News
UK CMA publishes AI Foundation Models update paper
22 April 2024
The UK Competition and Markets Authority (“CMA”) has published an “Update Paper” outlining its evolving views on AI foundation models as well as its approach to...
Representative experience
Multiple clients on the use of telehealth and other digital health applications to monitor COVID-19 patients in their homes.
Multiple clients – including high-technology companies – in drafting and negotiating agreements to develop and commercialize digital health products that depend on access to and exchange of data.
Multiple pharmaceutical companies on the use of software applications within a clinical trial setting.
A client on the development of a new digital health product consisting of a mobile app for the patient and web-based apps for HCPs.
A provider of advanced diagnostic imaging, outpatient, and cancer care on the generation of their digital architecture strategy through licensing, joint venture, and acquisition arrangements.
Two successful de novo applications to FDA for AI medical products. IDx's product for use in diabetic retinopathy screening and Viz.ai's product that analyzes CT angiographic images to support acute stroke care.
A leading consumer product company on the development and classification of a consumer-oriented wearable sensor and associated mobile application.
Various regulatory aspects of international telemedicine, including cross-border health care, data privacy, and medical device aspects.
Medical device manufacturers with structuring their connected medical device services to facilitate cross-border data transfers and streamline EU data protection constraints.
Multiple life sciences companies on the use of data (including patient data) from handheld devices, mobile apps, tracking, and other personal devices for various use scenarios.
Competition law aspects of blockchain technology, which is explored for use in pharmaceutical supply chain management and patient data handling.
Technology companies, as well as hospitals, health plans, and biotech companies, on issues related to the use of data in research contexts, health privacy and the cloud, and core HIPAA compliance.
Various regulatory aspects of international telemedicine, including cross-border health care, data privacy, and medical device aspects.
An international IT company concerning the use of AI in support of medical practice, especially diagnosis of diseases, and the potential classification of related software as a medical device in the EU.
Cisco Healthcare in rolling out its telemedicine products in China and related regulatory issues.
A surgical robotic company on competition law aspects, in particular as regards market definition in fields of nascent technologies.
