Internet of Things (IoT)

On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health and life sciences.  In the white paper, Senator Cassidy disfavors a one-size-fits-all approach to the regulation of AI and instead calls for a flexible approach that leverages existing frameworks depending on the particular context of use of AI.  “[O]nly if our current frameworks are unable to accommodate . . . AI, should Congress look to create new ones or modernize existing ones.”  The Senator seeks public feedback on the white paper by September 22, 2023.  Health care and life sciences stakeholders should consider providing comments. 

This blog outlines five key takeaways from the white paper from a health care and life sciences perspective. Note that beyond health and life sciences issues, the white paper also addresses considerations for other areas, such as use of AI in educational settings and labor/employment implications created by use of AI.

5 Key Takeaways for AI in Health Care and Life Sciences

The white paper – entitled “Exploring Congress’ Framework for the Future of AI: The Oversight and Legislative Role of Congress Over the Integration of Artificial Intelligence in Health, Education, and Labor” – describes the “enormous good” that AI in health care presents, such as “the potential to help create new cures, improve care, and reduce administrative burdens and overall health care spending.”  At the same time, Senator Cassidy notes that AI presents risks that legal frameworks should seek to minimize.  Five key takeaways from the white paper include:…

Continue Reading Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback

Updated August 8, 2023.  Originally posted May 1, 2023.

Last week, comment deadlines were announced for a Federal Communications Commission (“FCC”) Order and Notice of Proposed Rulemaking (“NPRM”) that could have significant compliance implications for all holders of international Section 214 authority (i.e., authorization to provide telecommunications services from points in the U.S. to points abroad).  The rule changes on which the FCC seeks comment are far-reaching and, if adopted as written, could result in significant future compliance burdens, both for entities holding international Section 214 authority, as well as the parties holding ownership interests in these entities.  Comments on these rule changes are due Thursday, August 31, with reply comments due October 2.

Adopted in April, the FCC’s item proposing the new rules also includes an Order requiring all holders of international Section 214 authority to respond to a one-time information request concerning their foreign ownership. Although last week’s Federal Register publication sets a comment deadline for the proposed rules, the reporting deadline for the one-time information request has not yet been established.  However, because the FCC has fulfilled its statutory obligations regarding the new information collection presented by the one-time reporting requirement, carriers — as well as entities holding an ownership interest in these carriers — should prepare for the announcement of the reporting deadline.

The FCC’s latest actions underscore the agency’s ongoing desire to closely scrutinize foreign ownership and involvement in telecommunications carriers serving the U.S. market, as well as to play a more active role in cybersecurity policy. These developments should be of interest to any carrier that serves the U.S. market and any financial or strategic investor focused on the telecommunications space, as well as other parties interested in national security developments affecting telecommunications infrastructure.

Proposed Rule Changes for International Section 214 Authority

The FCC’s proposed changes to its regulation of international Section 214 authorizations generally concern additional compliance, disclosure, and reporting requirements. The FCC’s proposed rule changes are far-reaching, but the most notable of the proposals concern the following:…

Continue Reading Comments Due August 31 on FCC’s Proposal to Step Up Review of Foreign Ownership in Telecom Carriers and Establish Cybersecurity Requirements

On July 18, 2023, Federal Communications Commission (FCC) Chairwoman Jessica Rosenworcel announced that she has circulated a proposal to the FCC’s commissioners to create “a voluntary cybersecurity labeling program that would provide consumers with clear information about the security of their Internet-enabled devices.”

According to the text of her announcement (the proposal itself is not…

This quarterly update summarizes key legislative and regulatory developments in the second quarter of 2023 related to key technologies and related topics, including Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and automated vehicles (“CAVs”), data privacy and cybersecurity, and online teen safety.

Artificial Intelligence

AI continued to be an area of significant interest of both lawmakers and regulators throughout the second quarter of 2023.  Members of Congress continue to grapple with ways to address risks posed by AI and have held hearings, made public statements, and introduced legislation to regulate AI.  Notably, Senator Chuck Schumer (D-NY) revealed his “SAFE Innovation framework” for AI legislation.  The framework reflects five principles for AI – security, accountability, foundations, explainability, and innovation – and is summarized here.  There were also a number of AI legislative proposals introduced this quarter.  Some proposals, like the National AI Commission Act (H.R. 4223) and Digital Platform Commission Act (S. 1671), propose the creation of an agency or commission to review and regulate AI tools and systems.  Other proposals focus on mandating disclosures of AI systems.  For example, the AI Disclosure Act of 2023 (H.R. 3831) would require generative AI systems to include a specific disclaimer on any outputs generated, and the REAL Political Advertisements Act (S. 1596) would require political advertisements to include a statement within the contents of the advertisement if generative AI was used to generate any image or video footage.  Additionally, Congress convened hearings to explore AI regulation this quarter, including a Senate Judiciary Committee Hearing in May titled “Oversight of A.I.: Rules for Artificial Intelligence.”

There also were several federal Executive Branch and regulatory developments focused on AI in the second quarter of 2023, including, for example:

  • White House:  The White House issued a number of updates on AI this quarter, including the Office of Science and Technology Policy’s strategic plan focused on federal AI research and development, discussed in greater detail here.  The White House also requested comments on the use of automated tools in the workplace, including a request for feedback on tools to surveil, monitor, evaluate, and manage workers, described here.
  • CFPB:  The Consumer Financial Protection Bureau (“CFPB”) issued a spotlight on the adoption and use of chatbots by financial institutions.
  • FTC:  The Federal Trade Commission (“FTC”) continued to issue guidance on AI, such as guidance expressing the FTC’s view that dark patterns extend to AI, that generative AI poses competition concerns, and that tools claiming to spot AI-generated content must make accurate disclosures of their abilities and limitations.
  • HHS Office of National Coordinator for Health IT:  This quarter, the Department of Health and Human Services (“HHS”) released a proposed rule related to certified health IT that enables or interfaces with “predictive decision support interventions” (“DSIs”) that incorporate AI and machine learning technologies.  The proposed rule would require the disclosure of certain information about predictive DSIs to enable users to evaluate DSI quality and whether and how to rely on the DSI recommendations, including a description of the development and validation of the DSI.  Developers of certified health IT would also be required to implement risk management practices for predictive DSIs and make summary information about these practices publicly available.

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Continue Reading U.S. Tech Legislative & Regulatory Update – Second Quarter 2023

Late yesterday, the EU institutions reached political agreement on the European Data Act (see the European Commission’s press release here and the Council’s press release here).  The proposal for a Data Act was first tabled by the European Commission in February 2022 as a key piece of the European Strategy for Data (see our…

In August 2022, the Chips and Science Act—a massive, $280 billion bill to boost public and private sector investments in critical and emerging technologies—became law.  We followed the bill from the beginning and anticipated significant opportunities for industry to inform and influence the direction of the new law’s programs. 

One such opportunity is available now.  The U.S. Department of Commerce recently published a request for information (RFI) “to inform the planning and design of the Regional Technology and Innovation Hub (Tech Hubs) program.”  The public comment period ends March 16, 2023.

Background

The Chips and Science Act authorized $10 billion for the U.S. Department of Commerce to establish a Regional Technology and Innovation Hub (Tech Hubs) program.  Specifically, Commerce was charged with designating at least 20 Tech Hubs and awarding grants to consortia composed of one or more institutions of higher education, political subdivisions, state governments, and “industry or firms in relevant technology, innovation, or manufacturing sectors” to develop and deploy critical technologies in those hubs.  $500 million has already been made available for the program, and Commerce will administer the program through the Economic Development Administration (EDA).…

Continue Reading Commerce Seeks Comments on Regional Tech Hubs Program

This quarterly update summarizes key legislative and regulatory developments in the fourth quarter of 2022 related to Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and autonomous vehicles (“CAVs”), and data privacy and cybersecurity.

Artificial Intelligence

In the last quarter of 2022, the annual National Defense Authorization Act (“NDAA”), which contained AI-related provisions, was enacted into law.  The NDAA creates a pilot program to demonstrate use cases for AI in government. Specifically, the Director of the Office of Management and Budget (“Director of OMB”) must identify four new use cases for the application of AI-enabled systems to support modernization initiatives that require “linking multiple siloed internal and external data sources.” The pilot program is also meant to enable agencies to demonstrate the circumstances under which AI can be used to modernize agency operations and “leverage commercially available artificial intelligence technologies that (i) operate in secure cloud environments that can deploy rapidly without the need to replace operating systems; and (ii) do not require extensive staff or training to build.” Finally, the pilot program prioritizes use cases where AI can drive “agency productivity in predictive supply chain and logistics,” such as predictive food demand and optimized supply, predictive medical supplies and equipment demand, predictive logistics for disaster recovery, preparedness and response.

At the state level, in late 2022, there were also efforts to advance requirements for AI used to make certain types of decisions under comprehensive privacy frameworks.  The Colorado Privacy Act draft rules were updated to clarify the circumstances that require controllers to provide an opt-out right for the use of automated decision-making and requirements for assessments of profiling decisions.  In California, although the California Consumer Privacy Act draft regulations do not yet cover automated decision-making, the California Privacy Protection Agency rules subcommittee provided a sample list of related questions concerning this during its December 16, 2022 board meeting.…

Continue Reading U.S. AI, IoT, CAV, and Privacy Legislative Update – Fourth Quarter 2022

On August 25, 2022, President Biden announced a new Executive Order (“EO”) addressing the Implementation of the CHIPS Act of 2022 (“CHIPS Act”).  The CHIPS Act was signed by President Biden on August 9, 2022, and, among other things, authorizes $39 billion in funding for new projects to establish semiconductor production facilities within the United…

On July 13, the Federal Trade Commission published a notice of proposed rulemaking regarding the Motor Vehicle Dealers Trade Regulation Rule.  The Motor Vehicle Dealers Trade Regulation Rule is aimed at combating certain unfair and deceptive trade practices by dealers and promoting pricing transparency.  Comments to the proposed rule are due on or before September 12, 2022. 

cav

The proposed rule:

  1. Prohibits dealers from making certain misrepresentations in the sales process, enumerated in proposed § 463.3.  The list of prohibited misrepresentations includes misrepresentations regarding the “costs or terms of purchasing, financing, or leasing a vehicle” or “any costs, limitation, benefit, or any other Material aspect of an Add-on Product or Service.”
  • Includes new disclosure requirements regarding pricing, financing and add-on products and services.  Notably, the proposed rule would obligate dealers to disclose the offering price in many advertisements and communications with consumers.
  • Prohibits charges for add-on products and services that confer no benefit to the consumer and prohibits charges for items without “Express, Informed Consent” from the consumer (which, notably, as defined, excludes any “signed or initialed document, by itself”).  The proposed rule outlines a specific process for presenting charges for add-on products and services to the consumer, which obligates the dealer to disclose and offer to close the transaction for the “Cash Price without Optional Add-Ons” and obtain confirmation in writing that the consumer has rejected that price.
  • Imposes additional record-keeping requirements on the dealer, in order to demonstrate compliance with the rule.  The record-keeping requirements apply for a period of 24 months from the date the applicable record is created.

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Continue Reading FTC Proposes Motor Vehicle Dealers Trade Regulation Rule

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.

Artificial Intelligence

Federal lawmakers introduced legislation in the second quarter of 2022 aimed at addressing risks in the development and use of AI systems, in particular risks related to algorithmic bias and discrimination.  Senator Michael Bennet (D-CO) introduced the Digital Platform Commission Act of 2022 (S. 4201), which would empower a new federal agency, the Federal Digital Platform Commission, to develop regulations for online platforms that facilitate interactions between consumers, as well as between consumers and entities offering goods and services.  Regulations contemplated by the bill include requirements that algorithms used by online platforms “are fair, transparent, and without harmful, abusive, anticompetitive, or deceptive bias.”  Although this bill does not appear to have the support to be passed in this Congress, it is emblematic of the concerns in Congress that might later lead to legislation.

Additionally, the bipartisan American Data Privacy and Protection Act (H.R. 8152), introduced by a group of lawmakers led by Representative Frank Pallone (D-NJ-6), would require “large data holders” (defined as covered entities and service providers with over $250 million in gross annual revenue that collect, process, or transfer the covered data of over five million individuals or the sensitive covered data of over 200,000 individuals) to conduct “algorithm impact assessments” on algorithms that “may cause potential harm to an individual.”  These assessments would be required to provide, among other information, details about the design of the algorithm and the steps the entity is taking to mitigate harms to individuals.  Separately, developers of algorithms would be required to conduct “algorithm design evaluations” that evaluate the design, structure, and inputs of the algorithm.  The American Data Privacy and Protection Act is discussed in further detail in the Data Privacy section below.…

Continue Reading U.S. AI, IoT, CAV, and Data Privacy Legislative and Regulatory Update – Second Quarter 2022