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Health Care and FDA: Digital Health

Digital health technologies are revolutionizing the global health care environment by advancing health care delivery, big data analytics, and medical product innovation.

Smart phones, wearables, telemedicine platforms, artificial intelligence software, internet applications, and similar digital health technologies are transforming research and development, disease monitoring and diagnosis, consumer health information, and health benefits administration. Companies and institutions in the private and public sector are increasingly investing in and integrating digital health technologies to enhance quality and reduce costs and inefficiencies. The use and development of digital health technologies raises complex and evolving legal challenges. Our team advises on the full spectrum of regulatory, litigation, policy, and corporate risks and opportunities to help our clients meet their digital health business goals.

Leveraging our experience in the health care, life sciences, and technology sectors, our global, multidisciplinary team of lawyers is positioned to advise clients on a broad spectrum of matters regarding digital health products and services, including Food and Drug Administration (FDA) regulatory strategy, enforcement, and compliance; privacy, including biometric privacy and security; coverage and reimbursement; fraud and abuse; practice of medicine considerations; intellectual property and licensing; data ownership; clinical trial agreements; government contracting; and cybersecurity risk mitigation and insurance.

Our lawyers assist clients with the development and implementation of health information technology to improve clinical outcomes, reduce health care costs, and enhance health care operations. Our lawyers have experience with the unique combination of privacy, security, intellectual property, and health care and FDA regulatory issues involved in the development, licensing, management, and deployment of electronic health or medical records and electronic prescription systems, as well as the legal and regulatory challenges to making those records available to physicians on a regional basis. In these matters, we help clients navigate requirements for complying with federal and state privacy and security standards, prohibitions on payments for referrals, documentation requirements, and health care transactions requirements, as well as obtaining administrative approvals or certifications.

We provide proactive guidance to enable clients developing new proprietary technology and applications for existing technology to build legal compliance into their technology or service offering, where possible. Our lawyers also provide counseling 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 health care e-commerce solutions; electronic health care claims processing and payment systems; physician practice management systems; consumer and patient health information portals; and health data mining applications.

Our lawyers counsel a holistic range of clients on digital health technologies including hospitals, health care systems, and physician practices; medical device, pharmaceutical, and biotech; pharmacy, retail, software, telecommunications, and technology companies; and venture capital and private equity firms.

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