Digital health technologies are revolutionizing the global health care environment by advancing health care delivery, big data analytics, and medical product innovation.
Telemedicine platforms, health IT applications, remote patient monitoring and other wearable devices, clinical decision-making software, and other digital health technologies are transforming health care. Innovations are enhancing disease monitoring and diagnosis, the availability and use of consumer health information, the evolution of remote delivery models, research and development, and service to underserved communities. Companies and institutions in the private and public sector are increasingly investing in and integrating digital health technologies to enhance quality care, reduce costs and inefficiencies, and improve access to data. The use and development of digital health technologies raise complex and evolving legal challenges. Our team advises on the full spectrum of regulatory, litigation, policy, and corporate risks and opportunities in the digital health space.
The development and use of digital health technologies raises complex and evolving legal challenges. Our team brings together numerous lawyers from practices across our integrated, global platform with significant experience in solving complex regulatory and transactional issues in the health care, life sciences, and technology sectors. Our multidisciplinary team of lawyers is committed to helping our clients transform the quality and delivery of health care and the evolution of health IT. We routinely advise clients on a broad spectrum of regulatory matters in the digital health space, including:
Federal and state licensure, reimbursement, and fraud and abuse compliance.
Traditional practice of medicine considerations, including corporate practice of medicine and fee-splitting restrictions.
U.S. Food and Drug Administration (FDA) regulatory strategy, enforcement, and compliance.
Privacy, including biometric privacy and security, information blocking, and interoperability.
Intellectual property and licensing.
Data ownership and data transactions.
Research and clinical trial agreements.
Government, commercial, and supplier contracting.
Cybersecurity risk mitigation and insurance, including responding to cyberattacks and government breach investigations.
We represent a broad range of clients in the digital health care space, such as:
Hospitals, health care systems, and academic medical centers.
Ancillary providers, including labs and pharmacies.
Direct-to-Consumer (D2C) health care providers, labs, and retail pharmacies.
Retail companies delivering health care products and services.
Biotechnology and research and development companies, including startups.
Medical device manufacturers.
Software developers, including mobile and e-health applications.
Telecommunications and technology platform solution providers .
Current federal funding expires this Saturday. As we approach the deadline, it is looking less likely that Congress will pass a continuing resolution, a short-term stopgap measure, to avoid a government shutdown.
Effective 27 June 2023, the Pregnant Workers Fairness Act (PWFA) is a new law that closes a gap in coverage under federal law for pregnant and postpartum workers and applicants.
Although still in their infancy, a growing number of recently-filed lawsuits associated with generative artificial intelligence (AI) training practices, products, and services have provided a meaningful first look into how US courts may address the privacy, consumer safety, and intellectual property protection concerns that have been raised by this new, and inherently evolving, technology.
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