Medical Apps

On March 9, 2020, the Department of Health and Human Services (HHS) issued two final rules aimed at improving patient access to electronic health information (EHI), as well as the standardization of modes of exchange for EHI.  The rules, which were issued by the Office of the National Coordinator for…
Continue Reading HHS Finalizes Interoperability Rules

On February 27, 2020 NHSX, the technology and digital unit of the NHS, published its draft Digital Health Technology Standard (the “Standard”) for consultation to stakeholders in the digital health space (the “Consultation”). The Consultation is open until 22 April, 2020 (and is available here).

The Standard, which is based on existing industry and health standards, is intended to streamline how digital health technologies are reviewed and commissioned by the NHS and social care.Continue Reading NHSX Consults on Draft Digital Health Technology Standard

Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps.  Accordingly, on January 15, 2020, the German government…
Continue Reading Germany Publishes Draft Regulation on the Reimbursement of Digital Health Applications

This is the ninth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: Who will own the intellectual property rights?


Continue Reading Ideation Question #9: Who Will Own the Intellectual Property Rights?

This is the eighth 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 is novel in the digital health solution and what will give the solution a competitive advantage?


Continue Reading Ideation Question #8: What is Novel in the Digital Health Solution and What Will Give the Solution a Competitive Advantage?

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?