As organizations adopt health IT for data sharing and automation, their attack surface expands. This increases their vulnerability to various attack vectors, including ransomware attacks, phishing, and IoT device compromises. Hackers often exploit these weaknesses to steal sensitive data, such as personally identifiable information (PII), which they sell on the darknet for use in fraud and identity theft.
Overall, 720 healthcare data breaches were reported in the U.S. in 2024, impacting approximately 186 million user records. In 2024, the average cost of a healthcare data breach surged to nearly $9.77 million, marking the highest among 17 industries for the 14th consecutive year. The high costs are driven by the sensitive nature of patient data, the complexity of healthcare IT systems, and frequent ransomware attacks targeting hospitals and health organizations.
Organizations must follow compliance frameworks to protect patient data, meet regulations, and strengthen resilience. This guide covers key frameworks, their purpose, applicability, requirements, and penalties for non-compliance.
What is Healthcare IT Security Compliance?
Healthcare IT security compliance refers to the adherence to industry-specific regulations and frameworks designed to protect sensitive patient information, ensure data integrity, and maintain confidentiality. These standards help organizations mitigate cybersecurity risks and maintain trust among patients and stakeholders.
Why is Healthcare IT Security Compliance Important?
Healthcare organizations handle vast amounts of sensitive data, including EHRs (electronic health records), PII, and financial details. A single data breach can result in severe financial penalties, reputational damage, and legal consequences. For patients dependent on advanced medical devices, the accuracy of healthcare data can be a matter of life and death.
1. Protection of patient data: Safeguards against cyber threats and unauthorized access.
2. Regulatory adherence: Meets legal and industry standards to avoid penalties.
3. Operational efficiency: Streamlines security processes and improves risk management.
4. Enhanced patient trust: Demonstrates a commitment to data security and privacy.
5. Improved security maturity: Promotes a structured and measurable approach to enhancing an organization’s security posture over time.
6. Increased credibility: Certification with recognized security frameworks boosts reputation and trustworthiness.
7. Regulatory alignment: Ensures that organizations consistently assess and align their security measures with industry regulations.
How to choose the right Healthcare IT Security Compliance?
When selecting a compliance framework, organizations should consider these key features:
1. Regulatory and security needs: Ensure the framework aligns with legal requirements based on geography, industry, and data type while providing strong data protection measures like encryption and access control.
2. Risk management and scalability: Choose a framework that matches the sensitivity of the data handled, supports business growth, and integrates seamlessly with existing IT infrastructure.
3. Framework-driven automation tools: After selecting a framework, evaluate automation tools that support compliance tracking, real-time monitoring, and incident response to enhance efficiency.
4. Audit and incident response: To ensure operational resilience, opt for frameworks with strong audit capabilities, real-time threat detection, and defined breach response protocols.
| One of the biggest healthcare cybersecurity breaches in 2024 was the Change Healthcare ransomware attack, which compromised the data of approximately 100 million individuals. The attack, attributed to the ALPHV ransomware gang, not only exposed sensitive electronic protected health information but also disrupted healthcare operations across the U.S., significantly affecting payment processing and delaying patient care. |
What are the different healthcare IT compliance standards and frameworks?
Compliance standards and frameworks play a crucial role in protecting sensitive patient data, ensuring secure transactions, and maintaining regulatory adherence in the healthcare industry.
Here are some leading healthcare IT security standards and frameworks.
1. HITRUST CSF (Health Information Trust Alliance Common Security Framework)
The HITRUST CSF is a certifiable risk management framework that integrates multiple regulations, including HIPAA, NIST, ISO 27001, and PCI DSS, into a single, scalable approach. Developed by the HITRUST Alliance in 2019, it provides healthcare organizations with a structured methodology to manage risk and demonstrate compliance with industry security and privacy standards.
By unifying various regulatory requirements, HITRUST CSF helps organizations streamline compliance efforts, enhance cybersecurity defenses, and reduce data breach risks.
While not legally required, many healthcare organizations, payers, and providers prefer HITRUST certification for third-party vendors. Non-compliance can lead to security breaches, reputational damage, and lost business opportunities. Primarily used in the U.S., it is increasingly recognized worldwide. Large and mid-sized organizations adopt it, while small businesses may opt for HITRUST Essentials due to cost considerations.
The HITRUST CSF integrates over 150 security controls across 19 domains, offering a comprehensive risk management framework tailored for healthcare organizations. These controls align with multiple industry standards and address critical areas such as Access Control, Network Security, Incident Management, and Data Protection & Privacy.
The number of required controls varies based on an organization’s risk profile, regulatory obligations, and selected HITRUST assessment level (e1, i1, or r2). The r2 (Risk-Based, 2-Year) certification mandates the full set of controls, while i1 (Implemented, 1-Year) and e1 (Essentials, 1-Year) require a reduced set.
Key requirements:
- HITRUST CSF includes 150+ security controls for risk management, data protection, incident response, and compliance monitoring. Control requirements vary based on an organization’s risk profile, regulations, and chosen assessment level.
- Certification is available at three levels (Essential, Implemented, and Certified).
2. NIST Cybersecurity Framework (CSF) & NIST 800-53
i) NIST Cybersecurity Framework (CSF)
The NIST Cybersecurity Framework (CSF) is a voluntary, structured risk management framework developed by the National Institute of Standards and Technology (NIST) in 2014. It is designed to help organizations, including private-sector healthcare entities, strengthen their cybersecurity posture.
CSF provides a flexible structure based on six core functions:
- Prepare
- Identify – Asset and risk management
- Protect – Access controls and safeguards
- Detect – Continuous monitoring
- Respond – Incident response planning
- Recover – Business continuity and resilience
It is used by healthcare providers, insurers, medical research institutions, and IT vendors. While not mandatory, it is widely adopted across the U.S. and internationally.
Non-compliance risks include increased exposure to cybersecurity threats and higher risk of data breaches.
Key requirements:
- Prepare – Establish cybersecurity governance, risk management strategies, and resource allocation.
- Core functions (Identify, Protect, Detect, Respond, Recover) – Implement a risk-based approach to cybersecurity covering asset management, threat detection, incident response, and recovery.
- Customizable and scalable – Adaptable to organizations of all sizes, aligning with various regulatory and business needs.
ii) NIST 800-53
NIST Special Publication 800-53 is a mandatory set of security controls for U.S. federal healthcare agencies (e.g., HHS, VA, CMS) and their contractors handling government healthcare data. It was first released in February 2005 and provides a comprehensive set of 800+ security controls covering:
- Access management
- Encryption standards
- Continuous monitoring
- Incident response
It is mandatory for federal healthcare agencies and contractors handling federal data. NIST 800-53 is used globally as a security benchmark by organizations working with the U.S. government.
Non-compliance risks include loss of federal funding and contracts and increased vulnerability to cyber threats
3. ISO/IEC 27001 (Information Security Management System – ISMS)
ISO 27001 is an international standard for establishing an information security management system (ISMS) to manage IT security risks. It was developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), first published in 2005 and later updated in 2013 and 2022.
It defines a structured approach for developing, implementing, managing, and continuously enhancing an ISMS. It applies to several industries, with the primary focus on establishing a structured ISMS. In the healthcare arena, it helps organizations secure patient health data, implement security policies, and prevent breaches.
Although not legally required, many healthcare providers, IT service providers, healthcare SaaS vendors, and pharmaceutical companies pursue certification to demonstrate cybersecurity compliance. While there are no direct legal penalties for non-compliance, failing to implement ISO 27001 increases security risks, reputational damage, and potential business losses due to data breaches.
Key requirements:
- Requires risk assessment, continuous monitoring, and security audits.
- Mandates a formal risk assessment process to identify, analyze, and mitigate security risks in healthcare environments.
- Requires implementation of 93 security controls covering areas like access control, cryptography, and incident management.
- Requires continuous monitoring, internal audits, and periodic external assessments to maintain data security and regulatory compliance.
4. HIPAA (Health Insurance Portability and Accountability Act)
Enacted in 1996 by the U.S. Congress and enforced by the Department of Health and Human Services (HHS), HIPAA establishes national standards for protecting sensitive patient health information (PHI) by ensuring the confidentiality, integrity, and availability of electronic PHI (ePHI). It safeguards privacy, prevents fraud, and ensures the portability of health insurance.
Compliance is mandatory for all covered entities, including healthcare providers, health plans, clearinghouses, and business associates handling PHI within the U.S. healthcare industry. Non-compliance can result in penalties ranging from a minimum of $137 to $68,928 per violation, with a maximum annual fine of $2,067,813 and in severe cases, criminal charges.
Key requirements:
- Organizations must adhere to HIPAA’s Privacy, Security, and Breach Notification Rules, which mandate administrative, physical, and technical safeguards to protect PHI.
- Security rule: Defines national standards for securing ePHI during creation, receipt, maintenance, and transmission.
- Privacy rule: Regulates PHI usage and disclosure while outlining individuals’ rights over their health information.
- Breach notification rule: If a breach affects over 500 individuals, the covered entity must notify HHS and a major media outlet in the affected state or jurisdiction. For breaches involving fewer than 500 individuals, entities must log the details and report them to HHS within 60 days after the calendar year ends via the HHS website.
HITECH Act (Health Information Technology for Economic and Clinical Health Act)
The HITECH Act, introduced in 2009 as a part of the American Recovery and Reinvestment Act (ARRA), strengthens HIPAA by promoting electronic health record (EHR) adoption and enforcing stricter breach notification rules. This is because HIPAA was written without considering the growth of the internet and web applications. HITECH bridges this gap and extends HIPAA’s reach by making business associates directly liable for compliance and strengthening enforcement of security and breach notification requirements. The Act enhances enforcement, increases penalties, and incentivizes EHR adoption.
5. GDPR (General Data Protection Regulation)
The General Data Protection Regulation (GDPR) is a European Union regulation that governs data privacy and protection, including healthcare data. The European Commission enforced it in 2018 to ensure the protection of EU and EEA citizens’ personal information and establish strict guidelines for data security. Health data is classified as sensitive personal data and has additional protections under Article 9.
GDPR compliance is mandatory for all organizations handling the personal data of EU and EEA residents, regardless of where the company is located. This means that even businesses outside the EU must comply if they process or store EU and EEA residents’ data. The regulation applies to a wide range of industries, including healthcare providers, pharmaceutical firms, SaaS companies, and telemedicine platforms.
Non-compliance with GDPR can result in severe penalties:
Tier 1: Fines up to €10 million or 2% of annual revenue, whichever is higher, for less severe violations.
Tier 2: Fines up to €20 million or 4% of annual revenue, whichever is higher, for more serious violations.
Key requirements:
- Organizations must implement Data Protection Impact Assessments (DPIAs) when processing poses a high risk to individuals’ rights and freedoms.
- Encryption is recommended, as is the right to erasure (also known as the ‘right to be forgotten’).
- Breach notification protocols to ensure transparency and accountability in data handling.
6. PCI DSS (Payment Card Industry Data Security Standard)
Established by the PCI SSC (PCI Security Standards Council)—comprising Visa, Mastercard, American Express, Discover, and JCB—PCI DSS ensures the secure handling of payment card data. It is a globally recognized standard recommended for any organization that processes, stores, or transmits cardholder data, including healthcare providers that accept credit card payments.
While PCI DSS is not a law, compliance is recommended for businesses handling payment card transactions in countries where these card networks operate, including the United States, Canada, the European Union, the United Kingdom, Australia, India, and many others.
Non-compliance can lead to penalties imposed by acquiring banks or payment networks, which may include fines ranging from $5,000 to $100,000 per month and the potential loss of payment processing privileges.
Key requirements:
Key requirements include securing network architecture, encrypting cardholder data, implementing strong access controls, maintaining vulnerability management, conducting regular security testing, logging and monitoring access to cardholder data, and establishing an incident response plan.
7. SOC 2 (Service Organization Control 2)
SOC 2 (Service Organization Control 2) was developed by the American Institute of Certified Public Accountants (AICPA) to evaluate an organization’s ability to protect sensitive data. In the healthcare sector, SOC 2 compliance is crucial for third-party vendors handling sensitive patient data.
While not a legal requirement, many healthcare organizations mandate SOC 2 compliance to ensure their service providers implement stringent security, availability, and confidentiality controls. Failure to meet SOC 2 standards can result in lost business opportunities, reputational damage, and increased risks of data breaches, which could also lead to violations of other healthcare regulations like HIPAA.
These controls help achieve compliance by ensuring that patient data is securely managed and accessible only to authorized personnel, reducing the risk of cyber threats and compliance violations.
Key requirements:
- SOC 2 compliance requires healthcare organizations and their vendors to implement controls and adhere to the Trust Services Criteria (TSC), which include security (which is mandatory), availability, processing integrity, confidentiality, and privacy (selected based on business needs).
- Continuous monitoring, risk assessments, employee training, vendor risk management, incident response, access controls, data encryption, and regular audits to uphold security and privacy standards.
8. COBIT (Control Objectives for Information and Related Technologies)
COBIT, developed by ISACA, is an IT governance framework followed worldwide to develop, implement, monitor, and improve information technology governance and management practices. It helps organizations align IT with business objectives while managing risks and resources.
Healthcare entities use COBIT to improve IT governance, optimize resource allocation, and enhance cybersecurity risk management.
The framework is structured around five domains:
- Evaluate, Direct, and Monitor (EDM);
- Align, Plan, and Organize (APO);
- Build, Acquire, and Implement (BAI);
- Deliver, Service, and Support (DSS); and
- Monitor, Evaluate, and Assess (MEA).
These principles help healthcare providers establish standardized IT processes and security controls to support compliance efforts.
While not legally required, it is widely adopted to improve cybersecurity resilience and streamline resource allocation. Non-compliance does not result in direct legal penalties, but weak IT governance can lead to regulatory violations, data breaches, and operational inefficiencies.
Key requirements:
- Key elements of COBIT include risk management, IT governance, resource optimization, and performance measurement, which support broader security and compliance efforts.
- Encourages continuous monitoring, performance measurement, and audits to enhance IT governance and operational efficiency.
9. CIS Controls (Center for Internet Security Controls)
CIS Controls are a set of prescriptive, prioritized cybersecurity guidelines developed by the Center for Internet Security (CIS) to protect organizations from cyber threats.
Although it is a set of general cybersecurity controls, implementing CIS Controls benefits healthcare organizations as it provides actionable steps to enhance cybersecurity defenses, prevent unauthorized access, and ensure continuous threat monitoring. The framework applies to any healthcare provider handling sensitive patient data, regardless of geographic location, and is often used alongside mandatory regulations like HIPAA and GDPR to enhance security.
While not legally required, many healthcare organizations adopt CIS Controls to strengthen their security posture, safeguard electronic health records (EHRs), and mitigate risks associated with ransomware and data breaches. Non-compliance increases the risk of cyberattacks, which can lead to financial losses and reputational damage.
CIS Controls are categorized into three implementation groups (IG1, IG2, and IG3) based on an organization’s cybersecurity maturity, resources, and risk profile.
The 18 CIS Controls focus on key cybersecurity areas to protect enterprise systems and data. These include asset and software inventory management, data protection, secure configurations, access control, vulnerability management, and audit logging. Additional controls address malware defenses, network security, incident response, penetration testing, and third-party risk management. Security awareness training and application security also play a crucial role in enhancing overall cybersecurity resilience.
Key requirements:
- Key requirements include asset inventory management, secure system configurations, continuous vulnerability management, and threat monitoring to protect against cyber threats.
- Enforce least privilege access, multi-factor authentication, and strong protection measures (including encryption) to safeguard patient data.
- Implement security monitoring, threat detection, logging, and response plans to mitigate security breaches.
10. FISMA (Federal Information Security Modernization Act)
The (FISMA) is a U.S. law that mandates federal agencies and their contractors, including healthcare organizations handling federal health data, to implement robust information security programs. Enacted in 2002 and updated in 2014, FISMA strengthens cybersecurity measures by requiring risk-based security controls, continuous monitoring, and compliance reporting to protect sensitive federal data, including patient health information. It mandates compliance with NIST standards (primarily NIST SP 800-53)
In healthcare, FISMA applies to federal agencies like the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), the Department of Veterans Affairs (VA), and any contractors or vendors handling federal health data. Non-compliance can result in the loss of federal contracts, reduced federal funding, reputational damage, increased regulatory scrutiny, and failure to achieve an Authorization to Operate (ATO) for federal systems.
Key requirements:
- Periodic risk assessments,
- Security categorization of health information systems,
- Continuous monitoring,
- Compliance with NIST Special Publication 800-53 security controls to ensure the confidentiality, integrity, and availability of healthcare data
How to maintain cybersecurity compliance in the healthcare sector
1. Implement zero-trust architecture (ZTA): Treat all network activity as a security threat until verified, adding an extra layer of protection against unauthorized access.
2. Deploy a third-party risk management (TPRM) solution: Assess and monitor the security posture of third- and fourth-party vendors using security assessments, ratings, and real-time attack surface scanning.
3. Identify and remediate data leaks: Detect and address data leaks in real time to prevent regulatory violations and reduce the risk of data breaches.
4. Invest in an attack surface monitoring solution: Continuously monitor vulnerabilities across internal and third-party ecosystems to strengthen security and meet regulatory compliance requirements.
Automating healthcare IT security compliance with Scrut
Scrut simplifies healthcare IT security compliance by automating risk management, evidence collection, and audit readiness for frameworks like HIPAA, GDPR, HITRUST CSF, NIST CSF, and ISO 27001. With real-time monitoring, pre-mapped controls, and automated alerts, it helps organizations proactively detect risks and ensure continuous compliance. By eliminating manual efforts, Scrut enables healthcare providers and IT vendors to stay audit-ready and secure while focusing on their core operations.
