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;
On 2 April 2025, President Trump announced a series of “reciprocal” tariffs on US imports from all countries. The tariffs apply at different rates by country, starting at a baseline of 10% and reaching as high as 50%.
The Hon. Jim Chalmers MP, Federal Treasurer and the Hon. Clare O'Neil MP, Minister for Housing, Minister for Homelessness issued a joint media release on 16 February 2025 titled "Albanese Government clamping down on foreign purchase of established homes and land banking".
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.
