Archives: Artificial Intelligence (AI)

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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

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 … Continue Reading

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 … 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

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 … Continue Reading

Significant FDA Digital Health Policy Development for Prescription Drug Sponsors

As previewed by Commissioner Gottlieb several months ago (see our earlier post here), FDA published a notice in the Federal Register on November 20, 2018, to propose a new framework for “prescription drug-use-related software.” The Agency defines this digital health category widely as software disseminated by a prescription drug sponsor for use with the sponsor’s … Continue Reading

AI Update: Medical Software and Preemption

In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification … 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

Inside FDA’s Latest Digital Health Developments: Gottlieb Sees “Vast Potential” Ahead

On April 26, Commissioner Gottlieb addressed the agency’s progress on FDA’s Digital Health Innovation Action Plan and announced several additional steps the agency is taking to advance the potential benefits of digital health. Here is a recap of the key updates: (1) Launch of New FDA Program to Apply Digital Health to Drugs As our … 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
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