Skip to contentSeptember 1, 2026
Holland & Knight Health Dose: September 1, 2026
A weekly dose of healthcare policy news
Jordan K. Brossi|Sarah Starling Crossan
Looking Ahead
Though the U.S. Senate remains adjourned until mid-September 2026, busy with campaign and re-election activities during the summer recess, the U.S. House of Representatives will return for what could be a quick week of activity centered around passage of the Senate-passed continuing resolution (CR) to fund the government through December 11, 2026. House Speaker Mike Johnson (R-La.) is expected to place the CR on the suspension calendar, allowing the legislation to be passed by the full House by a two-thirds vote. If and when the legislation is passed, the House is expected to adjourn again and allow members to return to their districts.
Upcoming Events
Congress
- House Committee on Ways and Means Subcommittee on Work and Welfare – Welfare Reform at 30: Restoring the Promise of Work and Personal Responsibility in Federal Welfare Programs
September 2, 2026
- House Committee on Veterans’ Affairs – Beyond Go-Live: VA Electronic Health Record Modernization Status Update
- House Committee on Rules – proposed changes for the 120th Congress
Federal Agencies
September 2-3, 2026
- U.S. Health and Human Services (HHS) Office for Civil Rights and National Institute of Standards and Technology – Safeguarding Health Information: Building Assurance through HIPAA Security 2026
September 16-17, 2026
- U.S. Food and Drug Administration (FDA) – public meetings on the Prescription Drug User Fee Act and Generic Drug User Fee Act
September 25, 2026
- FDA’s Center for Devices and Radiological Health – public meeting to discuss how the agency can improve the tools, standards and methodologies used to evaluate breakthrough medical devices and emerging technologies
Administrative Updates
Holland & Knight’s Health AI Navigator
Holland & Knight’s Health 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.
9 Drugmakers Announce Pricing Deals with Administration
President Donald Trump on August 31, 2026, announced drug pricing agreements with nine additional brand and generic drug manufacturers, bringing the total number of pharmaceutical manufacturers with most-favored nation (MFN) deals to 26. As part of the agreements, drug manufacturers will provide state Medicaid programs with access to MFN drug prices on products made by each company. The companies also committed to making varying sizes of investments in the U.S. to bolster domestic production and manufacturing, with several companies also donating active pharmaceutical ingredients to the Strategic Active Pharmaceutical Ingredients Reserve.
Personnel Updates
Dr. Heidi Overton, who currently serves as deputy director of the Domestic Policy Council, has been nominated by President Trump to be commissioner of the FDA. Sen. Bill Cassidy (R-La.), who serves as chair of the Senate Committee on Health, Education, Labor, and Pensions, has expressed concerns with her nomination, given her previous comments and statements regarding vaccines. A hearing on her nomination has not yet been scheduled
Congressional Updates
House Returns for Brief Stint to Tackle CR
The House reconvened on August 31, 2026, for what is expected to be a one-week period to consider and pass a CR to fund the government beyond the current deadline of September 30, 2026. The CR passed in the Senate by a vote of 90-6 on August 8, signaling strong bipartisan support for the legislation, which would extend government funding through December 11, 2026. The CR includes a number of extensions for healthcare programs that would have otherwise expired, including several policies to extend authority for veterans’ healthcare programs. The CR also includes a provision that would temporarily prohibit the U.S. Office of Management and Budget from issuing or finalizing a proposed rule titled “Regulation for Federal Financial Assistance.”
Republicans are likely to also seek progress on several other priorities, including potential action on the Farm Bill, National Defense Authorization Act, as well as the third budget reconciliation package. Though the House passed its version of the Farm Bill earlier this year, the Senate Committee on Agriculture has yet to advance a package from the committee for consideration by the full Senate. Meanwhile, conversations between Republican leadership in the House and Senate continue regarding next steps for the budget reconciliation bill, with some senators – including Sen. Ron Johnson (R-Wis.), who recently assumed the gavel to chair the Senate Committee on the Budget – indicating the House-passed budget resolution doesn’t go far enough to garner savings.
The main focus in both chambers remains the November 2026 elections, which are less than 90 days away
Regulatory Updates: CMS
CMS Announces RAPID Coverage Pathway for Breakthrough Devices
On August 7, 2026, the Centers for Medicare & Medicaid Services (CMS) released a 30-page notice with a comment period outlining the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a proposed framework designed to accelerate Medicare coverage for certain FDA-designated Breakthrough Devices. Under the proposal, CMS would issue a proposed National Coverage Determination on the same day a qualifying device receives FDA market authorization, with final coverage decisions expected approximately 60 days later for Class II devices and 90 days later for Class III devices. CMS describes RAPID as a mechanism to better align FDA review and Medicare coverage processes by leveraging clinical evidence generated during the premarket phase while maintaining existing Medicare coverage standards. The agency developed the proposal following stakeholder feedback on previous accelerated coverage initiatives, including the Medicare Coverage of Innovative Technologies rule and Transitional Coverage for Emerging Technologies pathway.
Regulatory Updates: FDA
FDA Plans to Create Two New Deputy Commissioner Roles Amid Wait for Confirmation Hearing
The FDA is reportedly planning to create two new deputy commissioner roles at the FDA, with one of the new deputy commissioners to cover technology and AI and the second deputy commissioner to oversee drugs. Though no final determinations or formal policy announcement has been made, the two new roles would be a part of broader restructuring efforts at the FDA
FDA Seeks Input on Regulatory Framework for Generative AI-Enabled Medical Devices
The FDA on August 18, 2026, released a discussion paper outlining potential approaches for regulating generative AI-enabled medical devices. The paper seeks stakeholder feedback on risk assessment, pre-market review, post-market monitoring and the use of third-party foundation models. FDA is considering a risk-based framework that would evaluate the function performed by an AI-enabled device and the potential consequences of an incorrect output. Comments are due October 19, 2026
FDA Authorizes First-of-Its-Kind Robotic Blood Draw System
On August 19, 2026, FDA authorized the first autonomous robotic blood draw device through the De Novo pathway. The device uses imaging and software technologies to identify suitable veins, perform venipuncture, collect blood samples and complete the blood draw process under clinician supervision. FDA stated that the authorization is intended to help address challenges associated with one of the most frequently performed medical procedures in the healthcare system and comes amid ongoing shortages of trained phlebotomists.
FDA Expands Digital Health Device Pilot Program
FDA continued expanding participation in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot during August 2026, selecting three additional digital health technologies for the program. The newly selected participants include a remote hypertension management platform, a clinician-supervised AI voice technology designed to support mental healthcare delivery and a digital health tool focused on chronic disease management. TEMPO is intended to evaluate how digital health technologies can be deployed in real-world clinical settings and generate evidence related to patient outcomes while informing FDA’s approach to evaluating and overseeing emerging digital health products.
Other Healthcare Updates
Major Electronic Health Record Vendor Announces New AI Clinical Workflow Tools
A leading electronic health record vendor announced several new AI capabilities in August 2026, including a tool designed to help clinicians prepare for patient visits by generating summaries from information already contained within the patient’s chart. The company also highlighted additional AI-enabled functionality intended to support clinical documentation, patient communications and workflow management within the electronic health record environment
Consumer AI Platform Introduces Personal Health Record Integration
In late July 2026, a leading consumer-facing AI platform launched a feature that allows U.S. users age 18 and older to connect personal health data and supported medical records directly to the platform. Users can receive explanations of laboratory results, compare historical health information, generate health summaries and prepare questions for healthcare visits. The company stated that connected health information will not be used to train its models or for advertising purposes
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.
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