Keeping Up with Regulatory Requirements in Healthcare

Regulatory requirements in healthcare are constantly changing. Why? Rules that govern healthcare sit at the intersection of public health, technology, economics, and policy—all of which evolve rapidly. A public health crisis or patient safety issues can trigger new standards, as can advancements in medicine and technology. Patient advocacy groups and professional associations also lobby for regulatory change to address gaps or improve service. 

Healthcare organizations need advanced warning of regulatory changes so they can adequately update their policies, processes, and technology to meet the new requirements. This cuts across multiple departments and requires careful coordination and communication to avoid gaps or errors.   

Consequences of non-compliance 

Non-compliance in healthcare is serious. It can result in substantial fines, criminal charges, reputational damage, and loss of accreditation. Even worse, it can cause lapses in patient care or safety. 

SAI360’s most recent survey of healthcare providers, the 2025 Healthcare Compliance Benchmark Survey, found one in two organizations surveyed experienced an enforcement encounter in the past three years, including visits from U.S. Department of Health and Human Services Office for Civil Rights (DHHS OCR), OIG (Office of Inspector General), and the Centers for Medicaid and Medicare Services (CMS). About one in four healthcare organizations reported they were actively addressing compliance risks identified by CMS, OIG, or the U.S. Department of Justice. 

Regulatory requirements in healthcare examples 

Healthcare organizations in the U.S. are subject to hundreds of regulations at the federal, state, and local levels. These laws cover everything from clinical care, privacy, and billing to licensing, reporting, and workplace safety.  

Here’s a glance at just a few regulatory requirements in healthcare: 

HIPAA & HITECH: Sets U.S. standards for protecting patient health information and requires administrative, physical, and technical safeguards plus breach notification. 

Stark Law: Bars physician self-referrals for certain Medicare-payable designated health services when a financial relationship exists, unless a specific exception applies. 

Anti-Kickback Statute: Makes it a crime to offer, pay, solicit, or receive anything of value to induce or reward referrals for items or services covered by federal health care programs. 

False Claims Act: Imposes liability for knowingly submitting or causing the submission of false or fraudulent claims to the federal government; includes whistleblower actions. 

Fraud and abuse laws: A family of rules, including civil monetary penalties and program exclusions, aimed at preventing improper referrals, billing, and benefit misuse across federal programs. 

OSHA: Requires a safe workplace; in hospitals, this includes controls for bloodborne pathogens, hazardous chemicals, respiratory protection, and injury prevention. 

Using technology to manage regulatory requirements in healthcare 

With hundreds of laws to follow, along with changes and new regulations, healthcare compliance teams rely on technology to stay informed of changes, develop policies and strong governance, manage disclosures, track deadlines, ensure audit readiness, and perform reporting. Integrated Governance, Risk, and Compliance (GRC) platforms break down complex regulatory requirements in healthcare into structured, auditable processes that support day-to-day operations.  

Regulatory compliance in healthcare works best when responsibility is clearly defined. GRC platforms reinforce this by enabling permissions-based roles. These roles ensure only the right people can access, update, or approve compliance activities. This capability improves efficiency, prevents duplication, and provides a clear audit trail.

Automated workflows within GRC platforms also support audit readiness and increased efficiency. Workflows are triggered by predefined rules to route tasks to the appropriate individuals within the organization to be actioned. For example, when a new regulation requires a policy update, the system can automatically alert the relevant team members to draft the update, route revisions to review and approval, and send timely reminders as deadlines approach. This reduces bottlenecks and ensure every process follows the right steps, approvals, and timelines. 

GRC platform dashboards and reporting features make it easy to visually track and monitor key performance indicators in real time. This helps organizations identify areas of concern, as well as avoid potential penalties. Reports can be tailored for specific audiences including board members and auditors.

Final thoughts 

Regulatory compliance in healthcare is an integral part of daily operations. By centralizing ownership, automating workflows, and tracking performance, GRC platforms help organizations stay audit ready at all times.

When done well, compliance is more than just a check-box exercise – it is a strategic, integrated program that protects patients, supports clinicians, minimizes disruptions, and gives leadership the assurance they need to face audits with confidence.