Archives: Digital Health

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

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

By Sarah Franklin on November 5, 2019 Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA

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

By Libbie Canter and Anna D. Kraus on October 29, 2019 Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA

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 #5: Who Will Pay for the Offering?

By Maree Gallagher and Rujul Desai on October 22, 2019 Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA, Uncategorized

This is the fifth 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 pay for the offering?… Continue Reading

EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

By Raj Gathani and Sarah Cowlishaw on October 21, 2019 Posted in Digital Health, European Union, Medical Apps, Software

The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect. The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply. In advance of these … Continue Reading

Ideation Question #4: What Data Will Be Needed to Substantiate the Offering?

By Wade Ackerman and Libbie Canter on October 15, 2019 Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA

This is the fourth 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 data will be needed to substantiate the offering?… Continue Reading

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

By Elizabeth Guo, Christina Kuhn, Wade Ackerman and Scott Danzis on October 8, 2019 Posted in Artificial Intelligence (AI), Digital Health, Medical Apps, Medical Devices and FDA, Software

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading

Ideation Question #2: Who Will Provide Aspects of the Offering?

By Priscilla Fasoro and David Wildman on October 1, 2019 Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA

This is the second 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 provide the various components of the offering?… Continue Reading