Digital Health
Even before COVID-19, disruptive digital health technologies were beginning to revolutionize healthcare. Digital health and telemedicine innovations like telehealth portals, wearables that track biometric data, and devices with Bluetooth connectivity that allow for remote monitoring continue to help increase access to healthcare. New technologies enabling more precise diagnostics and better targeted therapies, and technologies enhancing the efficacy or safety of existing therapies are also expanding. Mobile clinics and portable devices are taking healthcare to people where they live and work. New federal regulations promoting access to data through the use of APIs are fueling the development of new, interoperable technology solutions to further personalize healthcare.
King & Spalding’s Digital Health Group has guided the technology companies, pharmaceutical and device companies, diagnostic companies, start-ups, and healthcare providers that have pioneered the technology and transformative thinking that shape today’s evolving digital health landscape. Our team -- which includes former FDA and other government insiders, as well as thought leaders in privacy and cybersecurity, health and technology -- offers an unparalleled breadth of experience and perspective. The firm helps clients navigate FDA’s regulatory framework pre- and post-market, secure government reimbursement, and advocate in Congress for legislation. Our lawyers also help companies, from start-ups to global brands, in investigations, TCPA class actions, capital raising, M&A, strategic collaborations, antitrust, and intellectual property– all in pursuit of practical solutions that minimize legal risk.
July 22, 2024
EU Artificial Intelligence Regulation Published - What You Need to Know
March 25, 2024
FDA Publishes White Paper on Artificial Intelligence & Medical Products
October 11, 2023
FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices
Jim Boswell and Lisa Dwyer discuss regulatory and legislative considerations and risks in the digital health arena.
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October 16, 2024
Livia Kiser, Jeffrey Hammer, James Unger and Craig Bessenger counsel BetterHelp in a class action case before a California federal court
August 5, 2024
Kyle Gotchy discusses Harris Health and the establishment of its governance committee to move its AI framework forward