Meeting healthcare compliance regulations can feel like an uphill battle. Yet reaching the summit—a patient data security and privacy built on trust, safety, and ethical practice—is non-negotiable. Any organization handling patient data must prioritize patient data privacy, no matter the regulatory hurdles.
More than 700 large healthcare data breaches were reported in 2024 to the OCR, the agency responsible for enforcing HIPAA regulations. That figure represents a record-breaking 276,775,457 breached records, or over 80% of the United States’ total population.
Understanding key global healthcare regulations ensures patient data safety and quality care. It also helps your organization avoid fines and build trust with patients and partners. This blog delves into eight essential healthcare regulations all providers should be familiar with.
Why Healthcare Compliance is Critical
Regulatory compliance is the foundation on which patient data integrity and safety are built. Tech’s rapid integration into healthcare increases the urgency and complexity of regulatory compliance.
· Increased data volume and accessibility. Electronic health records (EHRs) and other digital platforms have increased the volume of patient data providers now create, store, and share. While this can improve efficiency and care coordination, it can also lead to a higher number of vulnerabilities that result in breaches or unauthorized access.
· New technologies=new risks. Telemedicine, AI diagnostics, and wearable health devices are welcome innovations, but they also introduce new rules and compliance challenges. Risks associated with transmitting data through telehealth platforms, potential AI biases that could lead to discriminatory treatment, and regulating personal health data collected by wearables demand state-of-the-art privacy and security protocols.
· Interoperability and data sharing, Increased data sharing calls for robust security frameworks that maintain privacy and integrity across diverse platforms.
· Expanded attack surfaces. A greater reliance on interconnected digital systems makes providers more vulnerable to cyberattacks. Data theft, ransomware attacks, and other malicious activities can disrupt healthcare delivery, compromise patient information, and result in financial and reputational damage.
· Real-time monitoring and accountability. The more efficient tracking of data breaches, auditing of electronic records, and identifying potential non-compliance efforts raise the stakes for healthcare organizations to maintain continuous compliance.
The bottom line: Technology’s speed and reach amplifies the potential risks of non-compliance. That makes it more vital than ever for providers to invest in comprehensive compliance policies and solutions.
The 8 Essential Healthcare Compliance Regulations Organizations Must Comply With
Hospitals, long-term care facilities, private practices, and more are subject to various healthcare regulations.
1. HIPAA
The US enacted HIPAA in 1996. The wide-ranging regulation establishes national standards for protecting sensitive patient health information (PHI). Its Privacy Rule governs who can access and disclose PHI, while its Security Rule mandates administrative, technical, and physical safeguards for electronic PHI (ePHI).
HIPAA requires healthcare providers, insurers, and business associates to create robust security policies, employee training, and breach notification procedures. Non-compliance can lead to financial penalties ranging from $100 to $50,000 per violation, with a maximum annual penalty of $1.5 million.
2. CCPA
Since 2020, the California Consumer Privacy Act (CCPA) has given the state’s residents significant rights over their personal information, including data held by healthcare providers and health-tech companies not already regulated by HIPAA. While many HIPAA-covered entities are for the most part exempt from the CCPA’s PHI provisions, many health-related services like wellness platforms and fitness apps must still comply.
Consumers also have the right to know what data about them is collected. They can also request deletion and opt out of data sales. Organizations must maintain transparent privacy policies and respond to verified consumer requests within strict timeframes or face fines of up to $7,500 per intentional violation.
3. HITECH
Passed in 2009, the HITECH Act represented a significant shift in digital health information management. Designed to strengthen HIPAA’s enforcement, it promotes accountability and transparency in digital health information management as well as the adoption of EHRs. It also incentivizes providers to digitize medical records and improve patient outcomes through meaningful technology use.
Notably, the act made covered entity business associates liable for HIPAA violations.
4. 21st Century Cures Act
Signed into law in 2016, the 21st Century Cures Act aims to accelerate medical innovation, improve patient access to health data, and ensure electronic health information (EHI) can be easily accessed, exchanged, and used across systems. The Act also requires healthcare providers, developers of certified health IT, and health information networks to avoid practices that block the flow of EHI. And it promotes allowing patients to choose third-party apps or tools to access their records. Non-compliance can result in an investigation by the Office of the National Coordinator for Health Information Technology (ONC) and other federal bodies.
5. GDPR
Since 2018, healthcare organizations collecting or processing the personal data of EU residents, even if based outside the EU, have been required to comply with the General Data Protection Regulation (GDPR).
Considered a powerful global standard for data privacy, GDPR prioritizes transparency, data minimization, and individual consent. It grants patients expanded rights over their personal information and requires covered entities to:
· Designate a Data Protection Officer (DPO).
· Conduct Data Protection Impact Assessments (DPIAs).
· Ensure secure processing of health data.
Penalties for non-compliance can be severe, including up to €20 million or 4% of global annual revenue, whichever is higher.
6. HITRUST CSF
Although not a law, HITRUST CSF is a certifiable framework that combines HIPAA, GDPR, ISO, and NIST standards to create a unified approach to healthcare risk management and compliance. Widely adopted across the industry, it demonstrates an organization’s commitment to data protection, which can offer a competitive edge in vendor relationships.
Its scalable controls evolve with the regulatory landscape and help reduce audit fatigue by aligning multiple compliance requirements into a single framework. The HITRUST certification process includes a rigorous assessment and ongoing validation, making it a trusted industry benchmark.
7. Information Blocking Rule
The Information Blocking Rule was first introduced under the Cures Act and is enforced by the ONC. It targets healthcare providers, certified health IT developers, and health information exchanges, prohibiting them from unreasonably restricting or blocking EHI access or exchange. An example would be failing to provide a patient timely access to their data or charging them an unreasonable fee for access.
The rule also requires data to be made available through standard APIs and other mechanisms that support health IT innovation. Offenses can result in investigations and civil monetary penalties of up to $1 million per violation.
8. Interoperability and Patient Access Final Rule
Issued in 2020 by the US Center for Medicare & Medicaid Service (CMS), Rule CMS-9115-F calls for Medicare, Medicaid, and CHIP providers to offer patients digital access to health records via standardized, secure application programming interfaces (APIs), including smartphone apps. Designed to reduce information silos across healthcare systems, it also requires:
· Payer-to-payer data exchange.
· Provider directory transparency.
· Patient data exchange upon plan changes.
Compliance requires substantial IT investment and operational coordination but is a key driver of the modern healthcare ecosystem.
Key Takeaways for Ensuring Patient Data Security and Privacy
Several fundamental concepts emerge from these crucial regulations:
· Transparency and empowering patients with control over their health data are paramount.
· Securely sharing data across systems to improve healthcare requires robust interoperability and stringent data protection.
· Accountability requires proactive security, risk management, and thorough oversight.
· Recognizing the global nature of data, organizations must consider international privacy laws alongside domestic rules, embedding data protection into their core operations.
Together, these principles create a clear framework for a privacy-first approach to healthcare—one that balances innovation with responsibility at every level of the organization.
FAQ – Healthcare Compliance Regulations
Healthcare regulations are extensive and multifaceted. While this post highlights the top critical regulations, the subject’s depth and scope mean it cannot answer every question. This FAQ section briefly explores other areas and clarifies this crucial aspect of healthcare operations.
Who is responsible for healthcare compliance within an organization?
Responsibility for healthcare compliance is typically handled by:
· A Chief Compliance Officer (CCO) or Compliance Officer who leads an organization’s compliance program and ensures adherence to various laws, regulations, and guidelines. Duties include conducting risk assessments, developing training programs, overseeing audits, and ensuring accurate and timely regulatory reporting.
· Executive leadership and boards of directors ensure an organization has a climate of compliance. They support the compliance officer with resources and authority.
· Legal counsel interprets regulatory requirements and helps ensure internal policies align with applicable laws.
· Department managers and supervisors ensure various departments, including billing, lab services, and patient care, follow compliance rules.
· All employees share responsibility for compliance. They must all follow established protocols, complete training, report violations, and help create an ethical, compliant work environment.
Who enforces compliance in the healthcare industry?
Various governmental and independent entities enforce compliance, and it differs by country. For instance, in the US, the Department of Health and Human Services (HHS) enforces HIPAA privacy and security rules. The country’s Office of Inspector General (OIG) investigates healthcare program fraud, waste, and abuses.
In the UK, the Care Quality Commission (CQC) regulates healthcare providers, and the General Medical Council (GMC) sets standards for licensed doctors. The Information Commissioner’s Office (ICO) enforces the GDPR, particularly around patient data privacy.
What are the risks of compliance failure?
Risks include:
· Data privacy violations, including unauthorized disclosure of PHI.
· Fraudulent billing or claims that violate the False Claims Act, such as charging for services not rendered.
· Regulatory non-compliance due to a failure to follow regulatory standards for safety, staffing, and training.
· Clinical and patient safety failures such as medication errors or ignoring safety protocols.
· Reputational and operational damages that lead to loss of public trust, exorbitant legal costs, and loss of accreditation.
AI-powered Velotix helps organizations easily prove full compliance while automatically maintaining privacy rules for PHI. Companies can take control of their data from day one, safely transferring, sharing, and collaborating on data to meet regulatory obligations without slowing down innovation or patient care.Book a demo today to experience the new age of data governance.
