Stacey Gray

for your use

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Check out my blog post on Make-A-Will Month hosted by our friends at CDP!

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Last week’s Supreme Court's decision to overturn the #Chevron doctrine has sent ripples through the regulatory and #policy communities, especially in the world of healthcare, particularly concerning #AI. This landmark ruling limits federal agencies' authority to interpret ambiguous laws, potentially complicating efforts to oversee rapidly evolving technologies like AI, something my colleague Joseph Hoefer and I have been tracking closely. Justice Elena Kagan, in her dissenting opinion, raised alarm bells about the decision's impact on regulating complex fields such as AI, warning that it could hinder Congress's ability to delegate regulatory power to federal agencies effectively. The ruling presents a significant challenge for lawmakers and regulatory bodies like the FDA, which have been working on programs to regulate health AI. These efforts, including draft guidance for AI/ML-enabled device software, may now face new hurdles under the changed legal landscape. Lawmakers are already at a crossroads, needing to decide whether to regulate health AI through existing agencies or create a new body dedicated to AI oversight. The Chevron ruling emphasizes the need for Congress to be more specific and prescriptive in future legislation, potentially delaying much-needed oversight of advancing technologies. The majority opinion, authored by Chief Justice John Roberts, argued that deferring to regulators under Chevron is inconsistent with the Administrative Procedure Act. However, dissenting justices contend that this ruling puts courts at the apex of the administrative process across all subjects, potentially overreaching their intended role. As AI continues to integrate into various aspects of healthcare, the implications of this ruling will likely be felt for years to come. The decision could significantly slow down efforts to establish necessary guardrails for AI in #healthcare, leaving the industry in a state of uncertainty as it grapples with how to ensure responsible development and deployment of these powerful technologies.

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Join Rob Berlin, Lauren Oliva, PharmD, Julie Tai, Jeffrey Siegel and me as we discuss " Challenges in exceeding the quality of existing endpoints and approaches using digital tools" on Tuesday, June 18 (session 223). Lets discuss whether the advantages of using digital tools to develop novel measures can be adequately validated using existing "gold standards" or whether it will dilute their potential. I'll speak about our publication "Incorporating digitally derived endpoints within clinical development programs by leveraging prior work" in #naturedigitalmedicine which builds on #DiME's V3 framework and much more. #patientfocusseddrugdevelopment #digitalhealth #DIAglobal2024

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Here is an example of how administrative agencies can make information about legal cases more accessible to unrepresented litigants: ***EOIR Stakeholder Update*** EOIR today announced it has launched Respondent Access Portal, part of the Access EOIR Initiative. Through a phased enrollment, Respondent Access Portal will allow unrepresented individuals who have cases before EOIR to view their case information, keep informed about hearing schedules, download electronic Records of Proceedings, and file case-related documents. Unrepresented adult noncitizens will receive an official notice from the immigration court. Please see the agency notice for more details. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://lnkd.in/eFiY6ryA Just one example of how to put the White House Legal Aid Interagency Roundtable (LAIR) 2023 report into action. https://lnkd.in/emAB2_a3 #A2J #ATJ #accesstojustice #immigration #humancentereddesign

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Today, the Progressive Policy Institute (PPI) published my report proposing a novel reform of the federal regulatory process. The concept is getting traction having recently been introduced in Congress as H.R.8204, the Regulatory Early Notice and Engagement Act (RENEA), sponsored by Reps. Don Davis (D-NC), Guy Reschenthaler (R-PA), and Tim Burchett (R-TN). If you have an interest in regulation and regulatory reform, please read the report and consider supporting this bipartisan legislation. #regulation #smartregulation #regreform #RENEA #regulatoryearlynotice #cutredtape #regulatoryearlynotice https://lnkd.in/ezg3MtY7

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ACF’s Children’s Bureau has issued a rule providing that federal matching funds will be available to IV-E (child welfare) agencies for costs of independent legal representation to carry out the requirements in the agency’s foster care plan for a child who is in or a candidate for IV-E foster care. Federal funding will also be available to IV-E agencies to provide legal representation for the child's parent(s) or relative caregiver(s), for the child's Indian custodian(s), and when a child's tribe participates or intervenes in a state court proceeding for foster care placement or termination of parental rights of an Indian child who is in or a candidate for IV-E foster care.   Under the rule, when necessary to carry out the requirements of the agency’s IV-E plan for the child, IV-E agencies could access federal funds for legal representation to help families experiencing conditions such as unemployment, inadequate income, unstable housing, evictions or homelessness, food insecurity, unmet health care needs, benefits access and domestic violence. https://lnkd.in/driFS459

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U.S. states are stepping up to regulate AI in the absence of federal legislation. From Colorado's comprehensive consumer protection laws to California's focus on potential discrimination in hiring, this Perkins Coie LLP Update explores the evolving regulatory landscape. #AI #AIregulation #ArtificialIntelligence

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I was honored to testify this morning before the House Energy and Commerce Committee concerning the recent bipartisan, bicameral draft privacy legislation, the American Privacy Rights Act (APRA), and various other privacy and kids-related bills. My main messages were straightforward: 1. APRA presents a renewed opportunity to finish the long overdue job of passing a federal privacy law. The need for such a law is clear, and the explosive emergence of AI has only heightened that need. 2. APRA provides a sound framework built on data minimization, non-discrimination requirements, consumer rights, restrictions on data brokers, and effective enforcement. 3. To be sure, APRA will need refinement, from strengthening the protections for kids to clarifying some of the provisions around advertising. But the release of the draft is encouraging. 4. CDT has long advocated for comprehensive federal privacy legislation, and we look forward to continuing to work with legislators from both parties and other stakeholders to help move APRA through the legislative process and (hopefully!) into law.

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Yesterday, I had an insightful conversation about civil discourse, consensus building, and bridging divisions in the criminal justice policy space. During our discussion, she posed a brilliant question: "What does the collective model look like?" If we want to pivot the criminal justice movement in a new direction—one that brings people together, focuses on similarities more than differences, and finds places of consensus rather than contention—it needs to be done collectively, not individually. So, what can this look like? How can we build a truly collective model that fosters unity and progress in criminal justice policy?

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We live in a social and behavioral world - Evidence-Based policy making needs to be informed by social and behavioral research. here's a road map:

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There is nothing better than using your legal skills to help a voter cast their ballot! Learn more about working in voter protection this year by attending one of these sessions!

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Thrilled to share this pre-print of my latest with Sean Tu & Alex Moss on the case for publicly owned & controlled pharmaceutical R&D (forthcoming in the Journal of Law, Medicine, and Ethics). We argue that "Public Research & Manufacturing Enterprises could transform the US pharmaceutical industry, creating benefits such as: reduced drug prices, increased innovation, fewer shortages, and directing investment towards drugs with significant social benefits.” Our approach would assure public risk yields public reward--unlike our current system of socialized risk and privatized rewards. Read more at: https://lnkd.in/g5zGgCE8

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There's some interesting details in this account of how a network of Christian legal activists laid the groundwork that led to the fall of Roe v. Wade that might be incorporated into the long-standing genre of "what progressives can learn from conservative success." But one thing that I was struck by was authors' claims, made at least twice in the piece (adapted from a soon to be published book), that progressive pro-choice orgs were unaware of the threat the network posed. "After so many decades of taking Roe for granted, supporters of abortion rights had grown dangerously complacent and disorganized in ways that made them slow to appreciate the severity of the threat." This isn't really explained--pro-choice groups aren't the subject of the piece. But in terms of what progressives can learn from the fall of Roe, that charge of complacency and disorganization is one that clearly needs to be interrogated further. https://lnkd.in/ev3gdNim

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Thank you, WFDD Public Radio, for highlighting our most recent #innovation, LANC-LIA! For more than 90% of low-income Americans, getting sufficient legal help for civil disputes can be out of reach. To bridge that justice gap, Legal Aid of North Carolina has launched LIA, an AI-powered Legal Information Assistant. LIA helps guide users to critical legal information and resources, ensuring more people get the help they need. Chief Innovation Officer Scheree Gilchrist emphasizes, "When you’re facing a crisis or have literacy challenges, dense information is really hard to wade through. LIA helps answer simple questions and guides users through their next steps." Read more: https://lnkd.in/gcvxyeJm #LegalAidNC #AccessToJustice #AIforGood #LegalAssistance

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Ep. 171 of the Bipartisan Policy Center's This Week in Immigration podcast is a fascinating discussion between Theresa Cardinal Brown and guest Michael Clemens. Listen to hear about: - Do more legal pathways reduce unlawful border crossings? - How does economic development in low-income countries impact on migration flows? - What is the global cost of migration barriers? - What migration data do we need to make effective policy? #immigration #border #development https://lnkd.in/e7MESVSE

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We had a wonderful opportunity today to host the U.S. Dept of Health and Human Services (HHS), Office of Civil Rights Director Melanie Fontes Rainer, the HHS Region 10 team, and community reproductive health leaders to discuss the newly published HHS rule to support healthcare privacy. https://lnkd.in/gprYVuqV HHS issued this Final Rule after hearing from communities that changes were needed to better protect patient confidentiality and prevent medical records from being used against people for providing or obtaining lawful reproductive health care. Director Fontes Rainer and her team are visiting communities around the country to share information about this rule and the final rule under Section 1557 of the Affordable Care Act. HHS is taking bold action to strengthen protections against discrimination on the basis of race, color, national origin, sex, age, and disability. This rule reduces language access barriers, expands physical and digital accessibility, tackles bias in health technology, and much more. https://lnkd.in/gmNPMW6e

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I've been sharing over the past few weeks reports out of countries from Chile to France to Nigeria and Taiwan on persons in prison voting. To lay the foundation of comparing the United States to other nations in terms of it's disenfranchisement policy. Today, The Sentencing Project, ACLU, and Human Rights Watch released "Out of Step: U.S. Policy on Voting Rights in a Global Perspective". It's a call back to Laleh Ispahani's work from the mid 2000s and builds on it. The report examines the laws of 136 countries around the world with populations of 1.5 million and above, and finds that the majority — 73 of the 136 — never or rarely deny a person’s right to vote because of a criminal conviction. In the other 63 countries, where some laws deny the right to vote in broader sets of circumstances, the United States sits at the top of the restrictive end of the spectrum, disenfranchising a wider swath of people overall. #unlockthevote #votingrights #outofstep See here:

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I often post about both abortion access and maternal health. Wise words from Kenna Titus and Lexi Rummel from the National Women's Law Center reminded me that as we get closer to the election, it’s important that voters and policymakers alike understand how the two are connected. “Let’s call state abortion bans what they are: intentional and direct attacks on maternal health and well-being.” Abortion access IS maternity care. It’s a vital component of healthcare that people who are pregnant rely on for a variety of health and life concerns. As a host of new policies restrict abortion access across the U.S., we’re already seeing a direct impact on *all* maternal health access and outcomes. Many care providers have closed their doors or moved across state lines, leading to a rise in maternity care deserts. This disproportionately impacts those without access to transportation or paid time off work. I’m calling on policymakers and decision makers to expand rather than restrict maternal healthcare in all forms, including abortion. https://lnkd.in/eYznAk8E

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