Supporting Innovation, Compliance, and Growth
Digital health represents more than technological innovation. It marks a fundamental transformation in healthcare delivery that requires sophisticated, forward-thinking legal counsel. Frier Levitt provides comprehensive legal services tailored to the unique needs of stakeholders operating in this rapidly evolving space, navigating the complex intersection of healthcare, technology, and regulation. Our team delivers strategic guidance that not only ensures regulatory compliance, but also supports innovation and drives sustainable growth for companies at every stage of development.
What is Digital Health?
Digital health encompasses a wide array of technologies designed to improve health outcomes, enhance healthcare delivery, and increase efficiency across the healthcare system. From telehealth platforms and mobile health applications to advanced cutting-edge AI technologies and wearable devices, the digital health sector is transforming patient care, clinical workflows, and overall health management.
With this transformation comes a need to address a host of complex legal and regulatory challenges, including compliance with licensing regulations, privacy and data protection laws, intellectual property considerations, reimbursement structures, and more.
At Frier Levitt, we leverage our deep expertise in healthcare, life sciences, pharmacy and technology law to deliver tailored, forward-looking legal strategies that help our clients thrive in this rapidly evolving sector.
Our Digital Health Services
We provide comprehensive legal counsel to stakeholders across the digital health ecosystem, including healthcare providers, technology developers, investors, and payers. From early-stage concept development and financing through product launch, commercialization, and ongoing regulatory oversight, our team delivers strategic guidance at every phase of growth.
Telehealth, in particular, has transformed the delivery of care by expanding access through virtual platforms and remote technologies. We advise telehealth providers, technology companies, and ancillary service partners, including pharmacies, on navigating the evolving federal and state regulatory landscape. Our counsel spans licensure, reimbursement frameworks, prescriptive authority, and data privacy requirements, ensuring clients remain compliant while preserving the agility needed to innovate. Through proactive risk management and reimbursement strategy, we help mitigate exposure and position organizations for sustainable expansion.
Chronic care management (CCM), remote therapeutic monitoring (RTM) and remote physiologic monitoring (RPM) are becoming central to value-based care models and helping patients manage long-term conditions outside of the traditional healthcare setting. These services also offer clinicians an opportunity to further engage with their patients in a manner that traditionally was unavailable. Our firm works with healthcare providers and management and technology companies to ensure compliance with regulatory requirements, including reimbursement from Medicare and other payers, as well as data privacy and security standards.
Mobile health solutions, including health apps and mobile-enabled devices, are rapidly becoming an essential part of managing patient care and wellness. We assist mobile health innovators with product development, intellectual property protection, and regulatory compliance, including FTC rules, HIPAA, and the FDA’s oversight of mobile medical apps. Our team works to ensure that mobile health technologies and applications targeted at providers and their patients, and those targeted directly to consumers, meet legal and regulatory standards while achieving market success.
AI is poised to revolutionize healthcare delivery, from diagnostics and clinical decision support to personalized treatment plans and operational efficiencies. Our attorneys are at the forefront of legal support for AI developers, healthcare providers, and self-funded payers. We assist clients in navigating the evolving regulatory landscape, including scope of practice considerations, data privacy concerns, algorithm accountability, and FDA approval pathways for AI-driven medical devices. Our team also assists in the negotiation of licensing agreements and protecting intellectual property in AI technologies.
The adoption of Electronic Health Record (EHR) systems and healthcare software is foundational to modern healthcare. We offer legal guidance to healthcare providers, software developers, and vendors on the regulatory and operational aspects of implementing and maintaining EHRs, integrating with Health Information Exchange (HIE) systems, and other healthcare software solutions. Our services include navigating federal and state health privacy laws, cybersecurity measures, contract negotiations, data sharing agreements, and HIPAA compliance.
Wearable health devices are empowering patients to monitor and manage their health in real time. Whether it’s fitness trackers, smartwatches, or medical-grade devices for chronic disease management, wearable technologies are reshaping patient engagement. We help wearable tech companies protect their innovations through intellectual property strategies, assist with regulatory compliance (FDA, clinical practice guidelines, etc.), and address privacy issues related to the collection and use of health data.
Comprehensive Legal Services
Our services extend beyond specialized practice areas to provide holistic legal support for digital health innovators, including:
Digital health is subject to an array of regulatory frameworks, including FTC guidance, HIPAA, fraud, waste and abuse prohibitions, FDA rules, and state-specific laws. Our attorneys provide guidance on achieving and maintaining compliance with these regulations, ensuring that our clients can navigate the complexities of healthcare law while innovating responsibly. We help clients obtain necessary certifications, approvals, and clearances, and we provide ongoing support to mitigate the risk of non-compliance.
Whether you are a startup seeking venture capital or an established company looking to enter new markets, we support digital health companies with the full spectrum of transactional matters. Our services include mergers and acquisitions, joint ventures, licensing agreements, partnerships, and the negotiation of complex commercial contracts with healthcare providers, payers, and technology vendors.
With the increasing volume of health data generated through digital health technologies, protecting patient privacy and ensuring data security are paramount. Our team is highly skilled in advising clients on HIPAA and state data privacy compliance, cybersecurity best practices, data sharing agreements, and breach response strategies. We also stay abreast of state-specific privacy laws and international data protection regulations to ensure your business remains compliant at all levels.
Innovation is at the heart of digital health, and protecting intellectual property is essential to maintaining a competitive edge. Our intellectual property team provides comprehensive services, including patent protection for novel technologies, trademark registration, copyrights, licensing agreements, and trade secret protection. We work closely with our clients to develop strategies to safeguard and maximize the value of healthcare technology innovations.
Why Frier Levitt?
We are more than legal advisors, we are strategic partners in advancing digital health innovation. Combining deep legal expertise with a commitment to shaping the future of healthcare, we support companies at the forefront of transformation. Whether developing or managing a telehealth platform, evaluating regulatory obligations related to emerging AI tools, expanding a wearable technology business, or launching a consumer-facing health-tech application, our team delivers practical, forward-looking counsel that helps clients navigate risk and seize opportunity.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you navigate your legal challenges and help stay compliant in this fast-paced industry.
