Digital health technologies are revolutionizing the global healthcare environment by advancing healthcare delivery, big data analytics, and medical product innovation.
Telemedicine platforms, health IT applications, remote patient monitoring and other wearable devices, and enhanced artificial intelligence and other technologies are transforming the delivery of healthcare. Innovations in health IT and the accessibility of data are enhancing disease monitoring and diagnosis tools, the 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, reduce costs and inefficiencies, and enable access to data. The use and development of digital health technologies and the delivery of care through remote modalities raises complex and evolving legal challenges at both the federal and state levels. Our team advises on the full spectrum of regulatory, litigation, policy, and corporate risks and opportunities in the digital health space to help our clients meet their goals.
Our team brings together more than 100 lawyers from practices across our integrated, global platform with significant experience in solving complex regulatory and transactional issues in the healthcare, life sciences, and technology sectors. Our multidisciplinary legal team is committed to helping our clients transform the quality and delivery of healthcare and the evolution of health IT, routinely advising 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;
US Food and Drug Administration (FDA) regulatory strategy, enforcement, and compliance;
Federal and state privacy and security, including information blocking, FTC consumer health, biometric data, and GDPR;
Intellectual property and licensing;
Data ownership and data transactions;
Research and clinical trial agreements;
Government, commercial, and supplier contracting; and
Cybersecurity risk mitigation and insurance, including responding to cyberattacks and government breach investigations.
We represent a broad range of clients across the healthcare sector, such as:
Hospitals, healthcare systems, and academic medical centers;
Ancillary providers, including labs and pharmacies;
Direct to Consumer (D2C) healthcare providers (i.e., telehealth providers), labs, and retail pharmacies;
Retail companies delivering healthcare products and services;
Biotechnology and research and development companies, including startups;
Medical device manufacturers;
Software developers, including mobile applications;
Telecommunications and technology platform solution providers;
The One Big Beautiful Bill Act makes major changes to the Internal Revenue Code’s clean energy tax provisions, particularly to the provisions that were extended, expanded, and established as part of the 2022 Inflation Reduction Act.
This edition of The Essentials coincides with the close of California’s 2025 legislative session and summarizes the most significant employment-related bills enacted this year. We have highlighted key provisions of the new laws taking effect in 2026 and one related to the use of artificial intelligence that took effect in October 2025.
The Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (H.R. 5371) (CR) was signed into law on 12 November 2025, thereby ending the federal-government shutdown that started 1 October 2025.
We welcome your email, but please understand that if you are not already a client of K&L Gates LLP, we cannot represent you until we confirm that doing so would not create a conflict of interest and is otherwise consistent with the policies of our firm. Accordingly, please do not include any confidential information until we verify that the firm is in a position to represent you and our engagement is confirmed in a letter. Prior to that time, there is no assurance that information you send us will be maintained as confidential. Thank you for your consideration.
