Regulatory uncertainty. Revenue pressure. Technology decisions. These three trends for 2026 point to outside forces squeezing clinical laboratory managers, but optimists are hoping for at least a sprinkling of relief.
Medical laboratories should expect continued murkiness from the administration of President Donald Trump over how his anti-regulatory stance will affect labs. Clinical lab advocates are also lobbying Congress to pass a reform bill that could save them billions in Medicare reimbursement dollars—all while the threat of Medicaid cuts looms in the coming years.
Artificial intelligence (AI) will produce more use cases in clinical lab settings, particularly in reimbursement activities. As the technology expands, the protection of patient data involved in AI algorithms will become a growing concern. Meanwhile, eyes will be on how AI integrates into the digital pathology market, which will continue its sluggish path to wider adoption in 2026.
Let’s look in further detail at these shifts:
Regulation: New bill aims at cuts to Medicare reimbursement
Among the biggest clinical labs trends for 2026 will be the effect of regulations. Diagnostic labs have experienced a swell of regulatory activity since 2024.
In September, a bill was filed on behalf of the medical lab industry called the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act. The proposal calls for reforming the Protecting Access to Medicare Act of 2014 (PAMA).
Among its provisions, PAMA has annual reductions in the Medicare reimbursement rate for hundreds of common lab tests. Early cuts were devastating to labs, but more recent cuts have been averted due to temporary moves by Congress. However, the next round of up to 15 percent decreases will come on January 1, 2026, unless something changes. Should those cuts occur, many labs will experience serious reductions in Medicare reimbursement.
The RESULTS Act, if passed, will cap annual cuts at five percent permanently and change how the government collects data on reimbursement rates. The lab industry is in strong support of the bill.
“We are hopeful the RESULTS Act will gain traction in Congress,” A. Joe Saad, MD, CPE, FCAP, a member of the board of governors at the College of American Pathologists (CAP), said in a brief interview. “It has bipartisan support and reflects a growing recognition of the essential role laboratories play in patient care.”
Trump’s anti-regulatory stance has left mixed messages for clinical labs since his second term started. Labs were generally relieved when the Food and Drug Administration (FDA) declined to appeal a federal court ruling that vacated an agency regulation on laboratory-developed tests.
On the other hand, lab industry associations were caught off guard when the Trump administration disbanded the longstanding Clinical Laboratory Improvement Advisory Committee, which counseled federal health officials about diagnostic lab matters. Many lab advocates are now unclear about how their voices will be heard at the federal level.
Most expect Trump to cull more regulations, oversight bodies, and potentially divisions of agencies. The Washington Post reported in July that the Department of Government Efficiency (DOGE) had circulated a slide deck discussing how to use AI to identify and reduce federal regulations by 50 percent. Should that occur in 2026, it’s reasonable to speculate that the industry would see significant compliance changes.
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Revenue: Medicaid cuts and tariffs could trickle down to labs
Clinical labs are also facing wider financial concerns in health care beyond PAMA. Trump’s “One Big Beautiful Bill,” which he signed into law in July, is expected to cut between $880 billion and $1 trillion from the Medicaid program over the next decade. Those cuts will result in fewer Medicaid recipients and changes to cost-sharing for individuals.
“If a lab has significant Medicaid revenues, it could start to feel the crunch if a meaningful portion of its patient population loses coverage and becomes uninsured,” Mike Ryan, a partner at law firm McDermott Will & Emery, told The Dark Report, a sibling brand to Lab Manager.
Clinical labs serving areas with poorer populations may take the brunt of this eventual hit.
Meanwhile, the continuing trade war between the US and other countries has resulted in healthcare organizations absorbing higher costs caused by tariffs. Lab Manager has chronicled tariff repercussions, such as increased costs for personal protective equipment and diagnostic test kits.
Becton Dickinson, one of the world’s largest in vitro diagnostics companies supplying clinical labs, noted tariff strain during an earnings call in August. “The landscape remains fluid, but based on policies in place today, we currently anticipate a full year 2026 tariff impact of around $275 million,” said chief financial officer Christopher DelOrefice.
AI: Interaction with HIPAA privacy rules will grow in importance
It will not come as a surprise to see AI listed among the top clinical lab trends for 2026. The real debate is exactly how much influence the technology will wield, given its rapid evolution.
For example, AI’s use in revenue cycle management activities, such as prior authorization for tests and insurance claims submissions, can help labs flag concerns before they reach a commercial payer. But labs should be careful to properly find the best return on investment when picking duties for AI to integrate with.
An AI aspect unique to the healthcare industry that labs need to monitor is how well algorithms steer clear of HIPAA privacy violations. If labs are not already doing so, a good New Year’s resolution would be to consistently review HIPAA compliance with AI tools. The nature of technology is that it continues to learn from new data, healthcare attorney Charles Dunham IV said during an interview at the 2025 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, a partner event of Lab Manager.
“That data must be obtained, utilized, shared, and secured in accordance with HIPAA and in accordance with state privacy laws,” Dunham said.
Digital pathology: Market and money remain fluid
Digital pathology and whole-slide imaging have long been touted as a pivotal change that clinical laboratories need to make. Yet adoption of the technology has been slower than anticipated, largely to due to costs.
As payer reimbursement of digital pathology claims slowly increases, it may become easier for labs to justify the tens to hundreds of thousands of dollars they must spend on scanners and software if they want to move forward with digital pathology.
Europe is ahead of the US with adoption, which may portend more favorable conditions in America for whole-slide imaging in 2026, particularly at labs in academic medical centers.
The niche market of AI in digital pathology is ripe for consolidation. Several years back, investors started pouring money into AI startups that crunch data within whole-slide imaging software. But the slow adoption by labs stymied the startups, and some of those nascent companies are running out of cash and other support. Witness the August acquisition of AI company Paige by healthcare technology firm Tempus. In five rounds of funding since 2017, Paige raised $220 million, yet the acquisition cost Tempus $81 million. It was clear that Paige’s AI software was not the prime target, but rather Paige’s data. “The acquisition allows Tempus to grow its dataset, expand its experienced technical team, and establish a strong footprint in digital pathology with an industry-leading technology portfolio,” Tempus stated in a press release. Similar AI digital pathology deals may bubble up in 2026 as the niche market adjusts.
Decisions loom for clinical labs in 2026
As we wrap up this review of clinical lab trends for 2026, medical laboratory managers have two prevailing decisions facing them in the new year:
- How can they absorb added costs and federal cuts to keep lab operations intact? In some respects, 2026 looks gloomy for clinical labs due to financial concerns.
- Does a new investment in technology, such as digital pathology or AI, make sense in the long run? As more use cases for digital pathology and AI receive publicity, it may be easier for lab managers to approach executives about operational investments supported by practical baseline assumptions.
Clinical labs will not have it easy in 2026. But there are at least slivers of hope in the crystal ball that may take some pressure off the diagnostics industry in the coming year.
