Oct 9, 2024 
Managing multiple compliance standards can be overwhelming, especially for organizations that operate in industries requiring adherence to both healthcare and financial regulations. Are you an organization dealing with patient medical information as well as processing payment information? That means you are needed to adhere to both HIPAA and PCI.
We understand that keeping track of both frameworks HIPAA and PCI DSS can get confusing and achieving compliance together can be very daunting.
But today, we’ll break them both down for you, key differences and key similarities so you can create a dual plan achieving compliance of both PCI and HIPAA! Sounds good right?
To start with, Health Insurance Portability and Accountability Act (HIPAA) and the Payment Card Industry Data Security Standard (PCI DSS) are both data security standard s designed to protect confidential data but they cater to different types of information. HIPAA focuses on securing healthcare data, ensuring the privacy of personal health information, while PCI compliance regulates the security of payment card transactions.
Why Compliance with Both HIPAA and PCI DSS Matters
What does it mean to be HIPAA Compliant?
HIPAA, or the Health Insurance Portability and Accountability Act, is a U.S. federal law enacted in 1996 to protect the privacy and security of individually identifiable health information or Protected Health Information (PHI). It mandates that eligible covered entities like healthcare organizations implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of patient data.
HIPAA’s Privacy, Security rules, and Breach Notification rules apply to healthcare providers, insurers, and other covered entities like business associates that handle sensitive health information, and it sets rules for how this data must be stored, accessed, and transmitted to prevent unauthorized access and data breaches. Along with making sure they protect patient data they also grant individuals more control over their health records.
Here’s a brief look at the requirements of HIPAA compliance:
Being HIPAA compliant means that an organization has implemented the necessary safeguards to protect the privacy and security of protected health information (PHI) and electronic protected health information (epHI). HIPAA Compliance Requirements divides these into three main categories: Technical, Administrative, and Physical safeguards. Here’s a breakdown:
1. Technical Safeguards
- Access Control: Ensure only authorized personnel can access protected health information (PHI)
- Encryption and Decryption: Protect ePHI during transmission and storage using data encryption.
- Audit Controls: Implement systems to record and examine access to ePHI.
- Integrity Controls: Ensure ePHI is not altered or destroyed in an unauthorized manner.
- Transmission Security: Safeguard ePHI transmitted over networks.
2. Administrative Safeguards
- Security Management: Identify and mitigate risks to ePHI through regular risk assessments.
- Workforce Security: Ensure employees have appropriate access to PHI and undergo HIPAA training.
- Contingency Planning: Prepare for emergencies by having a data backup and recovery plan.
- Security Incident Procedures: Implement a process for responding to security breaches involving PHI.
- Business Associate Agreements (BAAs): Ensure that all third-party vendors, or business associates, handling your organizations’ PHI sign BAAs to comply with HIPAA’s security rules and requirements.
3. Physical Safeguards
- Facility Access Controls: Restrict physical access to locations where ePHI is stored.
- Workstation Security: Ensure that workstations handling ePHI are secured and only used by authorized staff.
- Device and Media Controls: Govern the use and disposal of devices that store ePHI, such as hard drives and USBs.
What does it mean to be PCI DSS Compliant?
Credit card payment fraud and identity theft are a serious concern for the payment industry. To address these issues, the Payment Card Industry Data Security Standard (PCI DSS) was created to strengthen the security of payment card data and promote the adoption of consistent global data security practices. PCI DSS establishes a set of technical and operational guidelines to protect payment card information, and for processing payments.
PCI Compliance is mandatory for all merchants worldwide and are enforced by the major credit card brands through the PCI Security Standards Council. It applies to any organization that processes credit card transactions or stores cardholder data, or transmits sensitive payment information, such as credit card numbers or CVV numbers.
Here’s a brief look at your PCI compliance checklist
The PCI DSS security standard consists of 12 main requirements and over 300 sub-requirements that align with best practices in data security. In this article, we’ll just take you through the 12 main requirements that are expected in PCI compliance:
Build And Maintain A Secure Network And Systems
1. Install and maintain network security controls.
2. Apply secure configurations to all system components.
Protect Account Data
3. Protect stored cardholder data.
4. Use strong encryption to protect cardholder data during transmission over open, public networks.
Maintain A Vulnerability Management Program
5. Safeguard all systems and networks against malware.
6. Develop and maintain secure systems and software.
Implement Strong Access Control Measures
7. Restrict access to system components and cardholder data based on business need.
8. Identify and authenticate users accessing system components.
9. Control physical access to cardholder data.
Regularly Monitor And Test Networks
10. Log and monitor all access to system components and cardholder data.
11. Regularly test the security of systems and networks.
Maintain An Information Security Policy
12. Support information security with organizational policies and procedures.
Note: The PCI Council updates its standards every 3 years, with ongoing incremental changes.
Key Differences Between HIPAA and PCI DSS
Let’s get into some detailed key differences between PCI DSS and HIPAA; although we have already learnt that they are both safety and compliance standards but different in applications, it is still important to understand how exactly these standards differ. HIPAA tends to be broader with fewer explicit details on technical implementations, while PCI DSS specifies clear requirements. This knowledge helps meet specific regulatory demands between PCI DSS and HIPAA.
| Category | HIPAA Compliance | PCI DSS Compliance |
|---|---|---|
| Purpose | Protect individually identifiable health information (PHI) and electronic protected health information (ePHI) | Protects cardholder data (credit card numbers, CVV, etc.) |
| Who Needs to Comply? | Healthcare organizations, providers, health plans, clearinghouses | Merchants, financial institutions, payment processors |
| Enforcement Body | U.S. Department of Health and Human Services (HHS) | PCI Security Standards Council (Visa, Mastercard, etc.) |
| Type of Data Protected | Protected health information (medical records, treatment info) | Sensitive cardholder data (credit card information) |
| Geographical Applicability | U.S. only (for covered entities handling PHI of U.S. residents) | Global (for any entity handling cardholder data worldwide) |
| Assessment Type | Continuous assessment | Point-in-time assessment (usually annual) |
| Security Controls | Mix of “addressable” and “required” controls | Prescriptive controls; compensatory measures allowed |
| Penalties for Non-Compliance | Fines from $127 to $250,000 per violation | Fines up to $100,000 per month for major violations |
| Certification Process | No formal certification (self-assessment and audits) | Formal certification through Qualified Security Assessor (QSA) |
Though HIPAA and PCI DSS share a common goal of data protection, their approaches differ due to the types of data they protect and the industries they serve.
1. Types of Data Protected
- HIPAA compliance is concerned with protecting PHI, including patient medical records, treatments, and personal health details.
- PCI DSS compliance, meanwhile, focuses on securing cardholder data like credit card numbers and verification codes during transactions.
2. Who Needs to Comply?
- HIPAA compliance is required for healthcare organizations, providers, insurance companies, and healthcare clearinghouses that handle protected health information.
- PCI compliance applies to payment processing companies like merchants, financial institutions, and third-party processors that handle, store, or transmit credit card data.
3. Geographical Applicability of HIPAA and PCI DSS
- HIPAA is a U.S. federal law, meaning it is specifically applicable to organizations handling protected health information (PHI) of U.S. residents. It is mandatory for any eligible entity that deals with PHI within the U.S. or operates with U.S. patients, so businesses outside the U.S. that process or store PHI of U.S. citizens must also comply with HIPAA regulations to avoid penalties.
- PCI DSS, on the other hand, is a global standard. It applies to any organization worldwide that processes, stores, or transmits cardholder data from major credit card companies such as Visa, Mastercard, and American Express. Whether your business is in the U.S., Europe, Asia, or any other region, if you handle credit card payments, you must comply with PCI DSS requirements to ensure the security of payment card data.
3. Enforcement and Auditing
- HIPAA regulations are enforced by the Office for Civil Rights (OCR) under the U.S. Department of Health and Human Services (HHS). Non-compliance can result in fines, lawsuits, and reputational damage.
- PCI DSS is governed by the PCI Security Standards Council, an organization created by the major credit card brands like Visa and Mastercard. The framework is not mandated by law but failing to comply can result in fines from the credit card companies, which could absolutely cripple a business.
4. Security Controls
- HIPAA compliance involves both “addressable” and “required” controls, meaning some requirements can be tailored to the organization’s specific needs as long as they meet HIPAA’s security objectives.
- PCI compliance provides more prescriptive controls, including encryption and access management, but allows for compensatory controls in cases where specific requirements can’t be fully met.
5. Assessments
- HIPAA and PCI DSS also differ in how assessments are conducted. HIPAA compliance requires continuous assessment, meaning organizations must consistently review and update their security measures to remain compliant.
- On the other hand, PCI DSS compliance is evaluated at specific intervals or points in time, usually annually. While PCI standards direct a point-in-time assessment, businesses must maintain the necessary controls year-round.
Key Similarities Between HIPAA and PCI DSS
Despite the key differences in scope, HIPAA compliance and PCI DSS compliance share several overlapping security requirements. This is amazing news for organizations that need to adhere to both, because now you can streamline your efforts by implementing shared controls.
By building a solid security foundation, you can easily maintain compliance with both frameworks, ultimately leading to better data protection and simpler operations.
1. Data Security Focus
Both frameworks prioritize data security as their primary goal. Organizations are required to implement strong controls like encryption, secure networks, and firewalls to protect data, both patient data and cardholder data from unauthorized access and data breaches.
2. Non-Compliance Penalties
Failing to comply with either HIPAA or PCI DSS can lead to severe financial penalties.
- Non-compliance with HIPAA rules can lead to severe financial penalties, lawsuits, and reputational damage for covered entities. The fines for HIPAA violations can accumulate to hundreds of thousands of dollars per violation, depending on the level of negligence. In some cases, criminal charges and imprisonment are also possible. In a 2017 case, Florida based Memorial Healthcare System paid $5.5 million to settle potential HIPAA compliance violations after the protected health information (PHI) of 115,143 individuals was improperly accessed and disclosed. MHS failed to implement adequate audit controls, by allowing an affiliated physician’s office employee to use former login credentials to access PHI over a year without detection, affecting 80,000 individuals. If you’d like to know what constitutes HIPAA violations and their penalties in detail, read our article on this topic here.
- Failing to comply with PCI DSS compliance standards can also have major repercussions, particularly in the form of financial penalties from major credit card companies, which can reach up to $100,000 per month for large-scale violations. In 2013, Target suffered a major breach that exposed 40 million credit card data details, partly due to non-compliance with PCI standards. This breach resulted in over $18 million in fines and settlements.
3. Overlapping Controls
By implementing a single set of security measures, like access control, malware protection, and risk assessment, businesses can achieve compliance with both frameworks simultaneously. This greatly helps cross-enterprise communication by creating consistent data protection measures across departments, and reduces the effort and cost associated with managing two separate compliance processes AND also allows you to centralize compliance efforts, making it easier to manage, audit, and maintain both standards.
For example, online form builders that are commonly used by large organizations already have many of these features built into their security and compliance offerings. MakeForms is one such example.
Common Controls for PCI DSS and HIPAA regulations are:
- Risk Assessment
- System Activity Monitoring
- Access Control and Management
- Security Roles and Responsibilities
- Workforce Security
- Entry and Exit Procedures
- Training and Awareness Programs
- Malware Protection
- Login Activity Monitoring
- Account and Password Management
- Incident Response Planning
- Data Transmission Security
- Evaluation and Assessment Programs
- Third-Party Security
- Physical Security
- Device and Media Control
- Policy and Procedure Documentation
- Workstation Security
- Standard Operating Procedures
HIPAA-Specific Controls are:
- Contingency Planning
- Data Integrity Protection
- Denial of Service Protection
Creating a Combined Game Plan for HIPAA and PCI DSS Compliance
Achieving and maintaining HIPAA compliance and PCI DSS compliance requires a well organized and strategic approach. While each framework has key differences and validation points, it is also definitely possible to develop an integrated compliance game plan:
1. First, Understand the Requirements
- HIPAA: Identify if you are a covered identity that is eligible to follow HIPAA. Familiarize yourself with HIPAA’s Privacy, Security rules, and Breach Notification rules. Focus on technical safeguards (like encryption and access control), administrative safeguards (risk assessments and training), and physical security (facility access controls).
- PCI Standards: Understand the 12 core PCI compliance requirements, like securing networks, protecting cardholder data, monitoring system activity, and maintaining vulnerability management
2. Conduct a Risk Assessment
Evaluate all systems, processes, and data storage areas that handle protected health information (PHI), electronic protected health information (epHI) and cardholder data. Identify vulnerabilities in your current setup and assess the likelihood and impact of potential data breaches.
Both frameworks require regular risk assessments to uncover gaps in security and address them promptly.
3. Develop a Compliance Roadmap
Create a timeline for implementing necessary controls and addressing gaps. Start by focusing on overlapping controls, such as access management, encryption, and audit logging, which are required by both PCI DSS and HIPAA. Prioritize high-risk areas and tackle them first to ensure protection against potential data breaches.
4. Implement Technical Safeguards
For HIPAA, ensure proper encryption of PHI during storage and transmission. Implement robust access control measures to restrict unauthorized personnel from accessing sensitive data.
PCI standards dictate organizations to secure your network with firewall configuration, anti-virus software, and regular vulnerability scans. Implement strong data encryption for cardholder data during transactions over public networks.
If you’re collecting customer or patient data online, make sure to use PCI DSS and HIPAA compliant form builders like MakeForms, to securely collect and store both protected health information (PHI) and cardholder data.
5. Enforce Administrative Safeguards
Establish policies and procedures for data handling, system monitoring, and incident response that comply with both frameworks. This includes defining roles and responsibilities for data security within your organization.
Train employees or your team of healthcare professionals regularly on PCI and HIPAA compliance best practices. Ensure they understand how to safeguard both patient data and cardholder data.
6. Monitor, Audit, and Test
Continuously monitor your systems and networks for unauthorized access or suspicious activity. Both frameworks require regular audits of system activity logs and controls.
Conduct internal and external security assessments to verify and maintain HIPAA compliance. Under PCI standards you may need to complete a Self-Assessment Questionnaire (SAQ) or hire a Qualified Security Assessor (QSA) for validation.
7. Document E.v.e.r.ything
Keep detailed records of risk assessments, audits, security policies, training logs, and compliance efforts. For HIPAA, this may include Business Associate Agreements (BAAs) with third parties that handle PHI. For PCI DSS, maintain reports from vulnerability scans, penetration tests, and system monitoring.
If you’re collecting patient or sensitive data online through forms, then use form builders like MakeForms that have compliances in place already. For eg, MakeForms signs BAAs with all their healthcare industry clients.
8. Regularly Review and Update Compliance
To maintain PCI and HIPAA compliance, it’s essential to regularly conduct risk assessments, update security protocols, and ensure staff are properly trained. HIPAA compliance and PCI DSS compliance are not one-time efforts.
Reassess your compliance program regularly, especially when systems change or new threats emerge. Keep up with the latest updates from the PCI Security Standards Council and HIPAA regulations, as both standards are constantly evolving to address new risks and technologies.
You are Now PCI DSS and HIPAA Compliance-Ready!
By understanding the standard operating procedures and validation points of each framework, your business can confidently handle and safeguard sensitive data, both individually identifiable health information and card holder data! With these steps in place, we hope you feel ready enough to build out your HIPAA compliance checklist and PCI DSS compliance checklist, but also feel better equipped to avoid costly penalties, and foster a trustworthy environment for your customers and stakeholders.
FAQs
HIPAA compliance focuses on protecting PHI, including medical records and treatment information. PCI DSS compliance, on the other hand, is designed to secure cardholder data such as credit card numbers and CVV codes during transactions. While both standards aim to protect sensitive data, HIPAA applies to healthcare-related data, whereas PCI DSS is specific to payment card information.
HIPAA compliance primarily protects sensitive health records, including basic health insurance information and patient medical history, while PCI Security Standards are focused on safeguarding sensitive payment data, such as credit card numbers. Both standards aim to prevent data breaches, though they have finite security requirements tailored to their specific industry focus.
HIPAA applies to healthcare providers, health plans, and business associates that handle protected health information (PHI) in the U.S. In contrast, PCI DSS compliance is required for any business worldwide that processes, stores, or transmits credit card data. This includes merchants, payment processors, and financial institutions. But healthcare entities that handle both health records and credit card transactions are subject to both- HIPAA for patient data and PCI standards for financial data protection.
Yes! It is possible for organizations to achieve both HIPAA compliance and PCI DSS compliance by implementing overlapping security controls. For example, controls like access management, encryption, and audit logging are required by both frameworks. Using online form builders that are HIPAA compliant and PCI compliant, like MakeForms allows you to streamline these shared controls with ease.
