In April 2021, the European Commission released its proposed Regulation Laying Down Harmonized Rules on Artificial Intelligence (the “Regulation”), which would establish rules on the development, placing on the market, and use of artificial intelligence systems (“AI systems”) across the EU. The proposal, comprising 85 articles and nine annexes, is part of a wider package of Commission initiatives aimed at positioning the EU as a world leader in trustworthy and ethical AI and technological innovation.

The Commission’s objectives with the Regulation are twofold: to promote the development of AI technologies and harness their potential benefits, while also protecting individuals against potential threats to their health, safety, and fundamental rights posed by AI systems. To that end, the Commission proposal focuses primarily on AI systems identified as “high-risk,” but also prohibits three AI practices and imposes transparency obligations on providers of certain non-high-risk AI systems as well. Notably, it would impose significant administrative costs on high-risk AI systems of around 10 percent of the underlying value, based on compliance, oversight, and verification costs. This blog highlights several key aspects of the proposal.


Continue Reading European Commission Proposes New Artificial Intelligence Regulation

The Federal Communications Commission (“FCC”) is seeking comment on a Notice of Proposed Rulemaking (“NPRM”) that would modify certain aspects of the FCC’s device authorization rules.  Specifically, the FCC is seeking comment on a proposed revision to its device authorization rules to allow the importation of limited quantities of radiofrequency (“RF”) devices prior to authorization for pre-sale activities, including imaging, packaging, and delivery to retail locations.  The FCC also is proposing rule revisions that would allow conditional sales, but not delivery, of RF devices to consumers prior to authorization.

Continue Reading FCC Seeks Comment on Proposal to Change Device Marketing Rules

Connected and automated vehicle (“CAV”) developments in Washington are likely to pick up speed as 2021 rolls in. Indeed, a new presidential administration, new agency leadership, and a new Congress may drive new CAV regulation while also spurring innovation in an industry that many believe can enhance road safety, mobility, and accessibility. For instance, John Porcari, a Biden-Harris campaign advisor and former U.S. Deputy Secretary of Transportation under President Barack Obama, recently indicated that transportation agencies under President Biden would prioritize innovation and technological change and adopt a federal framework for autonomous vehicles.

Lawmakers and regulators, furthermore, will have the opportunity to build on some of the initiatives that picked up speed during the fall of 2020, such as the Safely Ensuring Lives Future Deployment and Research in Vehicle Evolution Act (H.R. 8350) (“SELF DRIVE Act”), the National Highway Traffic Safety Administration’s (“NHTSA”) AV TEST tool, and NHTSA’s request for comment on its proposed framework for Automated Driving Systems (“ADS”) safety. Additionally, the Federal Communications Commission’s (“FCC”) adoption of rules to modernize the 5.9 GHz Band could spur the deployment of CAV technology, and the new administration may reinvigorate inter-agency efforts to examine consumer data privacy and security issues posed by CAVs, as well as CAV-related developments in infrastructure. This post looks down the road ahead for CAV developments in Washington.
Continue Reading IoT Update: The Road Ahead for Connected and Automated Vehicle Developments in Washington

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

FCC Chairman Pai announced today that the FCC will move forward with a rulemaking to clarify the meaning of Section 230 of the Communications Decency Act (CDA).  To date, Section 230 generally has been interpreted to mean that social media companies, ISPs, and other “online intermediaries” have not been subject to liability for their users’ actions.

On July 27, the Trump Administration—acting through the National Telecommunications and Information Administration—submitted a Petition for Rulemaking on Section 230, and Chairman Pai announced on August 3 that the FCC would seek public comment on the petition.  That petition asked the FCC to adopt rules to “clarify” the circumstances under which the liability shield of Section 230 applies.  Citing the FCC General Counsel’s reported position that the Commission has the legal authority to interpret Section 230, Chairman Pai today stated that a forthcoming agency rulemaking will strive to “clarify its meaning.”


Continue Reading FCC Announces Section 230 Rulemaking

FCC Chairman Pai announced today that the FCC would seek public comment on the Administration’s July 27 Petition for Rulemaking on Section 230 of the Communications Decency Act (CDA)—the law that to date has meant that social media companies, ISPs, and other “online intermediaries” have not been subject to liability for their users’ actions. Comments will be due on Wednesday, September 2 and reply comments will be due on Thursday, September 17.

While there is much that is novel about the Petition itself, the FCC’s decision to seek comment on it appears to follow standard operating procedures. At this point, there is no indication of whether the FCC will take more formal steps attempting to adopt any of the rules proposed by the Administration.
Continue Reading FCC Seeks Comment on Section 230 Petition

Earlier this month, the Federal Communications Commission (“FCC”) asked for comment on a Petition for Rulemaking filed by the Consumer Technology Association (“CTA”) that proposes to modify the FCC’s device authorization rules to allow the importation and conditional, preauthorization marketing and sales of radiofrequency (“RF”) devices that have not yet been approved under the FCC’s rules.  The deadline for filing comments supporting or opposing the petition is July 9, 2020.
Continue Reading IoT Update: FCC Considering Changes to Device Rules

Lee Tiedrich, B.J. Altvater, and James Yoon recently published an article summarizing recent developments in artificial intelligence law and policy on the University of Pennsylvania Law School’s Regulatory Review.  The article primarily focuses on developments in the United States, including the National Artificial Intelligence Initiative Act introduced by members of the House Committee

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 concepts and apply generally — but, in places, they specifically mention healthcare and medical devices.

The Commission recognizes the important role that AI and big data analysis can play in improving healthcare, but also notes the specific risks that could arise given the effects that such new technologies may have on individuals’ health, safety, and fundamental rights. The Commission also notes that existing EU legislation already affords a high level of protection for individuals, including through medical devices laws and data protection laws. The Commission’s proposals therefore focus on addressing the gap between these existing rules and the residual risks that remain in respect of new technologies. Note that the Commission’s proposals in the White Paper on AI are open for public consultation until 19 May 2020.


Continue Reading AI Update: European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 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 week do not set out a comprehensive EU legal framework for AI, they do give a clear indication of the Commission’s key priorities and anticipated next steps.

The Commission strategies are set out in four separate papers—two on AI, and one each on Europe’s digital future and the data economy.  Read together, it is clear that the Commission seeks to position the EU as a digital leader, both in terms of trustworthy AI and the wider data economy.


Continue Reading AI Update: European Commission Presents Strategies for Data and AI (Part 1 of 4)