ML Strategies

This issue of Energy & Sustainability Connections includes features on litigation risks facing offshore wind projects, carbon capture innovator Mantel Capture, compliance with the Corporate Transparency Act, plus energy policy news from Washington, litigation updates, a roundup of recent M&A activity, and information on upcoming industry events.

Read about how the November elections could shape the financial services policies of the next presidential administration and 119th Congress.

Read about the FTC Staff Report on the data collection and data use practices of large social media and video streaming service platforms in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Our October 2024 Energy & Sustainability Washington Update covers the newly launched Environmental Justice Climate Corps Program, DOE’s 2024 Better Buildings Initiative progress report, energy bills recently passed in the House of Representatives, a Senate hearing on the DOE’s role in advanced computing research & technology, a DOE funding opportunity for wave energy, and Bipartisan Infrastructure Law and IRA opportunities.

Read about how the upcoming November elections could shape consumer product safety laws and regulations, depending on the outcome of the presidential race and whether one party takes control of Congress.

Read about the Democratic Senators urging the heads of the FTC and DOJ’s Antitrust Division to investigate generative AI models that may violate competition laws in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about the potential implications of the 2024 general election for infrastructure policy for the incoming presidential administration and the 119th Congress. 

Read about the second draft guidance released by the National Institute of Standards and Technology (NIST) in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about international trade priorities that may be pursued by the presidential candidates Donald Trump and Kamala Harris in the latest edition of our 2024 Pre-Election Analysis series on how the November 2024 election will impact the legislative and regulatory landscape.

Read about five AI bills Senator Mike Rounds (R-SD) introduced for Congress to consider when its members return on September 8 in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Agencies across the federal government continue to grapple with how to respond to the directives in President Biden’s October 2023 executive order on artificial intelligence, including the Food and Drug Administration (FDA) and its parent agency the Department of Health and Human Services (DHHS). As summarized in this handy Mintz/ML Strategies timeline of the actions set forth in President Biden’s AI executive order, DHHS has a mandate to “develop a strategy for regulating the use of AI in the drug development process” and a deadline of October 29, 2024 to meet that obligation. Notably, earlier this year DHHS announced a functional reorganization within the department that included creating the position of Chief AI Officer in response to the presidential order.

Read about the AI priorities of both presidential candidates and their likely actions if they take office in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about different health care priorities that may be pursued by the presidential candidates Donald Trump and Kamala Harris in the latest edition of our 2024 Pre-Election Analysis series on how the November 2024 election will impact the legislative and regulatory landscape.

Read about an FTC final rule banning fake reviews and testimonials, which takes effect in October, in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders. An announcement on August 7, 2024 by the Centers for Medicare and Medicaid Services (CMS) of a final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway was therefore a welcome development. However, digging under the surface of the TCET pathway uncovers some less than thrilling details. CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.

Read about key tax policy proposals put forth by presidential candidates  Donald Trump and Kamala Harris and what to expect on Capitol Hill from key leaders on tax policy in the 119th Congress in the latest edition of our 2024 Pre-Election Analysis series on how the November 2024 election will impact the legislative and regulatory landscape.

Read about 10 AI-related bills recently advanced by the Senate Commerce Committee for consideration in the full Senate in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about some of the most pressing cross-border issues that will be tackled by the next administration and 119th Congress in the second edition of our 2024 Pre-Election Analysis series on how the November 2024 election will impact the legislative and regulatory landscape in a variety of areas.

Read about the Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) joint workshop in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about how the outcome of the presidential election could impact energy and sustainability policy in the inaugural edition of our 2024 Pre-Election Analysis series on how the November 2024 election will impact the legislative and regulatory landscape in a variety of areas.