Digital Health

On December 5, 2023, the Spanish presidency of the Council of the EU issued a declaration to strengthen collaboration with Member States and the European Commission to develop a leading quantum technology ecosystem in Europe.

The declaration acknowledges the revolutionary potential of quantum computing, which uses quantum mechanics principles and quantum bits known as “qubits” to solve complex mathematical problems exponentially faster than classical computers.

The declaration was launched with eight Member State signatories (Denmark, Finland, Germany, Greece, Hungary, Italy, Slovenia, and Sweden), and invites other Member States to sign. By doing so, they agree to recognize the “strategic importance of quantum technologies for the scientific and industrial competitiveness of the EU” and commit to collaborating to make Europe the “’quantum valley’ of the world, the leading region globally for quantum excellence and innovation.Continue Reading Quantum Computing: Action in the EU and Potential Impacts

This quarterly update summarizes key legislative and regulatory developments in the first quarter of 2023 related to Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and autonomous vehicles (“CAVs”), and data privacy and cybersecurity.Continue Reading U.S. AI, IoT, CAV, and Privacy & Cybersecurity Legislative & Regulatory Update – First Quarter 2023

Yesterday, the National Telecommunications and Information Administration (NTIA) issued a Request for Comment that seeks input on a “National Spectrum Strategy,” which would include a plan to study federal spectrum usage to identify spectrum that could be reallocated or repurposed to commercial or shared federal/commercial use. This National Spectrum Strategy also would include a process for identifying the spectrum bands best suited for repurposing (a “Spectrum Pipeline”).  NTIA seeks input in creating a Spectrum Pipeline for the next decade, with the goal of identifying at least 1,500 megahertz of spectrum to study for potential repurposing to meet the future requirements of both commercial and federal users.  Continue Reading NTIA Seeks Public Comment on the Development of a National Spectrum Strategy and Spectrum-Sharing “Pipeline”

U.S. federal agencies and working groups have promulgated a number of issuances in January 2023 related to the development and use of artificial intelligence (“AI”) systems.  These updates join proposals in Congress to pass legislation related to AI.  Specifically, in January 2023, the Department of Defense (“DoD”) updated Department of Defense Directive 3000.09 and the National Artificial Intelligence Research Resource (“NAIRR”) Task Force Final Report on AI; the National Institute of Standards and Technology (“NIST”) released its AI Risk Management Framework, each discussed below.Continue Reading Roundup of January 2023 Artificial Intelligence Developments

On January 26, 2023, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) released its Artificial Intelligence Risk Management Framework (the “Framework”) guidance document, alongside a companion AI RMF Playbook that suggests ways to navigate and use the Framework.  The goal of the Framework is to provide a resource to organizations “designing, developing, deploying, or using AI systems to help manage the many risks of AI and promote trustworthy and responsible development and use of AI systems.”  NIST aims for the Framework to offer a practical resource that can be adapted as the AI technologies continue to develop.  The release of the Framework follows the release of previous drafts and opportunities for public comment.  An initial draft of the Framework was released in March 2022 and a second draft was released in August 2022, prior to the official launch of version 1.0 of the Framework (NIST AI 100-1).Continue Reading NIST Releases New Artificial Intelligence Risk Management Framework

This quarterly update summarizes key federal legislative and regulatory developments in the second quarter of 2022 related to artificial intelligence (“AI”), the Internet of Things, connected and automated vehicles (“CAVs”), and data privacy, and highlights a few particularly notable developments in U.S. state legislatures.  To summarize, in the second quarter of 2022, Congress and the Administration focused on addressing algorithmic bias and other AI-related risks and introduced a bipartisan federal privacy bill.Continue Reading U.S. AI, IoT, CAV, and Data Privacy Legislative and Regulatory Update – Second Quarter 2022

On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”).  The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.
Continue Reading AI Update: European Commission Conducts Open Consultation on the European Health Data Space Initiative

In what is expected to be one of the last meetings under the leadership of current Federal Communications Commission (“FCC”) Chairman Ajit Pai, the agency will consider adopting a Notice of Proposed Rulemaking (“NPRM”) that proposes to modify certain aspects of the FCC’s device authorization rules.  Specifically, the NPRM will propose to allow the importation and conditional marketing and sales of radiofrequency (“RF”) devices that have not yet been approved under the FCC’s rules.  If the rule is ultimately changed, that means companies marketing RF devices for the first time will have the same flexibility enjoyed by some car companies and many other manufacturers to offer a product to the public before it actually can be shipped for use.
Continue Reading FCC Plans to Advance Proposal to Change Device Marketing Rules

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