Technology is changing the way the healthcare industry operates. With changes come new challenges and opportunities — as well as a dramatic shift in the competitive and regulatory landscape.
The untapped business potential is tremendous. However, at the same time, there are new and complex technological, business, and legal issues that create uncertainty and ambiguity because they cannot be addressed within the borders of traditional law and local regulation.
Our cross-jurisdictional team of 40 life sciences lawyers take a holistic issues and technology-based approach to counseling on digital health products and services. We provide strategic guidance on how to leverage opportunities for growth, minimize legal barriers, comply with rules, protect your data, and realize its value.
Advising a leading pharmaceutical company in its digital health strategy in 21 jurisdictions.
Representing a high-technology company in connection with its life science business ventures, including exclusive licenses and joint ventures, to develop digital health products.
Advising several pharmaceutical and medical device companies on the regulatory status and the dissemination and marketing of mobile applications.
Advising a leading consumer product company on the development and classification of a consumer-oriented wearable sensor and associated mobile application.
Assisting a major diabetes manufacturer in seeking PMA approval for a sensor augmented insulin pump.
Advising on various regulatory aspects of international telemedicine, including cross-border healthcare, data privacy, and medical device aspects.
Advising a number of clients on the classification and regulation of software for communication between medical devices and physicians’/patients’ smartphones and agendas.
Assisting a major pharmaceutical company with an enterprise-wide review of Telephone Consumer Protection Act compliance issues.
Advising a biopharmaceutical company on its agreement with a supplier of digital technologies (e.g., data capture solutions) for use in clinical trials.
Representing biotechnology company in administrative law proceedings related to financial penalty imposed by Ministry of Health concerning a mobile health app.
Assisting the German Federal Government in the IP clearance for the German e-health card.
Advising developers of wearable technology and digital health platforms on liability risk mitigation strategies.
Representing global technology company before EU national authorities in dispute with competitors concerning appropriate classification of software that supports a medical device.
Assisting medical device manufacturers with structuring their connected medical device services to facilitate cross-border data transfers and streamline EU data protection constraints.
Advising multiple global medical device manufacturers on the development of variations to existing medical devices for use in sports activities and/or a healthy lifestyle.
Co-authoring a study for the French CNIL on the regulation of connected health (“quantified self”) devices.