Archives: Digital Health

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European Parliament Endorses Digital Health Resolution

By Sam Jungyun Choi on Posted in Data, Digital Health, European Union, Health Data, Innovation
On December 12, 2019, the European Parliament endorsed a non-binding resolution on enabling the digital transformation of health and care. The resolution calls on the European Commission to take a number of actions to foster the development of digital health systems in Europe to improve patient care and support research efforts — particularly those using … Continue Reading

Digital Healthcare Act Takes Effect in Germany

By Ulrike Elteste on Posted in Digital Health
Digital health applications that meet certain requirements will be covered by the German state health insurance schemes from 2020. This is one of the elements of the Digital Healthcare Act 2019 (Digitale Versorgung-Gesetz), which we discussed in an earlier post this year and which was approved by the German Parliament in November and published on … Continue Reading

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

By Jessica Parezo and Joshua Gray on Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA
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 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

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 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

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

By Elizabeth Guo, Christina Kuhn, Wade Ackerman and Scott Danzis on 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
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