What Does it Mean to be a HIPAA-Compliant Entity?
Whether you’re a covered entity or business associate, HIPAA compliance is a must. See the checklist to ensure you’re a HIPAA-compliant entity
If you’re running a business dealing with electronic protected health information (ePHI), complying with HIPAA is a must. HIPAA, or the Health Insurance Portability and Accountability Act, is a set of federal regulations that aim to protect the privacy and security of patients’ sensitive health information. Failure to comply with these regulations can result in hefty fines and legal and reputational consequences for your entity.
Let’s take a closer look at the requirements you need to meet to ensure you’re a HIPAA-compliant entity.
The HIPAA-Compliance Checklist
Whether you’re a healthcare provider or a business associate, ensuring HIPAA compliance is crucial to safeguarding your reputation, protecting your patients’ privacy, and avoiding potential legal and financial risks. To be a HIIPAA-compliant entity, you must implement appropriate administrative, physical, and technical safeguards to protect PHI.
1. Designate a responsible person or team to manage HIPAA compliance.
This and the five following requirements refer to administrative safeguards of the HIPAA Security Rule. Covered entities must identify the security official responsible for developing and implementing the HIPAA-required policies and procedures. Ideally, healthcare organizations should have a Privacy Officer and Security Officer. However, it’s up to the organization whether to designate one person combining both roles or if that should be two separate people. It is also practiced when one individual is designated as having overall responsibility while others may be assigned specific security responsibilities (e.g. facility security or network security). The matter of fact is that these roles should reflect the size, complexity, and technical capabilities of your organization.
2. Conduct regular risk assessments to identify potential security threats and vulnerabilities.
Covered entities must Implement policies and procedures to prevent, detect, contain, and correct security vulnerabilities to PHI. The risk assessment shows whether the implementation specifications you apply are reasonable and appropriate within your environment. In particular, the risk assessment outcomes are critical for designing relevant personnel screening processes, addressing what data must be authenticated, identifying how to use encryption, and determining the measures for protecting ePHI transmissions. Read our blog post Risk Assessment under HIPAA Security Rule to acquire the common risk assessment process.
3. Ensure workforce security and manage information access
HIPAA-compliant entities provide employees with the minimum necessary access to ePHI required to do their job. Ideally, you must identify the limited volume of ePHI for each workforce member commensurate with their job functions, duties, and responsibilities. Beyond this, making reasonable efforts to control access to ePHI is also necessary. The addressable implementation specifications for these requirements include authorization and/or supervision, workforce clearance, and termination procedures.
4. Train the workforce on HIPAA rules and regulations.
HIPAA safeguards won’t be effective unless your personnel knows their role in adhering to and enforcing them. Hence, HIPAA-compliant entities implement a security awareness and training program for all new and existing workforce members. In addition, periodic retraining should be given in case of any changes to people, processes, technologies, or the HIPAA Rules.
5. Maintain Incident Response Plan and Contingency Plan
HIPAA compliance reduces the type and amount of security incidents, but it cannot eliminate them. Even the best of HIPAA-compliant entities may experience data breaches. Similarly, a single security incident is not necessarily a downfall for an entity. The question is what policies and procedures you implement to address security incidents.
Covered entities must have an Incident Response Plan describing how workforce members would respond to a possible cyber incident. This should include: preserving evidence; mitigating the situation that caused the incident; documenting the incident and the outcome; and evaluating security incidents as part of ongoing risk management.
In addition, there is always a possibility of power outages, system failure, and natural disasters that may threaten your business. An entity’s capacity to recover access to ePHI in an emergency is also crucial for HIPAA compliance. The goal is to ensure your ePHI secure and available when needed. Your Contingency Plan should include a data backup plan, disaster recovery plan, emergency mode operation plan, testing procedures, and application analysis. More on this read blog post Ensuring Business Continuity at Time of Disaster.
6. Enter into Business Associate Agreements with Vendors.
Achieving HIPAA compliance is impossible without signing Business Associate Agreements (BAA) with business associates who have access to ePHI. Such an agreement obligates you to ensure your vendor implements all necessary safeguards to protect ePHI created, received, or transmitted on your behalf. You must also ensure that any agent with access to ePHI agrees to implement all necessary safeguards to protect it. Your business associate must report to you any security incident of which it becomes aware and authorize termination of the contract in case of violation of any material terms of the agreement.
7. Implement physical safeguards, including facility access controls, workstation security, and device management.
HIPAA-compliant entities always take necessary measures to protect their electronic information systems, related buildings, and equipment from natural and environmental hazards and unauthorized intrusion. The primary standards under physical safeguards are workstation use and security, facility access controls, and device/media controls. Implement these safeguards regardless of the physical location of your assets.
8. Implement technical safeguards, including access controls, encryption, and data backup.
Implementing technical safeguards is crucial to be a HIPAA-compliant entity. The technical safeguards include the technologies as well as policies and procedures for their use that protect ePHI and control access to it. One of the main requirements under this section is data encryption, access controls, and data backups. These measures would make ePHI unreadable, unusable, and recoverable in case of any breach.
9. Report any breaches of ePHI.
As we mentioned already, a single security incident is not necessarily a downfall for an entity. You must to report the incident and prove that all measures to avoid the data incident were in place. Any breaches of PHI must be reported to affected individuals, the Department of Health and Human Services (HHS), and, in some cases, the media.
Affected individuals must receive special notification letters within 60 days of breach discovery unless a shorter timeframe exists under state law. The Secretary of the Department of Health and Human Services must be notified via the Office for Civil Rights breach reporting tool. A breach of unsecured ePHI impacting more than 500 individuals must be reported to prominent media outlets in the states and jurisdictions where the breach victims reside.
10. Conduct regular audits and reviews to ensure ongoing HIPAA compliance.
Finally, HIPAA compliance requires performing periodic technical and non-technical evaluations in response to environmental or operational changes affecting the security of ePHI. The main purpose of the compliance evaluation is to ensure you maintain security policies, procedures, and technical safeguards reasonably and appropriately. Furthermore, evaluation of the current and possible future changes in your operations and environment raises confidence that the security of the e-PHI is not compromised.
Make Sure You’re HIPAA-Compliant with HIPAA Vitals
Covered entities may evaluate their HIPAA compliance on their own or using external help. You’re free to decide which option is more suitable based on your resources and operational capacity. To help organizations with their compliance evaluation efforts, Planet 9 developed an effective solution – the HIPAA Vitals application. Besides compliance evaluation, HIPAA Vitals also helps address ePHI security issues related to policies, procedures, and technical controls. Being based on such reputable sources as OCR Audit Protocol, NIST 800-66, HIPAA Security Series, as well as years of experience of our professionals, HIPAA Vitals is an effective tool for maintaining HIPAA compliance. To complete a compliance evaluation, just create an account, respond to the questionnaire, and review compliance gaps and recommendations.
HIPAA compliance is critical for businesses that deal with ePHI. Compliance with HIPAA regulations can help protect your patients’ privacy, safeguard your reputation, and avoid potential legal and financial risks. By following the requirements outlined in this guide, you can ensure that you’re meeting the requirements of HIPAA regulations and protecting PHI. Remember, HIPAA compliance is an ongoing process, and regular training, risk assessments, and evaluations are crucial to maintaining compliance.
Consider using Planet 9’s helpful tool to streamline your compliance efforts and achieve ongoing HIPAA compliance.
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