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, and enhanced artificial intelligence and other technologies are transforming the delivery of health care. 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 health care, life sciences, and technology sectors. Our multidisciplinary legal team is committed to helping our clients transform the quality and delivery of health care 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 health care sector, such as:
Hospitals, health care systems, and academic medical centers;
Ancillary providers, including labs and pharmacies;
Direct to Consumer (D2C) health care providers (i.e., telehealth 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 applications;
Telecommunications and technology platform solution providers;
On 3 December 2024, Judge Amos Mazzant of the Eastern District of Texas issued a nationwide preliminary injunction with respect to the Corporate Transparency Act (CTA), enjoining enforcement of the CTA as well as the implementing Treasury regulations, and staying the 1 January 2025 reporting deadline until further order of the Court.
On 22 December 2020, the U.S. Securities and Exchange Commission (SEC) adopted amendments (the final rule) to Rule 206(4)-1 under the Investment Advisers Act of 1940 (the Advisers Act) to modernize the regulation of investment adviser advertising and solicitation practices.
In the October edition of The Essentials, we summarize key provisions of California employment laws that took effect in 2024 and those that will take effect in 2025.
In this semiannual series on the U.S. Department of Labor's Regulatory Agenda, partners Craig Leen and Kathleen Parker discuss recent updates to the regulatory agenda and what employers should expect in terms of new labor and employment regulations in 2023.
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.
