American health care does not suffer from a shortage of regulations. It suffers from a shortage of regulations that work together.
Clinicians routinely enter the same information into several systems, hospitals report similar quality measures in slightly different formats, and patients may wait while an insurer decides whether a treatment their physician ordered is sufficiently treatment-like. Meanwhile, serious safety problems can slip through reporting systems built to document them.
The answer is not a regulatory bonfire. Patient protections governing medications, medical devices, infection control, privacy, and professional competency remain essential. The smarter goal is to remove low-value paperwork while strengthening oversight of activities that directly affect patient outcomes. In other words, retire the forms that mostly generate more forms and focus regulatory energy on preventing harm.
Why Health Regulation Needs a Serious Renovation
Health regulations generally begin with sensible intentions. One rule discourages unnecessary treatment. Another measures quality. A third protects patient data. Over time, however, agencies, states, insurers, accreditation organizations, and health systems may create overlapping requirements without removing outdated ones.
The result resembles a kitchen with six smoke detectors but no fire extinguisher. Everyone can prove that monitoring occurred, yet the system may still struggle to stop the actual fire.
Administrative complexity consumes clinical resources
Every hour spent manually reentering information, chasing an authorization, or reconciling conflicting reporting requirements is an hour unavailable for patient communication and care improvement. Administrative work also requires billing specialists, compliance teams, consultants, software interfaces, and appeals staff. Those costs do not disappear; they eventually show up in premiums, taxes, hospital charges, and patient bills.
Prior authorization illustrates the trade-off. It can discourage unnecessary services and protect public funds, but poorly designed programs may delay appropriate treatment. The Government Accountability Office has warned that authorization requirements and internally developed coverage criteria can impede access, even though the process is intended to control utilization and costs.
More rules do not automatically produce safer care
Patient harm remains a substantial problem despite extensive compliance requirements. A federal review found that one-quarter of Medicare patients in the study experienced either an adverse event or temporary harm during a hospital stay, and reviewers considered many of those events preventable. The Office of Inspector General later reported that hospitals failed to capture half of the identified harm events in their own reporting or surveillance systems.
That finding exposes a major regulatory weakness: a hospital can submit volumes of compliance data while still missing medication injuries, infections, pressure injuries, diagnostic failures, and other events that matter to patients. A checkbox completed on time is not the same thing as a hazard removed from the system.
Principles for Smarter Health Care Regulation
Measure outcomes rather than paperwork volume
Regulators should begin by asking a plain question: What patient outcome is this requirement supposed to improve? If a report, attestation, or inspection item has no credible connection to safety, access, affordability, or equity, it should be revised or retired.
High-value measures include preventable infections, medication-related harm, diagnostic delays, readmissions, treatment complications, patient-reported outcomes, and timely access to care. Low-value measures often count whether an activity was documented without determining whether the activity helped anyone.
Use one set of definitions whenever possible
A medication error should not become three different events because a hospital, insurer, and government agency use different terminology. AHRQ has emphasized the importance of shared definitions for adverse events, errors, and near misses, while federal investigators have recommended a more consistent national taxonomy for patient harm.
Standard definitions make comparison possible, reduce reporting disputes, and help safety teams identify patterns across facilities. They also prevent the regulatory equivalent of measuring one room in feet, another in meters, and a third in “roughly two exam tables.”
Match oversight to actual risk
Not every health care activity deserves the same regulatory intensity. A low-risk scheduling application should not face the same review structure as an implanted cardiac device. Routine prescription renewals should not require the same authorization process as experimental treatment.
Risk-based regulation directs inspections, reporting, and enforcement toward activities capable of causing the most serious harm. Lower-risk activities can use streamlined pathways, periodic audits, or automated monitoring. This approach reduces unnecessary compliance expense without weakening protections where the consequences are greatest.
Seven Reforms That Could Lower Costs and Improve Safety
1. Standardize and automate prior authorization
Prior authorization should become an electronic clinical transaction, not an archaeological expedition through fax machines. Payers should use common data standards, publish understandable coverage criteria, provide specific reasons for denials, and accept information directly from electronic health records.
The 2024 CMS Interoperability and Prior Authorization Final Rule requires affected payers to improve information exchange and implement major application programming interface provisions, primarily by 2027. In 2026, CMS also proposed extending similar electronic and transparency reforms to prescription-drug authorizations.
A modern system should approve routine requests automatically when established criteria are met. Urgent cases should receive rapid review by a qualified clinician. Repeatedly approved treatments for stable chronic conditions should qualify for longer authorizations or exemptions. Regulators should also track overturned denials and delays associated with emergency visits, hospitalization, or treatment abandonment.
2. Consolidate quality reporting
Federal agencies, state programs, insurers, and accrediting organizations should agree on a smaller core set of meaningful measures. Data should be extracted automatically from interoperable systems whenever possible and reused across programs rather than reported separately.
There is evidence that simplification can produce real savings. CMS reports that its Meaningful Measures initiative reduced the number of Medicare quality measures, saved more than three million reporting hours, and generated projected savings of $128 million. The number of unique measures fell from 764 in 2017 to 489 in 2024.
The next phase should prioritize outcomes, patient experience, and digital reporting. The aim is not to measure less simply because measurement is annoying. It is to stop counting activities that do not help patients and improve the measures that do.
3. Build a national learning system for patient harm
Health care organizations need a consistent method for reporting adverse events and near misses without discouraging frontline participation. Incident reports should feed a learning system capable of identifying patterns across hospitals, clinics, nursing facilities, pharmacies, and home health agencies.
Reporting alone is not enough. AHRQ notes that voluntary event-reporting systems are widely used, but they depend on people recognizing and submitting events. Regulators should therefore combine frontline reports with automated record review, pharmacy triggers, claims analysis, infection surveillance, patient complaints, and mortality review.
Rules should protect good-faith reporting while preserving accountability for reckless conduct, concealment, or repeated failure to correct known hazards. Staff members are more likely to report a near miss when the first response is “How did the system permit this?” rather than “Whose career shall we launch into the sun?”
4. Make health information portable by default
A patient’s clinical history should follow the patient. Regulations should require secure, standardized data exchange among authorized providers, laboratories, pharmacies, health plans, public-health agencies, and patients.
Federal information-blocking rules already establish electronic information sharing as an expected practice, subject to privacy, security, and other legitimate exceptions. Health information exchange can reduce duplicative testing, treatment delays, communication failures, and costly mistakes.
The next step is practical enforcement. Regulators should test whether data are usable, complete, timely, and understandablenot merely whether an interface technically exists. A portal that requires 14 clicks, a forgotten password, and the patience of a medieval monk is not seamless access.
5. Reform payment rules that reward expensive settings
When the same routine service is safely provided in a physician office, ambulatory surgery center, or hospital outpatient department, Medicare payments should not vary dramatically merely because of the building’s ownership.
MedPAC has recommended more closely aligning payment rates across ambulatory settings for selected services. It found that payment differences can encourage consolidation and shift care toward settings with higher reimbursement. The Congressional Budget Office has likewise noted that broader site-neutral payment policies could reduce federal spending.
Reform must include protections for rural hospitals, trauma centers, teaching institutions, and safety-net facilities that maintain costly standby capacity. Targeted support is more transparent than overpaying every routine service and hoping some of the extra money reaches essential community functions.
6. Review competition and professional licensing rules
States should regularly examine certificate-of-need laws, facility restrictions, and professional scope-of-practice rules to determine whether they still protect patients or mainly protect existing market participants.
In 2025, the Federal Trade Commission advised that certificate-of-need programs can raise entry costs, delay competition, and divert resources into legal and consulting battles. The FTC has also argued that unnecessarily restrictive rules for advanced practice nurses can limit access and increase costs when those professionals are trained and licensed to provide the services in question.
Reform should be evidence-based, not automatic deregulation. Legislatures should define competency standards, referral requirements, prescribing safeguards, and escalation protocols according to clinical risk. The objective is to let qualified professionals work at the top of their training while ensuring that complex cases receive appropriate specialist care.
7. Harmonize product-safety requirements
Manufacturers operating in several markets should not have to build separate quality systems that largely duplicate one another. Harmonized standards can lower compliance costs while making inspections and corrective actions more consistent.
The FDA’s Quality Management System Regulation, effective February 2, 2026, incorporates the ISO 13485 medical-device quality framework and aligns U.S. requirements more closely with those used by other regulators. FDA states that the approach promotes consistency, includes risk management, and preserves federal public-health protections.
This is the kind of regulatory modernization worth copying: align recognized standards, eliminate needless duplication, retain enforcement authority, and focus inspections on whether manufacturers can reliably design, produce, monitor, and correct products.
How to Implement Reform Without Creating New Risks
Test changes before scaling them
Major reforms should begin with pilots involving diverse health systems, independent practices, rural providers, patient representatives, and technology vendors. Agencies should evaluate administrative time, access delays, error rates, patient outcomes, and unintended effects before applying a new model nationwide.
Protect rural and safety-net access
Regulations that reduce payment or encourage competition may affect communities differently. A densely populated city may support several outpatient centers; a frontier county may struggle to support one hospital. Reform should include direct funding for emergency readiness, maternity access, behavioral health, and other essential services that cannot be sustained by service volume alone.
Include patients and frontline workers
Rules designed exclusively in conference rooms tend to behave differently when they meet an emergency department at 2 a.m. Nurses, physicians, pharmacists, technicians, caregivers, and patients should participate in drafting, testing, and reviewing requirements. Their experience reveals duplicate steps, confusing language, unsafe workarounds, and reporting systems that look excellent in a slide deck but behave like a printer with emotional problems.
Use expiration dates and retrospective review
Every major regulation should have a scheduled evaluation. Agencies should publish whether the rule improved its intended outcome, what it cost to implement, which groups were affected, and whether a simpler approach could work better. Requirements that no longer provide measurable value should expire, merge with related rules, or undergo revision.
Practical Experiences and Lessons From Regulatory Improvement
The following recurring experiences reflect common patterns seen in health care compliance and safety-improvement work. They are not tied to one named institution, but they show why implementation matters as much as policy language.
Experience 1: Removing a form does not remove the work
An organization may proudly announce that it eliminated a paper authorization form, only for staff to discover that the same questions now live in three online screens. The official burden falls, while the practical burden puts on a digital hat and continues working.
The lesson is to map the entire workflow before changing a requirement. Reform teams should count clicks, handoffs, phone calls, repeated data fields, correction rates, and time spent waiting. Success means reducing total effort from the patient’s request to the final decision, not merely replacing paper with pixels.
Experience 2: Staff report more incidents when reporting feels useful
Frontline workers often stop submitting safety reports when previous reports disappear into a silent database. Reporting improves when employees receive feedback: what investigators found, what changed, and whether similar events declined.
A strong program closes the loop. Leaders thank staff for identifying hazards, publish de-identified lessons, assign corrective actions, and verify that changes work. A weak program sends an automated email saying, “Your submission has been received,” which is bureaucratic language for “Your message now lives in a cave.”
Experience 3: Fewer measures can produce better conversations
Clinical teams sometimes monitor dozens of indicators without knowing which deserve immediate action. When leaders reduce the dashboard to a smaller set of high-priority outcomes, meetings become more focused. Teams can examine why infections rose, why follow-up appointments were missed, or why medication reconciliation failed.
The important step is not simply deleting measures. Organizations must preserve balancing measures that reveal unintended consequences. For example, reducing emergency-department waiting time should not encourage rushed discharges. Lowering readmissions should not make staff reluctant to readmit a patient who genuinely needs hospital care.
Experience 4: Automation magnifies both good and bad rules
Electronic systems can remove repetitive work, but they can also automate confusion at breathtaking speed. If authorization criteria are vague, an automated platform may produce faster vague denials. If patient-matching data are poor, rapid information exchange may deliver the wrong record more efficiently.
Successful automation begins with clear policy, standardized data, testing, human review, and an appeal pathway. Technology should handle routine cases while directing unusual or high-risk cases to qualified people. The best automated system is not the one that eliminates humans; it is the one that saves human attention for decisions requiring judgment.
Experience 5: Small providers need implementation support
Large health systems may have compliance officers, interface engineers, data analysts, and legal teams. A rural clinic may have one practice manager who also handles scheduling, payroll, supply orders, and whatever mysterious noise the copier started making Tuesday.
New requirements should therefore include technical assistance, affordable certified tools, realistic timelines, and simplified pathways for smaller organizations. Otherwise, a regulation intended to improve competition may create fixed costs that only large organizations can absorb.
Experience 6: Trust determines whether reform survives
Patients may worry that cost reduction means care denial. Clinicians may suspect that “efficiency” means another productivity target. Hospitals may fear that payment reform ignores standby capacity. Regulators may assume providers oppose every requirement merely because compliance is inconvenient.
Transparent goals and public measurement help overcome those concerns. Policymakers should explain which burdens will disappear, which protections will remain, how savings will be measured, and what safeguards will prevent reduced access. Reform succeeds when people can see that lower cost comes from removing waste and preventing harmnot from quietly making necessary care harder to obtain.
Conclusion: Regulate What Matters
The United States does not need to choose between affordable care and safe care. Preventable harm is expensive, and administrative waste can itself create safety risks by consuming time, fragmenting information, delaying treatment, and distracting clinicians.
A better regulatory system would standardize prior authorization, reduce duplicative quality measures, improve patient-harm reporting, make health data portable, align payments with the service provided, modernize outdated market restrictions, and harmonize product-safety standards. It would also protect rural access, preserve privacy, support small providers, and hold organizations accountable for measurable outcomes.
Good regulation should behave like a well-trained clinical team: clear about priorities, attentive to risk, willing to learn from mistakes, and never impressed by paperwork for paperwork’s sake.
