Medical Devices

NHSX recently published “A Buyer’s Checklist for AI in Health and Care” (Guidance) that sets out 10 key questions which will be of use to parties deploying AI solutions or conducting data driven projects (in a health and care setting or otherwise).  For example, the Guidance…
Continue Reading NHSX Publishes “Buyer’s Checklist” for AI Solutions

Yesterday, the Federal Communications Commission (“FCC”) granted GE Healthcare (“GEHC”) a waiver of its equipment authorization rules to allow for the importation, marketing, and operation of certain medical devices that have yet to receive authorization under applicable FCC requirements. The GEHC devices at issue include bedside and wearable patient monitors;…
Continue Reading FCC Waives Equipment Authorization Rules for GE Healthcare to Address COVID-19 Supply Chain and Testing Challenges

On April 21, 2020, the “Regulation on the Requirements and the Process for the Examination of the Eligibility of Digital Health Applications for Reimbursement by the State Health Schemes” (Digitale Gesundheitsanwendungen-Verordnung – „DiGAV“) came into force in Germany. It is accompanied by an extensive Guidance (Leitfaden) issued by the Medicines and Medical Devices Agency “BfArM”.
Continue Reading Germany Establishes a Simplified Procedure for Reimbursement of Digital Health Applications

Digital health companies are playing an important role in the global response to the COVID-19 public health emergency.  For example, the White House Office of Science and Technology Policy issued a Call to Action to the tech community requesting help in answering urgent scientific questions about COVID-19.  As readers of …
Continue Reading COVID-19: FDA Regulatory Considerations for Digital Health Solutions

This is the seventh of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: are healthcare providers involved, and what questions should be considered for collaborations?


Continue Reading Ideation Question #7: Are Healthcare Providers Involved, and What Questions Should Be Considered for Collaborations?

This is the sixth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: what are the limits on how the data can be used and disclosed?


Continue Reading Ideation Question #6: What Are the Limits on How the Data Can Be Used and Disclosed?