Shifts in Healthcare Policies in 2026

In 2026, the era of voluntary guidelines for healthcare technology ended. Policy has moved into an enforcement phase, with the U.S. federal government and individual states creating a complex patchwork of laws that prioritize cost transparency, AI safety, and patient rights. Below, I elaborate on the four most significant policy shifts currently impacting healthcare executives.

Pricing Transparency

A massive push for radical transparency in pricing is launched, moving beyond the simple previous chargemaster lists. Hospitals and insurers that accept Medicare or Medicaid must now prominently post all prices in a way that allows for easy consumer shopping. Through initiatives, the government is aggressively capping prices for hundreds of common drugs to match the lowest prices paid by other nations. Insurers are now required to publish detailed data on claim denial rates and how often those denials are overturned on appeal. The revenue cycle team must shift from a defensive billing posture to an open book model to avoid significant penalties for non-compliance.

Regulation

The FDA has officially finalized its rules for how medical software is regulated. Previously, any major software update required a new FDA clearance. Now, manufacturers can pre-agree with the FDA on how their artificial intelligence (AI) will learn and update over time. In the absence of a single federal AI law, states have enacted strict transparency requirements that went into effect on January 1, 2026. For example, in Tennessee and Colorado in the United States, laws prohibit AI from claiming it is a qualified mental health professional and regulate AI use in psychotherapy. In Texas, United States, an AI Governance Act requires providers to give patients a conspicuous written disclosure if AI is used in their diagnosis or treatment.

Consequently, the legal teams must perform an AI Inventory and map each tool used in the clinic against these varying state disclosure laws.

New Reimbursement

There are also opportunities. Secure messaging and AI-driven prompts can now count toward the interactive communication time required for billing, provided there is human oversight. This is a revenue opportunity.  Table 1 compares policy snapshots.

Area	2023 Policy	2026 Policy
Pricing	Hidden/Negotiated	Public & Shoppable
AI Updates	Static/Frozen code	Dynamic/PCCP pre-approved
Transparency	Voluntary disclosure	Mandatory "I am AI" notices
Remote Pay	High "16-day" bar	Low "2-day" bar (New Revenue)

Policy Snapshot: 2023 vs. 2026

Implication for Executives  

The policy landscape has shifted dramatically in 2026 as regulators have moved toward a framework of continuous oversight. For executives, this means compliance is no longer a one-time hurdle but an ongoing operational requirement. In the past, a medical device or algorithm was approved once. The FDA now heavily utilizes Predetermined Change Control Plans, allowing AI and digital twins to evolve and update their code in real-time without needing a new submission every time, provided the changes stay within pre-approved boundaries. An additional change, in many regions, is that virtual reality tools for chronic pain are now a reimbursable prescription digital therapeutic, treated financially like a drug rather than a piece of hardware. Virtual reality and AI agents are no longer marketing costs, they are revenue centers.

New mandates in the EU and several US states require that any AI agent making clinical decisions must process that data within specific geographic or institutional boundaries. Thus, executives cannot simply outsource their intelligence to a public cloud without violating residency laws. Executives must invest in Hybrid Edge Infrastructure, keeping the intelligence local while using the cloud for heavy lifting. If an AI agent denies a claim or suggests a surgery, the law now mandates that the system must provide a human-readable audit trail. An accurate model that can't explain itself is a massive legal liability in 2026.

A major 2026 policy trend is the right to explanation.  If an AI agent denies a claim or suggests surgery, the law now mandates that the system must provide a human-readable audit trail. Thus, when selecting vendors, explainability is a higher priority than accuracy. An accurate model that can't explain itself is a massive legal liability in 2026. Table 2 compares the policy in 2023 and in 2026. As AI agents become more autonomous, governments are tightening the supervision on where the data lives.

Policy Area	The Past (2023)	The Present (2026)
AI Governance	Voluntary guidelines	Enforceable AI Safety Standards (NIST)
Liability	Ambiguous (Doctor vs. Dev)	Shared Responsibility Frameworks
Data Privacy	HIPAA (Data at rest)	AI Transparency Act (Data in use)
Software Updates	Re-submission required	Continuous Surveillance (PCCP)

Table 2: Policy Comparison: 2023 vs. 2026

Conclusion

In 2026, health policy is no longer just about privacy; it’s about safety, fairness, and getting paid. There are new rules of the game for healthcare leaders.  While in the past, a change of a component of the medical software required months of waiting for the FDA to re-approve it, now as long as the AI improves within the boundaries agreed upon with the FDA, it can update itself automatically. Also, there are now specific billing codes for digital therapeutics and remote therapeutic monitoring. Systems can get paid for prescribing a virtual reality app for pain or an AI tool that monitors a patient's ADHD at home. It’s no longer just a gadget; it's a billable service.

Along with these changes, laws are changing as well. If an AI agent or a companion chatbot interacts with a patient, there must be a clear, unmissable disclaimer. Providers are legally barred from using terms that imply the AI has a medical license. In 2026, many state bars and the new AI safety standards have clarified that the provider, not the software company, is responsible for mistakes made by AI.  If the AI misses a diagnosis and there is no double-check by a human, the providers are liable.

Additional Reading 

• Keith K. Health Policy At A Crossroads: What To Watch In 2026. Health Affairs Forefront. 2026 Jun 20.

• Nordström A, e Silva MR, Clark H, Minghui R, Piot P, Teo YY. Four paradigm shifts to shape an agenda for global health reforms. The Lancet. 2026 Jan 16.

• Wallenburg I, Friebel R. Preparing for uncertainty and health system responses: a new year for Health Economics, Policy and Law. Health Economics, Policy and Law. 2026 Jan 12;21(1).

• Wu Y, Wang H, Zhang Z. Three Shifts That Will Redefine Health Systems. Health Care Science. 2026