On March 28, 2019, the Council of Europe* issued a new Recommendation on the protection of health-related data. The Recommendation calls on all Council of Europe member states to take steps to ensure that the principles for processing health-related data (in both the public and private sector) set out in the Appendix of the Recommendation
ICO opens beta phase of privacy “regulatory sandbox”
On 29 March 2019, the ICO opened the beta phase of the “regulatory sandbox” scheme (the “Sandbox”), which is a new service designed to support organizations that are developing innovative and beneficial projects that use personal data. The application process for participating in the Sandbox is now open, and applications must be submitted to the
UK’s NICE releases newly updated Digital Health Technologies (DHT) Evidence Standards Framework
Following on from the Evidence Standards Framework for DHTs published in December 2018 (the Original Standards, as reported in our previous blog post, here), the UK’s National Institute for Health and Care Excellence (NICE) recently published a newly updated version of the standards (the Updated Standards, available here).
The
EU Working Group Publishes Draft Guidance on AI Ethics
On 18 December 2018, the EU High-Level Expert Group on Artificial Intelligence (the “AI HLEG”) published new draft guidance on “AI Ethics” (the “guidance”). The AI HLEG is a European Commission-backed working group made up of representatives from industry, academia and NGOs, and was formed as part of the Commission’s ongoing work to develop EU policy responses to the development, challenges and new opportunities posed by AI technologies. Stakeholders are invited to comment on the draft through the European AI Alliance before it is finalized in March 2019.
The guidance recognizes the potential benefits of AI technologies for Europe, but also stresses that AI must be developed and implemented with a “human-centric approach” that results in “Trustworthy AI”. The guidance then explains in detail the concept of “Trustworthy AI” and the issues stakeholders should navigate in order to achieve it. A more detailed summary of the guidance is set out below.
This guidance is not binding, but it is likely to influence EU policymakers as they consider whether and how to legislate in the AI space going forwards. AI HLEG also envisages that the final version of the guidance in March 2019 will include a mechanism to allow stakeholders to voluntarily endorse its principles. The guidance also states that the AI HLEG will consider making legislative recommendations in its separate deliverable on “Policy & Investment Recommendations,” due May 2019.
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EESC supports the digital transformation of EU healthcare sector, emphasising data access and ownership as ‘crucial’ to the process
On 6 December 2018, the European Economic and Social Committee (EESC) published an opinion (“Opinion”) addressing the European Commission’s recent Communication on the digital transformation of health and care in the Digital Single Market (issued 25 April 2018).
The EESC is an advisory body of the European Union (“EU”) comprising representatives of workers’ and employers’
NICE adopts evidence standards for the development and assessment of digital health technologies (DHTs)
The UK’s National Institute for Health and Care Excellence (NICE) has recently published an evidence standards framework for DHTs (the Standards), available here. It did so through a working group led by NHS England, but supported by representatives from Public Health England, MedCity and DigitalHealth.London.
The Standards cover DHTs, such as apps, programs and
IoT Update: The UK Government’s Response to Centre for Data Ethics and Innovation Consultation
On 20 November 2018, the UK government published its response (the “Response”) to the June 2018 consultation (the “Consultation”) regarding the proposed new Centre for Data Ethics and Innovation (“DEI”). First announced in the UK Chancellor’s Autumn 2017 Budget, the DEI will identify measures needed to strengthen the way data and AI are used and regulated, advising on addressing potential gaps in regulation and outlining best practices in the area. The DEI is described as being the first of its kind globally, and represents an opportunity for the UK to take the lead the debate on how data is regulated.
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