Compliance
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HIPAA
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What is HIPAA Compliance? Complete Guide

[
19 Dec 2025
]
By
Orit Benzaquen

Is your businessmeeting its HIPAA requirements? Check out our guide for everything you need toknow about HIPAA compliance and its importance.

What is HIPAA Compliance?

It’s no secret thathealthcare is digitizing at a rapid pace, but we’ve seen exponential growth inthese technologies in this past year alone. Telehealth alone grew by154% during the first half of 2020.

As we digitizehealthcare information, HIPAA becomes increasingly important for businesses.Protected health information (PHI) is any demographic information that can beused to identify a patient or client of a HIPAA-beholden entity. But what isHIPAA? And what does it mean to be HIPAA compliant?

HIPAA compliance isregulated by the Department of Health and Human Services (HHS) and enforced bythe Office for Civil Rights (OCR). Organizations must adhere to HIPAAcompliance regulations and meet specific HIPAA compliance requirements toensure the protection of patient data.

That’s what we’re hereto look at today. Read on to find out what HIPAA compliance means forbusinesses like yours!

What Is the Health InsurancePortability and Accountability Act (HIPAA)?

The abbreviation HIPAA refers to the Health Insurance Portability andAccountability Act of 1996. It’s a law that allows for the sharing of medicalinformation to improve the quality of care while protecting patient privacy.

For organizations thatdeal with medical information in any way, HIPAA compliance is incrediblyimportant. Covered entities are those directly involved in providing oradministrating healthcare services, including healthcare providers, healthplans, and healthcare clearinghouses. Business associates are third-partyservice providers who access PHI while performing services on behalf of coveredentities. The HIPAA Privacy Rule establishes national standards for protectingindividuals' medical records and other personal health information. Thisencompasses private businesses and startups, not just hospitals and otherhealthcare organizations.

But what does itreally mean to be HIPAA compliant?

What Does It Mean to Be HIPAACompliant with Protected Health Information?

HIPAA compliancerefers to a business or other entity having the right procedures, systems, andframework to safeguard protected health information, or PHI, by implementingappropriate safeguards as required by HIPAA compliance regulations. Theseprocedures have to abide by HIPAA standards.

A comprehensive HIPAAcompliance program is essential for organizations to address all aspects ofcompliance and is often evaluated during regulatory investigations. The HIPAAPrivacy and Security Rules require organizations to implement physical and technicalsafeguards to protect PHI and ePHI. Data security, including access controls,encryption, and secure storage, is critical for meeting HIPAA securitystandards and maintaining patient privacy. The HIPAA Security Rule specificallyrequires administrative, physical, and technical safeguards to ensure theconfidentiality, integrity, and security of electronic protected healthinformation (ePHI). Additionally, organizations must address the Seven Elementsof an Effective Compliance Program to ensure HIPAA compliance.

HIPAA Privacy

HIPAA privacy is atthe heart of the Health Insurance Portability and Accountability Act, settingnational standards to protect the confidentiality of individually identifiablehealth information, also known as protected health information (PHI). The HIPAAPrivacy Rule requires covered entities, including healthcare providers, healthplans, and healthcare clearinghouses, as well as their business associates, toimplement robust policies and procedures that safeguard PHI. This means thatany organization handling sensitive health information must ensure that onlyauthorized personnel have access, and that patient data is not disclosedimproperly.

The Privacy Rule alsoempowers patients by granting them rights over their health information.Patients can request access to their medical records, ask for corrections, andreceive a record of who has accessed their PHI. For businesses, maintainingHIPAA privacy compliance involves regular employee training, cleardocumentation, and ongoing review of privacy practices. By adhering to thesenational standards, organizations not only comply with the insuranceportability and accountability act but also build trust with clients andpatients by demonstrating a commitment to privacy and security.

What Is HIPAA Compliance forBusinesses?

Any businesses orpersons who work with healthcare organizations or similar entities usually haveto be HIPAA compliant. Business associates (BAs) are third parties accessingpatient information to provide treatment, payment, or operations services on behalfof a HIPAA-covered entity. If they do any work that uses PHI, then HIPAAcompliance is needed.

To maintain HIPAAcompliance, organizations must implement ongoing efforts such as regular auditsand assessments to identify compliance gaps and ensure ongoing adherence toregulations. A HIPAA compliance checklist can help organizations identifypotential areas of noncompliance and take corrective action before an auditoccurs. Identifying and mitigating security risks associated with electronichealthcare data is essential, as digital systems increase the likelihood ofvulnerabilities and potential data breaches. Training and awareness programsfor employees are also crucial to ensure compliance with HIPAA regulations andprotect patient data.

Technical Safeguards

Technical safeguardsare a foundational element of the HIPAA Security Rule, designed to protectelectronic protected health information (ePHI) from unauthorized access ordisclosure. These safeguards require covered entities and business associatesto implement a range of security measures, such as access controls that limitwho can view or modify ePHI, audit controls that track system activity, andintegrity controls that ensure data is not altered or destroyed in anunauthorized manner.

Encryption, securepasswords, and secure transmission protocols are all examples of technicalsafeguards that help protect ePHI stored in electronic health records ortransmitted via email and other digital channels. The Office for Civil Rights(OCR) enforces these requirements, ensuring that healthcare providers and theirpartners maintain the confidentiality, integrity, and availability of sensitivehealth information. For any business working with healthcare data, implementingtechnical safeguards is not just about compliance, it’s about protecting yourorganization and your clients from costly data breaches and HIPAA violations.

Physical Safeguards

Physical safeguardsare a critical aspect of the HIPAA Security Rule, focusing on protectingelectronic protected health information (ePHI) from physical threats such astheft, loss, or unauthorized physical access. These safeguards requirehealthcare providers and related organizations to control physical access tofacilities, secure workstations, and manage devices and media that store ePHI.

Examples of physicalsafeguards include restricting access to server rooms, using security badges orbiometric systems, and ensuring that laptops, tablets, and other mobile devicesare locked and stored securely when not in use. The Department of Health andHuman Services (HHS) provides guidance on implementing these measures,emphasizing the need for organizations to regularly review and update theirphysical security protocols. By prioritizing physical safeguards, businessescan prevent unauthorized access to sensitive health information and maintaincompliance with HIPAA regulations.

Risk Analysis and Management

Risk analysis andmanagement are essential components of HIPAA compliance, requiringorganizations to proactively identify and address potential threats toelectronic protected health information (ePHI). Under the HIPAA Security Rule,covered entities and business associates must conduct comprehensive riskassessments to uncover vulnerabilities in their systems and processes. Thisinvolves evaluating how ePHI is created, received, maintained, and transmitted,and identifying any areas where data could be at risk.

Once risks areidentified, organizations must implement policies and procedures to mitigatethem, such as updating security measures, providing employee training, andestablishing incident response plans. Effective risk management also includesongoing monitoring and regular reviews to adapt to new threats. In the event ofa data breach, the HIPAA Breach Notification Rule requires prompt notificationto affected individuals and the Department of Health and Human Services,underscoring the importance of having a robust risk management strategy inplace. By prioritizing risk analysis and management, businesses can reduce thelikelihood of HIPAA violations and protect both their reputation and theirclients’ sensitive information.

Business Associate Compliance

Business associatecompliance is a crucial aspect of HIPAA regulations, ensuring that anythird-party vendors or partners who handle protected health information (PHI)on behalf of covered entities adhere to the same strict standards. Businessassociates can include a wide range of organizations, from billing companiesand IT service providers to cloud storage vendors and consultants. The HIPAAOmnibus Rule expanded the definition of business associates to includesubcontractors, making it essential for all parties in the healthcare datachain to comply with the HIPAA Security Rule and Breach Notification Rule.

To formalize thisrelationship, covered entities and business associates must enter into abusiness associate agreement (BAA), which outlines each party’sresponsibilities for safeguarding PHI and responding to data breaches. TheOffice for Civil Rights (OCR) enforces these requirements, and failure tocomply can result in significant penalties. For businesses operating in thehealthcare space, ensuring that all business associates are HIPAA compliant-andthat BAAs are in place, is a key step in maintaining the confidentiality,integrity, and availability of sensitive health information, as well as meetingthe requirements of the insurance portability and accountability act.

Becoming HIPAA Compliant

While you might assumeHIPAA compliance is just a regular administrative hurdle that businesses haveto go through, it’s actually quite valuable for organizations. The benefits ofHIPAA compliance go beyond legality.

To ensure allcompliance areas are addressed, organizations should use a HIPAA Privacy RuleChecklist and a HIPAA Security Rule Checklist as comprehensive guides. Aspecific HIPAA compliance checklist is especially important for ITorganizations to ensure their systems and procedures meet HIPAA regulations.Conducting a risk analysis is a critical first step in HIPAA compliance,identifying how an organization handles, stores, and transmits PHI and ePHI. ACompliance Officer should be appointed to oversee HIPAA implementation andadherence, and a designated HIPAA Privacy Officer is necessary for effectivecompliance management. Employee training and awareness are essential formaintaining HIPAA compliance. Additionally, the Seven Elements of an EffectiveCompliance Program are essential for organizations to vet compliance solutionsor create their own compliance programs.

It provides betteroverall security frameworks and other strategies that improve youradministrative processes. So what are some of these HIPAA rules that employerstypically follow?

  • Privacy Health Information: HIPAA compliantorganizations can usually only share private information between the person whoowns that information, i.e., a patient. This is typically for billing,procedure information, and other treatment. Privacy with health informationunder HIPAA emphasizes transparency. Businesses must tell patients why theyneed specific information and how they’re planning on using it.
  • Electronic Security: HIPAA compliantorganizations must have the right security infrastructure to protect allprivate information. It’s up to the business or startup to have the rightframework in place. Regulators take this aspect very seriously. Fines can getto the tens of thousands of dollars, especially with the threat of cyberattacksbecoming more common.
  • Breach Notification: When any breach thatcompromises private information occurs, businesses have to report it.Notifications have to be made to any affected individuals, while copies ofthose notifications have to be sent to the HHS.

HIPAA Security Rule EmployeeConsiderations

Those are only some ofthe main factors which affect HIPAA compliance for businesses. It's not all upto the employers, however, to ensure their business is following the rules.

Employees have to holdup their end of the bargain. Being careful not to share passwords or sharingsensitive information in unsecured channels is crucial. Locking one's screenand securing data when employees leave their workplace is another key consideration.Implementing two-factor authentication is a great way to improve employeecompliance.

HIPAA Compliance for Startups andOther Businesses

HIPAA compliance canbe daunting for startups and other businesses, but attaining that status iseasier than it might seem. The HIPAA Enforcement Rule clarifies penalties forHIPAA violations and establishes procedures for investigations and hearings. Organizationsthat fail to comply with HIPAA face serious penalties, including fines andcorrective action plans. The penalties for HIPAA non-compliance can includecivil monetary penalties, corrective action plans, and even criminal chargesfor severe violations. The OCR has the authority to impose fines for HIPAAviolations, and the amount of the fines can increase based on the level ofnegligence detected during an investigation. Organizations that experience adata breach due to HIPAA non-compliance may face significant financialpenalties and damage to their reputation. Organizations that do not comply withHIPAA regulations may incur indirect costs due to the disruption of businessactivities while addressing compliance issues. HIPAAstrongly recommends MFA and encryption as best practices, and regulatorsincreasingly expect them. Proposed HIPAA updates may require changes to Notices of PrivacyPractices in the future. Recentupdates to HIPAA regulations have strengthened how protected health information(PHI) is handled and protected, requiring organizations to implement robustcompliance measures. Protecting patient medical records is a critical part ofHIPAA compliance, ensuring sensitive health information is safeguardedaccording to the HIPAA Privacy Rule.

Use this guide to helpyou understand just what HIPAA compliance means.

Looking for reliablecybersecurity services to get HIPAA compliant? Contact us and schedule a demo today to find yourbest possible solution!

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