Tag Archives: Artificial Intelligence (AI)

NHSX Publishes “Buyer’s Checklist” for AI Solutions

NHSX recently published “A Buyer’s Checklist for AI in Health and Care” (Guidance) that sets out 10 key questions which will be of use to parties deploying AI solutions or conducting data driven projects (in a health and care setting or otherwise).  For example, the Guidance highlights: key data-related considerations, such as can the outcome … Continue Reading

UK Government’s Advisory Committee Publishes Report on Public Sector Use of AI

On February 10, 2020, the UK Government’s Committee on Standards in Public Life* (the “Committee”) published its Report on Artificial Intelligence and Public Standards (the “Report”). The Report examines potential opportunities and hurdles in the deployment of AI in the public sector, including how such deployment may implicate the “Seven Principles of Public Life” applicable to … Continue Reading

European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)

In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad … Continue Reading

European Commission’s plans on data and Europe’s digital future (Part 3 of 4)

On 19 February 2020, the new European Commission published two Communications relating to its five-year digital strategy: one on shaping Europe’s digital future, and one on its European strategy for data (the Commission also published a white paper proposing its strategy on AI; see our previous blogs here and here).  In both Communications, the Commission … Continue Reading

European Commission’s White Paper on Artificial Intelligence (Part 2 of 4)

The European Commission, as part of the launch of its digital strategy for the next five years, published on 19 February 2020 a White Paper On Artificial Intelligence – A European approach to excellence and trust (the “White Paper”).  (See our previous blog here for a summary of all four of the main papers published … Continue Reading

European Commission Presents Strategies for Data and AI (Part 1 of 4)

On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI.  These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days.  Although the papers published this … Continue Reading

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 … Continue Reading

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 … Continue Reading

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

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

European Parliamentary Research Service issues a briefing paper on implementing EU’s ethical guidelines on AI

On 19 September 2019, the European Parliamentary Research Service (“EPRS”)—the European Parliament’s in-house research service—released a briefing paper that summarizes the current status of the EU’s approach to developing a regulatory framework for ethical AI.  Although not a policymaking body, the EPRS can provide useful insights into the direction of EU policy on an issue. … Continue Reading

Commission relaunch of eHealth Stakeholder Group

On 13 August 2019, the European Commission opened a call for expression of interest to relaunch the eHealth Stakeholder Group with a view to supporting the “digital transformation of healthcare in the EU”. The eHealth Stakeholder Group was first launched in 2012 and in its first iteration (between 2012 and 2015), contributed to the development … Continue Reading

ICO publishes blog post on AI and trade-offs between data protection principles

On July 25, 2019, the UK’s Information Commissioner’s Office (“ICO”) published a blog on the trade-offs between different data protection principles when using Artificial Intelligence (“AI”).  The ICO recognizes that AI systems must comply with several data protection principles and requirements, which at times may pull organizations in different directions.  The blog identifies notable trade-offs … Continue Reading

ICO’s Call for Input on Bias and Discrimination in AI systems

On June 25, 2019, as part of their continuing work on the AI Auditing Framework, the UK Information Commissioner’s Office (ICO) published a blog setting out their views on human bias and discrimination in AI systems. The ICO has also called for input on specific questions relating to human bias and discrimination, set out below. … Continue Reading

UK Government’s Guide to Using AI in the Public Sector

On June 10, 2019, the UK Government’s Digital Service and the Office for Artificial Intelligence released guidance on using artificial intelligence in the public sector (the “Guidance”).  The Guidance aims to provide practical guidance for public sector organizations when they implement artificial intelligence (AI) solutions. The Guidance will be of interest to companies that provide … Continue Reading

ICO’s Interim Report on Explaining AI

On June 3, 2019, the UK Information Commissioner’s Office (“ICO”), released an Interim Report on a collaboration project with The Alan Turing Institute (“Institute”) called “Project ExplAIn.” The purpose of this project, according to the ICO, is to develop “practical guidance” for organisations on complying with UK data protection law when using artificial intelligence (“AI”) … Continue Reading

FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

On April 2, 2019, FDA released a discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” (the “AI Framework”). The AI Framework is the Agency’s first policy document describing a potential regulatory approach for medical devices that use artificial intelligence (“AI”) and machine learning (“ML”). The … Continue Reading

EU High-Level Working Group Publishes Ethics Guidelines for Trustworthy AI

On 8 April 2019, the EU High-Level Expert Group on Artificial Intelligence (the “AI HLEG”) published its “Ethics Guidelines for Trustworthy AI” (the “guidance”).  This follows a stakeholder consultation on its draft guidelines published December 2018 (the “draft guidance”) (see our previous blog post for more information on the draft guidance).  The guidance retains many … Continue Reading

Key Takeaways from FDA’s Framework for Real-World Evidence for Pharmaceuticals

On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”).  In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top … Continue Reading

ICO consults on privacy “regulatory sandbox”

Designing data-driven products and services in compliance with privacy requirements can be a challenging process.  Technological innovation enables novel uses of personal data, and companies designing new data-driven products must navigate new, untested, and sometimes unclear requirements of privacy laws, including the General Data Protection Regulation (GDPR).  These challenges are often particularly acute for companies … Continue Reading

UK Government publishes “Initial code of conduct for data-driven health and care technology” for consultation

On 5 September, in response to the opportunities presented by data-driven innovations, apps, clinician decision support tools, electronic health care records and advances in technology such as artificial intelligence, the UK Government published a draft “Initial code of conduct for data-driven health and care technology” (Code) for consultation.  The Code is designed to be supplementary … Continue Reading

Covington Artificial Intelligence Update: House of Lords Select Committee publishes report on the future of AI in the UK

Reflecting evidence from 280 witnesses from the government, academia and industry, and nine months of investigation, the UK House of Lords Select Committee on Artificial Intelligence published its report “AI in the UK: ready, willing and able?” on April 16, 2018 (the Report). The Report considers the future of AI in the UK, from perceived … Continue Reading

FDA Outlines Updated Approach to Regulating Digital Health Technologies

On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft guidances announce the … Continue Reading

Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity

In the third installment of our series, Covington’s global cross-practice Digital Health team considers some additional key questions about Artificial Intelligence (AI), data privacy, and cybersecurity that companies across the life sciences and technology sectors should be asking to address the regulatory and commercial pieces of the complex digital health puzzle. AI, Data Privacy, and Cybersecurity 1. … Continue Reading

European Cloud in Health Advisory Council Calls For Review of eHealth Rules and Ethics of Medical Data Re-Use

On May 11, 2017, the European Cloud in Health Advisory Council (ECHAC) – a group of healthcare organizations, technology companies and patient representatives  –  launched its second whitepaper focused on use of data to improve health outcomes and delivery of care. ECHAC launched the whitepaper at an eHealth Week 2017 session attended by ECHAC participants and … Continue Reading
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