Holland & Knight Health Dose: July 28, 2026

Looking Ahead

The U.S. House of Representatives departed for the summer recess on July 23, 2026, and will return on August 31, 2026. Prior to departing, the House advanced its version of the National Defense Authorization Act, as well as a continuing resolution to fund the government through December 4, 2026, and a budget resolution to provide $95 billion in funding for defense activities. The U.S. Senate is expected to remain in session through August 7, 2026, before departing for its summer recess, focusing on appropriations and potentially advancing legislation recently passed by the House related to government funding.

Upcoming Events

U.S. Congress

July 29, 2026

• The Senate Committee on Homeland Security and Governmental Affairs will hold a hearing to receive testimony from Dr. Anthony Fauci, former director of the National Institutes of Health (NIH) National Institute of Allergy Infectious Diseases.
• The Senate Select Committee on Aging will hold a hearing titled "The AI Deception Machine: Deepfakes, Chatbots, and the New Frontier of Senior Fraud."

July 30, 2026

• The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold an executive session to consider the nomination of Sean Kaufman to be Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services (HHS). In addition, the committee will consider several education-focused bills and the Health Information Privacy Reform Act (S. 3097).

Administrative Updates

Holland & Knight's Health AI Navigator

Holland & Knight's Health Artificial Intelligence (AI) Navigator is a centralized, interactive resource designed to help healthcare stakeholders track and interpret the rapidly evolving legal and regulatory landscape for artificial intelligence (AI) in healthcare. It provides regularly updated summaries of federal and state legislative, regulatory and executive activity, including developments from Congress, HHS and the White House. The Navigator also features an interactive state map and curated analysis to support compliance and policy insights.

Executive Order Updates

The Trump Administration has continued to release wide-ranging executive orders (EOs). For the latest updates, see our "Trump's Second-Term Executive Orders (2025-2026)" tracking chart.

• In a social media post on July 22, 2026, President Donald Trump raised the possibility of new tariffs on imported generic drugs, writing that the 100 percent tariffs on generic drugs imported into the U.S. would begin August 1, 2028, rising to 200 percent tariffs the following year. A penalty would be assessed on "companies that decide not to build Plant and Equipment within the stated period of time," with no further justification added or clarity on whether the tariffs would apply only to finished dosage forms or ingredients used to manufacture the drugs. Though the post led to immediate reactions from stakeholders within the generic and brand drug industry, there has not yet been a subsequent official executive action issued by President Trump to implement the policies.

Personnel Updates

• The Senate Committee on Indian Affairs on July 22, 2026, advanced by a vote of 8-2 the nomination of Mark Cruz to lead the Indian Health Service. His nomination will next be considered by the full Senate.

Congressional Updates

Sen. Warner Releases AI Framework

Sen. Mark Warner (D-Va.) released a comprehensive AI policy framework on July 21, 2026, alongside a package of legislative proposals focused on emerging AI technologies. The framework seeks to balance continued innovation with safeguards addressing AI-related risks, spanning issues such as consumer protection, national security, workforce impacts and infrastructure.

The accompanying legislative package includes the AI AGENT Act, which would establish requirements for consumer-facing AI agents related to privacy, cybersecurity, interoperability and transparency, as well as the Secure Artificial Intelligence Development Act of 2026, which would create security standards and voluntary safety reporting mechanisms for advanced AI models. Other proposals address workforce transition and training, data center oversight, AI-enabled fraud and broader economic impacts.

Though the framework is not specific to healthcare, it provides insight into how some lawmakers are approaching AI governance and highlights several policy areas that could shape future federal discussions around AI oversight. As Congress continues to examine AI policy, elements of the framework may have implications for digital health companies and other developers deploying AI-enabled technologies.

Senate HELP Committee Advances Healthcare Legislation to Senate Floor

The Senate HELP Committee on July 22, 2026, advanced several healthcare-related bills to the Senate floor for consideration. The committee advanced legislation to expand patient access to biosimilars, require country-of-origin disclosures on prescription drug labels and enhance transparency related to compounding pharmacies, incorporating changes made through a manager's amendment.

Regulatory Updates: HHS

Updates to Genesis Mission Address Chronic Disease

The HHS announced on July 22, 2026, new efforts to support the Genesis Mission, an initiative focused on applying AI to accelerate biomedical research and development, particularly as it relates to new treatments for chronic disease. The NIH, U.S. Food and Drug Administration (FDA) and Advanced Research Projects Agency for Health will contribute to the NIH-led "Bio Genesis Mission" to modernize biomedical research. HHS will also launch research challenges focused on pediatric cancer, as well as drug discovery and development.

In tandem with the new efforts, Office of Science and Technology Policy Director Michael Kratsios issued a report titled "Science: A New Golden Age," detailing four main pillars for action: revitalizing the science and technology enterprise in the U.S., securing U.S. dominance in critical and emerging technologies, launching a new "golden age" powered by "AI for science" initiatives, and ensuring that science and technology improve the lives of all Americans. A specific directive included in the report notes that within 100 days, "the head of each agency with $3 billion or more in FY 2026 budget authority for R&D shall submit to the Assistant to the President for Science and Technology (APST) and Director of the Office of Management and Budget (OMB Director) an action plan describing how the agency intends to implement the program implementation guidance set forth in the 'R&D Priority Practices' section of this memorandum."

HHS OCR Issues Final Rule to Rescind Regulations Implementing Title VI of the Civil Rights Act

The HHS Office of Civil Rights (OCR) issued a final rule on July 23, 2026, to amend its regulations implementing Title VI of the Civil Rights Act to remove provisions that "impose or exemplify liability based on disparate impact." Title VI of the Civil Rights Act prohibits discrimination based on race, color or national origin in programs or activities that receive federal funding. HHS writes in the proposed rule that disparate impact liability "encourages and, in some cases, requires funding recipients to engage in the intentional use of race and racial balancing to eliminate those disparate outcomes by treating certain racial groups different from others." The final rule follows an EO from April 23, 2025, titled "Restoring Equality of Opportunity and Meritocracy," which directed agencies to eliminate the use of disparate-impact liability to the maximum degree possible. The final rule is effective as of July 24, 2026.

Regulatory Updates: CMS

CMS Issues Proposed Provider Tax Rule

The Centers for Medicare & Medicaid Services (CMS) on July 21, 2026, issued a proposed rule titled "Medicaid Program; Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes." The proposed rule would implement provisions from the One Big Beautiful Bill Act to establish new indirect hold-harmless thresholds for healthcare-related taxes. In the proposed rule, CMS invites comments on several definitions, including "expansion state," "net patient revenue" and "non-expansion state," including whether there are other terms that should be included in the regulatory definitions. The proposed rule also seeks to address through the rulemaking scenarios where states imposed taxes on health insurers, which brought to light an "identification of numerous taxes on health insurers that may not have previously been evaluated."

CMS cites this as the rationale for proposing to expand the permissible class list to include a class for health insurers to provide clarity on the treatment of taxes. CMS seeks comment on the scope of the proposed permissible class. Other proposed changes include defining a tax "enacted" if a state or locality completed the legislative process necessary to authorize the tax by July 4, 2025, defining a tax "imposed" as one in effect on July 4, 2025, or earlier, and any approved waiver effective by or earlier than July 4, 2025. The CMS Office of the Actuary estimates that this rule will reduce federal government expenditures by $246 billion from 2026 to 2035. The proposed rule supports the Trump Administration's priorities to promote financial integrity in the Medicaid program. Stakeholders have until September 21, 2026, to submit comments.

Regulatory Updates: FDA

FDA Announces Digital Health Funding Opportunity

The FDA announced a new funding opportunity on July 20, 2026, to support research on the use of digital health technologies (DHTs) in clinical investigations for drugs and biologics. The initiative seeks projects that evaluate technologies such as wearable and contactless sensors, actigraphy, photography and other remote monitoring tools that can collect clinical trial data directly from patients outside traditional research settings. FDA notes that DHTs have the potential to enable continuous or more frequent measurement of clinical outcomes, capture novel health data that may not be observed during in-person visits and support decentralized clinical trial models through remote data collection. The agency is encouraging collaboration among academic researchers, biopharmaceutical companies, patient organizations and other stakeholders to advance the use of DHTs in drug development, particularly for identifying early manifestations of chronic disease, improving outcome assessment in underserved patient populations and reducing participation burdens through remote monitoring. Applications are due by August 20, 2026.

FDA Releases Rules Phasing Out Use of Certain Petroleum-Based Color Additives

The FDA released one proposed rule and order, along with a final amendment and order, on July 22, 2026, to revoke the use of certain color additives. The proposed rule and proposed order to revoke use of Citrus Red No. 2 would apply to use of the coloring on the skins of mature oranges, which the FDA states appears to no longer be used, making the color additive regulation "outdated and unnecessary." Comments are due by August 22, 2026. The final amendment and order repeals the use of Orange B on casings or surfaces of frankfurters and sausages, with the FDA's rationale being that Orange B use has been abandoned making the regulation outdated and unnecessary. Comments are due by September 6, 2026.

FDA TEMPO Announcement

The FDA announced on July 22, 2026, that a glucose management vendor has been selected as the first participant in the agency's Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The pilot is intended to help patients and providers monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI-enabled insights to support chronic disease management. The pilot is designed to evaluate how digital health technologies can be deployed in real-world clinical settings while generating evidence on their impact on patient outcomes. By design, the initiative is being conducted in coordination with CMS' Innovation Center and its Advancing Chronic Care with Effective, Scalable Solutions Model.

FDA Advisory Committee Allows Compounding Pharmacy Production of Certain Peptides

The FDA Pharmacy Compounding Advisory Committee voted on July 23, 2026, to add certain peptides to the list of substances that compounding pharmacies can produce. Members of the advisory committee voted in favor of allowing compounding pharmacies to produce a limited number of peptide substances – against the recommendations of some FDA scientists who shared concerns regarding dosing data and prescribing practices. Though the FDA is not required to adopt the committee's recommendations, the votes signal continued attention on peptides, as well as varying perspectives of the "Make America Healthy Again" agenda that supported increasing access to peptide substances.

Other Healthcare Regulatory Updates

DOL Releases Electronic Disclosure Proposed Rule

The U.S. Department of Labor's (DOL) Employee Benefits Security Administration on July 22, 2026, issued a proposed rule to allow health plan administrators to provide participants and beneficiaries digital copies of mandatory disclosures related to employer-provided health plans. The proposed rule provides a new safe harbor to group health plan administrators who may choose to rely on electronic media such as e-mail addresses or phone numbers for the distribution of certain mandatory disclosures. The proposed rule does not remove other existing options for disclosure and is instead expanding the disclosure methods. Electronic media can be used to provide any document or information that the administrator is required to furnish to participants and beneficiaries, such as notices required by the Employee Retirement Income Security Act of 1974 and plan documents. Comments are due by September 21, 2026.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.