Public Comments on Proposed Federal Rules
Here's a look at public comments on proposed Federal Register rules
Featured Stories
American Clinical Laboratory Association Submits Feedback to OSTP on Healthcare Regulatory Reform
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WASHINGTON, Nov. 13 -- The American Clinical Laboratory Association (ACLA) has submitted a public comment letter to the Office of Science and Technology Policy (OSTP) concerning regulatory reform on Artificial Intelligence (AI) within healthcare. This correspondence comes in response to the OSTP's request for information, as outlined in the White House's AI Action Plan released on July 23, 2025.
ACLA represents a national network of leading clinical laboratories that deliver critical diagnostic information. The organization underscores the importance of AI in enhancing healthcare delivery and
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WASHINGTON, Nov. 13 -- The American Clinical Laboratory Association (ACLA) has submitted a public comment letter to the Office of Science and Technology Policy (OSTP) concerning regulatory reform on Artificial Intelligence (AI) within healthcare. This correspondence comes in response to the OSTP's request for information, as outlined in the White House's AI Action Plan released on July 23, 2025.
ACLA represents a national network of leading clinical laboratories that deliver critical diagnostic information. The organization underscores the importance of AI in enhancing healthcare delivery andpatient outcomes. They acknowledge the administration's efforts to eliminate regulatory barriers that may hinder the adoption of innovative AI technologies in clinical laboratory settings.
The letter highlights the potential of AI to transform the diagnosis and treatment process by assisting trained healthcare professionals in making more accurate and comprehensive decisions. As clinical laboratories adopt AI tools to analyze large datasets, they aim to improve efficiency and customize patient care. ACLA advocates for the need for flexible regulatory frameworks that can keep pace with rapid advancements in AI technology.
Among the key issues raised in ACLA's letter is the need for federal preemption to prevent a confusing landscape of state regulations. The organization argues that this uniformity is essential for fostering innovation while ensuring compliance across the board. Furthermore, ACLA emphasizes the necessity of clarifying existing privacy regulations that can restrict AI adoption due to concerns over data usage and compliance with the Health Insurance Portability and Accountability Act (HIPAA).
The letter also addresses the approval process for reviewing digital laboratory data remotely without requiring additional certification. ACLA praises existing enforcement discretion but urges the administration to formalize these policies to facilitate ongoing innovation in digital pathology.
Additionally, the letter discusses reimbursement pathways for AI services in healthcare. As governmental programs evaluate how to pay for AI-driven services, ACLA stresses the importance of developing sustainable payment models that reflect not only the value of laboratory services but also the costs associated with emerging technologies. The organization warns against regulatory burdens that could impede the integration of AI in laboratory testing.
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The letter was signed by:
Susan Van Meter
President, ACLA
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Read full text of letter here: https://www.regulations.gov/comment/OSTP-TECH-2025-0067-0297
American Association of Independent Music Urges Office of Science & Technology Policy To Protect Artists Against AI Threats
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WASHINGTON, Nov. 13 -- The American Association of Independent Music (A2IM), New York, has submitted a public comment letter to the White House Office of Science and Technology Policy (OSTP) expressing concerns regarding the ramifications of artificial intelligence on the independent music community. A2IM, a signatory of a joint filing made with the National Music Publishers Association (NMPA) and Recording Industry Association of America (RIAA), underscores the necessity for legal and regulatory reforms to protect intellectual property rights that are crucial for smaller music creators.
As AI
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WASHINGTON, Nov. 13 -- The American Association of Independent Music (A2IM), New York, has submitted a public comment letter to the White House Office of Science and Technology Policy (OSTP) expressing concerns regarding the ramifications of artificial intelligence on the independent music community. A2IM, a signatory of a joint filing made with the National Music Publishers Association (NMPA) and Recording Industry Association of America (RIAA), underscores the necessity for legal and regulatory reforms to protect intellectual property rights that are crucial for smaller music creators.
As AItechnologies promise advancements in creativity and efficiency, A2IM emphasizes that unregulated AI development risks undermining copyright protections and artistic integrity. Independent musicians often lack the resources to combat copyright infringements, and the emergence of AI-generated content poses a new threat to their creative work. Transparency and fair licensing practices are vital for these artists to compete in an evolving digital landscape.
A2IM urges the agency to carefully evaluate AI systems, their underlying data, and the resultant content. Their submission highlights the need for AI standards that prioritize the interests of all stakeholders, not just developers, and promote ethical use alongside innovation. The unauthorized utilization of artists' names, images, or voices by AI systems creates an environment fraught with unfair practices that could erode both intellectual property rights and artists' personal data interests, thus calling for coordinated federal action to restore equity for creators.
Moreover, A2IM points out a troubling trend where many AI companies do not disclose the creative works used for training their models, leaving artists vulnerable when their materials are used without consent. They advocate for a regulatory framework mandating clear, meaningful transparency that would allow creators to verify if their works were implicated in these processes.
The organization also criticizes existing opt-out mechanisms provided by some AI platforms. A2IM argues that these often convoluted systems shift the burden of enforcement onto creators, allowing for unchecked use of copyrighted materials. Instead, they propose a streamlined opt-in licensing framework that empowers independent artists and ensures participation from small and mid-sized music companies.
The A2IM letter underscores the importance of collective bargaining protections, urging the administration to look to models like the Protect Working Musicians Act to safeguard independent musicians' rights amid the burgeoning intersection of AI and creativity. In conclusion, A2IM calls for regulatory measures that will not only protect independent music creators but also encourage a thriving environment where creativity and innovation can coexist.
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The letter was signed by:
Dr. Richard James Burgess
President and CEO
American Association of Independent Music (A2IM)
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Read full text of letter here: https://www.regulations.gov/comment/OSTP-TECH-2025-0067-0260
AI Progress Urges OSTP to Maintain Copyright Flexibility for AI Development
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WASHINGTON, Nov. 13 -- AI Progress, an organization dedicated to advancing the responsible development of artificial intelligence (AI), has submitted a public comment letter to the Office of Science and Technology Policy (OSTP) advocating for the preservation of existing copyright law and its fair use doctrine in light of the growing need for AI innovation. The organization, which includes major tech companies such as Amazon, Google, and Microsoft among its members, highlights that current federal regulations and administrative practices could hinder the development and adoption of AI technologies.
In
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WASHINGTON, Nov. 13 -- AI Progress, an organization dedicated to advancing the responsible development of artificial intelligence (AI), has submitted a public comment letter to the Office of Science and Technology Policy (OSTP) advocating for the preservation of existing copyright law and its fair use doctrine in light of the growing need for AI innovation. The organization, which includes major tech companies such as Amazon, Google, and Microsoft among its members, highlights that current federal regulations and administrative practices could hinder the development and adoption of AI technologies.
Inthe letter, AI Progress emphasizes the vital role that U.S. copyright law plays in fostering creativity and protecting intellectual property rights, which are crucial for maintaining America's competitive edge in the global AI landscape. The coalition calls for policymakers to ensure that the flexibility of copyright law remains intact, particularly concerning the training of AI models on copyrighted works, which it asserts is a fair use under existing legal interpretations.
AI Progress points to recent court rulings from the U.S. District Court for the Northern District of California that affirm AI training on copyrighted materials can be transformative and thus permissible. The organization urges the agency to resist both federal and state legislative measures that could undermine this legal principle and deter technological growth. Members of AI Progress argue that such misguided proposals often arise from a fundamental misunderstanding of how AI systems operate, particularly in their data training processes.
The organization warns that limiting access to training data would create barriers to innovation, making it challenging for startups and small businesses to compete. It emphasizes the importance of fostering an environment conducive to AI advancements that can lead to significant economic growth and employment opportunities across various sectors.
In outlining the potential positive impacts of AI, AI Progress references estimates that suggest the technology could boost the U.S. GDP substantially by 2038 and contribute to job creation in various fields, including healthcare and technology. The coalition highlights that AI is already yielding breakthroughs in several domains, from scientific discoveries to cybersecurity advancements.
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Read full text of letter here: https://www.regulations.gov/comment/OSTP-TECH-2025-0067-0435
ACOG, Society for Maternal-Fetal Medicine, Society of Family Planning Urge FDA to Reject Citizen Petition on Mifepristone
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WASHINGTON, Nov. 13 -- The American College of Obstetricians and Gynecologists (ACOG), Society for Maternal-Fetal Medicine, and Society of Family Planning, Denver, Colorado, has filed a public comment letter opposing citizen petition FDA-2025-P-3288-0001 concerning the regulation of mifepristone by the Food and Drug Administration (FDA). In their correspondence, they request the agency to reject the citizen petition in its entirety while calling for an expansion of mifepristone's labeling to include a miscarriage indication and the removal of the Risk Evaluation and Mitigation Strategy (REMS) for
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WASHINGTON, Nov. 13 -- The American College of Obstetricians and Gynecologists (ACOG), Society for Maternal-Fetal Medicine, and Society of Family Planning, Denver, Colorado, has filed a public comment letter opposing citizen petition FDA-2025-P-3288-0001 concerning the regulation of mifepristone by the Food and Drug Administration (FDA). In their correspondence, they request the agency to reject the citizen petition in its entirety while calling for an expansion of mifepristone's labeling to include a miscarriage indication and the removal of the Risk Evaluation and Mitigation Strategy (REMS) forthe drug.
The commenters argue that mifepristone is an integral component of effective miscarriage management and emphasize the need for any pending applications to modify its labeling accordingly. They contend that adding a miscarriage indication would align with evidence supporting mifepristone's safety and effectiveness in this context, thereby enhancing access to essential care for individuals experiencing miscarriages.
Furthermore, the letter highlights that scientific evidence does not support the continued enforcement of the REMS and its associated Elements to Assure Safe Use (ETASU). According to the organizations, these restrictions are unnecessary, hinder patient access, and fail to meet federally mandated justifications for such limitations. They assert that instead of introducing additional restrictions as suggested by the petition, the agency should take steps to ease current regulations.
The letter details a history of past petitions regarding mifepristone, with various organizations previously advocating for decreased restrictions based on substantial research. Emphasizing the substantial body of scientific support for their position, the commenters argue that existing regulations do not reflect the available medical evidence or the needs of patients requiring mifepristone.
With a clear call to action, the organizations urge the FDA to deny the citizen petition completely, arguing that it would only serve to reinforce barriers for patients needing this crucial medication. By addressing the existing regulatory framework around mifepristone, they hope to improve access to care and support better reproductive health outcomes. The ongoing discourse around mifepristone regulations is part of a broader conversation within the medical community about the importance of ensuring that patient care remains a priority in regulatory decision-making.
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The letter was signed by:
Sandra E. Brooks, MD, MBA, FACOG
American College of Obstetricians and Gynecologists
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Amanda Dennis, DrPH, MBE
Society of Family Planning
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Sindhu K. Srinivas, MD, MSCE
Society for Maternal-Fetal Medicine
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Read full text of letter here: https://www.regulations.gov/comment/FDA-2025-P-3288-0055
ACOG, Society for Maternal-Fetal Medicine, Society of Family Planning Push FDA to Scrap Mifepristone REMS Program
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WASHINGTON, Nov. 13 -- The American College of Obstetricians and Gynecologists (ACOG), Society for Maternal-Fetal Medicine, and Society of Family Planning, Denver, Colorado, have submitted a public comment letter to the Food and Drug Administration urging the agency to reconsider its regulation of mifepristone. The organizations supplement their prior citizen petition to remove the Mifepristone Shared System Risk Evaluation and Mitigation Strategy Program. They call for the agency to refrain from imposing burdens that might adversely affect access to the medication for patients.
In their letter,
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WASHINGTON, Nov. 13 -- The American College of Obstetricians and Gynecologists (ACOG), Society for Maternal-Fetal Medicine, and Society of Family Planning, Denver, Colorado, have submitted a public comment letter to the Food and Drug Administration urging the agency to reconsider its regulation of mifepristone. The organizations supplement their prior citizen petition to remove the Mifepristone Shared System Risk Evaluation and Mitigation Strategy Program. They call for the agency to refrain from imposing burdens that might adversely affect access to the medication for patients.
In their letter,the medical organizations emphasize the importance of conducting an open and transparent review process regarding mifepristone's safety and efficacy. They remind the agency of its legal obligation to consider all available evidence, including pending citizen petitions, which collectively affirm the drug's established safety profile. The petitioners reference decades of research highlighting mifepristone's effectiveness, noting its safety record over more than 7.5 million uses.
Furthermore, they argue that claims made by groups opposed to mifepristone's use are lacking scientific support, often relying on flawed publications. The organizations request that the FDA reject these claims and instead base regulatory decisions on sound, scientific evidence that reflects mifepristone's proven safety and utility in public health.
The letter also highlights the absence of credible evidence supporting assertions that mifepristone poses environmental risks. The petitioners point to previous FDA analyses that concluded the medication's exposure levels are negligible and do not threaten ecological systems or water supplies. They assert that concerns raised by opponents seem to represent an ulterior motive aimed at increasing restrictions on reproductive health access.
In addition to advocating for the removal of specific restrictions related to mifepristone, the organizations call on the FDA to allow for stakeholders with medical expertise to contribute to the review process. They believe this would enhance the decision-making transparency that is vital for public trust in health regulations.
The petitioners firmly oppose any measures that would suspend or withdraw mifepristone's approval, labeling such actions as illegal without substantial evidence of safety issues. Their stance is a response to new petitions aimed at challenging the medication's approval, as they call for adherence to established scientific standards.
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The letter was signed by:
Sandra E. Brooks, MD, MBA, FACOG
American College of Obstetricians and Gynecologists
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Amanda Dennis, DrPH, MBE
Society of Family Planning
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Sindhu K. Srinivas, MD, MSCE
Society for Maternal-Fetal Medicine
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Read full text of letter here: https://www.regulations.gov/comment/FDA-2025-P-0377-0250
Abridge AI Submits Comment on Regulatory Reform to Facilitate AI in Healthcare
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WASHINGTON, Nov. 13 -- Abridge AI Inc., San Francisco, California, has submitted a public comment letter to the Office of Science and Technology Policy (OSTP) regarding the agency's Request for Information (RFI) on regulatory reform for artificial intelligence (AI). The organization highlights the importance of clear regulatory guidelines to facilitate the development and integration of AI technologies in healthcare, aiming to enhance patient outcomes and streamline clinician workflows.
Founded in 2018, Abridge is dedicated to transforming healthcare interactions through AI, embedding its technology
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WASHINGTON, Nov. 13 -- Abridge AI Inc., San Francisco, California, has submitted a public comment letter to the Office of Science and Technology Policy (OSTP) regarding the agency's Request for Information (RFI) on regulatory reform for artificial intelligence (AI). The organization highlights the importance of clear regulatory guidelines to facilitate the development and integration of AI technologies in healthcare, aiming to enhance patient outcomes and streamline clinician workflows.
Founded in 2018, Abridge is dedicated to transforming healthcare interactions through AI, embedding its technologydirectly within electronic health records. The company's platform converts patient-clinician conversations into structured clinical notes in real-time, thereby reducing the administrative burden on healthcare professionals and improving the overall patient experience.
In the letter, Abridge emphasizes the need for the agency to address areas of ambiguity within existing regulatory frameworks that govern the use of AI in clinical support. This clarity is viewed as essential to unlocking the potential benefits of AI in reducing the workload on physicians and fostering better relationships with patients. Abridge expresses eagerness to collaborate with the OSTP and the wider Administration to navigate the identified challenges and advance healthcare innovation.
Specifically, Abridge points to the need for enhanced clarification on de-identification standards for voice and text data under the Health Insurance Portability and Accountability Act (HIPAA). The organization argues that clearer guidelines would provide assurance and a reliable framework for companies developing AI technologies. Currently, Abridge operates under stringent data security protocols and does not retain any protected health information.
The company notes that as AI becomes more integral in healthcare, it is crucial for data privacy frameworks to evolve in step with technological advancements. In response to the changing landscape, Abridge proposes that HHS consider pilot programs to enable ongoing AI model development while ensuring compliance with data privacy mandates.
Abridge also advocates for OSTP to spearhead cross-agency guidance on acceptable de-identification practices for various forms of data, including audio and text. This would promote uniformity in regulatory interpretation and enforcement among healthcare entities.
Further, Abridge suggests the establishment of federal standards for trustworthy AI in healthcare documentation that balance technical and ethical considerations, such as encryption and transparency. By fostering collaboration across various sectors, Abridge believes the agency can enhance innovation while prioritizing the protection of patient trust and data privacy.
Abridge concludes by commending OSTP's efforts in crafting a regulatory environment that nurtures the responsible deployment of AI technologies and expresses its willingness to engage further with federal agencies on these vital issues.
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Read full text of letter here: https://www.regulations.gov/comment/OSTP-TECH-2025-0067-0217
4 Creator Organizations Urge Federal Agency to Establish Fair AI Regulations
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WASHINGTON, Nov. 13 -- Four creator organizations submitted a public comment letter to the Office of Science and Technology Policy (OSTP) addressing regulatory reform on artificial intelligence. The organizations stressed the necessity of protecting creative rights while embracing the potential of AI, highlighting the importance of sustainable innovation within the music industry.
The letter, delivered in response to a Request for Information issued by the OSTP, reflects the concerns of the aligned Creator Organizations regarding the implications of AI on artistic creation. They argue that high-quality
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WASHINGTON, Nov. 13 -- Four creator organizations submitted a public comment letter to the Office of Science and Technology Policy (OSTP) addressing regulatory reform on artificial intelligence. The organizations stressed the necessity of protecting creative rights while embracing the potential of AI, highlighting the importance of sustainable innovation within the music industry.
The letter, delivered in response to a Request for Information issued by the OSTP, reflects the concerns of the aligned Creator Organizations regarding the implications of AI on artistic creation. They argue that high-qualitydata derived from musical works should be handled carefully to maintain the incentives that drive creativity and artistic progress. The coalition emphasized that AI technologies must engage with creative works responsibly, citing that unauthorized use of copyrighted material jeopardizes the foundation of both the artistic sector and the burgeoning AI industry.
In their remarks, the groups called for government initiatives that foster lawful licensing agreements between artists and AI firms. They envision a cooperative environment where both sectors can flourish through equitable partnerships, which would ultimately benefit original creators and support technological advancements.
The letter pointed out that the U.S. Constitution recognizes the importance of copyright in promoting science and the arts. They cautioned against poorly defined exceptions to copyright law, which could disrupt fair market practices and disadvantage compliant companies in favor of those that exploit copyright loopholes.
The collective noted that opt-out mechanisms are an ineffective remedy for protecting creators' works, placing undue burdens on artists who often lack the means to monitor AI systems for unauthorized use. They argued for transparency requirements that mandate AI companies disclose the specific content used in training their models, thereby fostering a fair environment where ethical practices thrive.
Their appeal posits that a healthy AI landscape should not compromise human creativity. The organizations expressed their readiness to collaborate with policymakers and AI developers to create a balanced framework that honors copyright protections while promoting innovation.
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The letter was signed by:
Songwriters of North America
Music Artists Coalition
Black Music Action Coalition
Artist Rights Alliance
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Read full text of letter here: https://www.regulations.gov/comment/OSTP-TECH-2025-0067-0460
