Smartphones, wearable devices, telemedicine platforms, artificial intelligence software, internet applications and similar digital health technologies are transforming research and development, disease surveillance and diagnosis, health information consumers and the administration of health benefits. Private and public sector companies and institutions are increasingly investing in and integrating digital health technologies to improve quality and reduce costs and inefficiencies. The use and development of digital health technologies raises complex and evolving legal challenges. Our team advises on all regulatory, litigation, policy and corporate risks and opportunities to help our clients achieve their digital health business objectives.
Leveraging our experience in the healthcare, life sciences and technology industries, our global, multi-disciplinary team of lawyers is able to advise clients on a wide range of matters relating to the products and services of digital health, including the Food and Drug Administration (FDA) regulatory strategy. , enforcement and compliance; privacy, including biometric privacy and security; coverage and reimbursement; fraud and abuse; considerations relating to the practice of medicine; intellectual property and licensing; data ownership; clinical trial agreements; public markets; and cybersecurity risk mitigation and insurance.
Our attorneys assist clients in the development and implementation of health information technology to improve clinical outcomes, reduce healthcare costs, and improve healthcare operations. Our attorneys are experienced with the unique combination of privacy, security, intellectual property, and FDA health and regulatory issues involved in development, licensing, management, and deployment electronic health or medical records and electronic prescription systems, as well as the legal framework and regulatory challenges related to making these records available to physicians on a regional basis. In these areas, we help clients navigate compliance requirements for federal and state privacy and security standards, payment bans for referrals, documentation requirements, and health care transaction requirements. health, as well as obtaining administrative approvals or certifications.
We provide proactive advice to enable clients to develop new technologies and proprietary applications for existing technology to integrate legal compliance into their technology or service offering, where possible. Our lawyers also provide advice and transactional representation in matters involving clinical decision support tools, including artificial intelligence applications; clinical data repositories and registries, including blockchain applications; telemedicine and teleradiology applications; Internet pharmacy and other e-commerce solutions for healthcare; electronic health care claims processing and payment systems; medical office management systems; consumer and patient health information portals; and health data mining applications.
Our lawyers advise a holistic range of clients on digital health technologies, including hospitals, healthcare systems and medical practices; medical, pharmaceutical and biotechnology devices; pharmaceutical, retail, software, telecommunications and technology companies; and venture capital and private equity firms.