms, and the protection of company-critical IP.
Members of our team co-founded the Health AI Partnership with Duke Health, Mayo Clinic, and UC Berkeley; advised the American Medical Association on its AI liability policy; and serve as lead AI, Digital Health, and healthtech counsel to several major life sciences and tech companies.
Experience in medical devices and digital health
Across the United States, Europe, Canada, China, Australia and the Asia-Pacific (APAC), as well as in emerging markets, our team assists clients in navigating classification, design, testing, commercialization, privacy/security, safety, compliance, and product lifecycle risks – all through a coordinated, global platform.
Our combination of experience with United States Food and Drug Administration (FDA), the European Union Medical Device Regulation (MDR) and Artificial Intelligence Act (AI Act), Health Canada, and Australian Therapeutic Goods Administration (TGA) regulatory requirements, and China and Asia-Pacific (APAC) market entry pathways, provides clients with coordinated classification, testing, engagement, and compliance strategies across jurisdictions.
AI governance, safety, and lifecycle strategy
Our team includes lawyer–data scientists, lawyers with medical qualifications, PhDs, former regulators and policy makers, and compliance professionals who work on Artificial Intelligence/Machine Learning (AI/ML) platforms, Software as a Medical Device (SaMD), Clinical Decision Support (CDS) tools, cybersecurity, algorithm transparency, validation, monitoring, and post-market compliance. We help companies adopt and scale Artificial Intelligence (AI) safely, aligning product development with regulatory expectations and emerging global AI frameworks.
We bring an exceptional understanding of life sciences and healthcare—built on decades of experience. This combination of scientific, technical, and regulatory knowledge means we understand the science behind your products, as well as the legal, regulatory and commercialization landscape. That critical crossover of deep tech, life sciences and healthcare experience enables us to guide clients from concept through development, testing and trial, to market launch, with confidence.
Engineering-level understanding of tech infrastructure
We advise companies designing products that rely on cloud, Kubernetes, containerized environments, sensor technologies, device-to-cloud communication, and cross-platform software architectures. This allows us to advise on risk, classification, and regulatory strategy with technical precision.
Coverage, Reimbursement and Compliance
We help clients assess the available coverage and payment options and pathways for their innovative technologies early in the development process, understanding that the design of a clinical trial and the resulting approvals could have a significant impact on potential government and commercial payor coverage. Members of our healthtech team include former health policymakers, health agency representatives, and healthcare regulatory attorneys with decades of experience in achieving CPT codes and product coverage under existing and new payment pathways. We also ensure that our clients’ financial relationships with business partners, vendors, and healthcare providers comply with applicable fraud and abuse laws and when necessary, defend against government investigations and enforcement actions.
Our litigators represent clients in all manner of disputes, from tort and contract claims to regulatory and patent cases.
Intellectual property
We help clients develop IP asset management and protection strategies designed to manage risk, continue growth and protect market share. We advise on how to best leverage IP assets into revenue streams through licensing agreements, royalty structures and other dispositions. We also undertake IP due diligence and IP audits for clients looking to make acquisitions or venture capital investments.
Cybersecurity and privacy
Our Privacy team advises extensively on the collection and use of individuals’ data, including for marketing, research, AI development and testing, and data analytics. We routinely advise on cybersecurity and privacy requirements under HIPAA, GDPR, state law (e.g. CCPA) and laws pertaining to email, text messaging and telemarketing, such as the CAN-SPAM Act, the Telemarketing Sales Rule and the Telephone Consumer Protection Act, as well as laws pertaining to the cybersecurity of medical devices. We help clients facilitate data transfer and data sharing arrangements in compliance with applicable laws.
Medical products and life sciences regulatory
Our FDA Regulatory and Global Life Sciences teams advise medical device, pharmaceutical and global tech companies on U.S. and global regulatory frameworks that govern the development and commercialization of digital health tools for medical uses. We routinely advise companies on FDA regulatory and global regulatory premarket and postmark requirements for SaMD, CDS, AI-enabled medical devices and the use of AI and other digital health tools for GxP, clinical trials and product development. We have assisted companies in obtaining market licenses for breakthrough AI-enabled devices and helped companies implement compliance processes to support the use and integration of digital health tools in compliance with applicable laws.
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“We understand the healthcare system, the legal landscape, and the challenges you need to solve, and we will partner with you to ensure you achieve your strategic goals.””
Regulatory strategy and global product classification
- Classification assessments for software, wearables, sensor-enabled devices, AI/ML tools, remote monitoring, and SaaS platforms (including when AI or digital devices become a regulated medical device)
- Evaluation of FDA, EU MDR/AI Act, Health Canada, Australian TGA and broader APAC requirements
- Product submission strategy and advice, including assistance with pre-subs, De Novo, 510(k), PMA strategy, and global engagement plans
- Design input for multi-function platforms mixing regulated and unregulated components
- Clinical validation and testing expectations
- Cybersecurity and safety-critical software requirements
- Product liability, safety, and risk governance across cloud and hardware environments
AI and digital health governance
- AI lifecycle governance frameworks
- Algorithmic validation, monitoring, model drift strategies
- AI bias, interoperability, liability and indemnity considerations for data sets
- Safety, transparency, labeling, and risk disclosures
- Ethical AI principles integrated with regulatory expectations
- Contracting and allocation of AI risk between developers, deployers, and healthcare providers
Product development and engineering alignment
- Intended use analysis
- Verification/validation requirements
- Clinical evidence strategies
- Software development practices, documentation, and quality management
- Multifunction device platform guidance
- Privacy, security and data strategy
- Building and maintaining compliance programs for HIPAA, state laws, and global data-transfer frameworks, including breach notification guidance, patient rights/requests, and interoperability for data access
- Health data classification, risk scoring, and retention frameworks, operational resilience and business continuity planning
- Integration of cloud infrastructure (Azure), communication platforms, and device interaction, telehealth, remote monitoring, and virtual care platform structuring
Commercialization and market access
- Labeling, promotion, and advertising compliance
- Post-market compliance, recalls, and surveillance
- Identifying potential coverage and reimbursement pathways and advising on product development and positioning to take advantage of existing payment opportunities
- When required, we also assist clients in exploring new coverage and reimbursement opportunities through agency advocacy and new AMA code requests
- Global commercialization frameworks for AI-enabled health solutions
Playbooks and deliverables
We design scalable, predictable deliverables that meet enterprise client expectations, including:
- Healthtech portfolio risk assessment
- Global product classification map
- Digital health compliance-by-design playbook
- AI in health blueprint
- BAA/DUA playbooks
Our services
Regulatory strategy and global product classification
- Classification assessments for software, wearables, sensor-enabled devices, AI/ML tools, remote monitoring, and SaaS platforms (including when AI or digital devices become a regulated medical device)
- Evaluation of FDA, EU MDR/AI Act, Health Canada, Australian TGA and broader APAC requirements
- Product submission strategy and advice, including assistance with pre-subs, De Novo, 510(k), PMA strategy, and global engagement plans
- Design input for multi-function platforms mixing regulated and unregulated components
- Clinical validation and testing expectations
- Cybersecurity and safety-critical software requirements
- Product liability, safety, and risk governance across cloud and hardware environments
AI and digital health governance
- AI lifecycle governance frameworks
- Algorithmic validation, monitoring, model drift strategies
- AI bias, interoperability, liability and indemnity considerations for data sets
- Safety, transparency, labeling, and risk disclosures
- Ethical AI principles integrated with regulatory expectations
- Contracting and allocation of AI risk between developers, deployers, and healthcare providers
Product development and engineering alignment
- Intended use analysis
- Verification/validation requirements
- Clinical evidence strategies
- Software development practices, documentation, and quality management
- Multifunction device platform guidance
- Privacy, security and data strategy
- Building and maintaining compliance programs for HIPAA, state laws, and global data-transfer frameworks, including breach notification guidance, patient rights/requests, and interoperability for data access
- Health data classification, risk scoring, and retention frameworks, operational resilience and business continuity planning
- Integration of cloud infrastructure (Azure), communication platforms, and device interaction, telehealth, remote monitoring, and virtual care platform structuring
Commercialization and market access
- Labeling, promotion, and advertising compliance
- Post-market compliance, recalls, and surveillance
- Identifying potential coverage and reimbursement pathways and advising on product development and positioning to take advantage of existing payment opportunities
- When required, we also assist clients in exploring new coverage and reimbursement opportunities through agency advocacy and new AMA code requests
- Global commercialization frameworks for AI-enabled health solutions
Playbooks and deliverables
We design scalable, predictable deliverables that meet enterprise client expectations, including:
- Healthtech portfolio risk assessment
- Global product classification map
- Digital health compliance-by-design playbook
- AI in health blueprint
- BAA/DUA playbooks