European Parliament Endorses Digital Health Resolution

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 innovative technologies such as AI.

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Digital Healthcare Act Takes Effect in Germany

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 December 18th, 2019.

To qualify for coverage, an app must be a low-risk medical device. In addition, the manufacturer must apply for registration with a new registry which will be kept by the Federal Institute for Medicinal Products and Medical Devices. The detailed requirements for registration will be set out in a regulation which is currently being drafted, but will include proof of privacy law compliance, a high level of data security and a concept for evaluation of the medical benefit of the app by an independent expert. Patients will need to obtain a prescription by a physician or psychotherapist or their health scheme’s prior approval.

Independently of this, the Act also contains amendments to the Social Code that will authorize state health insurance schemes to work with device manufacturers, IT companies and others to improve healthcare services through digital innovations. They will also be authorized to invest up to 2% of their financial reserves in investment funds with the aim of furthering the development of digital innovations.

UK ICO and The Alan Turing Institute Issue Draft Guidance on Explaining Decisions Made by AI

The UK’s Information Commissioner’s Office (“ICO”) has issued and is consulting on draft guidance about explaining decisions made by AI.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?

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?

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?

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?

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?

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?

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?

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