UK ICO and The Alan Turing Institute Issue Draft Guidance on Explaining Decisions Made by AI

By Mark Young and Sam Jungyun Choi on Posted in Artificial Intelligence (AI), Big Data

The UK’s Information Commissioner’s Office (“ICO”) has issued and is consulting on draft guidance about explaining decisions made by AI.  The ICO prepared the guidance with The Alan Turing Institute, which is the UK’s national institute for data science and artificial intelligence.  Among other things, the guidance sets out key principles to follow and steps to take when explaining AI-assisted decisions — including in relation to different types of AI algorithms — and the policies and procedures that organizations should consider putting in place.

The draft guidance builds upon the ICO’s previous work in this area, including its AI Auditing Framework, June 2019 Project ExplAIN interim report, and September 2017 paper ‘Big data, artificial intelligence, machine learning and data protection’.  (Previous blog posts that track this issue are available here.)  Elements of the new draft guidance touch on points that go beyond narrow GDPR requirements, such as AI ethics (see, in particular, the recommendation to provide explanations of the fairness or societal impacts of AI systems).  Other sections of the guidance are quite technical; for example, the ICO provides its own analysis of the possible uses and interpretability of eleven specific types of AI algorithms.

Organizations that develop, test or deploy AI decision-making systems should review the draft guidance and consider responding to the consultation. The consultation is open until January 24, 2020.  A final version is expected to be published later next year.

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Ideation Question #10: What Are the Priorities for the Solution?

By Elizabeth Guo and Wade Ackerman on Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA

This is the tenth 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 priorities for the solution?

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

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

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?

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?

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?

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

By Libbie Canter and Anna D. Kraus on 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?

Ideation Question #5: Who Will Pay for the Offering?

By Maree Gallagher and Rujul Desai on 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?

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 changes, the EU Medical Device Coordination Group (“MDCG”) has recently published guidance on the Qualification and Classification of Software in the MDR and IVDR (the “Guidance”).

The aim of the Guidance is to assist manufacturers with interpreting the new Regulations to assess whether their software meets the definition of a medical device or an in vitro diagnostic device (i.e., “qualification”); and if so, what regulatory class the software would fall under (i.e., “classification”).

The MDCG is a coordination group established under Article 103 of the MDR, comprising up to two medical device experts from each EU Member State.  Its key functions include contributing to the development of guidance to ensure effective and harmonized implementation of the EU’s new medical device rules.  The Guidance is not legally binding nor does it necessarily reflect the official position of the European Commission.  However, given the MDCG’s important role in the regulatory landscape, the Guidance is likely to be highly persuasive.

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

By Wade Ackerman and Libbie Canter on 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?

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