
To comply with HIPAA regulations, third-party vendors must sign a Business Associate Agreement (BAA) with covered entities.
A BAA is a contract that outlines the responsibilities and obligations of both parties.
The BAA must include a description of the permitted uses and disclosures of protected health information (PHI) by the third-party vendor.
Third-party vendors must also implement administrative, technical, and physical safeguards to protect PHI.
These safeguards include a risk assessment, a security management process, and a plan to mitigate identified risks.
Understanding Compliance Requirements
To establish a foundation for third-party risk compliance efforts, it's essential to understand the compliance requirements outlined in the HIPAA regulation. A HIPAA-compliant entity must have all necessary network and process controls to meet the personal data protection standards outlined in HIPAA's security and privacy rules.
The HIPAA regulation requires a cybersecurity program that meets ten specific requirements, including the implementation of security policies, designation of a compliance officer, and regular cyber threat awareness training for staff. A HIPAA-compliant entity must also ensure the continuous availability, security, integrity, and confidentiality of all electronic Protected Health Information (ePHI).
Some common HIPAA violations include failing to report a data breach, inadequate employee cyber threat awareness training, and unauthorized access and disclosures of Personal Health Information (PHI). To avoid these violations, it's crucial to establish a risk analysis and management program that includes regular internal and external threat landscape monitoring and security risk assessments.
Here are the 10 HIPAA requirements for a cybersecurity program:
- The implementation of security policies aligning behaviors and process standards against HIPAA’s privacy rule.
- The designation of a compliance officer and a compliance committee.
- Hosting regular cyber threat awareness training for staff.
- The establishment of efficient cyber threat communication streams.
- Regular internal and external threat landscape monitoring and security risk assessments.
- The enforcement of private information disclosure and security standards.
- The implementation of cyber mechanisms for prompt detection and remediation of sensitive data threats, including a Cyber Security Incident Response Plan.
- Ensuring the continuous availability, security, integrity, and confidentiality of all electronic Protected Health Information (ePHI).
- The implementation of a cybersecurity mechanism for detecting and mitigating anticipated threats to PHI.
- The establishment of processes for detecting and preventing unauthorized disclosures of PHI.
What Does It Mean?
Compliance with the HIPAA regulation is a complex process, but understanding the basics can help you get started.
A HIPAA-compliant entity has all the necessary network and process controls required to meet the personal data protection standards outlined in HIPAA's security and privacy rules.
To establish a foundation for your compliance efforts, you need to determine your starting degree of compliance with the HIPAA regulation. This evaluation should also consider prospective vendors in the pipeline since a new vendor's inherent risk profile could significantly impact your security posture.
A risk assessment should involve a comprehensive evaluation of all information systems, both internally and externally, to determine Personal Health Information access levels.
The HIPAA regulation requires a cybersecurity program that meets ten specific requirements, including the implementation of security policies, designation of a compliance officer, and regular cyber threat awareness training for staff.
Here are the ten requirements in brief:
- The implementation of security policies aligning behaviors and process standards against HIPAA’s privacy rule.
- The designation of a compliance officer and a compliance committee.
- Hosting regular cyber threat awareness training for staff.
- The establishment of efficient cyber threat communication streams.
- Regular internal and external threat landscape monitoring and security risk assessments.
- The enforcement of private information disclosure and security standards.
- The implementation of cyber mechanisms for prompt detection and remediation of sensitive data threats, including a Cyber Security Incident Response Plan.
- Ensuring the continuous availability, security, integrity, and confidentiality of all electronic Protected Health Information (ePHI).
- The implementation of a cybersecurity mechanism for detecting and mitigating anticipated threats to PHI.
- The establishment of processes for detecting and preventing unauthorized disclosures of PHI.
Understanding these requirements will help you identify areas for improvement and take steps towards compliance.
Understanding Compliance
Compliance with regulations like HIPAA is a complex process, but it's essential for protecting sensitive health information. A HIPAA-compliant entity has all the necessary network and process controls required to meet the personal data protection standards outlined in HIPAA's security and privacy rules.
To achieve this, a cybersecurity program must meet ten requirements, including implementing security policies that align behaviors and process standards against HIPAA's privacy rule and hosting regular cyber threat awareness training for staff.
A compliance officer and a compliance committee must be designated, and efficient cyber threat communication streams must be established. Regular internal and external threat landscape monitoring and security risk assessments are also necessary.
The enforcement of private information disclosure and security standards is crucial, as is the implementation of cyber mechanisms for prompt detection and remediation of sensitive data threats, including a Cyber Security Incident Response Plan.
Ensuring the continuous availability, security, integrity, and confidentiality of all electronic Protected Health Information (ePHI) is also a key requirement. This includes implementing a cybersecurity mechanism for detecting and mitigating anticipated threats to PHI and establishing processes for detecting and preventing unauthorized disclosures of PHI.
Some common violations of HIPAA regulations include failing to report a data breach to the Secretary within the stipulated time frame of 60 days for incidents involving more than 500 people, inadequate employee cyber threat awareness training, and unauthorized access and disclosures of Personal Health Information (PHI).
Here are the 10 HIPAA requirements for a cybersecurity program:
- Implementation of security policies aligning behaviors and process standards against HIPAA’s privacy rule.
- Designation of a compliance officer and a compliance committee.
- Hosting regular cyber threat awareness training for staff.
- Establishment of efficient cyber threat communication streams.
- Regular internal and external threat landscape monitoring and security risk assessments.
- Enforcement of private information disclosure and security standards.
- Implementation of cyber mechanisms for prompt detection and remediation of sensitive data threats, including a Cyber Security Incident Response Plan.
- Ensuring the continuous availability, security, integrity, and confidentiality of all electronic Protected Health Information (ePHI).
- Implementation of a cybersecurity mechanism for detecting and mitigating anticipated threats to PHI.
- Establishment of processes for detecting and preventing unauthorized disclosures of PHI.
Vendor Management and Compliance
Vendor management and compliance is a crucial aspect of HIPAA compliance. You should perform a thorough risk assessment before signing a contract with any vendor, including gaining an understanding of their compliance with HIPAA regulations.
To vet vendors, you should gain as much transparency into their security practices as possible. This includes assessing their policies and procedures, proof of controls, remote access to network, user access, data handling, audit logs, security training and awareness, and backup and recovery.
Here are some key areas of security to address when vetting a vendor:
By following these steps, you can ensure that your vendors are compliant with HIPAA regulations and that your organization is protected from potential risks.
Is Mandatory?
Compliance with HIPAA is enforced by the Department of Health and Human Services (HHS) and the Office for Civil Rights (OCR).
The HHS and OCR are responsible for ensuring that Covered Entities comply with the HIPAA regulation.
Covered Entities are defined as healthcare providers, health plans, healthcare clearinghouses, and business associates.
A business associate is any person or organization providing PHI services to a Covered Entity.
This includes a wide range of entities, such as all healthcare providers, health plans, and healthcare clearinghouses, as well as business associates.
The threat landscape has become so interconnected that a data breach involving a fourth-party vendor could put sensitive health information at risk of compromise.
The potential for non-compliance with the HIPAA regulation is high due to the many potential digital avenues to sensitive resources.
To effectively address the Vendor Risk Management component of HIPAA compliance, regulatory compliance with the remaining information security components becomes relatively easy.
Here are the types of entities that must comply with HIPAA:
- Healthcare Providers
- Health Plans
- Healthcare Clearinghouses
- Business Associates
These entities must be aware of the third-party data security requirements of HIPAA, including the establishment of a TPRM Program supportive of HIPAA compliance.
Complying with Vendor Management Requirements
Compliance with HIPAA regulations is essential for healthcare organizations, and vendor management is a critical aspect of this compliance. A HIPAA-compliant entity has all the necessary network and process controls required to meet the personal data protection standards outlined in HIPAA's security and privacy rules.
To ensure compliance, healthcare organizations must implement a comprehensive vendor risk management program that includes thorough due diligence, regular audits and assessments, and the implementation of targeted risk mitigation strategies.
When vetting vendors, healthcare organizations should perform a thorough risk assessment, gaining an understanding of each vendor's compliance with HIPAA regulations, how they securely collect, store, process, and transfer protected health information (PHI), and their security capabilities.
The following areas of security should be addressed when vetting a vendor:
- Policies and procedures
- Proof of controls
- Remote access to network
- User access
- Data handling
- Audit logs
- Security training and awareness
- Backup and recovery
Healthcare organizations should also adopt a risk-tiering approach, prioritizing vendors based on the level of access they have and the amount and type of data they require access to, and assigning a security risk rating for each vendor based on the types and levels of access.
Here is a list of key steps to follow when vetting a vendor:
By following these steps and implementing a comprehensive vendor risk management program, healthcare organizations can ensure compliance with HIPAA regulations and protect sensitive patient information.
About Schellman
Schellman is a leading provider of attestation and compliance services. They're a CPA firm, which means they have the expertise to handle complex financial and accounting tasks.
As a globally licensed PCI Qualified Security Assessor, Schellman can help organizations meet the security standards for protecting sensitive information.
Their independence is a key factor in their success, as it allows them to provide unbiased and objective advice to their clients. Schellman's professionals are renowned for their practical experience and expertise.
Schellman's approach to compliance is built around building long-term relationships with their clients. They help their clients achieve multiple compliance objectives through a single third-party assessor.
Business Associate Agreements (BAAs)
Business Associate Agreements (BAAs) are a crucial aspect of third-party HIPAA compliance. These agreements are legally binding contracts that define the relationship between a covered entity and its business associates regarding the handling and protection of Protected Health Information (PHI).
A Business Associate Agreement (BAA) is required from Business Associates to assure compliance with HIPAA's PHI security standards. UpGuard allows all third-party vendors to keep a repository of all relevant security documentation in a Trust Page, including completed Business Associate Agreements.
BAAs should clearly specify the permissible uses and disclosures of PHI by the business associate. This specification ensures that the business associate uses the PHI only for the purposes outlined by the covered entity and as permitted under HIPAA.
Business associates are required to put in place appropriate administrative, physical, and technical safeguards to prevent unauthorized use or disclosure of PHI. These safeguards might include data encryption, secure data transmission methods, access control measures, and employee training programs.
BAAs should include specific terms for reporting any breaches of PHI. This includes stipulating the timeframe within which the business associate must report a breach to the covered entity and the type of information that must be included in the breach notification.
Before granting access to any level of PHI, a BAA must be in place with each third-party vendor. If a vendor isn't willing to enter into a BAA, you'll need to move on to another vendor, as you'll be held accountable for that lack of agreement.
In a review of the BAA with each provider, make sure they understand the provisions regarding:
- How they will identify a data breach (which should be defined)
- How long they have to notify you (include exact timeframes in hours or days)
- How data should be stored and disposed
- The vendor's privacy and security programs,
- Right-to-audit clauses
- Protocols for disclosing when deficiencies in security systems have been identified
It's essential to ensure that your BAA requires your vendor to obtain a BAA from their vendors that includes the same security and privacy requirements as exist in the original BAA. This ensures true compliance with HIPAA obligations, which trickle down from health facility to vendor to subcontractor to sub-subcontractor, and on.
Risk and Security
Lack of data encryption and secure transmission can lead to huge penalties for healthcare providers, especially when dealing with sensitive health documents.
Third party vendors may not prioritize data encryption, increasing the likelihood of data breaches. This is a major risk for healthcare providers who rely on these vendors.
Inconsistent security policies across vendors can create vulnerabilities, as not all third party vendors follow industry-standard security practices. This inconsistency can expose healthcare organizations to unnecessary risks.
Covered Entities must supply evidence of an implemented cybersecurity program designed to protect PHI from compromise. This evidence should be kept updated and readily available.
Reports demonstrating relevant cybersecurity efforts can be instantly generated with UpGuard’s executive report creation tool, reducing the administrative burden of manual report creation.
Cyber risks threatening PHI safety, availability, and integrity must be identified and mitigated by healthcare organizations. This can be done through implementing new security controls or vulnerability remediation.
UpGuard maps security questionnaire submissions to popular cybersecurity frameworks to identify the particular risks of covered entities and business associates impeding compliance.
Conducting Thorough Assessments
Conducting thorough assessments of third-party vendors is a crucial step in maintaining HIPAA compliance. This involves identifying business associates that have access to Protected Health Information (PHI) and evaluating their data management practices, security protocols, and compliance history.
Business associates can include a range of entities such as billing companies, IT vendors, consultants, and data storage firms that store or process patient data. These entities must comply with HIPAA's stringent privacy and security rules.
A thorough risk assessment should scrutinize the business associate's security practices, including their use of encryption, firewall protection, and intrusion detection systems. It should also review their policies and procedures related to data security, employee training programs, and incident response plans.
The assessment can include a review of the business associate's compliance history, including past security breaches, incidents of non-compliance, and how these incidents were addressed. This is essential in evaluating the business associate's commitment to HIPAA compliance.
Key aspects to consider during the risk assessment include:
- Data management practices
- Security protocols
- Compliance history
- Employee training programs
- Incident response plans
Regular reviews and updates are necessary to ensure that the business associate continues to adhere to HIPAA requirements and to account for any changes in their operations or services that might affect the security and privacy of PHI.
Mitigating Risks and Non-Compliance
To mitigate risks and non-compliance, take the following steps.
Lack of data encryption and secure transmission is a major risk, as third-party vendors may not prioritize data encryption.
Failure to use proper encryption for data at rest and in transit increases the likelihood of data breaches, which could lead to huge penalties for healthcare providers.
There are five common third-party HIPAA compliance risks, including lack of data encryption and secure transmission.
To strengthen your Third-Party Risk Management (TPRM), you should take the following five steps.
You can ask your vendors to undergo an assessment against a relevant framework to prove their security and privacy practices.
A growing number of healthcare organizations require their business associates to obtain HITRUST certification as a means of demonstrating effective security and privacy practices aligned with the requirements of the health industry.
You can also ask your vendors to engage with a service that helps healthcare organizations manage risk and compliance, such as a HIPAA Express evaluation.
If your vendors can't meet HIPAA compliance requirements, it's best to avoid partnering with them to protect yourself from potential data breaches.
Sources
- https://www.upguard.com/blog/third-party-risk-requirements-hipaa
- https://www.schellman.com/blog/healthcare-compliance/how-to-manage-3rd-party-hipaa-risk
- https://www.ifaxapp.com/hipaa/what-is-third-party-hipaa-compliance/
- https://www.carosh.com/strategic-management-of-third-party-risks-in-hipaa-compliance/
- https://www.techtarget.com/healthtechsecurity/feature/How-updated-third-party-tech-guidance-affects-compliance-efforts
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