ML Strategies

The central tradeoff between a service’s affordability and the user’s right to privacy has been debated for the better part of two decades. The quickest jolt to the regulatory landscape may come via Federal Trade Commission (“FTC” or the “Commission”) enforcement. On August 11, the FTC issued an Advanced Notice of Proposed Rulemaking (“ANPR” or the “Notice”), asking the public to weigh in on whether new regulation is required to protect consumers and crackdown on “commercial surveillance.”

The next three weeks will be full of activity in Washington D.C., as the House of Representatives and Senate are working to push their legislative agendas to garner support from their constituents ahead of an August recess and before political “silly season” officially kicks in ahead of the upcoming mid-term elections in November. Here’s our latest update on what you can expect in Congress during the July work period.

In this post, the Mintz team breaks down the elements within the “American Data Privacy and Protection Act” (ADPPA) bill draft. Released to the public on Friday, June 3, this comprehensive bill touches on all facets of the privacy debate that has been ongoing in Congress for well over 20 years. 

It does not look as though Massachusetts will be state number 6 to enact a comprehensive data privacy law – or at least not the one that people have been talking about.  The Massachusetts Joint Committee on Health Care Financing has voted to send House Bill 4514, An Act Establishing the Massachusetts Information Security and Privacy Act to “study.”  This action by the influential legislative committee signals that this particular bill is not likely to advance during the current legislative session which concludes at the end of the calendar year.

Read about energy legislation and energy policy news, including President Biden’s FY 2023 request for $48.2 billion for the DOE, the Senate Climate Change Task Force’s proposal for energy independence, and the EPA’s Clean Air in Buildings Challenge.

On February 2, 2022, the Massachusetts Legislature’s Joint Committee on Advanced Information Technology, the Internet and Cybersecurity released a new draft of a bill designed to provide mechanisms for how personal information is used and to control how companies use such information.  This 65-page bill, known as the “Massachusetts Information Privacy and Security Act” or “MIPSA”, would be the first major piece of legislation related to data privacy passed since the Legislature updated the data breach legislation in 2019.

Today, Governor Charlie Baker released his Fiscal Year 2023 (FY2023) budget recommendations.  This is the unofficial start of “budget season” in Massachusetts that will culminate with a legislative conference committee agreeing on a budget bill sometime around late June or early July.

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.

On December 22, 2021, FDA took another step in rolling back enforcement policies implemented in response to the COVID-19 pandemic by publishing guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic once the Public Health Emergency for COVID-19 ends. The Transition Plan Guidances will help device manufacturers prepare for the end of the PHE and continue to commercialize devices necessary for the long-term response to COVID-19.

Over the past year, the demand for health care via telehealth has continued to skyrocket as a result of the COVID-19 pandemic and the public’s increased comfort with obtaining health care goods and services virtually. Join Ellen Janos, Karen Lovitch, Kate Stewart and Alex Hecht as they demystify the current status of laws and regulations, untangle the web of legislation before Congress related to the expansion of telehealth services, discuss recent enforcement activity, and look ahead to trends we see on the horizon.  

Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.

Read about the U.S. House Ways and Means Committee’s proposed tax legislation intended to partially fund the $3.5 trillion Build Back Better Act to fund Democratic priorities.